From ec478f31ef14938e2798b9f5f8319d5c845795c5 Mon Sep 17 00:00:00 2001 From: Leo Meyerovich Date: Wed, 1 Apr 2020 01:51:31 -0700 Subject: [PATCH 01/47] refactor(print): now via Python logger --- modules/DfHelper.py | 89 ++++++++++++++------ modules/FirehoseJob.py | 161 ++++++++++++++++++++----------------- modules/Neo4jDataAccess.py | 6 +- modules/Timer.py | 7 +- 4 files changed, 158 insertions(+), 105 deletions(-) diff --git a/modules/DfHelper.py b/modules/DfHelper.py index f2895e7..f7c8db7 100644 --- a/modules/DfHelper.py +++ b/modules/DfHelper.py @@ -3,6 +3,9 @@ from datetime import datetime import time +import logging +logger = logging.getLogger('DfHelper') + class DfHelper: def __init__(self, debug=False): self.debug=debug @@ -56,30 +59,66 @@ def __tag_status_type(self, pdf): return pdf2 def __flatten_status_col(self, pdf, col, status_type, prefix): - if self.debug: print('flattening %s...' % col) - if self.debug: print(' ', pdf.columns) - #retweet_status -> hash -> lookup json for hash -> pull out id/created_at/user_id - pdf_hashed = pdf.assign(hashed=pdf[col].apply(hash)) - retweets = pdf_hashed[ pdf_hashed['status_type'] == status_type ][['hashed', col]]\ - .drop_duplicates('hashed').reset_index(drop=True) - #print('sample', retweets[col].head(10), retweets[col].apply(type)) - retweets_flattened = pd.io.json.json_normalize( - retweets[col].replace("(").replace(")")\ - .apply(self.__try_load)) - if self.debug: print(' ... fixing dates') - retweets_flattened = retweets_flattened.assign( - created_at = pd.to_datetime(retweets_flattened['created_at']).apply(lambda dt: dt.timestamp), - user_id = retweets_flattened['user.id']) - if self.debug: print(' ... fixing dates') - retweets = retweets[['hashed']]\ - .assign(**{ - prefix + c: retweets_flattened[c] - for c in retweets_flattened if c in ['id', 'created_at', 'user_id'] - }) - if self.debug: print(' ... remerging') - pdf_with_flat_retweets = pdf_hashed.merge(retweets, on='hashed', how='left').drop(columns='hashed') - if self.debug: print(' ...flattened', pdf_with_flat_retweets.shape) - return pdf_with_flat_retweets + debug_retweets_flattened = None + debug_retweets = None + try: + logger.debug('flattening %s...', col) + logger.debug(' %s x %s: %s', len(pdf), len(pdf.columns), pdf.columns) + if len(pdf) == 0: + logger.debug('Warning: did not add mt case col output addition - pdf') + return pdf + #retweet_status -> hash -> lookup json for hash -> pull out id/created_at/user_id + pdf_hashed = pdf.assign(hashed=pdf[col].apply(hash)) + retweets = pdf_hashed[ pdf_hashed['status_type'] == status_type ][['hashed', col]]\ + .drop_duplicates('hashed').reset_index(drop=True) + if len(retweets) == 0: + logger.debug('Warning: did not add mt case col output addition - retweets') + return pdf + #print('sample', retweets[col].head(10), retweets[col].apply(type)) + retweets_flattened = pd.io.json.json_normalize( + retweets[col].replace("(").replace(")")\ + .apply(self.__try_load)) + if len(retweets_flattened.columns) == 0: + logger.debug('No tweets of type %s, early exit', status_type) + return pdf + debug_retweets_flattened = retweets_flattened + debug_retweets = retweets + logger.debug(' ... fixing dates') + logger.debug('avail cols of %s x %s: %s', len(retweets_flattened), len(retweets_flattened.columns), retweets_flattened.columns) + logger.debug(retweets_flattened) + if 'created_at' in retweets_flattened: + retweets_flattened = retweets_flattened.assign( + created_at = pd.to_datetime(retweets_flattened['created_at']).apply(lambda dt: dt.timestamp)) + if 'user.id' in retweets_flattened: + retweets_flattened = retweets_flattened.assign( + user_id = retweets_flattened['user.id']) + logger.debug(' ... fixing dates') + retweets = retweets[['hashed']]\ + .assign(**{ + prefix + c: retweets_flattened[c] + for c in retweets_flattened if c in ['id', 'created_at', 'user_id'] + }) + logger.debug(' ... remerging') + pdf_with_flat_retweets = pdf_hashed.merge(retweets, on='hashed', how='left').drop(columns='hashed') + logger.debug(' ...flattened: %s', pdf_with_flat_retweets.shape) + return pdf_with_flat_retweets + except Exception as e: + logger.error(('Exception __flatten_status_col', e)) + logger.error(('params', col, status_type, prefix)) + #print(pdf[:10]) + logger.error('cols debug_retweets %s x %s : %s', + len(debug_retweets), len(debug_retweets.columns), debug_retweets.columns) + logger.error('--------') + logger.error(debug_retweets[:3]) + logger.error('--------') + logger.error('cols debug_retweets_flattened %s x %s : %s', + len(debug_retweets_flattened), len(debug_retweets_flattened.columns), debug_retweets_flattened.columns) + logger.error('--------') + logger.error(debug_retweets_flattened[:3]) + logger.error('--------') + logger.error(debug_retweets_flattened['created_at']) + logger.error('--------') + raise e def __flatten_retweets(self, pdf): if self.debug: print('flattening retweets...') @@ -123,5 +162,5 @@ def __try_load(self, s): } except: if s != 0.0: - print('bad s',s) + if self.debug: print('bad s',s) return {} \ No newline at end of file diff --git a/modules/FirehoseJob.py b/modules/FirehoseJob.py index 1ba8f11..bebbe4f 100644 --- a/modules/FirehoseJob.py +++ b/modules/FirehoseJob.py @@ -13,6 +13,9 @@ from .TwarcPool import TwarcPool from .Neo4jDataAccess import Neo4jDataAccess +import logging +logger = logging.getLogger('fh') + ############################# ################### @@ -263,8 +266,8 @@ def clean_df(self, raw_df): sorted_df = all_cols_df.reindex(sorted(all_cols_df.columns), axis=1) return pd.DataFrame({c: self.clean_series(sorted_df[c]) for c in sorted_df.columns}) except Exception as exn: - print('failed clean') - print(exn) + logger.error('failed clean') + logger.error(exn) raise exn finally: self.timer.toc('clean') @@ -285,7 +288,7 @@ def pq_writer(self, table, job_name='generic_job'): job_name = self.clean_file_name(job_name) folder = "firehose_data/%s" % job_name - print('make folder if not exists: %s' % folder) + logger.debug('make folder if not exists: %s' % folder) os.makedirs(folder, exist_ok=True) self.__folder_last = folder @@ -300,7 +303,7 @@ def pq_writer(self, table, job_name='generic_job'): run = run + 1 file_prefix = "%s/%s_b%s." % ( folder, time_prefix, run ) if run > 1: - print('Starting new batch for existing hour') + logger.debug('Starting new batch for existing hour') vanilla_file_name = file_prefix + vanilla_file_suffix snappy_file_name = file_prefix + snappy_file_suffix @@ -309,13 +312,13 @@ def pq_writer(self, table, job_name='generic_job'): ######################################################### if ('vanilla' in self.writers) and ( (self.writers['vanilla'] is None) or self.last_write_epoch != file_prefix ): - print('Creating vanilla writer', vanilla_file_name) + logger.debug('Creating vanilla writer: %s', vanilla_file_name) try: #first write #os.remove(vanilla_file_name) 1 except Exception as exn: - print('Could not rm vanilla parquet', exn) + logger.debug(('Could not rm vanilla parquet', exn)) self.writers['vanilla'] = pq.ParquetWriter( vanilla_file_name, schema=table.schema, @@ -323,12 +326,12 @@ def pq_writer(self, table, job_name='generic_job'): self.__file_names.append(vanilla_file_name) if ('snappy' in self.writers) and ( (self.writers['snappy'] is None) or self.last_write_epoch != file_prefix ): - print('Creating snappy writer', snappy_file_name) + logger.debug('Creating snappy writer: %s', snappy_file_name) try: #os.remove(snappy_file_name) 1 except Exception as exn: - print('Could not rm snappy parquet', exn) + logger.error(('Could not rm snappy parquet', exn)) self.writers['snappy'] = pq.ParquetWriter( snappy_file_name, schema=table.schema, @@ -343,21 +346,27 @@ def pq_writer(self, table, job_name='generic_job'): for name in self.writers.keys(): try: - print('Writing %s (%s x %s)' % ( + logger.debug('Writing %s (%s x %s)' % ( name, table.num_rows, table.num_columns)) self.timer.tic('writing_%s' % name, 20, 1) writer = self.writers[name] writer.write_table(table) + logger.debug('========') + logger.debug(table.schema) + logger.debug('--------') + logger.debug(table.to_pandas()[:10]) + logger.debug('--------') self.timer.toc('writing_%s' % name, table.num_rows) ######### - print('######## TRANSACTING') + logger.debug('######## TRANSACTING') self.last_write_arr = table self.last_writes_arr.append(table) ######### except Exception as exn: - print('... failed to write to parquet') - print(exn) - print('######### ALL WRITTEN #######') + logger.error('... failed to write to parquet') + logger.error(exn) + raise exn + logger.debug('######### ALL WRITTEN #######') finally: self.timer.toc('write') @@ -366,7 +375,7 @@ def flush(self, job_name="generic_job"): try: if self.current_table is None or self.current_table.num_rows == 0: return - print('writing to parquet then clearing current_table..') + logger.debug('writing to parquet then clearing current_table..') deferred_pq_exn = None try: self.pq_writer(self.current_table, job_name) @@ -374,17 +383,17 @@ def flush(self, job_name="generic_job"): deferred_pq_exn = e try: if self.save_to_neo: - print('Writing to Neo4j') - Neo4jDataAccess(True, self.neo4j_creds).save_parquet_df_to_graph(self.current_table.to_pandas(), job_name) + logger.debug('Writing to Neo4j') + Neo4jDataAccess(self.debug, self.neo4j_creds).save_parquet_df_to_graph(self.current_table.to_pandas(), job_name) else: - print('Skipping Neo4j write') + logger.debug('Skipping Neo4j write') except Exception as e: - print('Neo4j write exn', e) + logger.error('Neo4j write exn', e) raise e if not (deferred_pq_exn is None): raise deferred_pq_exn finally: - print('flush clearing self.current_table') + logger.debug('flush clearing self.current_table') self.current_table = None def tweets_to_df(self, tweets): @@ -395,8 +404,8 @@ def tweets_to_df(self, tweets): self.last_df = df return df except Exception as exn: - print('Failed tweets->pandas') - print(exn) + logger.error('Failed tweets->pandas') + logger.error(exn) raise exn finally: self.timer.toc('to_pandas') @@ -412,55 +421,55 @@ def df_with_schema_to_arrow(self, df, schema): # raise Exception('ok') table = pa.Table.from_pandas(df, schema) if len(df.columns) != len(schema): - print('=========================') - print('DATA LOSS WARNING: df has cols not in schema, dropping') #reverse is an exn + logger.debug('=========================') + logger.debug('DATA LOSS WARNING: df has cols not in schema, dropping') #reverse is an exn for col_name in df.columns: hits = [field for field in schema if field.name==col_name] if len(hits) == 0: - print('-------') - print('arrow schema missing col %s ' % col_name) - print('df dtype',df[col_name].dtype) - print(df[col_name].dropna()) - print('-------') + logger.debug('-------') + logger.debug('arrow schema missing col %s ' % col_name) + logger.debug('df dtype',df[col_name].dtype) + logger.debug(df[col_name].dropna()) + logger.debug('-------') except Exception as exn: - print('============================') - print('failed nth arrow from_pandas') - print('-------') - print(exn) - print('-------') + logger.error('============================') + logger.error('failed nth arrow from_pandas') + logger.error('-------') + logger.error(exn) + logger.error('-------') try: - print('followers', df['followers'].dropna()) - print('--------') - print('coordinates', df['coordinates'].dropna()) - print('--------') - print('dtypes', df.dtypes) - print('--------') - print(df.sample(min(5, len(df)))) - print('--------') - print('arrow') - print([schema[k] for k in range(0, len(schema))]) - print('~~~~~~~~') + logger.error(('followers', df['followers'].dropna())) + logger.error('--------') + logger.error(('coordinates', df['coordinates'].dropna())) + logger.error('--------') + logger.error('dtypes: %s', df.dtypes) + logger.error('--------') + logger.error(df.sample(min(5, len(df)))) + logger.error('--------') + logger.error('arrow') + logger.error([schema[k] for k in range(0, len(schema))]) + logger.error('~~~~~~~~') if not (self.current_table is None): try: - print(self.current_table.to_pandas()[:3]) - print('----') - print([self.current_table.schema[k] for k in range(0, self.current_table.num_columns)]) + logger.error(self.current_table.to_pandas()[:3]) + logger.error('----') + logger.error([self.current_table.schema[k] for k in range(0, self.current_table.num_columns)]) except Exception as exn2: - print('cannot to_pandas print..', exn2) + logger.error(('cannot to_pandas print..', exn2)) except: 1 - print('-------') + logger.error('-------') err_file_name = 'fail_' + str(uuid.uuid1()) - print('Log failed batch and try to continue! %s' % err_file_name) + logger.error('Log failed batch and try to continue! %s' % err_file_name) df.to_csv('./' + err_file_name) raise exn for i in range(len(schema)): if not (schema[i].equals(table.schema[i])): - print('EXN: Schema mismatch on col # %s', i) - print(schema[i]) - print('-----') - print(table.schema[i]) - print('-----') + logger.error('EXN: Schema mismatch on col # %s', i) + logger.error(schema[i]) + logger.error('-----') + logger.error(table.schema[i]) + logger.error('-----') raise Exception('mismatch on col # ' % i) return table finally: @@ -472,18 +481,18 @@ def concat_tables(self, table_old, table_new): self.timer.tic('concat_tables', 1000) return pa.concat_tables([table_old, table_new]) #promote.. except Exception as exn: - print('=========================') - print('Error combining arrow tables, likely new table mismatches old') - print('------- cmp') + logger.error('=========================') + logger.error('Error combining arrow tables, likely new table mismatches old') + logger.error('------- cmp') for i in range(0, table_old.num_columns): if i >= table_new.num_columns: - print('new table does not have enough columns to handle %i' % i) + logger.error('new table does not have enough columns to handle %i' % i) elif table_old.schema[i].name != table_new.schema[i].name: - print('ith col name mismatch', i, - 'old', (table_old.schema[i]), 'vs new', table_new.schema[i]) - print('------- exn') - print(exn) - print('-------') + logger.error(('ith col name mismatch', i, + 'old', (table_old.schema[i]), 'vs new', table_new.schema[i])) + logger.error('------- exn') + logger.error(exn) + logger.error('-------') raise exn finally: self.timer.toc('concat_tables') @@ -606,16 +615,16 @@ def flusher(tweets_batch): print('Write fail, continuing..') finally: tweets_batch = [] - print('===== PROCESSED ALL GENERATOR TASKS, FINISHING ====') + logger.debug('===== PROCESSED ALL GENERATOR TASKS, FINISHING ====') yield flusher(tweets_batch) - print('/// FLUSHED, DONE') + logger.debug('/// FLUSHED, DONE') except KeyboardInterrupt as e: - print('========== FLUSH IF SLEEP INTERRUPTED') + logger.debug('========== FLUSH IF SLEEP INTERRUPTED') self.destroy() del fh gc.collect() - print('explicit GC...') - print('Safely exited!') + logger.debug('explicit GC...') + logger.debug('Safely exited!') ################################################################################ @@ -647,7 +656,7 @@ def process_id_file(self, path, job_name=None): lst = pdf['0'].to_list() if job_name is None: job_name = "id_file_%s" % path - print('loaded %s ids, hydrating..' % len(lst)) + logger.debug('loaded %s ids, hydrating..' % len(lst)) for arr in self.process_ids(lst, job_name): yield arr @@ -700,21 +709,21 @@ def user_timeline(self,input=[""], job_name=None, **kwargs): job_name = "user_timeline_%s_%s" % ( len(input), '_'.join(input) ) for user in input: - print('starting user %s' % user) + logger.debug('starting user %s' % user) tweet_count = 0 for tweet in self.twarc_pool.next_twarc().timeline(screen_name=user, **kwargs): - #print('got user', user, 'tweet', str(tweet)[:50]) + #logger.debug('got user', user, 'tweet', str(tweet)[:50]) self.process_tweets([tweet], job_name) tweet_count = tweet_count + 1 - print(' ... %s tweets' % tweet_count) + logger.debug(' ... %s tweets' % tweet_count) self.destroy() except KeyboardInterrupt as e: - print('Flushing..') + logger.debug('Flushing..') self.destroy(job_name) - print('Explicit GC') + logger.debug('Explicit GC') gc.collect() - print('Safely exited!') + logger.debug('Safely exited!') def ingest_range(self, begin, end, job_name=None): # This method is where the magic happens diff --git a/modules/Neo4jDataAccess.py b/modules/Neo4jDataAccess.py index fc2d5e1..31bc56d 100644 --- a/modules/Neo4jDataAccess.py +++ b/modules/Neo4jDataAccess.py @@ -182,7 +182,7 @@ def get_tweet_hydrated_status_by_id(self, df, job_name='generic_job'): ids.append({'id': int(row['id'])}) res = graph.run(self.fetch_tweet_status, ids = ids).to_data_frame() - print('Response info: %s rows, %s columns: %s' % (len(res), len(res.columns), res.columns)) + if self.debug: print('Response info: %s rows, %s columns: %s' % (len(res), len(res.columns), res.columns)) if len(res) == 0: return df[['id']].assign(hydrated=None) else: @@ -254,7 +254,7 @@ def __save_df_to_graph(self, df, job_name): self.__write_to_neo(params, url_params, mention_params) toc=time.perf_counter() - print(f"Neo4j Import Complete in {toc - global_tic:0.4f} seconds") + if self.debug: print(f"Neo4j Import Complete in {toc - global_tic:0.4f} seconds") def __write_to_neo(self, params, url_params, mention_params): try: @@ -265,9 +265,11 @@ def __write_to_neo(self, params, url_params, mention_params): tx.run(self.urls, urls = url_params) tx.commit() except Exception as inst: + print('Neo4j Transaction error') print(type(inst)) # the exception instance print(inst.args) # arguments stored in .args print(inst) # __str__ allows args to be printed directly, + raise inst def __normalize_hashtags(self, value): if value: diff --git a/modules/Timer.py b/modules/Timer.py index 720e424..199b9a3 100644 --- a/modules/Timer.py +++ b/modules/Timer.py @@ -1,5 +1,8 @@ import time +import logging +logger = logging.getLogger('Timer') + class Timer: def __init__(self): self.counters = {} @@ -42,11 +45,11 @@ def maybe_emit(self, name, show_val_per_second): counter['rolling_val_sum'] = counter['rolling_val_sum'] + sum_val if counter['print_freq'] > 0 and (k % counter['print_freq'] == 0): if sum_s > 0: - print('%s : %s / s (%s total)' % (name, sum_val / sum_s, counter['rolling_val_sum'])) + logger.info('%s : %s / s (%s total)' % (name, sum_val / sum_s, counter['rolling_val_sum'])) else: if counter['print_freq'] > 0 and (k % counter['print_freq'] == 0): lastN = counter['lastN'] sum_s = 0.0 + sum([lastN[i % n ] for i in range(max(k - n,0), k)]) - print('%s : %ss' % (name, sum_s / min(n, k + 1))) + logger.info('%s : %ss' % (name, sum_s / min(n, k + 1))) From eb4e7c65b50953876e759932d5fe84de68e8d391 Mon Sep 17 00:00:00 2001 From: Leo Meyerovich Date: Wed, 1 Apr 2020 01:53:23 -0700 Subject: [PATCH 02/47] fix(fh missing cols): handle --- modules/DfHelper.py | 10 +++++--- modules/Neo4jDataAccess.py | 51 +++++++++++++++++++++----------------- 2 files changed, 35 insertions(+), 26 deletions(-) diff --git a/modules/DfHelper.py b/modules/DfHelper.py index f7c8db7..053973a 100644 --- a/modules/DfHelper.py +++ b/modules/DfHelper.py @@ -30,9 +30,13 @@ def normalize_parquet_dataframe(self, df): def __clean_datetimes(self, pdf): if self.debug: print('cleaning datetimes...') - - pdf = pdf.assign(created_at=pd.to_datetime(pdf['created_at'])) - pdf = pdf.assign(created_date=pdf['created_at'].apply(lambda dt: dt.timestamp())) + try: + pdf = pdf.assign(created_at=pd.to_datetime(pdf['created_at'])) + pdf = pdf.assign(created_date=pdf['created_at'].apply(lambda dt: dt.timestamp())) + except Exception as e: + print('Error __clean_datetimes', e) + print(pdf) + raise e if self.debug: print(' ...cleaned') return pdf diff --git a/modules/Neo4jDataAccess.py b/modules/Neo4jDataAccess.py index 31bc56d..18cf099 100644 --- a/modules/Neo4jDataAccess.py +++ b/modules/Neo4jDataAccess.py @@ -205,30 +205,35 @@ def __save_df_to_graph(self, df, job_name): tweet_type='TWEET' if row["in_reply_to_status_id"] is not None and row["in_reply_to_status_id"] >0: tweet_type="REPLY" - elif row["quoted_status_id"] is not None and row["quoted_status_id"] >0: - tweet_type="QUOTE_RETWEET" - elif row["retweet_id"] is not None and row["retweet_id"] >0: + elif "quoted_status_id" in row and row["quoted_status_id"] is not None and row["quoted_status_id"] >0: + tweet_type="QUOTE_RETWEET" + elif "retweet_id" in row and row["retweet_id"] is not None and row["retweet_id"] >0: tweet_type="RETWEET" - params.append({'tweet_id': row['status_id'], - 'text': row['full_text'], - 'tweet_created_at': row['created_at'].to_pydatetime(), - 'favorite_count': row['favorite_count'], - 'retweet_count': row['retweet_count'], - 'tweet_type': tweet_type, - 'job_id': job_name, - 'hashtags': self.__normalize_hashtags(row['hashtags']), - 'user_id': row['user_id'], - 'user_name': row['user_name'], - 'user_location': row['user_location'], - 'user_screen_name': row['user_screen_name'], - 'user_followers_count': row['user_followers_count'], - 'user_friends_count': row['user_friends_count'], - 'user_created_at': pd.Timestamp(row['user_created_at'], unit='s').to_pydatetime(), - 'user_profile_image_url': row['user_profile_image_url'], - 'reply_tweet_id': row['in_reply_to_status_id'], - 'quoted_status_id': row['quoted_status_id'], - 'retweet_id': row['retweet_id'], - }) + try: + params.append({'tweet_id': row['status_id'], + 'text': row['full_text'], + 'tweet_created_at': row['created_at'].to_pydatetime(), + 'favorite_count': row['favorite_count'], + 'retweet_count': row['retweet_count'], + 'tweet_type': tweet_type, + 'job_id': job_name, + 'hashtags': self.__normalize_hashtags(row['hashtags']), + 'user_id': row['user_id'], + 'user_name': row['user_name'], + 'user_location': row['user_location'], + 'user_screen_name': row['user_screen_name'], + 'user_followers_count': row['user_followers_count'], + 'user_friends_count': row['user_friends_count'], + 'user_created_at': pd.Timestamp(row['user_created_at'], unit='s').to_pydatetime(), + 'user_profile_image_url': row['user_profile_image_url'], + 'reply_tweet_id': row['in_reply_to_status_id'], + 'quoted_status_id': row['quoted_status_id'], + 'retweet_id': row['retweet_id'] if 'retweet_id' in row else None, + }) + except Exception as e: + print('params.append exn', e) + print('row', row) + raise e #if there are urls then populate the url_params if row['urls']: From 771c1fb5906ba4d9a8444bf8d9571dbf59d5ea7d Mon Sep 17 00:00:00 2001 From: Leo Meyerovich Date: Wed, 1 Apr 2020 01:54:43 -0700 Subject: [PATCH 03/47] feat(fixed fh arrow schema): and jsonify nested cols bc pq writer cannot handle --- modules/FirehoseJob.py | 155 ++++++++++++++++++----------------------- 1 file changed, 68 insertions(+), 87 deletions(-) diff --git a/modules/FirehoseJob.py b/modules/FirehoseJob.py index bebbe4f..30b47a3 100644 --- a/modules/FirehoseJob.py +++ b/modules/FirehoseJob.py @@ -100,13 +100,17 @@ ### When dtype -> arrow ambiguious, override KNOWN_FIELDS = [ - #[0, 'contributors', ??], + [0, 'contributors', pa.string()], [1, 'coordinates', pa.string()], [2, 'created_at', pa.string()], - [3, 'display_text_range', pa.list_(pa.int64())], + + #[3, 'display_text_range', pa.list_(pa.int64())], + [3, 'display_text_range', pa.string()], + [4, 'entities', pa.string()], [5, 'extended_entities', pa.string()], #extended_entities_t ], [7, 'favorited', pa.bool_()], + [8, 'favorite_count', pa.int64()], [9, 'full_text', pa.string()], [10, 'geo', pa.string()], [11, 'id', pa.int64() ], @@ -118,20 +122,25 @@ [17, 'in_reply_to_user_id_str', pa.string() ], [18, 'is_quote_status', pa.bool_() ], [19, 'lang', pa.string() ], - # [20, 'place', pa.string()], - # [21, 'possibly_sensitive', pa.bool_()], - #[22, 'quoted_status', pa.string()], - #[23, 'quoted_status_id', pa.int64()], - #[24, 'quoted_status_id_str', pa.string()], - #[25, 'quoted_status_permalink', pa.string()], - # [26, 'retweet_count', pa.int64()], - # [27, 'retweeted', pa.bool_()], - #[28, 'retweeted_status', pa.string()], - # [29, 'scopes', pa.string()], # pa.struct({'followers': pa.bool_()})], - #[30, 'source', pa.string()], - # [31, 'truncated', pa.bool_()], - # [32, 'user', pa.string()], + [20, 'place', pa.string()], + [21, 'possibly_sensitive', pa.bool_()], + [22, 'quoted_status', pa.string()], + [23, 'quoted_status_id', pa.int64()], + [24, 'quoted_status_id_str', pa.string()], + [25, 'quoted_status_permalink', pa.string()], + [26, 'retweet_count', pa.int64()], + [27, 'retweeted', pa.bool_()], + [28, 'retweeted_status', pa.string()], + [29, 'scopes', pa.string()], + [30, 'source', pa.string()], + [31, 'truncated', pa.bool_()], + [32, 'user', pa.string()], + #[33, 'withheld_in_countries', pa.list_(pa.string())], + [33, 'withheld_in_countries', pa.string()], + + #[34, 'followers', pa.struct({'followers': pa.bool_()})] + [34, 'followers', pa.string()] ] ############################# @@ -149,16 +158,17 @@ class FirehoseJob: DROP_COLS = DROP_COLS - def __init__(self, creds = [], neo4j_creds = None, TWEETS_PER_PROCESS=100, TWEETS_PER_ROWGROUP=5000, save_to_neo=False, PARQUET_SAMPLE_RATE_TIME_S=None): + def __init__(self, creds = [], neo4j_creds = None, TWEETS_PER_PROCESS=100, TWEETS_PER_ROWGROUP=5000, save_to_neo=False, PARQUET_SAMPLE_RATE_TIME_S=None, debug=False, BATCH_LEN=100, writers = {'snappy': None}): self.queue = deque() - self.writers = { - 'snappy': None - #,'vanilla': None - } + self.writers = writers self.last_write_epoch = '' self.current_table = None - self.schema = None + self.schema = pa.schema([ + (name, t) + for (i, name, t) in KNOWN_FIELDS + ]) self.timer = Timer() + self.debug = debug self.twarc_pool = TwarcPool([ Twarc(o['consumer_key'], o['consumer_secret'], o['access_token'], o['access_token_secret']) @@ -175,6 +185,8 @@ def __init__(self, creds = [], neo4j_creds = None, TWEETS_PER_PROCESS=100, TWEET self.neo4j_creds = neo4j_creds + self.BATCH_LEN = BATCH_LEN + self.needs_to_flush = False self.__file_names = [] @@ -229,7 +241,7 @@ def clean_series(self, series): ##objects: put here to skip str coercion coercions = { - 'display_text_range': identity, + 'display_text_range': series_to_json_string, 'contributors': identity, 'created_at': lambda series: series.values.astype('unicode'), 'possibly_sensitive': (lambda series: series.fillna(False)), @@ -238,8 +250,8 @@ def clean_series(self, series): 'in_reply_to_status_id': (lambda series: series.fillna(0).astype('int64')), 'in_reply_to_user_id': (lambda series: series.fillna(0).astype('int64')), 'scopes': series_to_json_string, - 'followers': identity, #(lambda series: pd.Series([str(x) for x in series.tolist()]).values.astype('unicode')), - 'withheld_in_countries': identity, + 'followers': series_to_json_string, + 'withheld_in_countries': series_to_json_string } if series.name in coercions.keys(): return coercions[series.name](series) @@ -497,40 +509,6 @@ def concat_tables(self, table_old, table_new): finally: self.timer.toc('concat_tables') - - def df_to_arrow(self, df): - - print('first process..') - table = pa.Table.from_pandas(df) - - print('patching lossy dtypes...') - schema = table.schema - for [i, name, field_t] in FirehoseJob.KNOWN_FIELDS: - if schema[i].name != name: - raise Exception('Mismatched index %s: %s -> %s' % ( - i, schema[i].name, name - )) - schema = schema.set(i, pa.field(name, field_t)) - - print('re-coercing..') - table_2 = pa.Table.from_pandas(df, schema) - #if not table_2.schema.equals(schema): - for i in range(0, len(schema)): - if not (schema[i].equals(table_2.schema[i])): - print('=======================') - print('EXN: schema mismatch %s' % i) - print(schema[i]) - print('-----') - print(table_2.schema[i]) - print('-----') - raise Exception('schema mismatch %s' % i) - print('Success!') - print('=========') - print('First tweets arrow schema') - for i in range(0, len(table_2.schema)): - print(i, table_2.schema[i]) - print('////////////') - return table_2 def process_tweets_notify_hydrating(self): if not (self.current_table is None): @@ -551,16 +529,12 @@ def process_tweets(self, tweets, job_name='generic_job'): df = self.clean_df(raw_df) table = None - if self.schema is None: - table = self.df_to_arrow(df) - self.schema = table.schema - else: - try: - table = self.df_with_schema_to_arrow(df, self.schema) - except: - print('conversion failed, skipping batch...') - self.timer.toc('overall_compute') - return + try: + table = self.df_with_schema_to_arrow(df, self.schema) + except Exception as e: + #logger.error('conversion failed, skipping batch...') + self.timer.toc('overall_compute') + raise e self.last_arr = table @@ -572,7 +546,8 @@ def process_tweets(self, tweets, job_name='generic_job'): out = self.current_table #or just table (without intermediate concats since last flush?) if not (self.current_table is None) \ - and ((self.current_table.num_rows > self.TWEETS_PER_ROWGROUP) or self.needs_to_flush): + and ((self.current_table.num_rows > self.TWEETS_PER_ROWGROUP) or self.needs_to_flush) \ + and self.current_table.num_rows > 0: self.flush(job_name) self.needs_to_flush = False else: @@ -591,8 +566,9 @@ def flusher(tweets_batch): try: self.needs_to_flush = True return self.process_tweets(tweets_batch, job_name) - except: - print('failed processing batch, continuing...') + except Exception as e: + #logger.debug('failed processing batch, continuing...') + raise e tweets_batch = [] last_flush_time_s = time.time() @@ -611,8 +587,9 @@ def flusher(tweets_batch): if self.needs_to_flush: try: yield flusher(tweets_batch) - except: - print('Write fail, continuing..') + except Exception as e: + #logger.debug('Write fail, continuing..') + raise e finally: tweets_batch = [] logger.debug('===== PROCESSED ALL GENERATOR TASKS, FINISHING ====') @@ -621,7 +598,6 @@ def flusher(tweets_batch): except KeyboardInterrupt as e: logger.debug('========== FLUSH IF SLEEP INTERRUPTED') self.destroy() - del fh gc.collect() logger.debug('explicit GC...') logger.debug('Safely exited!') @@ -635,20 +611,25 @@ def process_ids(self, ids_to_process, job_name=None): if job_name is None: job_name = "process_ids_%s" % (ids_to_process[0] if len(ids_to_process) > 0 else "none") - - hydration_statuses_df = Neo4jDataAccess(True, self.neo4j_creds)\ - .get_tweet_hydrated_status_by_id(pd.DataFrame({'id': ids_to_process})) - missing_ids = hydration_statuses_df[ hydration_statuses_df['hydrated'] != 'FULL' ]['id'].tolist() - - print('Skipping cached %s, fetching %s, of requested %s' % ( - len(ids_to_process) - len(missing_ids), - len(missing_ids), - len(ids_to_process))) - - tweets = ( tweet for tweet in self.twarc_pool.next_twarc().hydrate(missing_ids) ) - for arr in self.process_tweets_generator(tweets, job_name): - yield arr + for i in range(0, len(ids_to_process), self.BATCH_LEN): + ids_to_process_batch = ids_to_process[i : (i + self.BATCH_LEN)] + + logger.info('Starting batch offset %s ( + %s) of %s', i, self.BATCH_LEN, len(ids_to_process)) + + hydration_statuses_df = Neo4jDataAccess(self.debug, self.neo4j_creds)\ + .get_tweet_hydrated_status_by_id(pd.DataFrame({'id': ids_to_process_batch})) + missing_ids = hydration_statuses_df[ hydration_statuses_df['hydrated'] != 'FULL' ]['id'].tolist() + + logger.debug('Skipping cached %s, fetching %s, of requested %s' % ( + len(ids_to_process_batch) - len(missing_ids), + len(missing_ids), + len(ids_to_process_batch))) + + tweets = ( tweet for tweet in self.twarc_pool.next_twarc().hydrate(missing_ids) ) + + for arr in self.process_tweets_generator(tweets, job_name): + yield arr def process_id_file(self, path, job_name=None): From 4bab6db4f6f61585cb7fdc896386d8049b518a21 Mon Sep 17 00:00:00 2001 From: Dave Date: Wed, 1 Apr 2020 10:58:57 -0800 Subject: [PATCH 04/47] Changed the print() statements for actual pythong logging statements --- modules/DfHelper.py | 125 +++++++++++---------- modules/Neo4jDataAccess.py | 216 ++++++++++++++++++++----------------- 2 files changed, 187 insertions(+), 154 deletions(-) diff --git a/modules/DfHelper.py b/modules/DfHelper.py index 053973a..a2040b3 100644 --- a/modules/DfHelper.py +++ b/modules/DfHelper.py @@ -6,16 +6,18 @@ import logging logger = logging.getLogger('DfHelper') -class DfHelper: - def __init__(self, debug=False): - self.debug=debug - + +class DfHelper: + def __init__(self): + pass + def __clean_timeline_tweets(self, pdf): #response_gdf = gdf[ (gdf['in_reply_to_status_id'] > 0) | (gdf['quoted_status_id'] > 0) ].drop_duplicates(['id']) - pdf = pdf.rename(columns={'id': 'status_id', 'id_str': 'status_id_str'}) + pdf = pdf.rename(columns={'id': 'status_id', + 'id_str': 'status_id_str'}) #pdf = pdf.reset_index(drop=True) return pdf - + def normalize_parquet_dataframe(self, df): pdf = df\ .pipe(self.__clean_timeline_tweets)\ @@ -29,19 +31,20 @@ def normalize_parquet_dataframe(self, df): return pdf def __clean_datetimes(self, pdf): - if self.debug: print('cleaning datetimes...') + logger.debug('cleaning datetimes...') try: pdf = pdf.assign(created_at=pd.to_datetime(pdf['created_at'])) - pdf = pdf.assign(created_date=pdf['created_at'].apply(lambda dt: dt.timestamp())) + pdf = pdf.assign(created_date=pdf['created_at'].apply( + lambda dt: dt.timestamp())) except Exception as e: - print('Error __clean_datetimes', e) - print(pdf) + logger.error('Error __clean_datetimes', e) + logger.error(pdf) raise e - if self.debug: print(' ...cleaned') + logger.debug(' ...cleaned') return pdf - #some reason always False - #this seems to match full_text[:2] == 'RT' + # some reason always False + # this seems to match full_text[:2] == 'RT' def __clean_retweeted(self, pdf): return pdf.assign(retweeted=pdf['retweeted_status'] != 'None') @@ -55,11 +58,11 @@ def __update_to_type(self, row): return 'original' def __tag_status_type(self, pdf): - ##only materialize required fields.. - if self.debug: print('tagging status...') + # only materialize required fields.. + logger.debug('tagging status...') pdf2 = pdf\ .assign(status_type=pdf[['is_quote_status', 'retweeted', 'in_reply_to_status_id']].apply(self.__update_to_type, axis=1)) - if self.debug: print(' ...tagged') + logger.debug(' ...tagged') return pdf2 def __flatten_status_col(self, pdf, col, status_type, prefix): @@ -67,56 +70,61 @@ def __flatten_status_col(self, pdf, col, status_type, prefix): debug_retweets = None try: logger.debug('flattening %s...', col) - logger.debug(' %s x %s: %s', len(pdf), len(pdf.columns), pdf.columns) + logger.debug(' %s x %s: %s', len(pdf), + len(pdf.columns), pdf.columns) if len(pdf) == 0: - logger.debug('Warning: did not add mt case col output addition - pdf') + logger.debug( + 'Warning: did not add mt case col output addition - pdf') return pdf - #retweet_status -> hash -> lookup json for hash -> pull out id/created_at/user_id + # retweet_status -> hash -> lookup json for hash -> pull out id/created_at/user_id pdf_hashed = pdf.assign(hashed=pdf[col].apply(hash)) - retweets = pdf_hashed[ pdf_hashed['status_type'] == status_type ][['hashed', col]]\ + retweets = pdf_hashed[pdf_hashed['status_type'] == status_type][['hashed', col]]\ .drop_duplicates('hashed').reset_index(drop=True) if len(retweets) == 0: - logger.debug('Warning: did not add mt case col output addition - retweets') + logger.debug( + 'Warning: did not add mt case col output addition - retweets') return pdf #print('sample', retweets[col].head(10), retweets[col].apply(type)) retweets_flattened = pd.io.json.json_normalize( - retweets[col].replace("(").replace(")")\ - .apply(self.__try_load)) + retweets[col].replace("(").replace(")") + .apply(self.__try_load)) if len(retweets_flattened.columns) == 0: logger.debug('No tweets of type %s, early exit', status_type) return pdf debug_retweets_flattened = retweets_flattened debug_retweets = retweets logger.debug(' ... fixing dates') - logger.debug('avail cols of %s x %s: %s', len(retweets_flattened), len(retweets_flattened.columns), retweets_flattened.columns) + logger.debug('avail cols of %s x %s: %s', len(retweets_flattened), len( + retweets_flattened.columns), retweets_flattened.columns) logger.debug(retweets_flattened) if 'created_at' in retweets_flattened: retweets_flattened = retweets_flattened.assign( - created_at = pd.to_datetime(retweets_flattened['created_at']).apply(lambda dt: dt.timestamp)) + created_at=pd.to_datetime(retweets_flattened['created_at']).apply(lambda dt: dt.timestamp)) if 'user.id' in retweets_flattened: - retweets_flattened = retweets_flattened.assign( - user_id = retweets_flattened['user.id']) - logger.debug(' ... fixing dates') + retweets_flattened = retweets_flattened.assign( + user_id=retweets_flattened['user.id']) + logger.debug(' ... fixing dates') retweets = retweets[['hashed']]\ .assign(**{ - prefix + c: retweets_flattened[c] + prefix + c: retweets_flattened[c] for c in retweets_flattened if c in ['id', 'created_at', 'user_id'] }) logger.debug(' ... remerging') - pdf_with_flat_retweets = pdf_hashed.merge(retweets, on='hashed', how='left').drop(columns='hashed') - logger.debug(' ...flattened: %s', pdf_with_flat_retweets.shape) + pdf_with_flat_retweets = pdf_hashed.merge( + retweets, on='hashed', how='left').drop(columns='hashed') + logger.debug(' ...flattened: %s', pdf_with_flat_retweets.shape) return pdf_with_flat_retweets except Exception as e: logger.error(('Exception __flatten_status_col', e)) logger.error(('params', col, status_type, prefix)) - #print(pdf[:10]) + # print(pdf[:10]) logger.error('cols debug_retweets %s x %s : %s', - len(debug_retweets), len(debug_retweets.columns), debug_retweets.columns) + len(debug_retweets), len(debug_retweets.columns), debug_retweets.columns) logger.error('--------') logger.error(debug_retweets[:3]) - logger.error('--------') + logger.error('--------') logger.error('cols debug_retweets_flattened %s x %s : %s', - len(debug_retweets_flattened), len(debug_retweets_flattened.columns), debug_retweets_flattened.columns) + len(debug_retweets_flattened), len(debug_retweets_flattened.columns), debug_retweets_flattened.columns) logger.error('--------') logger.error(debug_retweets_flattened[:3]) logger.error('--------') @@ -125,38 +133,45 @@ def __flatten_status_col(self, pdf, col, status_type, prefix): raise e def __flatten_retweets(self, pdf): - if self.debug: print('flattening retweets...') - pdf2 = self.__flatten_status_col(pdf, 'retweeted_status', 'retweet', 'retweet_') - if self.debug: print(' ...flattened', pdf2.shape) + logger.debug('flattening retweets...') + pdf2 = self.__flatten_status_col( + pdf, 'retweeted_status', 'retweet', 'retweet_') + logger.debug(' ...flattened', pdf2.shape) return pdf2 def __flatten_quotes(self, pdf): - if self.debug: print('flattening quotes...') - pdf2 = self.__flatten_status_col(pdf, 'quoted_status', 'retweet_quote', 'quote_') - if self.debug: print(' ...flattened', pdf2.shape) + logger.debug('flattening quotes...') + pdf2 = self.__flatten_status_col( + pdf, 'quoted_status', 'retweet_quote', 'quote_') + logger.debug(' ...flattened', pdf2.shape) return pdf2 def __flatten_users(self, pdf): - if self.debug: print('flattening users') - pdf_user_cols = pd.io.json.json_normalize(pdf['user'].replace("(").replace(")").apply(ast.literal_eval)) + logger.debug('flattening users') + pdf_user_cols = pd.io.json.json_normalize( + pdf['user'].replace("(").replace(")").apply(ast.literal_eval)) pdf2 = pdf.assign(**{ - 'user_' + c: pdf_user_cols[c] + 'user_' + c: pdf_user_cols[c] for c in pdf_user_cols if c in [ - 'id', 'screen_name', 'created_at', 'followers_count', 'friends_count', 'favourites_count', + 'id', 'screen_name', 'created_at', 'followers_count', 'friends_count', 'favourites_count', 'utc_offset', 'time_zone', 'verified', 'statuses_count', 'profile_image_url', 'location', 'name', 'description' ]}) - if self.debug: print(' ... fixing dates') - pdf2 = pdf2.assign(user_created_at=pd.to_datetime(pdf2['user_created_at']).apply(lambda dt: dt.timestamp())) - if self.debug: print(' ...flattened') + logger.debug(' ... fixing dates') + pdf2 = pdf2.assign(user_created_at=pd.to_datetime( + pdf2['user_created_at']).apply(lambda dt: dt.timestamp())) + logger.debug(' ...flattened') return pdf2 + def __flatten_entities(self, pdf): - if self.debug: print('flattening urls') - pdf_entities = pd.io.json.json_normalize(pdf['entities'].replace("(").replace(")").apply(ast.literal_eval)) - pdf['urls']=pdf_entities['urls'] - pdf['hashtags']=pdf_entities['hashtags'] - pdf['user_mentions']=pdf_entities['user_mentions'] + logger.debug('flattening urls') + pdf_entities = pd.io.json.json_normalize( + pdf['entities'].replace("(").replace(")").apply(ast.literal_eval)) + pdf['urls'] = pdf_entities['urls'] + pdf['hashtags'] = pdf_entities['hashtags'] + pdf['user_mentions'] = pdf_entities['user_mentions'] return pdf + def __try_load(self, s): try: out = ast.literal_eval(s) @@ -166,5 +181,5 @@ def __try_load(self, s): } except: if s != 0.0: - if self.debug: print('bad s',s) - return {} \ No newline at end of file + logger.debug('bad s', s) + return {} diff --git a/modules/Neo4jDataAccess.py b/modules/Neo4jDataAccess.py index 18cf099..f4bcd30 100644 --- a/modules/Neo4jDataAccess.py +++ b/modules/Neo4jDataAccess.py @@ -1,18 +1,24 @@ -import ast, json, time +import ast +import json +import time from datetime import datetime import pandas as pd from py2neo import Graph from urllib.parse import urlparse +import logging from .DfHelper import DfHelper +logger = logging.getLogger('Neo4jDataAccess') + + class Neo4jDataAccess: - BATCH_SIZE=2000 - - def __init__(self, debug=False, neo4j_creds = None): + + def __init__(self, debug=False, neo4j_creds=None, batch_size=2000): self.creds = neo4j_creds - self.debug=debug + self.debug = debug + self.batch_size = batch_size self.tweetsandaccounts = """ UNWIND $tweets AS t //Add the Tweet @@ -88,7 +94,7 @@ def __init__(self, debug=False, neo4j_creds = None): retweet.hydrated = 'PARTIAL' ) """ - + self.tweeted_rel = """UNWIND $tweets AS t MATCH (user:Account {id:t.user_id}) MATCH (tweet:Tweet {id:t.tweet_id}) @@ -112,7 +118,7 @@ def __init__(self, debug=False, neo4j_creds = None): ) """ - + self.mentions = """UNWIND $mentions AS t MATCH (tweet:Tweet {id:t.tweet_id}) MERGE (user:Account {id:t.user_id}) @@ -125,7 +131,7 @@ def __init__(self, debug=False, neo4j_creds = None): WITH user, tweet MERGE (tweet)-[:MENTIONED]->(user) """ - + self.urls = """UNWIND $urls AS t MATCH (tweet:Tweet {id:t.tweet_id}) MERGE (url:Url {full_url:t.url}) @@ -146,166 +152,178 @@ def __init__(self, debug=False, neo4j_creds = None): WITH url, tweet MERGE (tweet)-[:INCLUDES]->(url) """ - + self.fetch_tweet_status = """UNWIND $ids AS i MATCH (tweet:Tweet {id:i.id}) RETURN tweet.id, tweet.hydrated """ - def __get_neo4j_graph(self, role_type): creds = None + logging.debug('role_type: %s', role_type) if not (self.creds is None): creds = self.creds else: with open('neo4jcreds.json') as json_file: creds = json.load(json_file) - res = list(filter(lambda c: c["type"]==role_type, creds)) - if len(res): + res = list(filter(lambda c: c["type"] == role_type, creds)) + if len(res): + logging.debug("creds %s", res) creds = res[0]["creds"] - self.graph = Graph(host=creds['host'], port=creds['port'], user=creds['user'], password=creds['password']) - else: + self.graph = Graph( + host=creds['host'], port=creds['port'], user=creds['user'], password=creds['password']) + else: self.graph = None return self.graph - + def save_parquet_df_to_graph(self, df, job_name): - pdf = DfHelper(self.debug).normalize_parquet_dataframe(df) - if self.debug: print('Saving to Neo4j') + pdf = DfHelper().normalize_parquet_dataframe(df) + logging.info('Saving to Neo4j') self.__save_df_to_graph(pdf, job_name) # Get the status of a DataFrame of Tweets by id. Returns a dataframe with the hydrated status def get_tweet_hydrated_status_by_id(self, df, job_name='generic_job'): if 'id' in df: - graph = self.__get_neo4j_graph('reader') - ids=[] + graph = self.__get_neo4j_graph('reader') + ids = [] for index, row in df.iterrows(): ids.append({'id': int(row['id'])}) - res = graph.run(self.fetch_tweet_status, ids = ids).to_data_frame() + res = graph.run(self.fetch_tweet_status, ids=ids).to_data_frame() - if self.debug: print('Response info: %s rows, %s columns: %s' % (len(res), len(res.columns), res.columns)) + logging.debug('Response info: %s rows, %s columns: %s' % + (len(res), len(res.columns), res.columns)) if len(res) == 0: return df[['id']].assign(hydrated=None) else: - res=res.rename(columns={'tweet.id': 'id', 'tweet.hydrated': 'hydrated'}) - res = df[['id']].merge(res, how='left', on='id') #ensures hydrated=None if Neo4j does not answer for id + res = res.rename( + columns={'tweet.id': 'id', 'tweet.hydrated': 'hydrated'}) + # ensures hydrated=None if Neo4j does not answer for id + res = df[['id']].merge(res, how='left', on='id') return res else: - raise Exception('Parameter df must be a DataFrame with a column named "id" ') - + logging.debug('df columns %s', df.columns) + raise Exception( + 'Parameter df must be a DataFrame with a column named "id" ') + # This saves the User and Tweet data right now def __save_df_to_graph(self, df, job_name): - graph = self.__get_neo4j_graph('writer') - global_tic=time.perf_counter() + graph = self.__get_neo4j_graph('writer') + global_tic = time.perf_counter() params = [] mention_params = [] url_params = [] - tic=time.perf_counter() + tic = time.perf_counter() + logging.debug('df columns %s', df.columns) for index, row in df.iterrows(): - #determine the type of tweet - tweet_type='TWEET' - if row["in_reply_to_status_id"] is not None and row["in_reply_to_status_id"] >0: - tweet_type="REPLY" - elif "quoted_status_id" in row and row["quoted_status_id"] is not None and row["quoted_status_id"] >0: - tweet_type="QUOTE_RETWEET" - elif "retweet_id" in row and row["retweet_id"] is not None and row["retweet_id"] >0: - tweet_type="RETWEET" + # determine the type of tweet + tweet_type = 'TWEET' + if row["in_reply_to_status_id"] is not None and row["in_reply_to_status_id"] > 0: + tweet_type = "REPLY" + elif "quoted_status_id" in row and row["quoted_status_id"] is not None and row["quoted_status_id"] > 0: + tweet_type = "QUOTE_RETWEET" + elif "retweet_id" in row and row["retweet_id"] is not None and row["retweet_id"] > 0: + tweet_type = "RETWEET" try: - params.append({'tweet_id': row['status_id'], - 'text': row['full_text'], - 'tweet_created_at': row['created_at'].to_pydatetime(), - 'favorite_count': row['favorite_count'], - 'retweet_count': row['retweet_count'], - 'tweet_type': tweet_type, - 'job_id': job_name, - 'hashtags': self.__normalize_hashtags(row['hashtags']), - 'user_id': row['user_id'], - 'user_name': row['user_name'], - 'user_location': row['user_location'], - 'user_screen_name': row['user_screen_name'], - 'user_followers_count': row['user_followers_count'], - 'user_friends_count': row['user_friends_count'], - 'user_created_at': pd.Timestamp(row['user_created_at'], unit='s').to_pydatetime(), + params.append({'tweet_id': row['status_id'], + 'text': row['full_text'], + 'tweet_created_at': row['created_at'].to_pydatetime(), + 'favorite_count': row['favorite_count'], + 'retweet_count': row['retweet_count'], + 'tweet_type': tweet_type, + 'job_id': job_name, + 'hashtags': self.__normalize_hashtags(row['hashtags']), + 'user_id': row['user_id'], + 'user_name': row['user_name'], + 'user_location': row['user_location'], + 'user_screen_name': row['user_screen_name'], + 'user_followers_count': row['user_followers_count'], + 'user_friends_count': row['user_friends_count'], + 'user_created_at': pd.Timestamp(row['user_created_at'], unit='s').to_pydatetime(), 'user_profile_image_url': row['user_profile_image_url'], - 'reply_tweet_id': row['in_reply_to_status_id'], - 'quoted_status_id': row['quoted_status_id'], + 'reply_tweet_id': row['in_reply_to_status_id'], + 'quoted_status_id': row['quoted_status_id'], 'retweet_id': row['retweet_id'] if 'retweet_id' in row else None, - }) + }) except Exception as e: - print('params.append exn', e) - print('row', row) + logging.error('params.append exn', e) + logging.error('row', row) raise e - - #if there are urls then populate the url_params + + # if there are urls then populate the url_params if row['urls']: url_params = self.__parse_urls(row, url_params, job_name) - #if there are user_mentions then populate the mentions_params + # if there are user_mentions then populate the mentions_params if row['user_mentions']: for m in row['user_mentions']: mention_params.append({ - 'tweet_id': row['status_id'], - 'user_id': m['id'], - 'user_name': m['name'], - 'user_screen_name': m['screen_name'], - 'job_id': job_name, + 'tweet_id': row['status_id'], + 'user_id': m['id'], + 'user_name': m['name'], + 'user_screen_name': m['screen_name'], + 'job_id': job_name, }) - if index % self.BATCH_SIZE == 0 and index>0: + if index % self.batch_size == 0 and index > 0: self.__write_to_neo(params, url_params, mention_params) - toc=time.perf_counter() - if self.debug: print(f"Neo4j Periodic Save Complete in {toc - tic:0.4f} seconds") + toc = time.perf_counter() + logging.info( + f"Neo4j Periodic Save Complete in {toc - tic:0.4f} seconds") params = [] mention_params = [] url_params = [] - tic=time.perf_counter() - + tic = time.perf_counter() + self.__write_to_neo(params, url_params, mention_params) - toc=time.perf_counter() - if self.debug: print(f"Neo4j Import Complete in {toc - global_tic:0.4f} seconds") - + toc = time.perf_counter() + logging.info( + f"Neo4j Import Complete in {toc - global_tic:0.4f} seconds") + def __write_to_neo(self, params, url_params, mention_params): - try: + try: tx = self.graph.begin(autocommit=False) - tx.run(self.tweetsandaccounts, tweets = params) - tx.run(self.tweeted_rel, tweets = params) - tx.run(self.mentions, mentions = mention_params) - tx.run(self.urls, urls = url_params) + tx.run(self.tweetsandaccounts, tweets=params) + tx.run(self.tweeted_rel, tweets=params) + tx.run(self.mentions, mentions=mention_params) + tx.run(self.urls, urls=url_params) tx.commit() except Exception as inst: - print('Neo4j Transaction error') - print(type(inst)) # the exception instance - print(inst.args) # arguments stored in .args - print(inst) # __str__ allows args to be printed directly, + logging.error('Neo4j Transaction error') + logging.error(type(inst)) # the exception instance + logging.error(inst.args) # arguments stored in .args + # __str__ allows args to be printed directly, + logging.error(inst) raise inst - + def __normalize_hashtags(self, value): if value: - hashtags=[] + hashtags = [] for h in value: hashtags.append(h['text']) return ','.join(hashtags) else: return None - + def __parse_urls(self, row, url_params, job_name): for u in row['urls']: - try: + try: parsed = urlparse(u['expanded_url']) url_params.append({ - 'tweet_id': row['status_id'], - 'url': u['expanded_url'], - 'job_id': job_name, - 'schema': parsed.scheme, - 'netloc': parsed.netloc, - 'path': parsed.path, - 'params': parsed.params, - 'query': parsed.query, - 'fragment': parsed.fragment, - 'username': parsed.username, - 'password': parsed.password, - 'hostname': parsed.hostname, - 'port': parsed.port, + 'tweet_id': row['status_id'], + 'url': u['expanded_url'], + 'job_id': job_name, + 'schema': parsed.scheme, + 'netloc': parsed.netloc, + 'path': parsed.path, + 'params': parsed.params, + 'query': parsed.query, + 'fragment': parsed.fragment, + 'username': parsed.username, + 'password': parsed.password, + 'hostname': parsed.hostname, + 'port': parsed.port, }) except Exception as inst: print(type(inst)) # the exception instance print(inst.args) # arguments stored in .args - print(inst) # __str__ allows args to be printed directly, + # __str__ allows args to be printed directly, + print(inst) return url_params From 262e8d85e8ef4d7e62758a8d51ef650ea6c3721c Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Thu, 2 Apr 2020 11:29:56 +1100 Subject: [PATCH 05/47] addig gitignore --- .gitignore | 143 +++++++++++++++++++++++++++++++++++++++++++++++++++++ 1 file changed, 143 insertions(+) create mode 100644 .gitignore diff --git a/.gitignore b/.gitignore new file mode 100644 index 0000000..dd78eef --- /dev/null +++ b/.gitignore @@ -0,0 +1,143 @@ +# Byte-compiled / optimized / DLL files +__pycache__/ +*.py[cod] +*$py.class + +# C extensions +*.so + +# Distribution / packaging +.Python +build/ +develop-eggs/ +dist/ +downloads/ +eggs/ +.eggs/ +lib/ +lib64/ +parts/ +sdist/ +var/ +wheels/ +pip-wheel-metadata/ +share/python-wheels/ +*.egg-info/ +.installed.cfg +*.egg +MANIFEST + +# PyInstaller +# Usually these files are written by a python script from a template +# before PyInstaller builds the exe, so as to inject date/other infos into it. +*.manifest +*.spec + +# Installer logs +pip-log.txt +pip-delete-this-directory.txt + +# Unit test / coverage reports +htmlcov/ +.tox/ +.nox/ +.coverage +.coverage.* +.cache +nosetests.xml +coverage.xml +*.cover +*.py,cover +.hypothesis/ +.pytest_cache/ +cover/ + +# Translations +*.mo +*.pot + +# Django stuff: +*.log +local_settings.py +db.sqlite3 +db.sqlite3-journal + +# Flask stuff: +instance/ +.webassets-cache + +# Scrapy stuff: +.scrapy + +# Sphinx documentation +docs/_build/ + +# PyBuilder +.pybuilder/ +target/ + +# Jupyter Notebook +.ipynb_checkpoints + +# IPython +profile_default/ +ipython_config.py + +# pyenv +# For a library or package, you might want to ignore these files since the code is +# intended to run in multiple environments; otherwise, check them in: +# .python-version + +# pipenv +# According to pypa/pipenv#598, it is recommended to include Pipfile.lock in version control. +# However, in case of collaboration, if having platform-specific dependencies or dependencies +# having no cross-platform support, pipenv may install dependencies that don't work, or not +# install all needed dependencies. +#Pipfile.lock + +# PEP 582; used by e.g. github.com/David-OConnor/pyflow +__pypackages__/ + +# Celery stuff +celerybeat-schedule +celerybeat.pid + +# SageMath parsed files +*.sage.py + +# Environments +.env +.venv +env/ +venv/ +ENV/ +env.bak/ +venv.bak/ + +# Spyder project settings +.spyderproject +.spyproject + +# Rope project settings +.ropeproject + +# mkdocs documentation +/site + +# mypy +.mypy_cache/ +.dmypy.json +dmypy.json + +# Pyre type checker +.pyre/ + +# pytype static type analyzer +.pytype/ + +# Cython debug symbols +cython_debug/ + +# static files generated from Django application using `collectstatic` +media +static \ No newline at end of file From c331889cf2a287f266eef0e84c63d6403215da20 Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Thu, 2 Apr 2020 11:34:53 +1100 Subject: [PATCH 06/47] prints changed to logger --- .gitignore | 6 +++++- modules/FirehoseJob.py | 22 +++++++++++----------- 2 files changed, 16 insertions(+), 12 deletions(-) diff --git a/.gitignore b/.gitignore index dd78eef..5edd6bb 100644 --- a/.gitignore +++ b/.gitignore @@ -140,4 +140,8 @@ cython_debug/ # static files generated from Django application using `collectstatic` media -static \ No newline at end of file +static + +# Env files +.DominoEnv/ +.vscode/ diff --git a/modules/FirehoseJob.py b/modules/FirehoseJob.py index 30b47a3..e5150c0 100644 --- a/modules/FirehoseJob.py +++ b/modules/FirehoseJob.py @@ -192,26 +192,26 @@ def __init__(self, creds = [], neo4j_creds = None, TWEETS_PER_PROCESS=100, TWEET self.__file_names = [] def __del__(self): - print('__del__') + logger.debug('__del__') self.destroy() def destroy(self, job_name='generic_job'): - print('flush before destroying..') + logger.debug('flush before destroying..') self.flush(job_name) - print('destroy', self.writers.keys()) + logger.debug('destroy', self.writers.keys()) for k in self.writers.keys(): if not (self.writers[k] is None): - print('Closing parquet writer %s' % k) + logger.debug('Closing parquet writer %s' % k) writer = self.writers[k] writer.close() - print('... sleep 1s...') + logger.debug('... sleep 1s...') time.sleep(1) self.writers[k] = None - print('... sleep 1s...') + logger.debug('... sleep 1s...') time.sleep(1) - print('... Safely closed %s' % k) + logger.debug('... Safely closed %s' % k) else: - print('Nothing to close for writer %s' % k) + logger.debug('Nothing to close for writer %s' % k) ################### @@ -260,9 +260,9 @@ def clean_series(self, series): else: return series except Exception as exn: - print('coerce exn on col', series.name, series.dtype) - print('first', series[:1]) - print(exn) + logger.error('coerce exn on col', series.name, series.dtype) + logger.error('first', series[:1]) + logger.error(exn) return series #clean df before reaches arrow From cecb571b480260a64ddddc727a910cf6d07ae6a0 Mon Sep 17 00:00:00 2001 From: Dave Date: Wed, 1 Apr 2020 17:48:29 -0800 Subject: [PATCH 07/47] Added methods to get_from_neo and get_tweets_by_id --- modules/Neo4jDataAccess.py | 81 ++++++++++++++++++++++++++++++-------- 1 file changed, 65 insertions(+), 16 deletions(-) diff --git a/modules/Neo4jDataAccess.py b/modules/Neo4jDataAccess.py index f4bcd30..8d23b9f 100644 --- a/modules/Neo4jDataAccess.py +++ b/modules/Neo4jDataAccess.py @@ -29,6 +29,7 @@ def __init__(self, debug=False, neo4j_creds=None, batch_size=2000): tweet.favorite_count = t.favorite_count, tweet.retweet_count = t.retweet_count, tweet.record_created_at = timestamp(), + tweet.job_name = t.job_name, tweet.job_id = t.job_id, tweet.hashtags = t.hashtags, tweet.hydrated = 'FULL', @@ -38,6 +39,7 @@ def __init__(self, debug=False, neo4j_creds=None, batch_size=2000): tweet.favorite_count = t.favorite_count, tweet.retweet_count = t.retweet_count, tweet.record_updated_at = timestamp(), + tweet.job_name = t.job_name, tweet.job_id = t.job_id, tweet.hashtags = t.hashtags, tweet.hydrated = 'FULL', @@ -55,7 +57,8 @@ def __init__(self, debug=False, neo4j_creds=None, batch_size=2000): user.user_profile_image_url = t.user_profile_image_url, user.created_at = t.user_created_at, user.record_created_at = timestamp(), - user.job_name = t.job_id + user.job_name = t.job_name, + user.job_id = t.job_id ON MATCH SET user.name = t.user_name, user.screen_name = t.user_screen_name, @@ -65,13 +68,15 @@ def __init__(self, debug=False, neo4j_creds=None, batch_size=2000): user.location = t.user_location, user.created_at = t.user_created_at, user.record_updated_at = timestamp(), - user.job_name = t.job_id + user.job_name = t.job_name, + user.job_id = t.job_id //Add Reply to tweets if needed FOREACH(ignoreMe IN CASE WHEN t.tweet_type='REPLY' THEN [1] ELSE [] END | MERGE (retweet:Tweet {id:t.reply_tweet_id}) ON CREATE SET retweet.id=t.reply_tweet_id, retweet.record_created_at = timestamp(), + retweet.job_name = t.job_name, retweet.job_id = t.job_id, retweet.hydrated = 'PARTIAL' ) @@ -81,6 +86,7 @@ def __init__(self, debug=False, neo4j_creds=None, batch_size=2000): MERGE (quoteTweet:Tweet {id:t.quoted_status_id}) ON CREATE SET quoteTweet.id=t.quoted_status_id, quoteTweet.record_created_at = timestamp(), + quoteTweet.job_name = t.job_name, quoteTweet.job_id = t.job_id, quoteTweet.hydrated = 'PARTIAL' ) @@ -90,6 +96,7 @@ def __init__(self, debug=False, neo4j_creds=None, batch_size=2000): MERGE (retweet:Tweet {id:t.retweet_id}) ON CREATE SET retweet.id=t.retweet_id, retweet.record_created_at = timestamp(), + retweet.job_name = t.job_name, retweet.job_id = t.job_id, retweet.hydrated = 'PARTIAL' ) @@ -127,7 +134,8 @@ def __init__(self, debug=False, neo4j_creds=None, batch_size=2000): user.mentioned_name = t.name, user.mentioned_screen_name = t.user_screen_name, user.record_created_at = timestamp(), - user.job_name = t.job_id + user.job_name = t.job_name, + user.job_id = t.job_id WITH user, tweet MERGE (tweet)-[:MENTIONED]->(user) """ @@ -137,7 +145,8 @@ def __init__(self, debug=False, neo4j_creds=None, batch_size=2000): MERGE (url:Url {full_url:t.url}) ON CREATE SET url.full_url = t.url, - url.job_name = t.job_id, + url.job_name = t.job_name, + url.job_id = t.job_id, url.record_created_at = timestamp(), url.schema=t.scheme, url.netloc=t.netloc, @@ -158,6 +167,11 @@ def __init__(self, debug=False, neo4j_creds=None, batch_size=2000): RETURN tweet.id, tweet.hydrated """ + self.fetch_tweet = """UNWIND $ids AS i + MATCH (tweet:Tweet {id:i.id}) + RETURN tweet + """ + def __get_neo4j_graph(self, role_type): creds = None logging.debug('role_type: %s', role_type) @@ -176,13 +190,44 @@ def __get_neo4j_graph(self, role_type): self.graph = None return self.graph - def save_parquet_df_to_graph(self, df, job_name): + def get_from_neo(self, cypher, limit=100): + graph = self.__get_neo4j_graph('reader') + df = graph.run(cypher).to_data_frame() + return df.head(limit) + + def get_tweet_by_id(self, df, cols=[]): + if 'id' in df: + graph = self.__get_neo4j_graph('reader') + ids = [] + for index, row in df.iterrows(): + ids.append({'id': int(row['id'])}) + res = graph.run(self.fetch_tweet, ids=ids).to_data_frame() + + logging.debug('Response info: %s rows, %s columns: %s' % + (len(res), len(res.columns), res.columns)) + pdf = pd.DataFrame() + for r in res.iterrows(): + props = {} + for k in r[1]['tweet'].keys(): + if cols: + if k in cols: + props.update({k: r[1]['tweet'][k]}) + else: + props.update({k: r[1]['tweet'][k]}) + pdf = pdf.append(props, ignore_index=True) + return pdf + else: + logging.debug('df columns %s', df.columns) + raise Exception( + 'Parameter df must be a DataFrame with a column named "id" ') + + def save_parquet_df_to_graph(self, df, job_name, job_id=None): pdf = DfHelper().normalize_parquet_dataframe(df) logging.info('Saving to Neo4j') self.__save_df_to_graph(pdf, job_name) # Get the status of a DataFrame of Tweets by id. Returns a dataframe with the hydrated status - def get_tweet_hydrated_status_by_id(self, df, job_name='generic_job'): + def get_tweet_hydrated_status_by_id(self, df): if 'id' in df: graph = self.__get_neo4j_graph('reader') ids = [] @@ -206,7 +251,7 @@ def get_tweet_hydrated_status_by_id(self, df, job_name='generic_job'): 'Parameter df must be a DataFrame with a column named "id" ') # This saves the User and Tweet data right now - def __save_df_to_graph(self, df, job_name): + def __save_df_to_graph(self, df, job_name, job_id=None): graph = self.__get_neo4j_graph('writer') global_tic = time.perf_counter() params = [] @@ -230,7 +275,8 @@ def __save_df_to_graph(self, df, job_name): 'favorite_count': row['favorite_count'], 'retweet_count': row['retweet_count'], 'tweet_type': tweet_type, - 'job_id': job_name, + 'job_id': job_id, + 'job_name': job_name, 'hashtags': self.__normalize_hashtags(row['hashtags']), 'user_id': row['user_id'], 'user_name': row['user_name'], @@ -251,7 +297,8 @@ def __save_df_to_graph(self, df, job_name): # if there are urls then populate the url_params if row['urls']: - url_params = self.__parse_urls(row, url_params, job_name) + url_params = self.__parse_urls( + row, url_params, job_name, job_id) # if there are user_mentions then populate the mentions_params if row['user_mentions']: for m in row['user_mentions']: @@ -260,13 +307,14 @@ def __save_df_to_graph(self, df, job_name): 'user_id': m['id'], 'user_name': m['name'], 'user_screen_name': m['screen_name'], - 'job_id': job_name, + 'job_id': job_id, + 'job_name': job_name, }) if index % self.batch_size == 0 and index > 0: self.__write_to_neo(params, url_params, mention_params) toc = time.perf_counter() logging.info( - f"Neo4j Periodic Save Complete in {toc - tic:0.4f} seconds") + f'Neo4j Periodic Save Complete in {toc - tic:0.4f} seconds') params = [] mention_params = [] url_params = [] @@ -302,14 +350,15 @@ def __normalize_hashtags(self, value): else: return None - def __parse_urls(self, row, url_params, job_name): + def __parse_urls(self, row, url_params, job_name, job_id=None): for u in row['urls']: try: parsed = urlparse(u['expanded_url']) url_params.append({ 'tweet_id': row['status_id'], 'url': u['expanded_url'], - 'job_id': job_name, + 'job_id': job_id, + 'job_name': job_name, 'schema': parsed.scheme, 'netloc': parsed.netloc, 'path': parsed.path, @@ -322,8 +371,8 @@ def __parse_urls(self, row, url_params, job_name): 'port': parsed.port, }) except Exception as inst: - print(type(inst)) # the exception instance - print(inst.args) # arguments stored in .args + logging.error(type(inst)) # the exception instance + logging.error(inst.args) # arguments stored in .args # __str__ allows args to be printed directly, - print(inst) + logging.error(inst) return url_params From 207d32ca27ea3713999c610edb383e477d39e907 Mon Sep 17 00:00:00 2001 From: Ziyao Wei Date: Thu, 2 Apr 2020 00:41:12 -0400 Subject: [PATCH 08/47] Use pandas when cudf does not exist --- modules/FirehoseJob.py | 217 ++++++++++++++++++++++------------------- 1 file changed, 114 insertions(+), 103 deletions(-) diff --git a/modules/FirehoseJob.py b/modules/FirehoseJob.py index 30b47a3..4e1edb7 100644 --- a/modules/FirehoseJob.py +++ b/modules/FirehoseJob.py @@ -1,7 +1,7 @@ ### from collections import deque, defaultdict -import cudf, datetime, gc, os, string, sys, time, uuid +import datetime, gc, os, string, sys, time, uuid import numpy as np import pandas as pd import pyarrow as pa @@ -16,6 +16,11 @@ import logging logger = logging.getLogger('fh') +try: + import cudf +except: + logger.debug('Warning: no cudf') + ############################# ################### @@ -46,7 +51,7 @@ ('in_reply_to_user_id_str', string_dtype, None), ('is_quote_status', np.bool, None), ('lang', string_dtype, None), - ('place', string_dtype, None), + ('place', string_dtype, None), ('possibly_sensitive', np.bool_, False), ('quoted_status', string_dtype, 0.0), ('quoted_status_id', id_type, 0), @@ -99,14 +104,14 @@ # }))}) ### When dtype -> arrow ambiguious, override -KNOWN_FIELDS = [ +KNOWN_FIELDS = [ [0, 'contributors', pa.string()], [1, 'coordinates', pa.string()], [2, 'created_at', pa.string()], - - #[3, 'display_text_range', pa.list_(pa.int64())], + + #[3, 'display_text_range', pa.list_(pa.int64())], [3, 'display_text_range', pa.string()], - + [4, 'entities', pa.string()], [5, 'extended_entities', pa.string()], #extended_entities_t ], [7, 'favorited', pa.bool_()], @@ -135,7 +140,7 @@ [30, 'source', pa.string()], [31, 'truncated', pa.bool_()], [32, 'user', pa.string()], - + #[33, 'withheld_in_countries', pa.list_(pa.string())], [33, 'withheld_in_countries', pa.string()], @@ -147,17 +152,17 @@ class FirehoseJob: - + ################### MACHINE_IDS = (375, 382, 361, 372, 364, 381, 376, 365, 363, 362, 350, 325, 335, 333, 342, 326, 327, 336, 347, 332) SNOWFLAKE_EPOCH = 1288834974657 - + EXPECTED_COLS = EXPECTED_COLS KNOWN_FIELDS = KNOWN_FIELDS DROP_COLS = DROP_COLS - - + + def __init__(self, creds = [], neo4j_creds = None, TWEETS_PER_PROCESS=100, TWEETS_PER_ROWGROUP=5000, save_to_neo=False, PARQUET_SAMPLE_RATE_TIME_S=None, debug=False, BATCH_LEN=100, writers = {'snappy': None}): self.queue = deque() self.writers = writers @@ -169,15 +174,15 @@ def __init__(self, creds = [], neo4j_creds = None, TWEETS_PER_PROCESS=100, TWEET ]) self.timer = Timer() self.debug = debug - - self.twarc_pool = TwarcPool([ + + self.twarc_pool = TwarcPool([ Twarc(o['consumer_key'], o['consumer_secret'], o['access_token'], o['access_token_secret']) - for o in creds + for o in creds ]) - self.save_to_neo=save_to_neo + self.save_to_neo = save_to_neo self.TWEETS_PER_PROCESS = TWEETS_PER_PROCESS #100 self.TWEETS_PER_ROWGROUP = TWEETS_PER_ROWGROUP #100 1KB x 1000 = 1MB uncompressed parquet - self.PARQUET_SAMPLE_RATE_TIME_S = PARQUET_SAMPLE_RATE_TIME_S + self.PARQUET_SAMPLE_RATE_TIME_S = PARQUET_SAMPLE_RATE_TIME_S self.last_df = None self.last_arr = None self.last_write_arr = None @@ -186,19 +191,19 @@ def __init__(self, creds = [], neo4j_creds = None, TWEETS_PER_PROCESS=100, TWEET self.neo4j_creds = neo4j_creds self.BATCH_LEN = BATCH_LEN - + self.needs_to_flush = False self.__file_names = [] - + def __del__(self): print('__del__') - self.destroy() - + self.destroy() + def destroy(self, job_name='generic_job'): print('flush before destroying..') self.flush(job_name) - print('destroy', self.writers.keys()) + print('destroy', self.writers.keys()) for k in self.writers.keys(): if not (self.writers[k] is None): print('Closing parquet writer %s' % k) @@ -212,7 +217,7 @@ def destroy(self, job_name='generic_job'): print('... Safely closed %s' % k) else: print('Nothing to close for writer %s' % k) - + ################### def get_creation_time(self, id): @@ -223,22 +228,22 @@ def machine_id(self, id): def sequence_id(self, id): return id & 0b111111111111 - - + + ################### - + valid_file_name_chars = frozenset("-_%s%s" % (string.ascii_letters, string.digits)) - + def clean_file_name(self, filename): return ''.join(c for c in filename if c in FirehoseJob.valid_file_name_chars) #clean series before reaches arrow - def clean_series(self, series): + def clean_series(self, series): try: identity = lambda x: x - + series_to_json_string = (lambda series: series.apply(lambda x: json.dumps(x, ignore_nan=True))) - + ##objects: put here to skip str coercion coercions = { 'display_text_range': series_to_json_string, @@ -270,8 +275,8 @@ def clean_df(self, raw_df): self.timer.tic('clean', 1000) try: new_cols = { - c: pd.Series([c_default] * len(raw_df), dtype=c_dtype) - for (c, c_dtype, c_default) in FirehoseJob.EXPECTED_COLS + c: pd.Series([c_default] * len(raw_df), dtype=c_dtype) + for (c, c_dtype, c_default) in FirehoseJob.EXPECTED_COLS if not c in raw_df } all_cols_df = raw_df.assign(**new_cols) @@ -283,29 +288,29 @@ def clean_df(self, raw_df): raise exn finally: self.timer.toc('clean') - - + + def folder_last(self): return self.__folder_last - + def files(self): return self.__file_names.copy() - + #TODO ////<24hour_utc>_.parquet (don't clobber..) def pq_writer(self, table, job_name='generic_job'): try: self.timer.tic('write', 1000) - + job_name = self.clean_file_name(job_name) - - folder = "firehose_data/%s" % job_name - logger.debug('make folder if not exists: %s' % folder) + + folder = "firehose_data/%s" % job_name + logger.debug('make folder if not exists: %s' % folder) os.makedirs(folder, exist_ok=True) self.__folder_last = folder - + vanilla_file_suffix = 'vanilla2.parquet' - snappy_file_suffix = 'snappy2.parquet' + snappy_file_suffix = 'snappy2.parquet' time_prefix = datetime.datetime.now().strftime("%Y_%m_%d_%H") run = 0 file_prefix = "" @@ -318,10 +323,10 @@ def pq_writer(self, table, job_name='generic_job'): logger.debug('Starting new batch for existing hour') vanilla_file_name = file_prefix + vanilla_file_suffix snappy_file_name = file_prefix + snappy_file_suffix - + ######################################################### - - + + ######################################################### if ('vanilla' in self.writers) and ( (self.writers['vanilla'] is None) or self.last_write_epoch != file_prefix ): logger.debug('Creating vanilla writer: %s', vanilla_file_name) @@ -332,11 +337,11 @@ def pq_writer(self, table, job_name='generic_job'): except Exception as exn: logger.debug(('Could not rm vanilla parquet', exn)) self.writers['vanilla'] = pq.ParquetWriter( - vanilla_file_name, + vanilla_file_name, schema=table.schema, compression='NONE') self.__file_names.append(vanilla_file_name) - + if ('snappy' in self.writers) and ( (self.writers['snappy'] is None) or self.last_write_epoch != file_prefix ): logger.debug('Creating snappy writer: %s', snappy_file_name) try: @@ -345,17 +350,17 @@ def pq_writer(self, table, job_name='generic_job'): except Exception as exn: logger.error(('Could not rm snappy parquet', exn)) self.writers['snappy'] = pq.ParquetWriter( - snappy_file_name, + snappy_file_name, schema=table.schema, compression={ field.name.encode(): 'SNAPPY' for field in table.schema }) self.__file_names.append(snappy_file_name) - + self.last_write_epoch = file_prefix ###################################################### - + for name in self.writers.keys(): try: logger.debug('Writing %s (%s x %s)' % ( @@ -365,9 +370,9 @@ def pq_writer(self, table, job_name='generic_job'): writer.write_table(table) logger.debug('========') logger.debug(table.schema) - logger.debug('--------') + logger.debug('--------') logger.debug(table.to_pandas()[:10]) - logger.debug('--------') + logger.debug('--------') self.timer.toc('writing_%s' % name, table.num_rows) ######### logger.debug('######## TRANSACTING') @@ -407,7 +412,7 @@ def flush(self, job_name="generic_job"): finally: logger.debug('flush clearing self.current_table') self.current_table = None - + def tweets_to_df(self, tweets): try: self.timer.tic('to_pandas', 1000) @@ -421,7 +426,7 @@ def tweets_to_df(self, tweets): raise exn finally: self.timer.toc('to_pandas') - + def df_with_schema_to_arrow(self, df, schema): try: self.timer.tic('df_with_schema_to_arrow', 1000) @@ -486,8 +491,8 @@ def df_with_schema_to_arrow(self, df, schema): return table finally: self.timer.toc('df_with_schema_to_arrow') - - + + def concat_tables(self, table_old, table_new): try: self.timer.tic('concat_tables', 1000) @@ -500,7 +505,7 @@ def concat_tables(self, table_old, table_new): if i >= table_new.num_columns: logger.error('new table does not have enough columns to handle %i' % i) elif table_old.schema[i].name != table_new.schema[i].name: - logger.error(('ith col name mismatch', i, + logger.error(('ith col name mismatch', i, 'old', (table_old.schema[i]), 'vs new', table_new.schema[i])) logger.error('------- exn') logger.error(exn) @@ -508,21 +513,21 @@ def concat_tables(self, table_old, table_new): raise exn finally: self.timer.toc('concat_tables') - - + + def process_tweets_notify_hydrating(self): if not (self.current_table is None): self.timer.toc('tweet', self.current_table.num_rows) self.timer.tic('tweet', 40, 40) - + self.timer.tic('hydrate', 40, 40) - + # Call process_tweets_notify_hydrating() before def process_tweets(self, tweets, job_name='generic_job'): - + self.timer.toc('hydrate') - + self.timer.tic('overall_compute', 40, 40) raw_df = self.tweets_to_df(tweets) @@ -535,7 +540,7 @@ def process_tweets(self, tweets, job_name='generic_job'): #logger.error('conversion failed, skipping batch...') self.timer.toc('overall_compute') raise e - + self.last_arr = table if self.current_table is None: @@ -544,7 +549,7 @@ def process_tweets(self, tweets, job_name='generic_job'): self.current_table = self.concat_tables(self.current_table, table) out = self.current_table #or just table (without intermediate concats since last flush?) - + if not (self.current_table is None) \ and ((self.current_table.num_rows > self.TWEETS_PER_ROWGROUP) or self.needs_to_flush) \ and self.current_table.num_rows > 0: @@ -552,16 +557,16 @@ def process_tweets(self, tweets, job_name='generic_job'): self.needs_to_flush = False else: 1 - #print('skipping, has table ? %s, num rows %s' % ( - # not (self.current_table is None), + #print('skipping, has table ? %s, num rows %s' % ( + # not (self.current_table is None), # 0 if self.current_table is None else self.current_table.num_rows)) self.timer.toc('overall_compute') - + return out - + def process_tweets_generator(self, tweets_generator, job_name='generic_job'): - + def flusher(tweets_batch): try: self.needs_to_flush = True @@ -569,21 +574,21 @@ def flusher(tweets_batch): except Exception as e: #logger.debug('failed processing batch, continuing...') raise e - + tweets_batch = [] last_flush_time_s = time.time() - + try: for tweet in tweets_generator: tweets_batch.append(tweet) - + if len(tweets_batch) > self.TWEETS_PER_PROCESS: self.needs_to_flush = True elif not (self.PARQUET_SAMPLE_RATE_TIME_S is None) \ - and time.time() - last_flush_time_s >= self.PARQUET_SAMPLE_RATE_TIME_S: + and time.time() - last_flush_time_s >= self.PARQUET_SAMPLE_RATE_TIME_S: self.needs_to_flush = True last_flush_time_s = time.time() - + if self.needs_to_flush: try: yield flusher(tweets_batch) @@ -601,22 +606,22 @@ def flusher(tweets_batch): gc.collect() logger.debug('explicit GC...') logger.debug('Safely exited!') - - + + ################################################################################ def process_ids(self, ids_to_process, job_name=None): self.process_tweets_notify_hydrating() - + if job_name is None: job_name = "process_ids_%s" % (ids_to_process[0] if len(ids_to_process) > 0 else "none") - + for i in range(0, len(ids_to_process), self.BATCH_LEN): ids_to_process_batch = ids_to_process[i : (i + self.BATCH_LEN)] - + logger.info('Starting batch offset %s ( + %s) of %s', i, self.BATCH_LEN, len(ids_to_process)) - + hydration_statuses_df = Neo4jDataAccess(self.debug, self.neo4j_creds)\ .get_tweet_hydrated_status_by_id(pd.DataFrame({'id': ids_to_process_batch})) missing_ids = hydration_statuses_df[ hydration_statuses_df['hydrated'] != 'FULL' ]['id'].tolist() @@ -630,56 +635,63 @@ def process_ids(self, ids_to_process, job_name=None): for arr in self.process_tweets_generator(tweets, job_name): yield arr - + def process_id_file(self, path, job_name=None): - - pdf = cudf.read_csv(path, header=None).to_pandas() - lst = pdf['0'].to_list() + + pdf = None + lst = None + try: + pdf = cudf.read_csv(path, header=None).to_pandas() + lst = pdf['0'].to_list() + except: + pdf = pd.read_csv(path, header=None) + lst = pdf[0].to_list() + if job_name is None: job_name = "id_file_%s" % path logger.debug('loaded %s ids, hydrating..' % len(lst)) - + for arr in self.process_ids(lst, job_name): yield arr - - - def search(self,input="", job_name=None): - + + + def search(self,input="", job_name=None): + self.process_tweets_notify_hydrating() - + if job_name is None: job_name = "search_%s" % input[:20] - + tweets = (tweet for tweet in self.twarc_pool.next_twarc().search(input)) self.process_tweets_generator(tweets, job_name) - - + + def search_stream_by_keyword(self,input="", job_name=None): self.process_tweets_notify_hydrating() - + if job_name is None: job_name = "search_stream_by_keyword_%s" % input[:20] tweets = [tweet for tweet in self.twarc_pool.next_twarc().filter(track=input)] - + self.process_tweets(tweets, job_name) def search_by_location(self,input="", job_name=None): - + self.process_tweets_notify_hydrating() if job_name is None: job_name = "search_by_location_%s" % input[:20] tweets = [tweet for tweet in self.twarc_pool.next_twarc().filter(locations=input)] - + self.process_tweets(tweets, job_name) - - # + + # def user_timeline(self,input=[""], job_name=None, **kwargs): if not (type(input) == list): input = [ input ] @@ -692,12 +704,12 @@ def user_timeline(self,input=[""], job_name=None, **kwargs): for user in input: logger.debug('starting user %s' % user) tweet_count = 0 - for tweet in self.twarc_pool.next_twarc().timeline(screen_name=user, **kwargs): + for tweet in self.twarc_pool.next_twarc().timeline(screen_name=user, **kwargs): #logger.debug('got user', user, 'tweet', str(tweet)[:50]) self.process_tweets([tweet], job_name) tweet_count = tweet_count + 1 logger.debug(' ... %s tweets' % tweet_count) - + self.destroy() except KeyboardInterrupt as e: logger.debug('Flushing..') @@ -711,7 +723,7 @@ def ingest_range(self, begin, end, job_name=None): # This method is where the m if job_name is None: job_name = "ingest_range_%s_to_%s" % (begin, end) - + for epoch in range(begin, end): # Move through each millisecond time_component = (epoch - FirehoseJob.SNOWFLAKE_EPOCH) << 22 for machine_id in FirehoseJob.MACHINE_IDS: # Iterate over machine ids @@ -723,4 +735,3 @@ def ingest_range(self, begin, end, job_name=None): # This method is where the m for i in range(0, self.TWEETS_PER_PROCESS): ids_to_process.append(self.queue.popleft()) self.process_ids(ids_to_process, job_name) - From f1426b673293ab79ad48ef1ff12bba97389a3f13 Mon Sep 17 00:00:00 2001 From: Ziyao Wei Date: Thu, 2 Apr 2020 01:37:44 -0400 Subject: [PATCH 09/47] Prototype rehydrate pipeline --- Pipeline.py | 193 ++++++++++++++++++++++++++++++++++++++++++++++++++++ 1 file changed, 193 insertions(+) create mode 100644 Pipeline.py diff --git a/Pipeline.py b/Pipeline.py new file mode 100644 index 0000000..f5bfcc6 --- /dev/null +++ b/Pipeline.py @@ -0,0 +1,193 @@ +from prefect import Flow, Client, task +from prefect.tasks.shell import ShellTask +import arrow, ast, graphistry, json, os, pprint +import pandas as pd +import numpy as np +from pathlib import Path +from modules.FirehoseJob import FirehoseJob +from datetime import timedelta, datetime +from prefect.schedules import IntervalSchedule +import prefect +from prefect.engine.signals import ENDRUN +from prefect.engine.state import Cancelled + +@task(log_stdout=True) +def load_creds(): + with open('twittercreds.json') as json_file: + creds = json.load(json_file) + print([{k: "zzz" for k in creds[0].keys()}]) + return creds + +@task(log_stdout=True) +def load_path(): + data_dirs = ['COVID-19-TweetIDs/2020-01', 'COVID-19-TweetIDs/2020-02', 'COVID-19-TweetIDs/2020-03'] + + timestamp = None + if 'backfill_timestamp' in prefect.context: + timestamp = arrow.get(prefect.context['backfill_timestamp']) + else: + timestamp = prefect.context['scheduled_start_time'] + print('TIMESTAMP = ', timestamp) + suffix = timestamp.strftime('%Y-%m-%d-%H') + + for data_dir in data_dirs: + if os.path.isdir(data_dir): + for path in Path(data_dir).iterdir(): + if path.name.endswith('{}.txt'.format(suffix)): + print(path) + return str(path) + else: + print('WARNING: not a dir', data_dir) + # TODO: (wzy) Figure out how to cancel this gracefully + raise ENDRUN(state=Cancelled()) + +@task(log_stdout=True) +def clean_timeline_tweets(pdf): + return pdf.rename(columns={'id': 'status_id', 'id_str': 'status_id_str'}) + +@task(log_stdout=True) +def clean_datetimes(pdf): + print('cleaning datetimes...') + pdf = pdf.assign(created_at=pd.to_datetime(pdf['created_at'])) + pdf = pdf.assign(created_date=pdf['created_at'].apply(lambda dt: dt.timestamp())) + print(' ...cleaned') + return pdf + +#some reason always False +#this seems to match full_text[:2] == 'RT' +@task(log_stdout=True) +def clean_retweeted(pdf): + return pdf.assign(retweeted=pdf['retweeted_status'] != 'None') + +def update_to_type(row): + if row['is_quote_status']: + return 'retweet_quote' + if row['retweeted']: + return 'retweet' + if row['in_reply_to_status_id'] is not None and row['in_reply_to_status_id'] > 0: + return 'reply' + return 'original' + +@task(log_stdout=True) +def tag_status_type(pdf): + ##only materialize required fields.. + print('tagging status...') + pdf2 = pdf\ + .assign(status_type=pdf[['is_quote_status', 'retweeted', 'in_reply_to_status_id']].apply(update_to_type, axis=1)) + print(' ...tagged') + return pdf2 + +def try_load(s): + try: + out = ast.literal_eval(s) + return { + k if type(k) == str else str(k): out[k] + for k in out.keys() + } + except: + if s != 0.0: + print('bad s', s) + return {} + +def flatten_status_col(pdf, col, status_type, prefix): + print('flattening %s...' % col) + print(' ', pdf.columns) + #retweet_status -> hash -> lookup json for hash -> pull out id/created_at/user_id + pdf_hashed = pdf.assign(hashed=pdf[col].apply(hash)) + retweets = pdf_hashed[ pdf_hashed['status_type'] == status_type ][['hashed', col]]\ + .drop_duplicates('hashed').reset_index(drop=True) + retweets_flattened = pd.io.json.json_normalize( + retweets[col].replace("(").replace(")")\ + .apply(try_load)) + print(' ... fixing dates') + import pdb; pdb.set_trace() + retweets_flattened = retweets_flattened.assign( + created_at = pd.to_datetime(retweets_flattened['created_at']).apply(lambda dt: dt.timestamp()), + user_id = retweets_flattened['user.id']) + retweets = retweets[['hashed']]\ + .assign(**{ + prefix + c: retweets_flattened[c] + for c in retweets_flattened if c in ['id', 'created_at', 'user_id'] + }) + print(' ... remerging') + pdf_with_flat_retweets = pdf_hashed.merge(retweets, on='hashed', how='left').drop(columns='hashed') + print(' ...flattened', pdf_with_flat_retweets.shape) + return pdf_with_flat_retweets + +@task(log_stdout=True) +def flatten_retweets(pdf): + print('flattening retweets...') + pdf2 = flatten_status_col(pdf, 'retweeted_status', 'retweet', 'retweet_') + print(' ...flattened', pdf2.shape) + import pdb; pdb.set_trace() + return pdf2 + +@task(log_stdout=True) +def flatten_quotes(pdf): + print('flattening quotes...') + pdf2 = flatten_status_col(pdf, 'quoted_status', 'retweet_quote', 'quote_') + print(' ...flattened', pdf2.shape) + return pdf2 + +@task(log_stdout=True) +def flatten_users(pdf): + print('flattening users') + pdf_user_cols = pd.io.json.json_normalize(pdf['user'].replace("(").replace(")").apply(ast.literal_eval)) + pdf2 = pdf.assign(**{ + 'user_' + c: pdf_user_cols[c] + for c in pdf_user_cols if c in [ + 'id', 'screen_name', 'created_at', 'followers_count', 'friends_count', 'favourites_count', + 'utc_offset', 'time_zone', 'verified', 'statuses_count', 'profile_image_url', + 'name', 'description' + ]}) + print(' ... fixing dates') + import pdb; pdb.set_trace() + pdf2 = pdf2.assign(user_created_at=pd.to_datetime(pdf2['user_created_at']).apply(lambda dt: dt.timestamp())) + print(' ...flattened') + return pdf2 + +@task(log_stdout=True) +def load_tweets(creds, path): + print(path) + fh = FirehoseJob(creds, PARQUET_SAMPLE_RATE_TIME_S=30) + data = [] + for arr in fh.process_id_file(path, job_name="500m_COVID-REHYDRATE"): + data.append(arr.to_pandas()) + print('{}/{}'.format(len(data), len(arr))) + break + return pd.concat(data, ignore_index=True, sort=False) + +@task(log_stdout=True) +def sample(tweets): + print('responses shape', tweets.shape) + print(tweets.columns) + print(tweets.sample(5)) + +schedule = IntervalSchedule( + start_date=datetime(2020, 1, 20), + interval=timedelta(hours=1), + # start_date=datetime.now() + timedelta(seconds=1), + # interval=timedelta(minutes=1), +) + +with Flow("Rehydration Pipeline") as flow: +# with Flow("Rehydration Pipeline", schedule=schedule) as flow: + creds = load_creds() + path_list = load_path() + tweets = load_tweets(creds, path_list) + tweets = clean_timeline_tweets(tweets) + tweets = clean_datetimes(tweets) + tweets = clean_retweeted(tweets) + tweets = tag_status_type(tweets) + tweets = flatten_retweets(tweets) + tweets = flatten_quotes(tweets) + tweets = flatten_users(tweets) + + sample(tweets) + +with prefect.context( + backfill_timestamp=datetime(2020, 1, 29), + ): + flow.run() + flow.register(project_name="rehydrate") + flow.run_agent() From f14dffe4a605899ead1fee4ffff3576f38f54cbb Mon Sep 17 00:00:00 2001 From: Ziyao Wei Date: Thu, 2 Apr 2020 07:26:38 -0400 Subject: [PATCH 10/47] Fix bug --- Pipeline.py | 23 +++++++++++++---------- 1 file changed, 13 insertions(+), 10 deletions(-) diff --git a/Pipeline.py b/Pipeline.py index f5bfcc6..f5d8686 100644 --- a/Pipeline.py +++ b/Pipeline.py @@ -100,9 +100,11 @@ def flatten_status_col(pdf, col, status_type, prefix): retweets[col].replace("(").replace(")")\ .apply(try_load)) print(' ... fixing dates') - import pdb; pdb.set_trace() + created_at_datetime = pd.to_datetime(retweets_flattened['created_at']) + created_at = np.full_like(created_at_datetime, np.nan, dtype=np.float64) + created_at[created_at_datetime.notnull()] = created_at_datetime[created_at_datetime.notnull()].apply(lambda dt: dt.timestamp()) retweets_flattened = retweets_flattened.assign( - created_at = pd.to_datetime(retweets_flattened['created_at']).apply(lambda dt: dt.timestamp()), + created_at = created_at, user_id = retweets_flattened['user.id']) retweets = retweets[['hashed']]\ .assign(**{ @@ -119,7 +121,6 @@ def flatten_retweets(pdf): print('flattening retweets...') pdf2 = flatten_status_col(pdf, 'retweeted_status', 'retweet', 'retweet_') print(' ...flattened', pdf2.shape) - import pdb; pdb.set_trace() return pdf2 @task(log_stdout=True) @@ -141,7 +142,6 @@ def flatten_users(pdf): 'name', 'description' ]}) print(' ... fixing dates') - import pdb; pdb.set_trace() pdf2 = pdf2.assign(user_created_at=pd.to_datetime(pdf2['user_created_at']).apply(lambda dt: dt.timestamp())) print(' ...flattened') return pdf2 @@ -170,8 +170,7 @@ def sample(tweets): # interval=timedelta(minutes=1), ) -with Flow("Rehydration Pipeline") as flow: -# with Flow("Rehydration Pipeline", schedule=schedule) as flow: +with Flow("Rehydration Pipeline", schedule=schedule) as flow: creds = load_creds() path_list = load_path() tweets = load_tweets(creds, path_list) @@ -185,9 +184,13 @@ def sample(tweets): sample(tweets) -with prefect.context( - backfill_timestamp=datetime(2020, 1, 29), - ): - flow.run() +LOCAL_MODE = True + +if LOCAL_MODE: + with prefect.context( + backfill_timestamp=datetime(2020, 1, 29), + ): + flow.run() +else: flow.register(project_name="rehydrate") flow.run_agent() From 325db35147b95d3f2d7f5495f06497942ee85c0a Mon Sep 17 00:00:00 2001 From: lmeyerov Date: Thu, 2 Apr 2020 11:21:39 -0700 Subject: [PATCH 11/47] docs(README): add calendar --- README.md | 2 ++ 1 file changed, 2 insertions(+) diff --git a/README.md b/README.md index 4c77259..e5c7d2d 100644 --- a/README.md +++ b/README.md @@ -6,6 +6,8 @@ * [Community Slack channel: #COVID](https://thedataridealongs.slack.com/) via an [open invite link](https://join.slack.com/t/thedataridealongs/shared_invite/zt-d06nq64h-P1_3sENXG4Gg0MjWh1jPEw) +* [Meetings: Google calendar](https://calendar.google.com/calendar?cid=Z3JhcGhpc3RyeS5jb21fdTQ3bmQ3YTdiZzB0aTJtaW9kYTJybGx2cTBAZ3JvdXAuY2FsZW5kYXIuZ29vZ2xlLmNvbQ) + * **Graph4good contributors:** We're excited to work with you! Check out the subprojects below we are actively seeking help on, and ping on Slack for which you're curious about tackling. We can then share our current thoughts and tips for getting started. Most will be useful as pure Python [Google Collab notebook](https://colab.research.google.com) proveouts and local Neo4j Docker + Python proveouts: You can move quickly, and we can more easily integrate into our automation pipelines. **One of the most important steps in stopping the COVID-19 pandemic is influencing mass behavior change for citizens to take appropriate, swift action on mitigating infection and human-to-human contact.** Government officials at all levels have advocated misinformed practices such as dining out or participating in outdoor gatherings that have contributed to amplifying the curve rather than flattening it. At time of writing, the result of poor crisis emergency risk communication has led to over 14,000 US citizens testing positive, 2-20X more are likely untested, and over 200 deaths. The need to influence appropriate behavior and mitigation actions are extreme: The US has shot up from untouched to become the 6th most infected nation. From 3c24774f07fa1580c15360f8a33cd77428433330 Mon Sep 17 00:00:00 2001 From: Dave Date: Thu, 2 Apr 2020 14:02:03 -0800 Subject: [PATCH 12/47] Fixed issue with limit on get_from_neo, added timeout parameter, and changed to neo4j driver --- .gitignore | 5 +++ modules/Neo4jDataAccess.py | 48 ++++++++++++++++++---------- test_neo.py | 65 ++++++++++++++++++++++++++++++++++++++ 3 files changed, 101 insertions(+), 17 deletions(-) create mode 100644 .gitignore create mode 100644 test_neo.py diff --git a/.gitignore b/.gitignore new file mode 100644 index 0000000..7cc0048 --- /dev/null +++ b/.gitignore @@ -0,0 +1,5 @@ +neo4jcreds.json + +.vscode/ +data/ +__pycache__/ \ No newline at end of file diff --git a/modules/Neo4jDataAccess.py b/modules/Neo4jDataAccess.py index 8d23b9f..771df07 100644 --- a/modules/Neo4jDataAccess.py +++ b/modules/Neo4jDataAccess.py @@ -1,10 +1,11 @@ import ast import json import time +import re from datetime import datetime import pandas as pd -from py2neo import Graph +from neo4j import GraphDatabase, basic_auth from urllib.parse import urlparse import logging @@ -15,9 +16,10 @@ class Neo4jDataAccess: - def __init__(self, debug=False, neo4j_creds=None, batch_size=2000): + def __init__(self, debug=False, neo4j_creds=None, batch_size=2000, timeout="60s"): self.creds = neo4j_creds self.debug = debug + self.timeout = timeout self.batch_size = batch_size self.tweetsandaccounts = """ UNWIND $tweets AS t @@ -184,16 +186,23 @@ def __get_neo4j_graph(self, role_type): if len(res): logging.debug("creds %s", res) creds = res[0]["creds"] - self.graph = Graph( - host=creds['host'], port=creds['port'], user=creds['user'], password=creds['password']) + uri = f'bolt://{creds["host"]}:{creds["port"]}' + self.graph = GraphDatabase.driver( + uri, auth=basic_auth(creds['user'], creds['password']), encrypted=False) else: self.graph = None return self.graph - def get_from_neo(self, cypher, limit=100): + def get_from_neo(self, cypher, limit=1000): graph = self.__get_neo4j_graph('reader') - df = graph.run(cypher).to_data_frame() - return df.head(limit) + # If the limit isn't set in the traversal then add it + if not re.search('LIMIT', cypher, re.IGNORECASE): + cypher = cypher + " LIMIT " + str(limit) + with graph.session() as session: + result = session.run(cypher, timeout=self.timeout) + df = pd.DataFrame([dict(record) for record in result]) + rdf = df.head(limit) + return rdf def get_tweet_by_id(self, df, cols=[]): if 'id' in df: @@ -201,8 +210,10 @@ def get_tweet_by_id(self, df, cols=[]): ids = [] for index, row in df.iterrows(): ids.append({'id': int(row['id'])}) - res = graph.run(self.fetch_tweet, ids=ids).to_data_frame() - + with graph.session() as session: + result = session.run( + self.fetch_tweet, ids=ids, timeout=self.timeout) + res = pd.DataFrame([dict(record) for record in result]) logging.debug('Response info: %s rows, %s columns: %s' % (len(res), len(res.columns), res.columns)) pdf = pd.DataFrame() @@ -233,8 +244,9 @@ def get_tweet_hydrated_status_by_id(self, df): ids = [] for index, row in df.iterrows(): ids.append({'id': int(row['id'])}) - res = graph.run(self.fetch_tweet_status, ids=ids).to_data_frame() - + with graph.session() as session: + result = session.run(self.fetch_tweet_status, ids=ids) + res = pd.DataFrame([dict(record) for record in result]) logging.debug('Response info: %s rows, %s columns: %s' % (len(res), len(res.columns), res.columns)) if len(res) == 0: @@ -327,12 +339,14 @@ def __save_df_to_graph(self, df, job_name, job_id=None): def __write_to_neo(self, params, url_params, mention_params): try: - tx = self.graph.begin(autocommit=False) - tx.run(self.tweetsandaccounts, tweets=params) - tx.run(self.tweeted_rel, tweets=params) - tx.run(self.mentions, mentions=mention_params) - tx.run(self.urls, urls=url_params) - tx.commit() + with self.graph.session() as session: + session.run(self.tweetsandaccounts, + tweets=params, timeout=self.timeout) + session.run(self.tweeted_rel, tweets=params, + timeout=self.timeout) + session.run(self.mentions, mentions=mention_params, + timeout=self.timeout) + session.run(self.urls, urls=url_params, timeout=self.timeout) except Exception as inst: logging.error('Neo4j Transaction error') logging.error(type(inst)) # the exception instance diff --git a/test_neo.py b/test_neo.py new file mode 100644 index 0000000..eff45ee --- /dev/null +++ b/test_neo.py @@ -0,0 +1,65 @@ +import pandas as pd +import logging +from modules.Neo4jDataAccess import Neo4jDataAccess + +df = pd.DataFrame({'id': [1219746154621165568, + 1219746203652456448, + 1219746235038474243, + 1219746508955967488, + 1219746544955453441] + }) +# DEBUG, INFO, WARNING, ERROR, CRITICAL +logging.getLogger().setLevel(logging.WARNING) +pd.set_option('display.max_columns', 500) +pd.set_option('display.max_colwidth', None) + + +# Test save_parquet_df_to_graph +print('----') +print('Testing Parquet Save') +tdf = pd.read_parquet( + './data/2020_03_22_02_b1.snappy2.parquet', engine='pyarrow') +Neo4jDataAccess().save_parquet_df_to_graph(tdf, 'dave') +print('----') + +# Test get_tweet_hydrated_status_by_id +print('----') +print('Testing get_tweet_hydrated_status_by_id') +df = Neo4jDataAccess().get_tweet_hydrated_status_by_id(df) +print(df) + +# Test get_tweet_by_id +print('----') +print('Testing get_tweet_by_id') +df = Neo4jDataAccess().get_tweet_by_id(df) +print(df) +print('----') +print('Testing get_tweet_by_id for cols') +df = Neo4jDataAccess().get_tweet_by_id( + df, cols=['id', 'job_name', 'created_at']) +print('Column check: ' + df.columns) +print('----') + +# Test get_from_neo +print('----') +print('Testing get_from_neo for Limit 1') +df = Neo4jDataAccess().get_from_neo( + 'MATCH (n:Tweet) WHERE n.hydrated=\'FULL\' RETURN n.id, n.text LIMIT 5') +print(df) +print('----') + +print('----') +print('Testing get_from_neo for Limit 1') +df = Neo4jDataAccess().get_from_neo( + 'MATCH (n:Tweet) WHERE n.hydrated=\'FULL\' RETURN n.id, n.text LIMIT 5', limit=1) +print(df) +print('----') + +print('----') +print('Testing get_from_neo with limit only') +df = Neo4jDataAccess().get_from_neo( + 'MATCH (n:Tweet) RETURN n', limit=1) +print(df) +print('----') + +print('Done') From 83a22942746831a343d165dc6046709a360db011 Mon Sep 17 00:00:00 2001 From: lmeyerov Date: Thu, 2 Apr 2020 18:13:21 -0700 Subject: [PATCH 13/47] docs(tightening) --- README.md | 13 +++++++------ 1 file changed, 7 insertions(+), 6 deletions(-) diff --git a/README.md b/README.md index e5c7d2d..5556f19 100644 --- a/README.md +++ b/README.md @@ -8,20 +8,20 @@ * [Meetings: Google calendar](https://calendar.google.com/calendar?cid=Z3JhcGhpc3RyeS5jb21fdTQ3bmQ3YTdiZzB0aTJtaW9kYTJybGx2cTBAZ3JvdXAuY2FsZW5kYXIuZ29vZ2xlLmNvbQ) -* **Graph4good contributors:** We're excited to work with you! Check out the subprojects below we are actively seeking help on, and ping on Slack for which you're curious about tackling. We can then share our current thoughts and tips for getting started. Most will be useful as pure Python [Google Collab notebook](https://colab.research.google.com) proveouts and local Neo4j Docker + Python proveouts: You can move quickly, and we can more easily integrate into our automation pipelines. +* **Graph4good contributors:** We're excited to work with you! Check out the subprojects below we are actively seeking help on, look at some of the Github Issues, and ping on Slack for which you're curious about tackling and others not here. We can then share our current thoughts and tips for getting started. Most will be useful as pure Python [Google Collab notebook](https://colab.research.google.com) proveouts and local Neo4j Docker + Python proveouts: You can move quickly, and we can more easily integrate into our automation pipelines. **One of the most important steps in stopping the COVID-19 pandemic is influencing mass behavior change for citizens to take appropriate, swift action on mitigating infection and human-to-human contact.** Government officials at all levels have advocated misinformed practices such as dining out or participating in outdoor gatherings that have contributed to amplifying the curve rather than flattening it. At time of writing, the result of poor crisis emergency risk communication has led to over 14,000 US citizens testing positive, 2-20X more are likely untested, and over 200 deaths. The need to influence appropriate behavior and mitigation actions are extreme: The US has shot up from untouched to become the 6th most infected nation. **Project Domino accelerates research on developing capabilities for information hygiene at the mass scale necessary for the current national disaster and for future ones.** We develop and enable the use of 3 key data capabilities for modern social discourse: -* Identifying at-risk behavior groups and viable local behavior change influencers * Detecting misinformation campaigns +* Identifying at-risk behavior groups and viable local behavior change influencers * Automating high-precision interventions ## The interventions We are working with ethics groups to identify safe interventions along the following lines: -* **Targeting of specific underserved issues**: Primary COVID public health issues such as unsafe social behavior, unsafe medicine, unsafe science, dangerous government policy influence, and adjacent issues such as fake charities, phishing, malware, and hate groups +* **Targeting of specific underserved issues**: Primary COVID public health issues such as unsafe social behavior, unsafe medicine, unsafe science, dangerous government policy influence, and adjacent issues such as fake charities, phishing, malware, and hate group propaganda * **Help top social platforms harden themselves**: Trust and safety teams at top social networks need to be able to warn users about misinformation, de-trend it, and potentially take it down before it has served its purpose. The status quo is handling incidents months after the fact. We will provide real-time alert feeds and scoring APIs to help take action during the critical minutes before misinformation gains significant reach. @@ -38,9 +38,10 @@ We are working with ethics groups to identify safe interventions along the follo * Twitter firehose monitor * Data integration pipeline for sources of known scams, fraud, lies, bots, propaganda, extremism, and other misinformation sources * Misinformation knowledge graph connecting accounts, posts, reports, and models -* Automated GPU / graph / machine learning pipeline +* Automated GPU / graph / machine learning pipeline: general classification (bot, community, ...) and targeted (clinical disinformation, ...) * Automated alerting & reporting pipeline * Interactive visual analytics environment for data scientists and analysts: GPU, graph, notebooks, ML, ... +* Intervention bots ## How to help @@ -48,8 +49,8 @@ We are actively seeking several forms of support: * **Volunteers**: Most immediate priority is on data engineering and advisors on marketing/public health * **Data engineers: Orchestration (Airflow, Prefect.io, Nifi, ...), streaming (Kafka, ...), graph (Neo4j, cuGraph), GPU (RAPIDS), ML (NLP libs), and databases** - * Analysts: OSINT, threat intel, campaign tracking, ... - * Data scientists: especially around graph, misinformation, neural networks, NLP, with backgrounds such as security, fraud, misinformation, marketing + * **Analysts: OSINT, threat intel, campaign tracking, ...** + * **Data scientists: especially around graph, misinformation, neural networks, NLP, with backgrounds such as security, fraud, misinformation, marketing** * Developers & designers: intelligence integrations, website for search & reports, automations, intervention bots, API * Marketing: Strategy & implementation * Public health and communications: Especially around intervention design From 328c997987064af61fa7dd012c861a84a371f33a Mon Sep 17 00:00:00 2001 From: Ziyao Wei Date: Thu, 2 Apr 2020 19:00:08 -0400 Subject: [PATCH 14/47] Skip when there is no data --- Pipeline.py | 45 +++++++++++++++++++++++------------------- modules/FirehoseJob.py | 2 +- 2 files changed, 26 insertions(+), 21 deletions(-) diff --git a/Pipeline.py b/Pipeline.py index f5d8686..b108834 100644 --- a/Pipeline.py +++ b/Pipeline.py @@ -9,16 +9,16 @@ from prefect.schedules import IntervalSchedule import prefect from prefect.engine.signals import ENDRUN -from prefect.engine.state import Cancelled +from prefect.engine.state import Skipped -@task(log_stdout=True) +@task(log_stdout=True, skip_on_upstream_skip=True) def load_creds(): with open('twittercreds.json') as json_file: creds = json.load(json_file) print([{k: "zzz" for k in creds[0].keys()}]) return creds -@task(log_stdout=True) +@task(log_stdout=True, skip_on_upstream_skip=True) def load_path(): data_dirs = ['COVID-19-TweetIDs/2020-01', 'COVID-19-TweetIDs/2020-02', 'COVID-19-TweetIDs/2020-03'] @@ -39,13 +39,13 @@ def load_path(): else: print('WARNING: not a dir', data_dir) # TODO: (wzy) Figure out how to cancel this gracefully - raise ENDRUN(state=Cancelled()) + raise ENDRUN(state=Skipped()) -@task(log_stdout=True) +@task(log_stdout=True, skip_on_upstream_skip=True) def clean_timeline_tweets(pdf): return pdf.rename(columns={'id': 'status_id', 'id_str': 'status_id_str'}) -@task(log_stdout=True) +@task(log_stdout=True, skip_on_upstream_skip=True) def clean_datetimes(pdf): print('cleaning datetimes...') pdf = pdf.assign(created_at=pd.to_datetime(pdf['created_at'])) @@ -55,7 +55,7 @@ def clean_datetimes(pdf): #some reason always False #this seems to match full_text[:2] == 'RT' -@task(log_stdout=True) +@task(log_stdout=True, skip_on_upstream_skip=True) def clean_retweeted(pdf): return pdf.assign(retweeted=pdf['retweeted_status'] != 'None') @@ -68,7 +68,7 @@ def update_to_type(row): return 'reply' return 'original' -@task(log_stdout=True) +@task(log_stdout=True, skip_on_upstream_skip=True) def tag_status_type(pdf): ##only materialize required fields.. print('tagging status...') @@ -116,21 +116,21 @@ def flatten_status_col(pdf, col, status_type, prefix): print(' ...flattened', pdf_with_flat_retweets.shape) return pdf_with_flat_retweets -@task(log_stdout=True) +@task(log_stdout=True, skip_on_upstream_skip=True) def flatten_retweets(pdf): print('flattening retweets...') pdf2 = flatten_status_col(pdf, 'retweeted_status', 'retweet', 'retweet_') print(' ...flattened', pdf2.shape) return pdf2 -@task(log_stdout=True) +@task(log_stdout=True, skip_on_upstream_skip=True) def flatten_quotes(pdf): print('flattening quotes...') pdf2 = flatten_status_col(pdf, 'quoted_status', 'retweet_quote', 'quote_') print(' ...flattened', pdf2.shape) return pdf2 -@task(log_stdout=True) +@task(log_stdout=True, skip_on_upstream_skip=True) def flatten_users(pdf): print('flattening users') pdf_user_cols = pd.io.json.json_normalize(pdf['user'].replace("(").replace(")").apply(ast.literal_eval)) @@ -146,28 +146,33 @@ def flatten_users(pdf): print(' ...flattened') return pdf2 -@task(log_stdout=True) +@task(log_stdout=True, skip_on_upstream_skip=True) def load_tweets(creds, path): print(path) fh = FirehoseJob(creds, PARQUET_SAMPLE_RATE_TIME_S=30) + cnt = 0 data = [] for arr in fh.process_id_file(path, job_name="500m_COVID-REHYDRATE"): data.append(arr.to_pandas()) print('{}/{}'.format(len(data), len(arr))) - break - return pd.concat(data, ignore_index=True, sort=False) - -@task(log_stdout=True) + cnt += len(arr) + print('TOTAL: ' + str(cnt)) + data = pd.concat(data, ignore_index=True, sort=False) + if len(data) == 0: + raise ENDRUN(state=Skipped()) + return data + +@task(log_stdout=True, skip_on_upstream_skip=True) def sample(tweets): print('responses shape', tweets.shape) print(tweets.columns) print(tweets.sample(5)) schedule = IntervalSchedule( - start_date=datetime(2020, 1, 20), + # start_date=datetime(2020, 1, 20), + # interval=timedelta(hours=1), + start_date=datetime.now() + timedelta(seconds=1), interval=timedelta(hours=1), - # start_date=datetime.now() + timedelta(seconds=1), - # interval=timedelta(minutes=1), ) with Flow("Rehydration Pipeline", schedule=schedule) as flow: @@ -188,7 +193,7 @@ def sample(tweets): if LOCAL_MODE: with prefect.context( - backfill_timestamp=datetime(2020, 1, 29), + backfill_timestamp=datetime(2020, 2, 6, 9), ): flow.run() else: diff --git a/modules/FirehoseJob.py b/modules/FirehoseJob.py index 4e1edb7..73646d5 100644 --- a/modules/FirehoseJob.py +++ b/modules/FirehoseJob.py @@ -626,7 +626,7 @@ def process_ids(self, ids_to_process, job_name=None): .get_tweet_hydrated_status_by_id(pd.DataFrame({'id': ids_to_process_batch})) missing_ids = hydration_statuses_df[ hydration_statuses_df['hydrated'] != 'FULL' ]['id'].tolist() - logger.debug('Skipping cached %s, fetching %s, of requested %s' % ( + print('Skipping cached %s, fetching %s, of requested %s' % ( len(ids_to_process_batch) - len(missing_ids), len(missing_ids), len(ids_to_process_batch))) From b72eb75078a1dbb91ba095058c5ae4ff2fa540fa Mon Sep 17 00:00:00 2001 From: Ziyao Wei Date: Thu, 2 Apr 2020 22:23:15 -0400 Subject: [PATCH 15/47] Fix logging, add parameter for saving to Neo4j --- Pipeline.py | 7 ++++--- modules/FirehoseJob.py | 2 +- 2 files changed, 5 insertions(+), 4 deletions(-) diff --git a/Pipeline.py b/Pipeline.py index b108834..07eff40 100644 --- a/Pipeline.py +++ b/Pipeline.py @@ -149,7 +149,7 @@ def flatten_users(pdf): @task(log_stdout=True, skip_on_upstream_skip=True) def load_tweets(creds, path): print(path) - fh = FirehoseJob(creds, PARQUET_SAMPLE_RATE_TIME_S=30) + fh = FirehoseJob(creds, PARQUET_SAMPLE_RATE_TIME_S=30, save_to_neo=prefect.context.get('save_to_neo', False)) cnt = 0 data = [] for arr in fh.process_id_file(path, job_name="500m_COVID-REHYDRATE"): @@ -175,7 +175,8 @@ def sample(tweets): interval=timedelta(hours=1), ) -with Flow("Rehydration Pipeline", schedule=schedule) as flow: +# with Flow("Rehydration Pipeline", schedule=schedule) as flow: +with Flow("Rehydration Pipeline") as flow: creds = load_creds() path_list = load_path() tweets = load_tweets(creds, path_list) @@ -189,7 +190,7 @@ def sample(tweets): sample(tweets) -LOCAL_MODE = True +LOCAL_MODE = False if LOCAL_MODE: with prefect.context( diff --git a/modules/FirehoseJob.py b/modules/FirehoseJob.py index 73646d5..4e1edb7 100644 --- a/modules/FirehoseJob.py +++ b/modules/FirehoseJob.py @@ -626,7 +626,7 @@ def process_ids(self, ids_to_process, job_name=None): .get_tweet_hydrated_status_by_id(pd.DataFrame({'id': ids_to_process_batch})) missing_ids = hydration_statuses_df[ hydration_statuses_df['hydrated'] != 'FULL' ]['id'].tolist() - print('Skipping cached %s, fetching %s, of requested %s' % ( + logger.debug('Skipping cached %s, fetching %s, of requested %s' % ( len(ids_to_process_batch) - len(missing_ids), len(missing_ids), len(ids_to_process_batch))) From 4c2b1abd97d5934eac5683d96460e644761f653b Mon Sep 17 00:00:00 2001 From: lmeyerov Date: Thu, 2 Apr 2020 22:10:55 -0700 Subject: [PATCH 16/47] docs(issue tracker): link gh projects on README --- README.md | 2 ++ 1 file changed, 2 insertions(+) diff --git a/README.md b/README.md index 5556f19..0be52b3 100644 --- a/README.md +++ b/README.md @@ -8,6 +8,8 @@ * [Meetings: Google calendar](https://calendar.google.com/calendar?cid=Z3JhcGhpc3RyeS5jb21fdTQ3bmQ3YTdiZzB0aTJtaW9kYTJybGx2cTBAZ3JvdXAuY2FsZW5kYXIuZ29vZ2xlLmNvbQ) +* [Issue tracker](https://github.com/TheDataRideAlongs/ProjectDomino/projects/1?fullscreen=true) + * **Graph4good contributors:** We're excited to work with you! Check out the subprojects below we are actively seeking help on, look at some of the Github Issues, and ping on Slack for which you're curious about tackling and others not here. We can then share our current thoughts and tips for getting started. Most will be useful as pure Python [Google Collab notebook](https://colab.research.google.com) proveouts and local Neo4j Docker + Python proveouts: You can move quickly, and we can more easily integrate into our automation pipelines. **One of the most important steps in stopping the COVID-19 pandemic is influencing mass behavior change for citizens to take appropriate, swift action on mitigating infection and human-to-human contact.** Government officials at all levels have advocated misinformed practices such as dining out or participating in outdoor gatherings that have contributed to amplifying the curve rather than flattening it. At time of writing, the result of poor crisis emergency risk communication has led to over 14,000 US citizens testing positive, 2-20X more are likely untested, and over 200 deaths. The need to influence appropriate behavior and mitigation actions are extreme: The US has shot up from untouched to become the 6th most infected nation. From a89528a5571919bad351fc16cc2d40a4fce9163f Mon Sep 17 00:00:00 2001 From: lmeyerov Date: Fri, 3 Apr 2020 10:33:17 -0700 Subject: [PATCH 17/47] docs(volunteers): Add legal --- README.md | 3 ++- 1 file changed, 2 insertions(+), 1 deletion(-) diff --git a/README.md b/README.md index 0be52b3..699b447 100644 --- a/README.md +++ b/README.md @@ -55,7 +55,8 @@ We are actively seeking several forms of support: * **Data scientists: especially around graph, misinformation, neural networks, NLP, with backgrounds such as security, fraud, misinformation, marketing** * Developers & designers: intelligence integrations, website for search & reports, automations, intervention bots, API * Marketing: Strategy & implementation - * Public health and communications: Especially around intervention design + * Public health and communications: Especially around safe and effective intervention design + * Legal: Risk & legal analysis for various interventions * **APIs and Data**: * Feeds & enriching APIs: Lists and intel on URLs, domains, keywords, emails, topics, blockchain accounts, social media accounts & content, clinical trials, esp. if tunable on topic From 8ec9061f379668002a6bd143e92ecb58976685aa Mon Sep 17 00:00:00 2001 From: lmeyerov Date: Fri, 3 Apr 2020 10:52:30 -0700 Subject: [PATCH 18/47] docs(README): project tracker links --- README.md | 2 +- 1 file changed, 1 insertion(+), 1 deletion(-) diff --git a/README.md b/README.md index 699b447..c2f1e6a 100644 --- a/README.md +++ b/README.md @@ -8,7 +8,7 @@ * [Meetings: Google calendar](https://calendar.google.com/calendar?cid=Z3JhcGhpc3RyeS5jb21fdTQ3bmQ3YTdiZzB0aTJtaW9kYTJybGx2cTBAZ3JvdXAuY2FsZW5kYXIuZ29vZ2xlLmNvbQ) -* [Issue tracker](https://github.com/TheDataRideAlongs/ProjectDomino/projects/1?fullscreen=true) +* Project Tackers: [Core](https://github.com/TheDataRideAlongs/ProjectDomino/projects/1), [Interventions](https://github.com/TheDataRideAlongs/ProjectDomino/projects/2), and [Issues](https://github.com/TheDataRideAlongs/ProjectDomino/issues) * **Graph4good contributors:** We're excited to work with you! Check out the subprojects below we are actively seeking help on, look at some of the Github Issues, and ping on Slack for which you're curious about tackling and others not here. We can then share our current thoughts and tips for getting started. Most will be useful as pure Python [Google Collab notebook](https://colab.research.google.com) proveouts and local Neo4j Docker + Python proveouts: You can move quickly, and we can more easily integrate into our automation pipelines. From 80c86221cfcde554daee556f5a1e639a7f8689b6 Mon Sep 17 00:00:00 2001 From: Dave Date: Fri, 3 Apr 2020 15:43:47 -0800 Subject: [PATCH 19/47] Got initial version of the unit tests working for Neo --- infra/neo4j/docker/docker-compose.yml | 11 ++- infra/neo4j/scripts/neo4j-indexes.cypher | 6 +- modules/tests/__init__.py | 0 modules/tests/requirements.txt | 1 + modules/tests/test_Neo4jDataAccess.py | 116 +++++++++++++++++++++++ test_neo.py | 65 ------------- 6 files changed, 128 insertions(+), 71 deletions(-) create mode 100644 modules/tests/__init__.py create mode 100644 modules/tests/requirements.txt create mode 100644 modules/tests/test_Neo4jDataAccess.py delete mode 100644 test_neo.py diff --git a/infra/neo4j/docker/docker-compose.yml b/infra/neo4j/docker/docker-compose.yml index f730ef6..855e7cd 100644 --- a/infra/neo4j/docker/docker-compose.yml +++ b/infra/neo4j/docker/docker-compose.yml @@ -1,11 +1,11 @@ services: neo4j: image: neo4j:4.0.2-enterprise - network_mode: "bridge" + network_mode: 'bridge' ports: - - "10001:7687" - - "10002:7473" - - "10003:7474" + - '10001:7687' + - '10002:7473' + - '10003:7474' restart: unless-stopped volumes: - /datadrive/neo4j/plugins:/plugins @@ -20,6 +20,7 @@ services: - NEO4J_apoc_export_file_enabled=true - NEO4J_dbms_backup_enabled=true - NEO4J_dbms_transaction_timeout=60s + - NEO4j_apoc_trigger_enabled=true logging: options: - tag: "ImageName:{{.ImageName}}/Name:{{.Name}}/ID:{{.ID}}/ImageFullID:{{.ImageFullID}}" + tag: 'ImageName:{{.ImageName}}/Name:{{.Name}}/ID:{{.ID}}/ImageFullID:{{.ImageFullID}}' diff --git a/infra/neo4j/scripts/neo4j-indexes.cypher b/infra/neo4j/scripts/neo4j-indexes.cypher index a9605a6..768622f 100644 --- a/infra/neo4j/scripts/neo4j-indexes.cypher +++ b/infra/neo4j/scripts/neo4j-indexes.cypher @@ -9,4 +9,8 @@ ON (n:Url) ASSERT n.full_url IS UNIQUE CREATE INDEX tweet_by_type FOR (n:Tweet) -ON (n.tweet_type) \ No newline at end of file +ON (n.tweet_type) + +CREATE INDEX tweet_by_hydrated +FOR (n:Tweet) +ON (n.hydrated) \ No newline at end of file diff --git a/modules/tests/__init__.py b/modules/tests/__init__.py new file mode 100644 index 0000000..e69de29 diff --git a/modules/tests/requirements.txt b/modules/tests/requirements.txt new file mode 100644 index 0000000..55b033e --- /dev/null +++ b/modules/tests/requirements.txt @@ -0,0 +1 @@ +pytest \ No newline at end of file diff --git a/modules/tests/test_Neo4jDataAccess.py b/modules/tests/test_Neo4jDataAccess.py new file mode 100644 index 0000000..d3dc285 --- /dev/null +++ b/modules/tests/test_Neo4jDataAccess.py @@ -0,0 +1,116 @@ +from modules.Neo4jDataAccess import Neo4jDataAccess +from neo4j import GraphDatabase, basic_auth +import pandas as pd +import pytest +import os +import sys +from pathlib import Path + + +class TestNeo4jDataAccess: + @classmethod + def setup_class(cls): + cls.creds = [ + { + "type": "writer", + "creds": { + "host": "localhost", + "port": "7687", + "user": "neo4j", + "password": "neo4j123" + } + }, + { + "type": "reader", + "creds": { + "host": "localhost", + "port": "7687", + "user": "neo4j", + "password": "neo4j123" + } + } + ] + data = [{'tweet_id': 1, 'text': 'Tweet 1', 'hydrated': 'FULL'}, + {'tweet_id': 2, 'text': 'Tweet 2', 'hydrated': 'FULL'}, + {'tweet_id': 3, 'text': 'Tweet 3'}, + {'tweet_id': 4, 'text': 'Tweet 4', 'hydrated': 'PARTIAL'}, + {'tweet_id': 5, 'text': 'Tweet 5', 'hydrated': 'PARTIAL'}, + ] + + traversal = '''UNWIND $tweets AS t + MERGE (tweet:Tweet {id:t.tweet_id}) + ON CREATE SET + tweet.text = t.text, + tweet.hydrated = t.hydrated + ''' + res = list(filter(lambda c: c["type"] == 'writer', cls.creds)) + creds = res[0]["creds"] + uri = f'bolt://{creds["host"]}:{creds["port"]}' + graph = GraphDatabase.driver( + uri, auth=basic_auth(creds['user'], creds['password']), encrypted=False) + try: + with graph.session() as session: + session.run(traversal, tweets=data) + cls.ids = pd.DataFrame({'id': [1, 2, 3, 4, 5]}) + except Exception as err: + print(err) + + def test_get_tweet_hydrated_status_by_id(self): + df = Neo4jDataAccess( + neo4j_creds=self.creds).get_tweet_hydrated_status_by_id(self.ids) + + assert len(df) == 5 + assert df[df['id'] == 1]['hydrated'][0] == 'FULL' + assert df[df['id'] == 2]['hydrated'][1] == 'FULL' + assert df[df['id'] == 3]['hydrated'][2] == None + assert df[df['id'] == 4]['hydrated'][3] == 'PARTIAL' + assert df[df['id'] == 5]['hydrated'][4] == 'PARTIAL' + + def test_save_parquet_to_graph(self): + filename = os.path.join(os.path.dirname(__file__), + 'data/2020_03_22_02_b1.snappy2.parquet') + tdf = pd.read_parquet(filename, engine='pyarrow') + Neo4jDataAccess( + neo4j_creds=self.creds).save_parquet_df_to_graph(tdf, 'dave') + assert True + + # Test get_tweet_by_id + def test_get_tweet_by_id(self): + df = pd.DataFrame([{"id": 1}]) + df = Neo4jDataAccess( + neo4j_creds=self.creds).get_tweet_by_id(df) + assert len(df) == 1 + assert df.at[0, 'id'] == 1 + assert df.at[0, 'text'] == 'Tweet 1' + assert df.at[0, 'hydrated'] == 'FULL' + + def test_get_tweet_by_id_with_cols(self): + df = pd.DataFrame([{"id": 1}]) + df = Neo4jDataAccess( + neo4j_creds=self.creds).get_tweet_by_id(df, cols=['id', 'text']) + assert len(df) == 1 + assert len(df.columns) == 2 + assert df.at[0, 'id'] == 1 + assert df.at[0, 'text'] == 'Tweet 1' + + def test_get_from_neo(self): + df = Neo4jDataAccess(neo4j_creds=self.creds).get_from_neo( + 'MATCH (n:Tweet) WHERE n.hydrated=\'FULL\' RETURN n.id, n.text LIMIT 5') + assert len(df) == 5 + assert len(df.columns) == 2 + + def test_get_from_neo_with_limit(self): + df = Neo4jDataAccess(neo4j_creds=self.creds).get_from_neo( + 'MATCH (n:Tweet) WHERE n.hydrated=\'FULL\' RETURN n.id, n.text LIMIT 5', limit=1) + assert len(df) == 1 + assert len(df.columns) == 2 + + def test_get_from_neo_with_limit_only(self): + df = Neo4jDataAccess(neo4j_creds=self.creds).get_from_neo( + 'MATCH (n:Tweet) WHERE n.hydrated=\'FULL\' RETURN n.id, n.text', limit=1) + assert len(df) == 1 + assert len(df.columns) == 2 + + +def setup_cleanup(self): + print("I want to perfrom some cleanup action!") diff --git a/test_neo.py b/test_neo.py deleted file mode 100644 index eff45ee..0000000 --- a/test_neo.py +++ /dev/null @@ -1,65 +0,0 @@ -import pandas as pd -import logging -from modules.Neo4jDataAccess import Neo4jDataAccess - -df = pd.DataFrame({'id': [1219746154621165568, - 1219746203652456448, - 1219746235038474243, - 1219746508955967488, - 1219746544955453441] - }) -# DEBUG, INFO, WARNING, ERROR, CRITICAL -logging.getLogger().setLevel(logging.WARNING) -pd.set_option('display.max_columns', 500) -pd.set_option('display.max_colwidth', None) - - -# Test save_parquet_df_to_graph -print('----') -print('Testing Parquet Save') -tdf = pd.read_parquet( - './data/2020_03_22_02_b1.snappy2.parquet', engine='pyarrow') -Neo4jDataAccess().save_parquet_df_to_graph(tdf, 'dave') -print('----') - -# Test get_tweet_hydrated_status_by_id -print('----') -print('Testing get_tweet_hydrated_status_by_id') -df = Neo4jDataAccess().get_tweet_hydrated_status_by_id(df) -print(df) - -# Test get_tweet_by_id -print('----') -print('Testing get_tweet_by_id') -df = Neo4jDataAccess().get_tweet_by_id(df) -print(df) -print('----') -print('Testing get_tweet_by_id for cols') -df = Neo4jDataAccess().get_tweet_by_id( - df, cols=['id', 'job_name', 'created_at']) -print('Column check: ' + df.columns) -print('----') - -# Test get_from_neo -print('----') -print('Testing get_from_neo for Limit 1') -df = Neo4jDataAccess().get_from_neo( - 'MATCH (n:Tweet) WHERE n.hydrated=\'FULL\' RETURN n.id, n.text LIMIT 5') -print(df) -print('----') - -print('----') -print('Testing get_from_neo for Limit 1') -df = Neo4jDataAccess().get_from_neo( - 'MATCH (n:Tweet) WHERE n.hydrated=\'FULL\' RETURN n.id, n.text LIMIT 5', limit=1) -print(df) -print('----') - -print('----') -print('Testing get_from_neo with limit only') -df = Neo4jDataAccess().get_from_neo( - 'MATCH (n:Tweet) RETURN n', limit=1) -print(df) -print('----') - -print('Done') From 609b95ac891c8c5146109354d59fb7b4f833c359 Mon Sep 17 00:00:00 2001 From: Ziyao Wei Date: Sat, 4 Apr 2020 12:15:24 -0400 Subject: [PATCH 20/47] Add docker-compose.yml for prefect UI --- infra/prefect/docker/docker-compose.yml | 110 ++++++++++++++++++++++++ 1 file changed, 110 insertions(+) create mode 100644 infra/prefect/docker/docker-compose.yml diff --git a/infra/prefect/docker/docker-compose.yml b/infra/prefect/docker/docker-compose.yml new file mode 100644 index 0000000..2ff5164 --- /dev/null +++ b/infra/prefect/docker/docker-compose.yml @@ -0,0 +1,110 @@ +# Copied from https://github.com/PrefectHQ/prefect/blob/master/src/prefect/cli/docker-compose.yml +# +# Example command: +# APOLLO_HOST_PORT=4200 \ +# GRAPHQL_HOST_PORT=4201 \ +# HASURA_HOST_PORT=3000 \ +# POSTGRES_HOST_PORT=5432 \ +# UI_HOST_PORT=8080 \ +# POSTGRES_USER=prefect \ +# POSTGRES_PASSWORD=test-password \ +# POSTGRES_DB=prefect_server \ +# DB_CONNECTION_URL=postgresql://$POSTGRES_USER:$POSTGRES_PASSWORD@postgres:$POSTGRES_HOST_PORT/$POSTGRES_DB \ +# HASURA_API_URL=http://hasura:$HASURA_HOST_PORT/v1alpha1/graphql \ +# HASURA_WS_URL=ws://hasura:$HASURA_HOST_PORT/v1alpha1/graphql \ +# PREFECT_API_HEALTH_URL=http://graphql:$GRAPHQL_HOST_PORT/health \ +# PREFECT_API_URL=http://graphql:$GRAPHQL_HOST_PORT/graphql/ \ +# PREFECT_SERVER_DB_CMD='prefect-server database upgrade -y' \ +# docker-compose up +# +# Note: The server port cannot be overriden (issue: https://github.com/PrefectHQ/prefect/issues/2237); +# When support is added APOLLO_HOST_PORT should be set to the server port number. + +version: "3.7" + +services: + postgres: + image: "postgres:11" + ports: + - "${POSTGRES_HOST_PORT:-5432}:5432" + environment: + POSTGRES_USER: ${POSTGRES_USER} + POSTGRES_PASSWORD: ${POSTGRES_PASSWORD} + POSTGRES_DB: ${POSTGRES_DB} + networks: + - prefect-server + restart: "always" + command: + - "postgres" + # explicitly set max connections + - "-c" + - "max_connections=150" + hasura: + image: "hasura/graphql-engine:v1.1.0" + ports: + - "${HASURA_HOST_PORT:-3000}:3000" + command: "graphql-engine serve" + environment: + HASURA_GRAPHQL_DATABASE_URL: ${DB_CONNECTION_URL} + HASURA_GRAPHQL_ENABLE_CONSOLE: "true" + HASURA_GRAPHQL_SERVER_PORT: "3000" + HASURA_GRAPHQL_QUERY_PLAN_CACHE_SIZE: 100 + networks: + - prefect-server + restart: "always" + depends_on: + - postgres + graphql: + image: "prefecthq/server:${PREFECT_SERVER_TAG:-latest}" + ports: + - "${GRAPHQL_HOST_PORT:-4201}:4201" + command: bash -c "${PREFECT_SERVER_DB_CMD} && python src/prefect_server/services/graphql/server.py" + environment: + PREFECT_SERVER_DB_CMD: ${PREFECT_SERVER_DB_CMD:-"echo 'DATABASE MIGRATIONS SKIPPED'"} + PREFECT_SERVER__DATABASE__CONNECTION_URL: ${DB_CONNECTION_URL} + PREFECT_SERVER__HASURA__ADMIN_SECRET: ${PREFECT_SERVER__HASURA__ADMIN_SECRET:-hasura-secret-admin-secret} + PREFECT_SERVER__HASURA__HOST: hasura + networks: + - prefect-server + restart: "always" + depends_on: + - hasura + scheduler: + image: "prefecthq/server:${PREFECT_SERVER_TAG:-latest}" + command: "python src/prefect_server/services/scheduler/scheduler.py" + environment: + PREFECT_SERVER__HASURA__ADMIN_SECRET: ${PREFECT_SERVER__HASURA__ADMIN_SECRET:-hasura-secret-admin-secret} + PREFECT_SERVER__HASURA__HOST: hasura + networks: + - prefect-server + restart: "always" + depends_on: + - graphql + apollo: + image: "prefecthq/apollo:${PREFECT_SERVER_TAG:-latest}" + ports: + - "${APOLLO_HOST_PORT:-4200}:4200" + command: "npm run serve" + environment: + HASURA_API_URL: ${HASURA_API_URL:-http://hasura:3000/v1alpha1/graphql} + PREFECT_API_URL: ${PREFECT_API_URL:-http://graphql:4201/graphql/} + PREFECT_API_HEALTH_URL: ${PREFECT_API_HEALTH_URL:-http://graphql:4201/health} + networks: + - prefect-server + restart: "always" + depends_on: + - graphql + ui: + image: "prefecthq/ui:${PREFECT_SERVER_TAG:-latest}" + ports: + - "${UI_HOST_PORT:-8080}:8080" + command: "/intercept.sh" + networks: + - prefect-server + restart: "always" + depends_on: + - apollo + +networks: + prefect-server: + name: prefect-server From dea4f035ca54fe114a496c9ca9a3326d36f2a8b9 Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Mon, 6 Apr 2020 11:38:00 +1000 Subject: [PATCH 21/47] fixed getting interlnational trials, with utf8 encoding --- modules/IngestDrugSynonyms.py | 58 +++++++ modules/TempNB/IngestDrugSynonyms.ipynb | 198 ++++++++++++++++++++++++ modules/clinicaltrialsapi.py | 177 +++++++++++++++++++++ modules/drugbank_vocab.py | 53 +++++++ 4 files changed, 486 insertions(+) create mode 100644 modules/IngestDrugSynonyms.py create mode 100644 modules/TempNB/IngestDrugSynonyms.ipynb create mode 100644 modules/clinicaltrialsapi.py create mode 100644 modules/drugbank_vocab.py diff --git a/modules/IngestDrugSynonyms.py b/modules/IngestDrugSynonyms.py new file mode 100644 index 0000000..a99603b --- /dev/null +++ b/modules/IngestDrugSynonyms.py @@ -0,0 +1,58 @@ +import requests +import pandas as pd +import json +import sys +from pathlib import Path +import xlrd +import csv +import os +import tempfile + + +def api(query,from_study,to_study): + url = "https://www.clinicaltrials.gov/api/query/full_studies?expr={}&min_rnk={}&max_rnk={}&fmt=json".format(query,from_study,to_study) + response = requests.request("GET", url) + return response.json() + +def apiWrapper(query,from_study): + return api(query,from_study,from_study+99) + +def xlsUrlToDF(url:str) -> pd.DataFrame: + r = requests.get(url, allow_redirects=True) + df = pd.DataFrame() + with tempfile.NamedTemporaryFile("wb") as xls_file: + xls_file.write(r.content) + + try: + book = xlrd.open_workbook(xls_file.name,encoding_override="cp1251") + except: + book = xlrd.open_workbook(file) + + sh = book.sheet_by_index(0) + with tempfile.NamedTemporaryFile("w") as csv_file: + wr = csv.writer(csv_file, quoting=csv.QUOTE_ALL) + + for rownum in range(sh.nrows): + wr.writerow(sh.row_values(rownum)) + df = pd.read_csv(csv_file.name) + csv_file.close() + + xls_file.close() + return df + +def getAllStudiesByQuery(query:str) -> list: + studies:list = [] + from_study = 1 + temp = apiWrapper(query,from_study) + nstudies = temp['FullStudiesResponse']['NStudiesFound'] + print("> {} studies found by '{}' keyword".format(nstudies,query)) + if nstudies > 0: + studies = temp['FullStudiesResponse']['FullStudies'] + for study_index in range(from_study+100,nstudies,100): + temp = apiWrapper(query,study_index) + studies.extend(temp['FullStudiesResponse']['FullStudies']) + + return studies + +url = "https://www.who.int/docs/default-source/coronaviruse/covid-19-trials.xls" +internationalstudies = xlsUrlToDF(url) \ No newline at end of file diff --git a/modules/TempNB/IngestDrugSynonyms.ipynb b/modules/TempNB/IngestDrugSynonyms.ipynb new file mode 100644 index 0000000..348384c --- /dev/null +++ b/modules/TempNB/IngestDrugSynonyms.ipynb @@ -0,0 +1,198 @@ +{ + "cells": [ + { + "cell_type": "code", + "execution_count": 1, + "metadata": {}, + "outputs": [], + "source": [ + "import requests\n", + "import pandas as pd\n", + "import json\n", + "import sys\n", + "from pathlib import Path\n", + "import xlrd\n", + "import csv\n", + "import os\n", + "import tempfile" + ] + }, + { + "cell_type": "code", + "execution_count": 2, + "metadata": {}, + "outputs": [ + { + "data": { + "text/html": [ + "" + ], + "text/plain": [ + "" + ] + }, + "metadata": {}, + "output_type": "display_data" + } + ], + "source": [ + "from IPython.core.display import display, HTML\n", + "display(HTML(\"\"))" + ] + }, + { + "cell_type": "code", + "execution_count": 19, + "metadata": {}, + "outputs": [], + "source": [ + "def xlsUrlToDF(url:str) -> pd.DataFrame:\n", + " r = requests.get(url, allow_redirects=True)\n", + " df = pd.DataFrame()\n", + " with tempfile.NamedTemporaryFile(\"wb\") as xls_file:\n", + " xls_file.write(r.content)\n", + " \n", + " try:\n", + " book = xlrd.open_workbook(xls_file.name,encoding_override=\"cp1251\") \n", + " except:\n", + " book = xlrd.open_workbook(xls_file.name)\n", + "\n", + " sh = book.sheet_by_index(0)\n", + " with tempfile.NamedTemporaryFile(\"w\") as csv_file:\n", + " wr = csv.writer(csv_file, quoting=csv.QUOTE_ALL)\n", + "\n", + " for rownum in range(sh.nrows):\n", + " wr.writerow(sh.row_values(rownum))\n", + " df = pd.read_csv(csv_file.name)\n", + " csv_file.close()\n", + "\n", + " xls_file.close()\n", + " return df" + ] + }, + { + "cell_type": "code", + "execution_count": 20, + "metadata": {}, + "outputs": [], + "source": [ + "# TODO url to config\n", + "def api(query,from_study,to_study):\n", + " url = \"https://www.clinicaltrials.gov/api/query/full_studies?expr={}&min_rnk={}&max_rnk={}&fmt=json\".format(query,from_study,to_study)\n", + " response = requests.request(\"GET\", url)\n", + " return response.json()" + ] + }, + { + "cell_type": "code", + "execution_count": 21, + "metadata": {}, + "outputs": [], + "source": [ + "def apiWrapper(query,from_study):\n", + " return api(query,from_study,from_study+99)" + ] + }, + { + "cell_type": "code", + "execution_count": 25, + "metadata": {}, + "outputs": [], + "source": [ + "def getAllStudiesByQuery(query:str) -> list:\n", + " studies:list = []\n", + " from_study = 1\n", + " temp = apiWrapper(query,from_study)\n", + " nstudies = temp['FullStudiesResponse']['NStudiesFound']\n", + " print(\"> {} studies found by '{}' keyword\".format(nstudies,query))\n", + " if nstudies > 0:\n", + " studies = temp['FullStudiesResponse']['FullStudies']\n", + " for study_index in range(from_study+100,nstudies,100):\n", + " temp = apiWrapper(query,study_index)\n", + " studies.extend(temp['FullStudiesResponse']['FullStudies'])\n", + " \n", + " return studies" + ] + }, + { + "cell_type": "code", + "execution_count": 26, + "metadata": {}, + "outputs": [], + "source": [ + "#TODO to config\n", + "url = \"https://www.who.int/docs/default-source/coronaviruse/covid-19-trials.xls\"" + ] + }, + { + "cell_type": "code", + "execution_count": 27, + "metadata": {}, + "outputs": [ + { + "ename": "UnicodeDecodeError", + "evalue": "'charmap' codec can't decode byte 0x9d in position 158: character maps to ", + "output_type": "error", + "traceback": [ + "\u001b[0;31m---------------------------------------------------------------------------\u001b[0m", + "\u001b[0;31mUnicodeDecodeError\u001b[0m Traceback (most recent call last)", + "\u001b[0;32m\u001b[0m in \u001b[0;36mxlsUrlToDF\u001b[0;34m(url)\u001b[0m\n\u001b[1;32m 7\u001b[0m \u001b[0;32mtry\u001b[0m\u001b[0;34m:\u001b[0m\u001b[0;34m\u001b[0m\u001b[0;34m\u001b[0m\u001b[0m\n\u001b[0;32m----> 8\u001b[0;31m \u001b[0mbook\u001b[0m \u001b[0;34m=\u001b[0m \u001b[0mxlrd\u001b[0m\u001b[0;34m.\u001b[0m\u001b[0mopen_workbook\u001b[0m\u001b[0;34m(\u001b[0m\u001b[0mxls_file\u001b[0m\u001b[0;34m.\u001b[0m\u001b[0mname\u001b[0m\u001b[0;34m,\u001b[0m\u001b[0mencoding_override\u001b[0m\u001b[0;34m=\u001b[0m\u001b[0;34m\"cp1251\"\u001b[0m\u001b[0;34m)\u001b[0m\u001b[0;34m\u001b[0m\u001b[0;34m\u001b[0m\u001b[0m\n\u001b[0m\u001b[1;32m 9\u001b[0m \u001b[0;32mexcept\u001b[0m\u001b[0;34m:\u001b[0m\u001b[0;34m\u001b[0m\u001b[0;34m\u001b[0m\u001b[0m\n", + "\u001b[0;32m~/Projects/Graphs4GoodHackathon/ProjectDomino/.XLS2CSV/lib/python3.7/site-packages/xlrd/__init__.py\u001b[0m in \u001b[0;36mopen_workbook\u001b[0;34m(filename, logfile, verbosity, use_mmap, file_contents, encoding_override, formatting_info, on_demand, ragged_rows)\u001b[0m\n\u001b[1;32m 156\u001b[0m \u001b[0mon_demand\u001b[0m\u001b[0;34m=\u001b[0m\u001b[0mon_demand\u001b[0m\u001b[0;34m,\u001b[0m\u001b[0;34m\u001b[0m\u001b[0;34m\u001b[0m\u001b[0m\n\u001b[0;32m--> 157\u001b[0;31m 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} + }, + "nbformat": 4, + "nbformat_minor": 4 +} diff --git a/modules/clinicaltrialsapi.py b/modules/clinicaltrialsapi.py new file mode 100644 index 0000000..baec3f3 --- /dev/null +++ b/modules/clinicaltrialsapi.py @@ -0,0 +1,177 @@ +#!/usr/bin/env python +# coding: utf-8 + +# In[16]: + + +import requests +import pandas as pd +import json +import sys +from pathlib import Path +import xlrd +import csv +import os +import tempfile + + +# In[23]: + + +pd.set_option('display.max_colwidth', -1) +pd.set_option('display.max_rows', 500) +pd.set_option('display.max_columns', 500) +pd.set_option('display.width', 1000) + + +# In[17]: + + +from IPython.core.display import display, HTML +display(HTML("")) + + +# In[41]: + + +def xlsUrlToDF(url:str) -> pd.DataFrame: + r = requests.get(url, allow_redirects=True) + df = pd.DataFrame() + with tempfile.NamedTemporaryFile("wb") as xls_file: + xls_file.write(r.content) + + try: + book = xlrd.open_workbook(xls_file.name,encoding_override="cp1251") + except: + book = xlrd.open_workbook(file) + + sh = book.sheet_by_index(0) + with tempfile.NamedTemporaryFile("w") as csv_file: + wr = csv.writer(csv_file, quoting=csv.QUOTE_ALL) + + for rownum in range(sh.nrows): + wr.writerow(sh.row_values(rownum)) + df = pd.read_csv(csv_file.name) + csv_file.close() + + xls_file.close() + return df + + +# In[113]: + + +def api(query,from_study,to_study): + url = "https://www.clinicaltrials.gov/api/query/full_studies?expr={}&min_rnk={}&max_rnk={}&fmt=json".format(query,from_study,to_study) + response = requests.request("GET", url) + return response.json() + + +# In[75]: + + +def apiWrapper(query,from_study): + return api(query,from_study,from_study+99) + + +# In[100]: + + +def getAllStudiesByQuery(query:str) -> list: + studies:list = [] + from_study = 1 + temp = apiWrapper(query,from_study) + nstudies = temp['FullStudiesResponse']['NStudiesFound'] + print("> {} studies found by '{}' keyword".format(nstudies,query)) + if nstudies > 0: + studies = temp['FullStudiesResponse']['FullStudies'] + for study_index in range(from_study+100,nstudies,100): + temp = apiWrapper(query,study_index) + studies.extend(temp['FullStudiesResponse']['FullStudies']) + + return studies + + +# In[111]: + + +all_studies_by_keyword:dict = {} +queries:list = ["covid-19 Lopinavir","covid-19 Ritonavir" ,"covid-19 chloroquine"] + +for key in queries: + all_studies_by_keyword[key] = getAllStudiesByQuery(key) + + +# In[107]: + + +print(all_studies_by_keyword.keys()) +print([len(all_studies_by_keyword[key]) for key in all_studies_by_keyword.keys()]) + + +# In[89]: + + + +temp = api(query="covid-19",from_study=201,to_study=300) + + +# In[90]: + + +# dict_keys(['APIVrs', 'DataVrs', 'Expression', 'NStudiesAvail', 'NStudiesFound', 'MinRank', 'MaxRank', 'NStudiesReturned', 'FullStudies']) +print(temp['FullStudiesResponse']['NStudiesFound']) +print(temp['FullStudiesResponse']['FullStudies'][-1]["Rank"]) + + +# ## api query + +# In[114]: + + +api(query="covid-19 Lopinavir",from_study=1,to_study=from_study+99) + + +# In[28]: + + +df = pd.DataFrame(api(query="coronavirus",from_study=101,to_study=200)) + + +# In[11]: + + +df + + +# ## who database + +# In[29]: + + +url = "https://www.who.int/docs/default-source/coronaviruse/covid-19-trials.xls" + + +# In[30]: + + +internationalstudies = xlsUrlToDF(url) + + +# In[31]: + + +internationalstudies + + +# In[34]: + + +internationalstudies.count() + + +# In[ ]: + + + + diff --git a/modules/drugbank_vocab.py b/modules/drugbank_vocab.py new file mode 100644 index 0000000..6d66aa4 --- /dev/null +++ b/modules/drugbank_vocab.py @@ -0,0 +1,53 @@ +#!/usr/bin/env python +# coding: utf-8 + +# In[1]: + + +import pandas as pd + + +# In[2]: + + +pd.set_option('display.max_colwidth', -1) +pd.set_option('display.max_rows', 500) +pd.set_option('display.max_columns', 500) +pd.set_option('display.width', 1000) + + +# In[17]: + + +get_ipython().system(' wget -O drug_vocab.csv.zip https://www.drugbank.ca/releases/5-1-5/downloads/all-drugbank-vocabulary') + + +# In[18]: + + +vocab=pd.read_csv("drug_vocab.csv.zip") + + +# In[21]: + + +vocab.head(20) + + +# In[ ]: + + + + + +# In[ ]: + + + + + +# In[ ]: + + + + From 55958d22e526d421ab26e5dadac07fe2a94007d3 Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Mon, 6 Apr 2020 11:54:18 +1000 Subject: [PATCH 22/47] urls to config --- modules/TempNB/IngestDrugSynonyms.ipynb | 19039 +++++++++++++++++++++- 1 file changed, 18998 insertions(+), 41 deletions(-) diff --git a/modules/TempNB/IngestDrugSynonyms.ipynb b/modules/TempNB/IngestDrugSynonyms.ipynb index 348384c..8e886df 100644 --- a/modules/TempNB/IngestDrugSynonyms.ipynb +++ b/modules/TempNB/IngestDrugSynonyms.ipynb @@ -42,7 +42,19 @@ }, { "cell_type": "code", - "execution_count": 19, + "execution_count": 23, + "metadata": {}, + "outputs": [], + "source": [ + "with open(\"config.json\") as f:\n", + " config = json.load(f)\n", + " for key in config:\n", + " os.environ[key] = config[key]" + ] + }, + { + "cell_type": "code", + "execution_count": 15, "metadata": {}, "outputs": [], "source": [ @@ -53,9 +65,9 @@ " xls_file.write(r.content)\n", " \n", " try:\n", - " book = xlrd.open_workbook(xls_file.name,encoding_override=\"cp1251\") \n", + " book = xlrd.open_workbook(xls_file.name,encoding_override=\"utf-8\") \n", " except:\n", - " book = xlrd.open_workbook(xls_file.name)\n", + " book = xlrd.open_workbook(xls_file.name,encoding_override=\"cp1251\")\n", "\n", " sh = book.sheet_by_index(0)\n", " with tempfile.NamedTemporaryFile(\"w\") as csv_file:\n", @@ -72,20 +84,21 @@ }, { "cell_type": "code", - "execution_count": 20, + "execution_count": 24, "metadata": {}, "outputs": [], "source": [ "# TODO url to config\n", + "\n", "def api(query,from_study,to_study):\n", - " url = \"https://www.clinicaltrials.gov/api/query/full_studies?expr={}&min_rnk={}&max_rnk={}&fmt=json\".format(query,from_study,to_study)\n", + " url = os.environ[\"URL_USA\"].format(query,from_study,to_study)\n", " response = requests.request(\"GET\", url)\n", " return response.json()" ] }, { "cell_type": "code", - "execution_count": 21, + "execution_count": 25, "metadata": {}, "outputs": [], "source": [ @@ -95,7 +108,7 @@ }, { "cell_type": "code", - "execution_count": 25, + "execution_count": 26, "metadata": {}, "outputs": [], "source": [ @@ -116,54 +129,18998 @@ }, { "cell_type": "code", - "execution_count": 26, + "execution_count": 29, "metadata": {}, "outputs": [], "source": [ "#TODO to config\n", - "url = \"https://www.who.int/docs/default-source/coronaviruse/covid-19-trials.xls\"" + "url_int = os.environ[\"URL_INT\"]" + ] + }, + { + "cell_type": "code", + "execution_count": 30, + "metadata": {}, + "outputs": [], + "source": [ + "internationalstudies = xlsUrlToDF(url_int)" ] }, { "cell_type": "code", - "execution_count": 27, + "execution_count": 31, "metadata": {}, "outputs": [ { - "ename": "UnicodeDecodeError", - "evalue": 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last)", - "\u001b[0;32m\u001b[0m in \u001b[0;36m\u001b[0;34m\u001b[0m\n\u001b[0;32m----> 1\u001b[0;31m \u001b[0minternationalstudies\u001b[0m \u001b[0;34m=\u001b[0m \u001b[0mxlsUrlToDF\u001b[0m\u001b[0;34m(\u001b[0m\u001b[0murl\u001b[0m\u001b[0;34m)\u001b[0m\u001b[0;34m\u001b[0m\u001b[0;34m\u001b[0m\u001b[0m\n\u001b[0m", - "\u001b[0;32m\u001b[0m in \u001b[0;36mxlsUrlToDF\u001b[0;34m(url)\u001b[0m\n\u001b[1;32m 8\u001b[0m \u001b[0mbook\u001b[0m \u001b[0;34m=\u001b[0m \u001b[0mxlrd\u001b[0m\u001b[0;34m.\u001b[0m\u001b[0mopen_workbook\u001b[0m\u001b[0;34m(\u001b[0m\u001b[0mxls_file\u001b[0m\u001b[0;34m.\u001b[0m\u001b[0mname\u001b[0m\u001b[0;34m,\u001b[0m\u001b[0mencoding_override\u001b[0m\u001b[0;34m=\u001b[0m\u001b[0;34m\"cp1251\"\u001b[0m\u001b[0;34m)\u001b[0m\u001b[0;34m\u001b[0m\u001b[0;34m\u001b[0m\u001b[0m\n\u001b[1;32m 9\u001b[0m \u001b[0;32mexcept\u001b[0m\u001b[0;34m:\u001b[0m\u001b[0;34m\u001b[0m\u001b[0;34m\u001b[0m\u001b[0m\n\u001b[0;32m---> 10\u001b[0;31m 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\u001b[0mdecode\u001b[0m\u001b[0;34m(\u001b[0m\u001b[0mself\u001b[0m\u001b[0;34m,\u001b[0m\u001b[0minput\u001b[0m\u001b[0;34m,\u001b[0m\u001b[0merrors\u001b[0m\u001b[0;34m=\u001b[0m\u001b[0;34m'strict'\u001b[0m\u001b[0;34m)\u001b[0m\u001b[0;34m:\u001b[0m\u001b[0;34m\u001b[0m\u001b[0;34m\u001b[0m\u001b[0m\n\u001b[0;32m---> 15\u001b[0;31m \u001b[0;32mreturn\u001b[0m \u001b[0mcodecs\u001b[0m\u001b[0;34m.\u001b[0m\u001b[0mcharmap_decode\u001b[0m\u001b[0;34m(\u001b[0m\u001b[0minput\u001b[0m\u001b[0;34m,\u001b[0m\u001b[0merrors\u001b[0m\u001b[0;34m,\u001b[0m\u001b[0mdecoding_table\u001b[0m\u001b[0;34m)\u001b[0m\u001b[0;34m\u001b[0m\u001b[0;34m\u001b[0m\u001b[0m\n\u001b[0m\u001b[1;32m 16\u001b[0m \u001b[0;34m\u001b[0m\u001b[0m\n\u001b[1;32m 17\u001b[0m \u001b[0;32mclass\u001b[0m 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TrialIDLast Refreshed onPublic titleScientific titleAcronymPrimary sponsorDate registrationDate registration3Export dateSource Register...ConditionInterventionPrimary outcomeresults date postedresults date completedresults url linkRetrospective flagBridging flag truefalseBridged typeresults yes no
0ChiCTR200002995343878.0Construction and Analysis of Prognostic Predic...Construction and Analysis of Prognostic Predic...NaNZhongnan Hospital of Wuhan University43878.020200217.043834.660579ChiCTR...2019-nCoV Pneumoniasurvival group:none;died:none;duration of in hospital;in hospital mortality;...NaNNaNNaNNo0NaN
1ChiCTR200002993543878.0A Single-arm Clinical Trial for Chloroquine Ph...A Single-arm Clinical Trial for Chloroquine Ph...NaNHwaMei Hospital, University of Chinese Academy...43877.020200216.043834.660579ChiCTR...Novel Coronavirus Pneumonia (COVID-19)Case series:Treated with conventional treatmen...Length of hospital stay;NaNNaNNaNNo0NaN
2ChiCTR200002985043878.0Study on convalescent plasma treatment for sev...Effecacy and safty of convalescent plasma trea...NaNThe First Affiliated Hospital of Zhejiang Univ...43876.020200215.043834.660579ChiCTR...Novel Coronavirus Pneumonia (COVID-19)experimental group:standardized comprehensive ...Fatality rate;NaNNaNNaNYes0NaN
3ChiCTR200002981443878.0Clinical Trial for Integrated Chinese and West...Clinical Trial for Integrated Chinese and West...NaNChildren's Hospital of Fudan University43875.020200214.043834.660579ChiCTR...Novel Coronavirus Pneumonia (COVID-19)control group:Western Medicine;experimental gr...Time fo fever reduction;Time of nucleic acid n...NaNNaNNaNYes0NaN
4NCT0424563143878.0Development of a Simple, Fast and Portable Rec...Development of a Simple, Fast and Portable Rec...NaNBeijing Ditan Hospital43856.020200126.043834.660579ClinicalTrials.gov...New CoronavirusDiagnostic Test: Recombinase aided amplificati...Detection sensitivity is greater than 95%;Dete...NaNNaNNaNYes0NaN
..................................................................
774ChiCTR200003120443920.0A multicenter, single-blind, randomized contro...A multicenter, single-blind, randomized contro...NaNBeijing you'an Hospital, Capital Medical Unive...43914.020200324.043834.660579ChiCTR...Novel Coronavirus Pneumonia (COVID-19)Experimental treatment group:Oral chloroquine ...Clearance time of virus RNA;NaNNaNNaNNo0NaN
775ChiCTR200003118743920.0A medical records based retrospective study fo...A medical records based retrospective study fo...NaNWuhan Third Hospital & Tongren Hospital of Wuh...43913.020200323.043834.660579ChiCTR...Novel Coronavirus Pneumonia (COVID-19)Case series:?;PT-PCR test;NaNNaNNaNYes0NaN
776ChiCTR200003093643920.0A real-world study for the Chinese medicines '...Hospital of Chengdu University of Traditional ...NaNHospital of Chengdu University of Traditional ...43908.020200318.043834.660579ChiCTR...Novel Coronavirus Pneumonia (COVID-19)CM group:Xinguan No. 2 / Xinguan No. 3 alone o...Body temperature returns to normal time;After ...NaNNaNNaNNo0NaN
777ChiCTR200003092343920.0The treatment and diagnosis plan of integrated...The treatment and diagnosis plan of integrated...NaNAffiliated Hospital of Shaanxi University of T...43907.020200317.043834.660579ChiCTR...Novel Coronavirus Pneumonia (COVID-19)Suspected case treatment group:TCM formula 1 o...Incidence of COVID-19 pneumonia;COVID-19 pneum...NaNNaNNaNNo0NaN
778ChiCTR200002997643920.0The effect of Gymnastic Qigong Yangfeifang on ...Novel coronavirus pneumonia (COVID-19) emergen...NaNShanghai University of Traditional Chinese Med...43879.020200218.043834.660579ChiCTR...Novel Coronavirus Pneumonia (COVID-19)experimental group:Fitness Qigong Yangfei pres...Oxygen Inhalation Frequency;Oxygen Intake Time...NaNNaNNaNYes0NaN
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" + ], + "text/plain": [ + " TrialID Last Refreshed on \\\n", + "0 ChiCTR2000029953 43878.0 \n", + "1 ChiCTR2000029935 43878.0 \n", + "2 ChiCTR2000029850 43878.0 \n", + "3 ChiCTR2000029814 43878.0 \n", + "4 NCT04245631 43878.0 \n", + ".. ... ... \n", + "774 ChiCTR2000031204 43920.0 \n", + "775 ChiCTR2000031187 43920.0 \n", + "776 ChiCTR2000030936 43920.0 \n", + "777 ChiCTR2000030923 43920.0 \n", + "778 ChiCTR2000029976 43920.0 \n", + "\n", + " Public title \\\n", + "0 Construction and Analysis of Prognostic Predic... \n", + "1 A Single-arm Clinical Trial for Chloroquine Ph... \n", + "2 Study on convalescent plasma treatment for sev... \n", + "3 Clinical Trial for Integrated Chinese and West... \n", + "4 Development of a Simple, Fast and Portable Rec... \n", + ".. ... \n", + "774 A multicenter, single-blind, randomized contro... \n", + "775 A medical records based retrospective study fo... \n", + "776 A real-world study for the Chinese medicines '... \n", + "777 The treatment and diagnosis plan of integrated... \n", + "778 The effect of Gymnastic Qigong Yangfeifang on ... \n", + "\n", + " Scientific title Acronym \\\n", + "0 Construction and Analysis of Prognostic Predic... NaN \n", + "1 A Single-arm Clinical Trial for Chloroquine Ph... NaN \n", + "2 Effecacy and safty of convalescent plasma trea... NaN \n", + "3 Clinical Trial for Integrated Chinese and West... NaN \n", + "4 Development of a Simple, Fast and Portable Rec... NaN \n", + ".. ... ... \n", + "774 A multicenter, single-blind, randomized contro... NaN \n", + "775 A medical records based retrospective study fo... NaN \n", + "776 Hospital of Chengdu University of Traditional ... NaN \n", + "777 The treatment and diagnosis plan of integrated... NaN \n", + "778 Novel coronavirus pneumonia (COVID-19) emergen... NaN \n", + "\n", + " Primary sponsor Date registration \\\n", + "0 Zhongnan Hospital of Wuhan University 43878.0 \n", + "1 HwaMei Hospital, University of Chinese Academy... 43877.0 \n", + "2 The First Affiliated Hospital of Zhejiang Univ... 43876.0 \n", + "3 Children's Hospital of Fudan University 43875.0 \n", + "4 Beijing Ditan Hospital 43856.0 \n", + ".. ... ... \n", + "774 Beijing you'an Hospital, Capital Medical Unive... 43914.0 \n", + "775 Wuhan Third Hospital & Tongren Hospital of Wuh... 43913.0 \n", + "776 Hospital of Chengdu University of Traditional ... 43908.0 \n", + "777 Affiliated Hospital of Shaanxi University of T... 43907.0 \n", + "778 Shanghai University of Traditional Chinese Med... 43879.0 \n", + "\n", + " Date registration3 Export date Source Register ... \\\n", + "0 20200217.0 43834.660579 ChiCTR ... \n", + "1 20200216.0 43834.660579 ChiCTR ... \n", + "2 20200215.0 43834.660579 ChiCTR ... \n", + "3 20200214.0 43834.660579 ChiCTR ... \n", + "4 20200126.0 43834.660579 ClinicalTrials.gov ... \n", + ".. ... ... ... ... \n", + "774 20200324.0 43834.660579 ChiCTR ... \n", + "775 20200323.0 43834.660579 ChiCTR ... \n", + "776 20200318.0 43834.660579 ChiCTR ... \n", + "777 20200317.0 43834.660579 ChiCTR ... \n", + "778 20200218.0 43834.660579 ChiCTR ... \n", + "\n", + " Condition \\\n", + "0 2019-nCoV Pneumonia \n", + "1 Novel Coronavirus Pneumonia (COVID-19) \n", + "2 Novel Coronavirus Pneumonia (COVID-19) \n", + "3 Novel Coronavirus Pneumonia (COVID-19) \n", + "4 New Coronavirus \n", + ".. ... \n", + "774 Novel Coronavirus Pneumonia (COVID-19) \n", + "775 Novel Coronavirus Pneumonia (COVID-19) \n", + "776 Novel Coronavirus Pneumonia (COVID-19) \n", + "777 Novel Coronavirus Pneumonia (COVID-19) \n", + "778 Novel Coronavirus Pneumonia (COVID-19) \n", + "\n", + " Intervention \\\n", + "0 survival group:none;died:none; \n", + "1 Case series:Treated with conventional treatmen... \n", + "2 experimental group:standardized comprehensive ... \n", + "3 control group:Western Medicine;experimental gr... \n", + "4 Diagnostic Test: Recombinase aided amplificati... \n", + ".. ... \n", + "774 Experimental treatment group:Oral chloroquine ... \n", + "775 Case series:?; \n", + "776 CM group:Xinguan No. 2 / Xinguan No. 3 alone o... \n", + "777 Suspected case treatment group:TCM formula 1 o... \n", + "778 experimental group:Fitness Qigong Yangfei pres... \n", + "\n", + " Primary outcome results date posted \\\n", + "0 duration of in hospital;in hospital mortality;... NaN \n", + "1 Length of hospital stay; NaN \n", + "2 Fatality rate; NaN \n", + "3 Time fo fever reduction;Time of nucleic acid n... NaN \n", + "4 Detection sensitivity is greater than 95%;Dete... NaN \n", + ".. ... ... \n", + "774 Clearance time of virus RNA; NaN \n", + "775 PT-PCR test; NaN \n", + "776 Body temperature returns to normal time;After ... NaN \n", + "777 Incidence of COVID-19 pneumonia;COVID-19 pneum... NaN \n", + "778 Oxygen Inhalation Frequency;Oxygen Intake Time... NaN \n", + "\n", + " results date completed results url link Retrospective flag \\\n", + "0 NaN NaN No \n", + "1 NaN NaN No \n", + "2 NaN NaN Yes \n", + "3 NaN NaN Yes \n", + "4 NaN NaN Yes \n", + ".. ... ... ... \n", + "774 NaN NaN No \n", + "775 NaN NaN Yes \n", + "776 NaN NaN No \n", + "777 NaN NaN No \n", + "778 NaN NaN Yes \n", + "\n", + " Bridging flag truefalse Bridged type results yes no \n", + "0 0 NaN \n", + "1 0 NaN \n", + "2 0 NaN \n", + "3 0 NaN \n", + "4 0 NaN \n", + ".. ... ... ... \n", + "774 0 NaN \n", + "775 0 NaN \n", + "776 0 NaN \n", + "777 0 NaN \n", + "778 0 NaN \n", + "\n", + "[779 rows x 40 columns]" + ] + }, + "execution_count": 31, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "internationalstudies" + ] + }, + { + "cell_type": "code", + "execution_count": 32, + "metadata": {}, + "outputs": [ + { + "data": { + "text/plain": [ + "{'FullStudiesResponse': {'APIVrs': '1.01.02',\n", + " 'DataVrs': '2020:04:03 00:51:56.804',\n", + " 'Expression': 'covid-19',\n", + " 'NStudiesAvail': 335064,\n", + " 'NStudiesFound': 318,\n", + " 'MinRank': 1,\n", + " 'MaxRank': 100,\n", + " 'NStudiesReturned': 100,\n", + " 'FullStudies': [{'Rank': 1,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04330261',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'REB18-0107_MOD9'},\n", + " 'Organization': {'OrgFullName': 'University of Calgary',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Clinical Characteristics and Outcomes of Pediatric COVID-19',\n", + " 'OfficialTitle': 'Clinical Characteristics and Outcomes of Children Potentially Infected by Severe Acute Respiratory Distress Syndrome (SARS)-CoV-2 Presenting to Pediatric Emergency Departments',\n", + " 'Acronym': 'PERN-COVID-19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 18, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 17, 2021',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'March 17, 2022',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 30, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 30, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 30, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'University of Calgary',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Rationale: The clinical manifestations of SARS-CoV-2 infection in children are poorly characterized. Preliminary findings indicate that they may be atypical. There is a need to identify the spectrum of clinical presentations, predictors of severe disease (COVID-19) outcomes, and successful treatment strategies in this population.\\n\\nGoals:\\n\\nPrimary - Describe and compare characteristics of confirmed SARS-CoV-2 infected children with symptomatic test-negative children.\\n\\nSecondary - 1) Describe and compare confirmed SARS-CoV-2 infected children with mild versus severe COVID-19 outcomes; 2) Describe healthcare resource utilization for, and outcomes of, screening and care of pediatric COVID-19 internationally, alongside regional public health policy changes.\\n\\nMethods: This prospective observational study will occur in 50 emergency departments across 11 countries. We will enroll 12,500 children who meet institutional screening guidelines and undergo SARS-CoV-2 testing. Data collection focuses on epidemiological risk factors, demographics, signs, symptoms, interventions, laboratory testing, imaging, and outcomes. Collection will occur at enrollment, 14 days, and 90 days.\\n\\nTimeline: Recruitment will last for 12 months (worst-case model) and will begin within 7-14 days of funding notification after ongoing expedited review of ethics and data sharing agreements.\\n\\nImpact: Results will be shared in real-time with key policymakers, enabling rapid evidence-based adaptations to pediatric case screening and management.',\n", + " 'DetailedDescription': \"Pediatric COVID-19: The characteristics of pediatric 2019 novel coronavirus disease (COVID-19) are not yet well understood. Preliminary findings indicate that atypical presentations of COVID-19 occur in children. Thus, there is an urgent need to identify risk factors for pediatric COVID-19 infection, the range of clinical manifestations, predictors of severe outcomes, and successful treatment strategies.\\n\\nObjectives: Primary: To contribute to the optimization of medical countermeasures to pediatric COVID-19 through describing and comparing the clinical characteristics of SARS-CoV-2 infected children (i.e. test positive) with children who were screened for SARS-CoV-2 but tested negative. We will also describe and compare SARS-CoV-2 infected children with mild versus those with severe outcomes. This study will also describe the health care resources utilized for screening, isolation, and care of pediatric COVID-19, examined alongside relevant public health policies.\\n\\nMethods: This is a two-year prospective observational study that will take place at 50 EDs across 19 countries. We will enroll children (<18 years old) presenting to participating study EDs who meet institutional screening guidelines and undergo testing for COVID-19. Data collection is aligned with WHO templates and focuses on epidemiological factors, demographics, signs, symptoms, exposures, interventions, and test results. Collection will occur at the time of enrolment, during the course of illness, at hospital discharge (if admitted), and at two weeks and three months following enrolment. Over a period of 18 months (starting March 31st, 2020) we aim to enroll and complete follow-up for a total of 5000 children with screened for suspected SARS-CoV-2 infection. Data will be entered into a centralized database, and analyzed using simple and multiple ordinal logistic regression models. Data will be interpreted alongside detailed, prospectively collected, information on the changes to case isolation, screening, and management policies that occur throughout the epidemic in each institution and study region.\\n\\nFeasibility: The Pediatric Emergency Research Networks (PERN) represents the largest international acute pediatric care collaboration in the world, including more than 200 hospitals across 35 countries. Currently, PERN is carrying out the PERN-Pneumonia prospective cohort study, designed to identify predictors of severe pneumonia at 70 hospitals around the globe, including at eight Canadian pediatric emergency departments (ED). This study will build onto the PERN-Pneumonia study infrastructure (e.g. ethics approvals, data sharing agreements, research teams) in order to facilitate a unique, rapid, and global response to the COVID-19 epidemic. Feasibility is enhanced by our design - we will not interfere with the existing COVID-19 screening and management procedures in-place in study EDs; we will not collect any biological specimens, and will not prescribe any interventions.\\n\\nProject Team: This international multidisciplinary team includes pediatric emergency medicine and infectious disease clinicians, epidemiologists, statisticians, and public health leaders from around the globe. Team members have led many landmark trials in pediatric emergency medicine, and lead large pediatric research networks and studies including the PERN-Pneumonia study. They also came together to study the H1N1 pandemic and identified predictors of severe outcomes. Team members also have expertise in pediatric lower respiratory tract infections, biostatistics, and epidemiology (including the CDC lead on the MERS-CoV outbreak). This study team also includes the Public Health Agency of Canada's senior medical/technical expert on COVID-19.\\n\\nImpact of the research: The results of this study, which will be shared in real-time with appropriate national and international authorities, will enable policymakers to make rapid evidence-based adaptations to case screening and management procedures that will then allow for the earlier identification of children likely to have confirmed infection with COVID-19 as well as to prioritize those children likely to have severe outcomes. Finally, the establishment of this global multi-site study will be the first trial of a rapid PERN networks response to a pandemic novel respiratory virus, which, applying lessons-learned, can be urgently reactivated for future public health emergencies.\"},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", + " 'SARS-CoV-2 Infection',\n", + " 'Pediatric ALL',\n", + " 'Pneumonia, Viral',\n", + " 'Pandemic Response']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '12500',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'SARS-CoV-2 Positive Children',\n", + " 'ArmGroupDescription': 'All children screened for SARS-CoV-2 and presenting to participating sites will be enrolled in this study. Children who are eventually test-positive for SARS-CoV-2 will be considered the exposed group in this study. These children will have exactly the same prospective follow-up as the other group.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: Exposure (not intervention) - SARS-CoV-2 infection']}},\n", + " {'ArmGroupLabel': 'SARS-CoV-2 Negative Children',\n", + " 'ArmGroupDescription': 'All children screened for SARS-CoV-2 and presenting to participating sites will be enrolled in this study. Children who are eventually test-negative for SARS-CoV-2 will be considered the unexposed (control) group in this study. These children will have exactly the same prospective follow-up as the other group.'}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", + " 'InterventionName': 'Exposure (not intervention) - SARS-CoV-2 infection',\n", + " 'InterventionDescription': 'Exposure is infection with the virus. There is no intervention',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['SARS-CoV-2 Positive Children']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Clinical characteristics of children with SARS-CoV-2',\n", + " 'PrimaryOutcomeDescription': \"Clinical characteristics among children presenting to a participating hospital's EDs who meet each site's local SARS-CoV-2 screening criteria, will be described and compared between children with confirmed SARS-CoV-2 (i.e. test-positive) versus suspected (i.e. test-negative) infections.\",\n", + " 'PrimaryOutcomeTimeFrame': '18 months'},\n", + " {'PrimaryOutcomeMeasure': 'Factors associated with severe COVID-19 outcomes',\n", + " 'PrimaryOutcomeDescription': 'Factors associated with severe outcomes [i.e. positive pressure ventilation (invasive or noninvasive) OR intensive care unit admission with ventilatory or inotropic support OR death; other outcomes may be added as the understanding of the epidemic evolves) will be identified in confirmed paediatric COVID-19 cases.',\n", + " 'PrimaryOutcomeTimeFrame': '18 months'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Health care resource utilization for COVID-19 patient management',\n", + " 'SecondaryOutcomeDescription': 'Health care resource utilization for patient management (e.g. frequencies of isolation, laboratory testing, imaging, and supportive care, with associated costs) of both suspected and confirmed SARS-CoV-2 infected children according to changes in national and regional policies.',\n", + " 'SecondaryOutcomeTimeFrame': '18 months'},\n", + " {'SecondaryOutcomeMeasure': 'Sensitivity and specificity of COVID-19 case screening policies',\n", + " 'SecondaryOutcomeDescription': 'The sensitivity and specificity of various case screening policies for the detection of confirmed symptomatic SARS-CoV-2 infection (i.e. COVID-19) in children (e.g. addition of vomiting/diarrhoea).',\n", + " 'SecondaryOutcomeTimeFrame': '18 months'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\n< 18 years-old, and\\nPresent to a participating ED for care, and\\nUndergo SARS-CoV-2 testing.\\n\\nExclusion Criteria:\\n\\n1) Refusal to participate (no informed consent)',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MaximumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Child', 'Adult']},\n", + " 'StudyPopulation': 'All children presenting to a participating ED who are screened (i.e. tested) for SARS-CoV-2 during the duration of the study. Children will be mainly from urban areas across Canada, United States of America, Italy, France, Spain, Switzerland, Australia, New Zealand, Argentina, and other countries.',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Stephen Freedman, MDCM, MSc',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '4039557740',\n", + " 'CentralContactEMail': 'stephen.freedman@ahs.ca'},\n", + " {'CentralContactName': 'Anna Funk, PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactEMail': 'anna.funk@ucalgary.ca'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Stephen Freedman, MD',\n", + " 'OverallOfficialAffiliation': 'University of Calgary',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': \"University of Calgary/Alberta Children's Hospital\",\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Calgary',\n", + " 'LocationState': 'Alberta',\n", + " 'LocationZip': 'T3B 6A8',\n", + " 'LocationCountry': 'Canada',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Stephen Freedman, MDCM, MSc',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '4039557740',\n", + " 'LocationContactEMail': 'stephen.freedman@ahs.ca'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", + " 'IPDSharingDescription': 'In keeping with the joint statement on sharing research data and findings relevant to the novel coronavirus (nCoV) outbreak, this study will share data rapidly with local governments as well as international stakeholders.',\n", + " 'IPDSharingInfoTypeList': {'IPDSharingInfoType': ['Study Protocol',\n", + " 'Statistical Analysis Plan (SAP)']},\n", + " 'IPDSharingTimeFrame': 'Ideally in real-time, over the next 18 months'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000011024',\n", + " 'ConditionMeshTerm': 'Pneumonia, Viral'},\n", + " {'ConditionMeshId': 'D000011014', 'ConditionMeshTerm': 'Pneumonia'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000008171',\n", + " 'ConditionAncestorTerm': 'Lung Diseases'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M14938',\n", + " 'ConditionBrowseLeafName': 'Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13547',\n", + " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Newborn',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13548',\n", + " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Adult',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M12487',\n", + " 'ConditionBrowseLeafName': 'Pneumonia',\n", + " 'ConditionBrowseLeafAsFound': 'Pneumonia',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M6379',\n", + " 'ConditionBrowseLeafName': 'Emergencies',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M26731',\n", + " 'ConditionBrowseLeafName': 'Acute Lung Injury',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M12497',\n", + " 'ConditionBrowseLeafName': 'Pneumonia, Viral',\n", + " 'ConditionBrowseLeafAsFound': 'Pneumonia, Viral',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M9751',\n", + " 'ConditionBrowseLeafName': 'Lung Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T4953',\n", + " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Infant',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T191',\n", + " 'ConditionBrowseLeafName': 'Acute Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T1141',\n", + " 'ConditionBrowseLeafName': 'Childhood Acute Lymphoblastic Leukemia',\n", + " 'ConditionBrowseLeafAsFound': 'Pediatric ALL',\n", + " 'ConditionBrowseLeafRelevance': 'high'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC16',\n", + " 'ConditionBrowseBranchName': 'Diseases and Abnormalities at or Before Birth'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 2,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04333862',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '2020-00563'},\n", + " 'Organization': {'OrgFullName': 'University Hospital Inselspital, Berne',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Assessment of Covid-19 Infection Rates in Healthcare Workers Using a Desynchronization Strategy',\n", + " 'OfficialTitle': 'Assessment of Covid-19 Infection Rates in Healthcare Workers Using a Desynchronization Strategy',\n", + " 'Acronym': 'Covid-19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 19, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'June 30, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2021',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'April 1, 2020',\n", + " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 3, 2020',\n", + " 'StudyFirstPostDateType': 'Estimate'},\n", + " 'LastUpdateSubmitDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", + " 'LastUpdatePostDateType': 'Estimate'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'University Hospital Inselspital, Berne',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Desynchronization of infection rates in healthcare workers will potentially reduce the early infection rates and therefore maintain workforce for late time points of the epidemic. Given the current threat of the COVID-19 epidemic, the department for Visceral Surgery and Medicine, Bern University Hospital, has decided to limit its elective interventions to oncological and life-saving procedures only. At the same time, the medical team were split in two teams, each working for 7 days, followed by 7 days off, called a desynchronization strategy. Contacts between the two teams are avoided.\\n\\nThe main aim of present study is to determine, if the infection rate between the two populations (at work versus at home) is different. Secondary aims are to determine if the workforce can be maintained for longer periods compared standard of care, and if the infection rate among patients hospitalized for other reasons varies compared to the community.',\n", + " 'DetailedDescription': 'Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads rapidly and causes a pandemic of coronavirus disease 2019 (COVID-19, the disease caused by SARS-CoV-2). Protecting and supporting caregivers is essential to maintain the workforce in the hospital to treat patients.\\n\\nThe use of recommended barrier precautions such as masks, gloves and gowns is of highest priority in the care of all patients with respiratory symptoms. However, given the long incubation period of 5 days there will be undiagnosed but infected patients with clinically mild cases, atypical presentations or even no symptoms at all. Thus, healthcare workers are on the one side at risk to get infected by asymptomatic patients and on the other side are critically needed for later phases of the epidemic, when the resources will in all likelihood be scarce or depleted.\\n\\nOne potential strategy to maintain workforce throughout an epidemic is to reduce the workforce in the early phases. Reducing workforce at early phases might potentially reduce in-hospital infection of the caregivers and reduces early burnout. One way of reducing the active workforce is to postpone all elective and non-urgent medical interventions to later phases of the epidemic.\\n\\nDesynchronization of infection rates in healthcare workers will potentially reduce the early infection rates and therefore maintain workforce for late time points of the epidemic. Given the current threat of the COVID-19 epidemic, the department for Visceral Surgery and Medicine, Bern University Hospital, has decided to limit its elective interventions to oncological and life-saving procedures only. At the same time, the medical team were split in two teams, each working for 7 days followed by 7 days off, called a desynchronization strategy. Contacts between the two teams are avoided. This new regulation took effect on March 16th 2020.\\n\\nCurrently available resources to perform tests for SARS-CoV-2 infection are limited for the clinical routine and are therefore not available for research purposes. Thus, in the context of a clinical study the investigators aim to perform additional testing of SARS-CoV-2 of healthcare workers and patients in order to determine the clinical consequences of such desynchronization strategy, firstly within the current epidemic and secondly for future outbreaks.\\n\\nThe main aim of present study is to determine if the infection rate between the two populations (at work versus at home) is different. Secondary aims are to determine if the workforce can be maintained for longer periods compared standard of care, and if the infection rate among patients hospitalized for other reasons varies compared to the community.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['SARS-CoV-2']},\n", + " 'KeywordList': {'Keyword': ['SARS-CoV-2', 'COVID-19']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'BioSpec': {'BioSpecRetention': 'Samples With DNA',\n", + " 'BioSpecDescription': 'Collection of nasal swabs twice per week and blood.'},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '500',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Healthcare workers providing healthcare',\n", + " 'ArmGroupDescription': 'To determine the infection rate of healthcare workers providing healthcare versus those who are staying at home, in a desynchronization work strategy'},\n", + " {'ArmGroupLabel': 'Healthcare workers staying at home',\n", + " 'ArmGroupDescription': 'To determine the infection rate of healthcare workers providing healthcare versus those who are staying at home, in a desynchronization work strategy'},\n", + " {'ArmGroupLabel': 'Hospitalized patients',\n", + " 'ArmGroupDescription': 'To compare the infection rate of hospitalized patients versus healthcare workers'}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Fraction of healthcare workers infected with SARS-CoV-2',\n", + " 'PrimaryOutcomeDescription': 'To determine the infection rate of healthcare workers providing healthcare versus those who are staying at home, in a desynchronization work strategy',\n", + " 'PrimaryOutcomeTimeFrame': '90 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Fraction of healthcare workers with COVID-19',\n", + " 'SecondaryOutcomeDescription': 'To compare the infection rate of hospitalized patients versus healthcare workers',\n", + " 'SecondaryOutcomeTimeFrame': '90 days'},\n", + " {'SecondaryOutcomeMeasure': 'Number of patients infected in the hospital',\n", + " 'SecondaryOutcomeDescription': 'Tracing origins of infection in healthcare workers to distinguish between community versus hospital acquired.',\n", + " 'SecondaryOutcomeTimeFrame': '90 days'},\n", + " {'SecondaryOutcomeMeasure': 'Development of SARS-CoV2 specific antibody repertoire',\n", + " 'SecondaryOutcomeDescription': 'To determine the T and B cell specific antibody repertoire in the course of a COVID-19 infection.',\n", + " 'SecondaryOutcomeTimeFrame': '18 months'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\nHealthcare workers of the Department for Visceral Surgery and Medicine\\nPatients of the Department for Visceral Surgery and Medicine\\nWritten informed consent\\n\\nExclusion Criteria:\\n\\nNo informed consent\\nPatients with known COVID-19 infection before hospitalization in the investigators' department\",\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'Health care workers and patients of the Department for Visceral Surgery and Medicine',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Guido Beldi',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '0316328275',\n", + " 'CentralContactPhoneExt': '0316328275',\n", + " 'CentralContactEMail': 'Guido.Beldi@insel.ch'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Guido Beldi, Prof. Dr.',\n", + " 'OverallOfficialAffiliation': 'University Hospital Inselspital, Berne',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Guido Beldi',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Bern',\n", + " 'LocationCountry': 'Switzerland',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Guido Beldi',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '0316328275',\n", + " 'LocationContactPhoneExt': '0316328275',\n", + " 'LocationContactEMail': 'Guido.Beldi@insel.ch'}]}}]}}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", + " 'ConditionMeshTerm': 'Infection'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafAsFound': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", + " {'Rank': 3,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04332380',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'ABN011-1'},\n", + " 'Organization': {'OrgFullName': 'Universidad del Rosario',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Convalescent Plasma for Patients With COVID-19: A Pilot Study',\n", + " 'OfficialTitle': 'Convalescent Plasma for Patients With COVID-19: A Pilot Study',\n", + " 'Acronym': 'CP-COVID-19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'August 31, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 30, 2020',\n", + " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 2, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Juan Manuel Anaya Cabrera',\n", + " 'ResponsiblePartyInvestigatorTitle': 'MD, PhD, Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Universidad del Rosario'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Universidad del Rosario',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'CES University',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'Instituto Distrital de Ciencia Biotecnologia e Innovacion en salud',\n", + " 'CollaboratorClass': 'UNKNOWN'},\n", + " {'CollaboratorName': 'Fundación Universitaria de Ciencias de la Salud',\n", + " 'CollaboratorClass': 'OTHER'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy when there is no vaccine or treatment available for infectious diseases. In the latest viral epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization issued a document outlining a protocol for the use of whole blood or plasma collected from patients who have recovered from the Ebola virus disease by transfusion to empirically treat local infectious outbreaks.',\n", + " 'DetailedDescription': 'The process is based on obtaining plasma from patients recovered from COVID-19 in Colombia, and through a donation of plasma from the recovered, the subsequent transfusion of this to patients infected with coronavirus disease (COVID-19). Our group has reviewed the scientific evidence regarding the application of convalescent plasma for emergency viral outbreaks and has recommended the following protocol'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus',\n", + " 'Coronavirus Infection']},\n", + " 'KeywordList': {'Keyword': ['COVID-19', 'Coronavirus Disease 2019']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 2']},\n", + " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '10',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Intervention Group',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Participants included in the experimental group will receive 500 milliliters of convalescent plasma, distributed in two 250 milliliters transfusions on the first and second day after starting the protocol.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Plasma']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Plasma',\n", + " 'InterventionDescription': 'Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Intervention Group']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Convalescent Plasma COVID-19']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Change in Viral Load',\n", + " 'PrimaryOutcomeDescription': 'Copies of COVID-19 per ml',\n", + " 'PrimaryOutcomeTimeFrame': 'Days 0, 4, 7, 14 and 28'},\n", + " {'PrimaryOutcomeMeasure': 'Change in Immunoglobulin M COVID-19 antibodies Titers',\n", + " 'PrimaryOutcomeDescription': 'Immunoglobulin M COVID-19 antibodies',\n", + " 'PrimaryOutcomeTimeFrame': 'Days 0, 4, 7, 14 and 28'},\n", + " {'PrimaryOutcomeMeasure': 'Change in Immunoglobulin G COVID-19 antibodies Titers',\n", + " 'PrimaryOutcomeDescription': 'Immunoglobulin G COVID-19 antibodies',\n", + " 'PrimaryOutcomeTimeFrame': 'Days 0, 4, 7, 14 and 28'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Intensive Care Unit Admission',\n", + " 'SecondaryOutcomeDescription': 'Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28)',\n", + " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", + " {'SecondaryOutcomeMeasure': 'Length of Intensive Care Unit stay',\n", + " 'SecondaryOutcomeDescription': 'Days of Intensive Care Unit management (days 7, 14 and 28)',\n", + " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", + " {'SecondaryOutcomeMeasure': 'Length of hospital stay (days)',\n", + " 'SecondaryOutcomeDescription': 'Days of Hospitalization (days 7, 14 and 28)',\n", + " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", + " {'SecondaryOutcomeMeasure': 'Requirement of mechanical ventilation',\n", + " 'SecondaryOutcomeDescription': 'Proportion of patients with mechanical ventilation (days 7, 14 and 28)',\n", + " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", + " {'SecondaryOutcomeMeasure': 'Duration (days) of mechanical ventilation',\n", + " 'SecondaryOutcomeDescription': 'Days with mechanical ventilation (days 7, 14 and 28)',\n", + " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", + " {'SecondaryOutcomeMeasure': 'Clinical status assessed according to the World Health Organization guideline',\n", + " 'SecondaryOutcomeDescription': '1. Hospital discharge; 2. Hospitalization, not requiring supplemental oxygen; 3. Hospitalization, requiring supplemental oxygen (but not Noninvasive Ventilation/ HFNC); 4. Intensive care unit/hospitalization, requiring Noninvasive Ventilation/ HFNC therapy; 5. Intensive care unit, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 6. Death. (days 7, 14 and 28)',\n", + " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", + " {'SecondaryOutcomeMeasure': 'Mortality',\n", + " 'SecondaryOutcomeDescription': 'Proportión of death patients at days 7, 14 and 28',\n", + " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:Fulfilling all the following criteria\\n\\nAged between 18 and 60 years, male or female.\\nHospitalized participants with diagnosis for COVID 19 by Real Time - Polymerase Chain Reaction.\\nWithout treatment.\\nModerate cases according to the official guideline \"Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)\".\\nConfusion, Urea, Respiratory rate, Blood pressure-65 (CURB-65) >= 2.\\nSequential Organ Failure Assessment score (SOFA) < 6.\\nAbility to understand and the willingness to sign a written informed consent document.\\n\\nExclusion Criteria:\\n\\nFemale subjects who are pregnant or breastfeeding.\\nPatients with prior allergic reactions to transfusions.\\nCritical ill patients in intensive care units.\\nPatients with surgical procedures in the last 30 days.\\nPatients with active treatment for cancer (Radiotherapy or Chemotherapy).\\nHIV diagnosed patients with viral failure (detectable viral load> 1000 copies / ml persistent, two consecutive viral load measurements within a 3 month interval, with medication adherence between measurements after at least 6 months of starting a new regimen antiretrovirals).\\nPatients who have suspicion or evidence of coinfections.\\nEnd-stage chronic kidney disease (Glomerular Filtration Rate <15 ml / min / 1.73 m2).\\nChild Pugh C stage liver cirrhosis.\\nHigh cardiac output diseases.\\nAutoimmune diseases or Immunoglobulin A nephropathy.\\nPatients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '60 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Juan M Anaya Cabrera, MD, PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+57 321 233 9828',\n", + " 'CentralContactEMail': 'anayajm@gmail.com'},\n", + " {'CentralContactName': 'Manuel E Rojas Quintana, MD, MSc',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+57 315 459 9951',\n", + " 'CentralContactEMail': 'manuel_9316@hotmail.com'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Juan M Anaya Cabrera, MD, PhD',\n", + " 'OverallOfficialAffiliation': 'Universidad del Rosario',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Universidad del Rosario',\n", + " 'LocationCity': 'Bogota',\n", + " 'LocationState': 'Cundinamarca',\n", + " 'LocationZip': '11100',\n", + " 'LocationCountry': 'Colombia',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Gustavo Quintero, MD, MSc',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+57 318 3606458',\n", + " 'LocationContactEMail': 'gustavo.quintero@urosario.edu.co'},\n", + " {'LocationContactName': 'Juan M Anaya Cabrera, MD, PhD',\n", + " 'LocationContactRole': 'Principal Investigator'},\n", + " {'LocationContactName': 'Manuel E Rojas Quintana, MD, MSc',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Sara Velez Gomez',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Juan C Diaz Coronado, MD, MSc',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Anha M Robledo Moreno',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Juan E Gallo Bonilla, MSc, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Ruben D Manrique Hernández, MSc, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Oscar M Gómez Guzmán, MSc, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Isaura P Torres Gómez, MSc, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Paula A Pedroza Rodríguez',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Bernardo Camacho Rodríguez, MD, MSc',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Jeser S Grass Guaqueta, MSc',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Gustavo A Salguero López, MD, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Luisa P Duarte Correales',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Cristian A Ricaurte Perez, MSc',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Adriana Rojas Villarraga, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Heily C Ramírez Santana, MSc, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Diana M Monsalve Carmona, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Yhojan A Rodríguez Velandia, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Yeny Y Acosta Ampudia, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Carlos E Perez, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Ruben D Mantilla, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Paula Gaviria, MSc',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}}]}},\n", + " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '31986264',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:.'},\n", + " {'ReferencePMID': '32134116',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Wang Y, Wang Y, Chen Y, Qin Q. Unique epidemiological and clinical features of the emerging 2019 novel coronavirus pneumonia (COVID-19) implicate special control measures. J Med Virol. 2020 Mar 5. doi: 10.1002/jmv.25748. [Epub ahead of print] Review.'},\n", + " {'ReferencePMID': '32125362',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Young BE, Ong SWX, Kalimuddin S, Low JG, Tan SY, Loh J, Ng OT, Marimuthu K, Ang LW, Mak TM, Lau SK, Anderson DE, Chan KS, Tan TY, Ng TY, Cui L, Said Z, Kurupatham L, Chen MI, Chan M, Vasoo S, Wang LF, Tan BH, Lin RTP, Lee VJM, Leo YS, Lye DC; Singapore 2019 Novel Coronavirus Outbreak Research Team. Epidemiologic Features and Clinical Course of Patients Infected With SARS-CoV-2 in Singapore. JAMA. 2020 Mar 3. doi: 10.1001/jama.2020.3204. [Epub ahead of print]'},\n", + " {'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Infectious, D. & Outbreaks, D. Maintaining a safe and adequate blood supply during the pandemic outbreak of coronavirus disease ( COVID-19 ). OMS 1-5 (2020).'}]},\n", + " 'SeeAlsoLinkList': {'SeeAlsoLink': [{'SeeAlsoLinkLabel': 'FDA recommendations for convalescent plasma clinical research',\n", + " 'SeeAlsoLinkURL': 'https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", + " {'ConditionMeshId': 'D000045169',\n", + " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M14938',\n", + " 'ConditionBrowseLeafName': 'Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 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{'Rank': 4,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04303299',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'TH-DMS-COVID19 study'},\n", + " 'Organization': {'OrgFullName': 'Rajavithi Hospital',\n", + " 'OrgClass': 'OTHER_GOV'},\n", + " 'BriefTitle': 'Various Combination of Protease Inhibitors, Oseltamivir, Favipiravir, and Hydroxychloroquine for Treatment of COVID19 : A Randomized Control Trial',\n", + " 'OfficialTitle': 'A 6 Week Prospective, Open Label, Randomized, in Multicenter Study of, Oseltamivir Plus Hydroxychloroquine Versus Lopipinavir/ Ritonavir Plus Oseltamivir Versus Darunavir/ Ritonavir Plus Oseltamivir Plus Hydroxychloroquine in Mild COVID19 AND Lopipinavir/ Ritonavir Plus Oseltamivir Versus Favipiravir Plus Lopipinavir / Ritonavir Versus Darunavir/ Ritonavir Plus Oseltamivir Plus Hydroxychloroquine Versus Favipiravir Plus Darunavir and Ritonavir Plus Hydroxychloroquine in Moderate to Critically Ill COVID19',\n", + " 'Acronym': 'THDMS-COVID19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 15, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'October 31, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'November 30, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'February 24, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 8, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 11, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 23, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 25, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Dr Subsai Kongsaengdao',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Associate Professor',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Rajavithi Hospital'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Rajavithi Hospital',\n", + " 'LeadSponsorClass': 'OTHER_GOV'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No',\n", + " 'IsUSExport': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'A 6-Week Prospective, Open label, Randomized, in Multicenter Study of, Oseltamivir 300mg per day plus Hydroxychloroquine 800 mg per day versus Combination of Lopipinavir 800mg (or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Oseltamivir 300 mg ( or 4-6 mg /kg ) per day versus Combination of Darunavir 400 mg every 8 hours plus ritonavir 200 mg (or 2.5 mg/kg ) per day plus Oseltamivir 300mg ( or 4-6 mg /kg ) per day plus Hydroxychloroquine 400 mg per day in mild COVID 19 and Combination of Lopipinavir 800 mg (or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Oseltamivir 300 mg ( or 4-6 mg /kg ) per day versus Favipiravir 2400 mg, 2400 mg, and 1200 mg every 8 h on day 1, and a maintenance dose of 1200 mg twice a day plus Lopipinavir 800 mg ( or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day versus Combination of Darunavir 400 mg every 8 hours plus ritonavir 200 mg (or 2.5 mg/kg ) plus Oseltamivir 300 mg (or 4-6 mg /kg ) per day plus Hydroxychloroquine 400 mg per day versus Favipiravir 2400 mg, 2400 mg, and 1200 mg every 8 h on day 1, and a maintenance dose of 1200 mg twice a day plus Darunavir 400 mg every 8 hours Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Hydroxychloroquine 400 mg per day in moderate to critically illness in COVID 19',\n", + " 'DetailedDescription': 'Overall Study Design and Plan Various Combination of Protease inhibitors, Oseltamivir, Favipiravir, and Chloroquin for treatment of COVID19. Non parametric and parametric statistical analysis will be analysed in the efficacy of treatment. For the pair-wise comparison, 2-sided p-value was used to ensure that the overall Type I error=0.05. Beta error 80%. Demographic and safety analyses were based on the summary of descriptive statistics.\\n\\nPre-randomization Phase The pre-randomization phase consisted of a screening period (0 to 1 day prior to randomization).\\n\\nScreening Period (Day -1 to 0) At the screening visit and prior to performance of any study procedures, the investigators would explain the details of the study and the subject would have to sign on the written informed consent, exclusion criteria, and inclusion criteria Each subject who was willing to enrol into the study was asked about their medical history as well as their recent and current medications being taken. All enrolled subjects were asked to undertake an initial physical examination and had to satisfy the criteria for the inclusion /exclusion before being enrolled into the study.\\n\\nAll patients were asked to complete physical examination, CXR, CBC plt, proBNP, High sensitive C reactive protein and Laboratory blood (livers tests, haematology,) examinations, urine pregnancy test) were performed amount 5.5 mL for safety reasons. Nasopharyngeal swabs were collected to detect the ORF 1ab and E genes (sensitivity: 1000 copies per milliliter) by polymerase chain reactions. Will be performed The inclusion visit included the following examination and tests: - physical examination,- vital signs,- weight,- CBC laboratory test result,-Chest X ray or CT chest Blood for plasma cytokine assay -Pro BNP and High sensitive C reactive protein, D dimer Treatment period All patient will be treated with specific arm for 7-10 days or until negative for Nasopharyngeal swabs were collected to detect the ORF 1ab and E genes of SARS -CoV-2 for 3 consecutive tests every 24 -48 hours The quarantine period will be performed for 7-14 days after swab negative All cases may be treated with Antibiotics as prophylaxis or specific treatment Other standard treatment will be allowed for investigator judgments. CXR nasoparyngeal swab will be performed every 1-2 days or up to investigator judgments Follow up Visits Patient will be check up CXR CT scan nasoparyngeal swab will be performed every 1-2 weeks until 6 weeks or clinical complete recovery'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus Infections',\n", + " 'COVID19']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 3']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)',\n", + " 'DesignMaskingDescription': \"The study is described as 'open' unblinded, however all clinical, virological and laboratory data, as well as adverse events were reviewed by two independent physicians, and all radiological images were reviewed by two independent radiologists who were blinded to the treatment assignments.\\n\\nThe study outcomes assessed blinded to randomized group ( PROBE design - prospective randomised open blinded evaluation)\"}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '80',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Oseltamivir plus Chloroquine in Mild COVID19',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Oseltamivir 300mg ( or 4-6 mg/kg) per day plus Hydroxychloroquine 800 mg per day In mild COVID19',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Oral']}},\n", + " {'ArmGroupLabel': 'Darunavir and Ritonavir plus oseltamivir',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Darunavir 400 mg every 8 hours Ritonavir 200 mg (or 2.5 mg/kg ) per day plus plus Oseltamivir 300mg ( or 4-6 mg/kg) per day plus Hydroxychloroquine 400mg per day in Mild COVID19',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Oral']}},\n", + " {'ArmGroupLabel': 'Lopinavir and Ritonavir plus Oseltamivir in mild COVID19',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Lopinavir 800 mg ( or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Oseltamivir 300 mg ( or 4-6 mg /kg ) per day In mild COVID19',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Oral']}},\n", + " {'ArmGroupLabel': 'Lopinavir and Ritonavir Oseltamivir moderate to severe COVID19',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Lopinavir 800 mg ( or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Oseltamivir 300 mg ( or 4-6 mg /kg ) per day In moderate to critically ill COVID19',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Oral']}},\n", + " {'ArmGroupLabel': 'Favipiravir lopinavir /Ritonavir for mod. To severe',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Lopinavir 800 mg (or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Favipiravir 2400 mg, 2400 mg, and 1200 mg every 8 h on day 1, and a maintenance dose of 1200 mg twice a day in Mild COVID19 In moderate to critically ill COVID19',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Oral']}},\n", + " {'ArmGroupLabel': 'Darunavir /ritonavir oseltamivir chloroquine mod-severe',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Darunavir 400 mg every 8 hours Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Oseltamivir 300 mg (or 4-6 mg /kg ) per day plus Hydroxychloroquine 400 mg per day In moderate to critically ill COVID19',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Oral']}},\n", + " {'ArmGroupLabel': 'Darunavir /ritonavir favipiravir chloroquine mod-severe',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Darunavir 400 mg every 8 hours Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Favipiravir 2400 mg, 2400 mg, and 1200 mg every 8 h on day 1, and a maintenance dose of 1200 mg twice a day plus Hydroxychloroquine 400 mg per day In moderate to critically ill COVID19',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Oral']}},\n", + " {'ArmGroupLabel': 'Conventional Qurantine',\n", + " 'ArmGroupType': 'No Intervention',\n", + " 'ArmGroupDescription': 'Patient who unwilling to treatment and willing to quarantine in mild COVID19'}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Oral',\n", + " 'InterventionDescription': 'Anti virus treatment',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Darunavir /ritonavir favipiravir chloroquine mod-severe',\n", + " 'Darunavir /ritonavir oseltamivir chloroquine mod-severe',\n", + " 'Darunavir and Ritonavir plus oseltamivir',\n", + " 'Favipiravir lopinavir /Ritonavir for mod. To severe',\n", + " 'Lopinavir and Ritonavir Oseltamivir moderate to severe COVID19',\n", + " 'Lopinavir and Ritonavir plus Oseltamivir in mild COVID19',\n", + " 'Oseltamivir plus Chloroquine in Mild COVID19']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'SARS-CoV-2 eradication time',\n", + " 'PrimaryOutcomeDescription': 'Eradication of nasopharyngeal SARS-CoV-2',\n", + " 'PrimaryOutcomeTimeFrame': 'Up to 24 weeks'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Number of patient with Death',\n", + " 'SecondaryOutcomeDescription': 'Any death after treatment adjusted by initial severity in each arm',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 24 weeks'},\n", + " {'SecondaryOutcomeMeasure': 'Number of patient with Recovery adjusted by initial severity in each arm',\n", + " 'SecondaryOutcomeDescription': 'Normal pulmonary function, normal O2 saturation after treatment Adjusted by initial severity in each arm',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 24 weeks'},\n", + " {'SecondaryOutcomeMeasure': 'Number of day With ventilator dependent adjusted by initial severity in each arm',\n", + " 'SecondaryOutcomeDescription': 'Number of day with ventilator assistant',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 24 weeks'},\n", + " {'SecondaryOutcomeMeasure': 'Number of patient developed Acute Respiratory Distress Syndrome After treatment',\n", + " 'SecondaryOutcomeDescription': 'Number of patient developed new ARDS',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 24 weeks'}]},\n", + " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'Number of patient with Acute Respiratory Distress Syndrome Recovery',\n", + " 'OtherOutcomeDescription': 'Acute Respiratory Distress Syndrome Recovery rate',\n", + " 'OtherOutcomeTimeFrame': 'Up to 24 weeks'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nThe subject has to grant permission to enter into the study by signing and dating the informed consent form before completing any study-related procedure such as any assessment or evaluation not related to the normal medical care of the subject.\\nAble to give written inform consent and retained one copy of the consent form\\nMale or female subject, aged between 16 - 100 years old.\\nSubject diagnosed to be COVID19\\nFemale subject in good health and sexually active was instructed by the investigator to avoid pregnancy during the study and to use condom or other contraceptive measure if necessary. The subject was required to have a negative urine pregnancy test before being eligible for the study. (At each of the subsequent visit, a urine pregnancy test was performed).\\nSubject judged to be reliable for compliance for taking medication and capable of recording the effects of the medication and motivated in receiving benefits from the treatment.and compliance to quarantine procedure 7-14 days after treatment\\n\\nExclusion Criteria:\\n\\nThe subject was pregnant or lactating.\\nThe subject was a female at risk of pregnancy during the study and not taking adequate precautions against pregnancy.\\nThe subject had a known hypersensitivity to any of the test materials or related compounds.\\nThe subject was unable or unwilling to comply fully with the protocol.\\nTreatment with investigational drug (s) within 6 months before the screening visit.\\nThe subject had previously entered in this study.\\nPatient who planned to schedule elective surgery during the study\\nThe used of other antiviral agents',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '16 Years',\n", + " 'MaximumAge': '100 Years',\n", + " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Subsai Kongsaengdao, M.D.',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '66818180890',\n", + " 'CentralContactEMail': 'skhongsa@gmail.com'},\n", + " {'CentralContactName': 'Narumol Sawanpanyalert, M.D., M.P.H',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '66818424148',\n", + " 'CentralContactEMail': 'thailandemt2019@gmail.com'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Assistant Professor Subsai Kongsaengdao',\n", + " 'LocationCity': 'Bangkok',\n", + " 'LocationZip': '10400',\n", + " 'LocationCountry': 'Thailand'}]}},\n", + " 'ReferencesModule': {'AvailIPDList': {'AvailIPD': [{'AvailIPDId': 'Thai government data',\n", + " 'AvailIPDType': 'Data references',\n", + " 'AvailIPDURL': 'https://ddc.moph.go.th'},\n", + " {'AvailIPDType': 'News',\n", + " 'AvailIPDURL': 'https://world.kbs.co.kr/service/news_view.htm?lang=e&Seq_Code=151108'},\n", + " {'AvailIPDType': 'Reference News',\n", + " 'AvailIPDURL': 'https://world.kbs.co.kr/service/news_view.htm?lang=e&Seq_Code=151108'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000019438',\n", + " 'InterventionMeshTerm': 'Ritonavir'},\n", + " {'InterventionMeshId': 'D000061466',\n", + " 'InterventionMeshTerm': 'Lopinavir'},\n", + " {'InterventionMeshId': 'D000069454',\n", + " 'InterventionMeshTerm': 'Darunavir'},\n", + " {'InterventionMeshId': 'D000006886',\n", + " 'InterventionMeshTerm': 'Hydroxychloroquine'},\n", + " {'InterventionMeshId': 'D000002738',\n", + " 'InterventionMeshTerm': 'Chloroquine'},\n", + " {'InterventionMeshId': 'D000053139',\n", + " 'InterventionMeshTerm': 'Oseltamivir'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000017320',\n", + " 'InterventionAncestorTerm': 'HIV Protease Inhibitors'},\n", + " {'InterventionAncestorId': 'D000011480',\n", + " 'InterventionAncestorTerm': 'Protease Inhibitors'},\n", + " {'InterventionAncestorId': 'D000004791',\n", + " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000019380',\n", + " 'InterventionAncestorTerm': 'Anti-HIV Agents'},\n", + " {'InterventionAncestorId': 'D000044966',\n", + " 'InterventionAncestorTerm': 'Anti-Retroviral Agents'},\n", + " {'InterventionAncestorId': 'D000000998',\n", + " 'InterventionAncestorTerm': 'Antiviral Agents'},\n", + " {'InterventionAncestorId': 'D000000890',\n", + " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", + " {'InterventionAncestorId': 'D000065692',\n", + " 'InterventionAncestorTerm': 'Cytochrome P-450 CYP3A Inhibitors'},\n", + " {'InterventionAncestorId': 'D000065607',\n", + " 'InterventionAncestorTerm': 'Cytochrome P-450 Enzyme Inhibitors'},\n", + " {'InterventionAncestorId': 'D000000962',\n", + " 'InterventionAncestorTerm': 'Antimalarials'},\n", + " {'InterventionAncestorId': 'D000000981',\n", + " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", + " {'InterventionAncestorId': 'D000000977',\n", + " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", + " {'InterventionAncestorId': 'D000018501',\n", + " 'InterventionAncestorTerm': 'Antirheumatic Agents'},\n", + " {'InterventionAncestorId': 'D000000563',\n", + " 'InterventionAncestorTerm': 'Amebicides'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M4562',\n", + " 'InterventionBrowseLeafName': 'Chloroquine',\n", + " 'InterventionBrowseLeafAsFound': 'Chloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M151035',\n", + " 'InterventionBrowseLeafName': 'Chloroquine diphosphate',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M8523',\n", + " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M19978',\n", + " 'InterventionBrowseLeafName': 'Ritonavir',\n", + " 'InterventionBrowseLeafAsFound': 'Ritonavir',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M28424',\n", + " 'InterventionBrowseLeafName': 'Lopinavir',\n", + " 'InterventionBrowseLeafAsFound': 'Lopinavir',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M25733',\n", + " 'InterventionBrowseLeafName': 'Oseltamivir',\n", + " 'InterventionBrowseLeafAsFound': 'Oseltamivir',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M18192',\n", + " 'InterventionBrowseLeafName': 'HIV Protease Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M12926',\n", + " 'InterventionBrowseLeafName': 'Protease Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M423',\n", + " 'InterventionBrowseLeafName': 'Darunavir',\n", + " 'InterventionBrowseLeafAsFound': 'Darunavir',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M19934',\n", + " 'InterventionBrowseLeafName': 'Anti-HIV Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M24015',\n", + " 'InterventionBrowseLeafName': 'Anti-Retroviral Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2895',\n", + " 'InterventionBrowseLeafName': 'Antiviral Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2795',\n", + " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M29151',\n", + " 'InterventionBrowseLeafName': 'Cytochrome P-450 CYP3A Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M29124',\n", + " 'InterventionBrowseLeafName': 'Cytochrome P-450 Enzyme Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2861',\n", + " 'InterventionBrowseLeafName': 'Antimalarials',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2879',\n", + " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2875',\n", + " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19188',\n", + " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", + " {'InterventionBrowseBranchAbbrev': 'Infl',\n", + " 'InterventionBrowseBranchName': 'Anti-Inflammatory Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'Analg',\n", + " 'InterventionBrowseBranchName': 'Analgesics'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", + " {'ConditionMeshId': 'D000045169',\n", + " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M17593',\n", + " 'ConditionBrowseLeafName': 'Critical Illness',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M14938',\n", + " 'ConditionBrowseLeafName': 'Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 5,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04332835',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'ABN011-2'},\n", + " 'Organization': {'OrgFullName': 'Universidad del Rosario',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Convalescent Plasma for Patients With COVID-19: A Randomized, Open Label, Parallel, Controlled Clinical Study',\n", + " 'OfficialTitle': 'Convalescent Plasma for Patients With COVID-19: A Randomized, Open Label, Parallel, Controlled Clinical Study',\n", + " 'Acronym': 'CP-COVID-19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'August 31, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 31, 2020',\n", + " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 3, 2020',\n", + " 'StudyFirstPostDateType': 'Estimate'},\n", + " 'LastUpdateSubmitDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", + " 'LastUpdatePostDateType': 'Estimate'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Juan Manuel Anaya Cabrera',\n", + " 'ResponsiblePartyInvestigatorTitle': 'MD, PhD, Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Universidad del Rosario'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Universidad del Rosario',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Fundación Universitaria de Ciencias de la Salud',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'CES University', 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'Instituto Distrital de Ciencia Biotecnología e Innovacion en Salud',\n", + " 'CollaboratorClass': 'UNKNOWN'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy when there is no vaccine or treatment available for infectious diseases. In the latest viral epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization issued a document outlining a protocol for the use of whole blood or plasma collected from patients who have recovered from the Ebola virus disease by transfusion to empirically treat local infectious outbreaks',\n", + " 'DetailedDescription': 'The process is based on obtaining plasma from patients recovered from COVID-19 in Colombia, and through a donation of plasma from the recovered, the subsequent transfusion of this to patients infected with coronavirus disease (COVID-19). Our group has reviewed the scientific evidence regarding the application of convalescent plasma for emergency viral outbreaks and has recommended the following protocol'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus',\n", + " 'Coronavirus Infection']},\n", + " 'KeywordList': {'Keyword': ['COVID-19', 'Coronavirus Disease 2019']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 2', 'Phase 3']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '80',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Intervention Group',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Participants included in the experimental group will receive 500 milliliters of convalescent plasma, distributed in two 250 milliliters transfusions on the first and second day after starting the protocol. Simultaneously, they will receive standard therapy Azithromycin (500 milligrams daily) and Hydroxychloroquine (400 milligrams each 12 hours) for 10 days.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Plasma',\n", + " 'Drug: Hydroxychloroquine',\n", + " 'Drug: Azithromycin']}},\n", + " {'ArmGroupLabel': 'Control Group',\n", + " 'ArmGroupType': 'Active Comparator',\n", + " 'ArmGroupDescription': 'Participants included in the control group will receive standard therapy Azithromycin (500 milligrams daily) and Hydroxychloroquine (400 milligrams each 12 hours) for 10 days.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine',\n", + " 'Drug: Azithromycin']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Plasma',\n", + " 'InterventionDescription': 'Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Intervention Group']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Convalescent Plasma COVID-19']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Hydroxychloroquine',\n", + " 'InterventionDescription': '400 milligrams each 12 hours for 10 days',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Control Group',\n", + " 'Intervention Group']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Azithromycin',\n", + " 'InterventionDescription': '500 milligrams daily for 10 days',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Control Group',\n", + " 'Intervention Group']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Change in Viral Load',\n", + " 'PrimaryOutcomeDescription': 'Copies of COVID-19 per ml',\n", + " 'PrimaryOutcomeTimeFrame': 'Days 0, 4, 7, 14 and 28'},\n", + " {'PrimaryOutcomeMeasure': 'Change in Immunoglobulin M COVID-19 Titers',\n", + " 'PrimaryOutcomeDescription': 'Immunoglobulin M COVID-19 antibodies',\n", + " 'PrimaryOutcomeTimeFrame': 'Days 0, 4, 7, 14 and 28'},\n", + " {'PrimaryOutcomeMeasure': 'Change in Immunoglobulin G COVID-19 Titers',\n", + " 'PrimaryOutcomeDescription': 'Immunoglobulin G COVID-19 antibodies',\n", + " 'PrimaryOutcomeTimeFrame': 'Days 0, 4, 7, 14 and 28'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Intensive Care Unit Admission',\n", + " 'SecondaryOutcomeDescription': 'Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28)',\n", + " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", + " {'SecondaryOutcomeMeasure': 'Length of Intensive Care Unit stay',\n", + " 'SecondaryOutcomeDescription': 'Days of Intensive Care Unit management (days 7, 14 and 28)',\n", + " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", + " {'SecondaryOutcomeMeasure': 'Length of hospital stay (days)',\n", + " 'SecondaryOutcomeDescription': 'Days of Hospitalization (days 7, 14 and 28)',\n", + " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", + " {'SecondaryOutcomeMeasure': 'Requirement of mechanical ventilation',\n", + " 'SecondaryOutcomeDescription': 'Proportion of patients with mechanical ventilation (days 7, 14 and 28)',\n", + " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", + " {'SecondaryOutcomeMeasure': 'Duration (days) of mechanical ventilation',\n", + " 'SecondaryOutcomeDescription': 'Days with mechanical ventilation (days 7, 14 and 28)',\n", + " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", + " {'SecondaryOutcomeMeasure': 'Clinical status assessed according to the World Health Organization guideline',\n", + " 'SecondaryOutcomeDescription': '1. Hospital discharge; 2. Hospitalization, not requiring supplemental oxygen; 3. Hospitalization, requiring supplemental oxygen (but not Noninvasive Ventilation/ HFNC); 4. Intensive care unit/hospitalization, requiring Noninvasive Ventilation/ HFNC therapy; 5. Intensive care unit, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 6. Death. (days 7, 14 and 28)',\n", + " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", + " {'SecondaryOutcomeMeasure': 'Mortality',\n", + " 'SecondaryOutcomeDescription': 'Proportion of death patients at days 7, 14 and 28',\n", + " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:Fulfilling all the following criteria\\n\\nAged between 18 and 60 years, male or female.\\nHospitalized participants with diagnosis of COVID 19 by Real Time - Polymerase Chain Reaction.\\nModerate cases according to the official guideline \"Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)\".\\nConfusion, Urea, Respiratory rate, Blood pressure-65 (CURB-65) >= 2.\\nSequential Organ Failure Assessment score (SOFA) < 6.\\nAbility to understand and the willingness to sign a written informed consent document.\\n\\nExclusion Criteria:\\n\\nFemale subjects who are pregnant or breastfeeding.\\nPatients with prior allergic reactions to transfusions.\\nCritical ill patients in intensive care units.\\nPatients with surgical procedures in the last 30 days.\\nPatients with active treatment for cancer (Radiotherapy or Chemotherapy).\\nHIV diagnosed patients with viral failure (detectable viral load> 1000 copies / ml persistent, two consecutive viral load measurements within a 3 month interval, with medication adherence between measurements after at least 6 months of starting a new regimen antiretrovirals).\\nPatients who have suspicion or evidence of coinfections.\\nEnd-stage chronic kidney disease (Glomerular Filtration Rate <15 ml / min / 1.73 m2).\\nChild Pugh C stage liver cirrhosis.\\nHigh cardiac output diseases.\\nAutoimmune diseases or Immunoglobulin A nephropathy.\\nPatients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '60 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Juan M Anaya Cabrera, MD, PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+57 321 233 9828',\n", + " 'CentralContactEMail': 'anayajm@gmail.com'},\n", + " {'CentralContactName': 'Manuel E Rojas Quintana, MD, MSc',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+57 315 459 9951',\n", + " 'CentralContactEMail': 'manuel_9316@hotmail.com'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Juan M Anaya Cabrera, MD, PhD',\n", + " 'OverallOfficialAffiliation': 'Universidad del Rosario',\n", + " 'OverallOfficialRole': 'Study Director'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Universidad del Rosario',\n", + " 'LocationCity': 'Bogota',\n", + " 'LocationState': 'Cundinamarca',\n", + " 'LocationZip': '11100',\n", + " 'LocationCountry': 'Colombia',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Gustavo Quintero, MD, MSc',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+57 318 3606458',\n", + " 'LocationContactEMail': 'gustavo.quintero@urosario.edu.co'},\n", + " {'LocationContactName': 'Juan M Anaya Cabrera, MD, PhD',\n", + " 'LocationContactRole': 'Principal Investigator'},\n", + " {'LocationContactName': 'Manuel E Rojas Quintana, MD, MSc',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Sara Velez Gomez',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Juan C Diaz Coronado, MD, MSc',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Anha M Robledo Moreno',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Juan E Gallo Bonilla, MSc, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Ruben D Manrique Hernández, MSc, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Oscar M Gómez Guzmán, MSc, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Isaura P Torres Gómez, MSc, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Paula A Pedroza Rodríguez',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Bernardo Camacho Rodríguez, MD, MSc',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Jeser S Grass Guaqueta, MSc',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Gustavo A Salguero López, MD, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Luisa P Duarte Correales',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Cristian A Ricaurte Perez, MSc',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Adriana Rojas Villarraga, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Heily C Ramírez Santana, MSc, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Diana M Monsalve Carmona, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Yhojan A Rodríguez Velandia, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Yeny Y Acosta Ampudia, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Carlos E Perez, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Ruben D Mantilla, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Paula Gaviria, MSc',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}}]}},\n", + " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '31986264',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:.'},\n", + " {'ReferencePMID': '32134116',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Wang Y, Wang Y, Chen Y, Qin Q. Unique epidemiological and clinical features of the emerging 2019 novel coronavirus pneumonia (COVID-19) implicate special control measures. J Med Virol. 2020 Mar 5. doi: 10.1002/jmv.25748. [Epub ahead of print] Review.'},\n", + " {'ReferencePMID': '32125362',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Young BE, Ong SWX, Kalimuddin S, Low JG, Tan SY, Loh J, Ng OT, Marimuthu K, Ang LW, Mak TM, Lau SK, Anderson DE, Chan KS, Tan TY, Ng TY, Cui L, Said Z, Kurupatham L, Chen MI, Chan M, Vasoo S, Wang LF, Tan BH, Lin RTP, Lee VJM, Leo YS, Lye DC; Singapore 2019 Novel Coronavirus Outbreak Research Team. Epidemiologic Features and Clinical Course of Patients Infected With SARS-CoV-2 in Singapore. JAMA. 2020 Mar 3. doi: 10.1001/jama.2020.3204. [Epub ahead of print]'},\n", + " {'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Infectious, D. & Outbreaks, D. Maintaining a safe and adequate blood supply during the pandemic outbreak of coronavirus disease ( COVID-19 ). OMS 1-5 (2020)'}]},\n", + " 'SeeAlsoLinkList': {'SeeAlsoLink': [{'SeeAlsoLinkLabel': 'FDA recommendations for convalescent plasma clinical research',\n", + " 'SeeAlsoLinkURL': 'https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", + " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", + " 'InterventionAncestorTerm': 'Antimalarials'},\n", + " {'InterventionAncestorId': 'D000000981',\n", + " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", + " {'InterventionAncestorId': 'D000000977',\n", + " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", + " {'InterventionAncestorId': 'D000000890',\n", + " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", + " {'InterventionAncestorId': 'D000004791',\n", + " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000018501',\n", + " 'InterventionAncestorTerm': 'Antirheumatic Agents'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", + " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M18715',\n", + " 'InterventionBrowseLeafName': 'Azithromycin',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2861',\n", + " 'InterventionBrowseLeafName': 'Antimalarials',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2879',\n", + " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2875',\n", + " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2795',\n", + " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19188',\n", + " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", + " {'ConditionMeshId': 'D000045169',\n", + " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M14938',\n", + " 'ConditionBrowseLeafName': 'Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 6,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04331574',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'SARS-RAS'},\n", + " 'Organization': {'OrgFullName': \"Societa Italiana dell'Ipertensione Arteriosa\",\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Renin-Angiotensin System Inhibitors and COVID-19',\n", + " 'OfficialTitle': 'Phase IV Observational Study to Associate Hypertension and Hypertensinon Treatment to COVID19',\n", + " 'Acronym': 'SARS-RAS'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 10, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 10, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'April 30, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 30, 2020',\n", + " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 2, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': \"Societa Italiana dell'Ipertensione Arteriosa\",\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Multicentric non-profit observational study, in patients with COVID-19 hospitalized in Italy, conducted through a pseudonymised survey.',\n", + " 'DetailedDescription': 'The recent SARS-CoV-2 Coronavirus pandemic and subsequent spread of the disease called COVID-19 brought back to the discussion a topic already highlighted during the SARS-CoV-4 crown-related SARS epidemic of 2002. In particular, the angiotensin converting enzyme 2 (ACE2) has been identified as a functional receptor for coronaviruses, therefore including SARS-CoV-2. ACE2 is strongly expressed in the heart and lungs. SARS-CoV-2 mainly invades alveolar epithelial cells, resulting in respiratory symptoms. These symptoms could be made more severe in the presence of increased expression of ACE2. ACE2 levels can be increased by the use of renin-angiotensin system inhibitors (RAS). This therapeutic class is particularly widespread, as it represents the most important pharmacological protection for widespread diseases such as high blood pressure, heart failure and ischemic heart disease. It is therefore possible to hypothesize that pharmacological treatment with RAS inhibitors may be associated with a more severe symptomatology and clinic than COVID-19.\\n\\nHowever, several observations from studies on SARSCoV, which are most likely also relevant for SARS-CoV-2 seem to suggest otherwise. Indeed, it has been shown that the binding of coronavirus to ACE2 leads to downregulation of ACE2, which in turn causes an ACE / ACE2 imbalance excessive production of angiotensin by the related ACE enzyme. Angiotensin II receptor 1 (AT1R) stimulated by angiotensin causes an increase in pulmonary vascular permeability, thereby mediating an increase in lung damage. Therefore, according to this hypothesis, the upregulation of ACE2, caused by the chronic intake of AT1R and ACE Inhibitors, could be protective through two mechanisms: the first, that of blocking in the AT1 receptor; second, increasing ACE2 levels decreases ACE production of angiotensin and increases ACE2 production of angiotensin 1-7.\\n\\nThe quickest approach to evaluating these two opposing hypotheses is to analyze the medical records of COVID-19 patients to determine whether patients on RAS antagonist therapy have a different disease outcome than patients without the above therapy.\\n\\nThis research aims to verify whether the chronic intake of RAS inhibitors modifies the prevalence and severity of the clinical manifestation of COVID-19.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", + " 'Hypertension',\n", + " 'Cardiovascular Diseases']},\n", + " 'KeywordList': {'Keyword': ['risk factors',\n", + " 'SARS',\n", + " 'ACE Inibitors',\n", + " 'ARB']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'Yes',\n", + " 'TargetDuration': '3 Months',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Case-Only']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Cross-Sectional']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '2000',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'covid-19 patients',\n", + " 'ArmGroupDescription': 'Patients with certified diagnosis of COVID-19 recruited in Italian hospitals'}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Numbers of COVID-19 patients enrolled that use ACE inhibitors and/or Angiotensin Receptor Blockers (ARB) as antihypertensive agents',\n", + " 'PrimaryOutcomeDescription': 'Using anamnestic data collected from the health record of the hospital or of the general practitioner, we will count the number of COVID-19 patients enrolled that were treated with ACE Inhibitors or ARB.',\n", + " 'PrimaryOutcomeTimeFrame': '3 months'},\n", + " {'PrimaryOutcomeMeasure': 'Numbers of COVID-19 patients enrolled with no symptoms, with moderate symptoms or with severe symptoms of pneumoni based on the WHO specification for ARDS that also used ACE inhibitors and/or Angiotensin Receptor Blockers (ARB) as antihypertensive agents',\n", + " 'PrimaryOutcomeDescription': 'This study want to observe whether the assumption of antihypertensive ACE inhibitors or ARB increases the severity of the clinical manifestation of COVID19',\n", + " 'PrimaryOutcomeTimeFrame': '3 months'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Number and type of anthropometric and clinical parameters that associate with COVID19 and COVID-19 severity',\n", + " 'SecondaryOutcomeDescription': 'Collecting selected data from the health record and hospital charts of the patients we will assess whether among the recorded parameters there are any that can predict COVID19 prevalence and severity',\n", + " 'SecondaryOutcomeTimeFrame': '3 months'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nPatients affected by COVID19 referring to italian outpatient clinics or hospitals\\n\\nExclusion Criteria:\\n\\n-',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '120 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'COVID-19 patients enrolled in infectious disease and resuscitation centers in Italy or in home isolation and health surveillance',\n", + " 'SamplingMethod': 'Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Guido Iaccarino, MD, PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+390817464717',\n", + " 'CentralContactEMail': 'guiaccar@unina.it'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Guido Iaccarino, MD',\n", + " 'OverallOfficialAffiliation': 'Federico II University',\n", + " 'OverallOfficialRole': 'Study Chair'},\n", + " {'OverallOfficialName': 'Guido Grassi, MD',\n", + " 'OverallOfficialAffiliation': 'Inversity of Milan, BICOCCA',\n", + " 'OverallOfficialRole': 'Study Director'},\n", + " {'OverallOfficialName': 'MariaLorenza Muiesan, MD',\n", + " 'OverallOfficialAffiliation': 'Università degli Studi di Brescia',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Claudio Borghi, MD',\n", + " 'OverallOfficialAffiliation': 'University of Bologna',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Claudio Ferri, MD',\n", + " 'OverallOfficialAffiliation': \"University of L'Aquila\",\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'MASSIMO VOLPE, MD',\n", + " 'OverallOfficialAffiliation': 'Univerity of Rome \"La Sapienza\"',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Leonardo Sechi',\n", + " 'OverallOfficialAffiliation': 'University of Udine',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Spedali Civili di Brescia',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Brescia',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Marialorenza Muiesan',\n", + " 'LocationContactRole': 'Contact'}]}}]}},\n", + " 'ReferencesModule': {'SeeAlsoLinkList': {'SeeAlsoLink': [{'SeeAlsoLinkLabel': 'Related Info',\n", + " 'SeeAlsoLinkURL': 'https://siia.it/notizie-siia/inibitori-del-sistema-renina-angiotensina-e-sars-cov-2-lindagine-della-siia/'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000006973',\n", + " 'ConditionMeshTerm': 'Hypertension'},\n", + " {'ConditionMeshId': 'D000002318',\n", + " 'ConditionMeshTerm': 'Cardiovascular Diseases'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000014652',\n", + " 'ConditionAncestorTerm': 'Vascular Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8607',\n", + " 'ConditionBrowseLeafName': 'Hypertension',\n", + " 'ConditionBrowseLeafAsFound': 'Hypertension',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M15983',\n", + " 'ConditionBrowseLeafName': 'Vascular Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC14',\n", + " 'ConditionBrowseBranchName': 'Heart and Blood Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", + " {'Rank': 7,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04318301',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'Zhenhuazen2018'},\n", + " 'Organization': {'OrgFullName': 'Nanfang Hospital of Southern Medical University',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Hypertension in Patients Hospitalized With COVID-19',\n", + " 'OfficialTitle': 'Hypertension in Patients Hospitalized With COVID-19 in Wuhan, China: A Single-center Retrospective Observational Study',\n", + " 'Acronym': 'HT-COVID19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Active, not recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 21, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 28, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'March 30, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 20, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 20, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 23, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 21, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 24, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor-Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Zhenhua Zen',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Associate Professor',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Nanfang Hospital of Southern Medical University'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Zhenhua Zen',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Some studies have shown that the main pathogenesis of patients with covid19 is related to ACE2 receptor. Lung is one of the main organs, and there are many ACE2 receptors in cardiovascular system. ACEI / ARB is the main target of antihypertensive drugs. Previous reports suggested that there were large number of patients with covid19 also suffered from hypertension, suggesting that patients with hypertension may be the susceptible to covid19. Therefore, we try to follow up the patients admitted to Hankou hospital to explore the impact of hypertension and hypertension treatment on the severity and prognosis of patients with covid19, so as to provide new methods for the treatment of patients with covid19 in the future.',\n", + " 'DetailedDescription': 'In December, 2019, a cluster of severe pneumonia cases of unknown cause emerged in Wuhan, China, with clinical presentations greatly resembling viral pneumonia1. Deep sequencing analysis from lower respiratory tract samples indicated a novel coronavirus, which was named 2019 novel coronavirus (2019-nCoV, then named COVID-19). Up to Mar 16, 2020, the total number of patients had risen sharply to 153,546 confirmed cases worldwide (http://2019ncov.chinacdc.cn/2019-nCoV/global.html). The data extracted from 1099 patients with laboratory-confirmed COVID-19 in China from January 29, 2020 showed that hypertension is the most common coexisting illness of COVID-19 patients, ranging from 13.4% in nonsevere patient vs. 23.4% in severe patients, and the total incidence is as high as 15%2. Interestingly, ACE2 is involved in the pathogenesis of both hypertension and SARS-COV-2 pneumonia. The above reasons prompted us to speculate that the organs attacked by SARS-COV-2 might not only be lungs, but also include other ACE2 expression organs, especially cardiovascular system. In addition, patients with comorbid hypertension, especially those with long-term oral ACEI/ARB medication for hypertension, might have different susceptibility and severity levels of pneumonia upon SARS-COV-2 attack. Therefore, we investigated and compared the demographic characteristics, coexisting disease, severity of pneumonia, and the effect of antihypertensive drugs (ACEI/ARB versus non-ACEI/ARB) in patients with COVID-19 coexisting hypertension, thereby, hopefully, to reduce the mortality and morbidity associated with hypertension in patients with COVID-19.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", + " 'Hypertension']},\n", + " 'KeywordList': {'Keyword': ['COVID-19', 'Hypertension', 'ACE2']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Case-Control']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Retrospective']}},\n", + " 'BioSpec': {'BioSpecRetention': 'None Retained',\n", + " 'BioSpecDescription': 'Blood'},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '275',\n", + " 'EnrollmentType': 'Actual'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'ACEI/ARB',\n", + " 'ArmGroupDescription': 'COVID-19 patients with hypertension who had previously taken ACEI/ARB for antihypertensive treatment'},\n", + " {'ArmGroupLabel': 'non ACEI/ARB',\n", + " 'ArmGroupDescription': 'COVID-19 patients with hypertension who had not previously taken ACEI/ARB for antihypertensive treatment'}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Rate of Death',\n", + " 'PrimaryOutcomeDescription': 'mortality in 28-day',\n", + " 'PrimaryOutcomeTimeFrame': 'From date of admission until the date of death from any cause, up to 60 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'the severity of pneumonia',\n", + " 'SecondaryOutcomeDescription': 'evaluate the severity of pneumonia according to CT scans and clinical manifestation',\n", + " 'SecondaryOutcomeTimeFrame': 'From date of admission until the date of discharge or death from any cause, up to 60 days'}]},\n", + " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'the length of hospital stay',\n", + " 'OtherOutcomeDescription': 'days from admission to discharge or death',\n", + " 'OtherOutcomeTimeFrame': 'From date of admission until the date of discharge or death from any cause, up to 60 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nCOVID-19 pneumonia patients diagnosed by WHO criteria\\n\\nExclusion Criteria:\\n\\nPatients who were younger than 18 years.\\nPatients whose entire stay lasted for less than 48 hours.',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '100 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'Patients with clinically confirmed COVID-19 admitted to Hankou Hospital, Wuhan, China from January 5 to March 8, 2020.',\n", + " 'SamplingMethod': 'Probability Sample'},\n", + " 'ContactsLocationsModule': {'LocationList': {'Location': [{'LocationFacility': 'Hankou Hospital',\n", + " 'LocationCity': 'Hankou',\n", + " 'LocationState': 'Hubei',\n", + " 'LocationZip': '430000',\n", + " 'LocationCountry': 'China'}]}},\n", + " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '31978945',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.'},\n", + " {'ReferencePMID': '14647384',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Li W, Moore MJ, Vasilieva N, Sui J, Wong SK, Berne MA, Somasundaran M, Sullivan JL, Luzuriaga K, Greenough TC, Choe H, Farzan M. Angiotensin-converting enzyme 2 is a functional receptor for the SARS coronavirus. Nature. 2003 Nov 27;426(6965):450-4.'},\n", + " {'ReferencePMID': '31986264',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:.'},\n", + " {'ReferencePMID': '29449338',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Wang Z, Chen Z, Zhang L, Wang X, Hao G, Zhang Z, Shao L, Tian Y, Dong Y, Zheng C, Wang J, Zhu M, Weintraub WS, Gao R; China Hypertension Survey Investigators. Status of Hypertension in China: Results From the China Hypertension Survey, 2012-2015. Circulation. 2018 May 29;137(22):2344-2356. doi: 10.1161/CIRCULATIONAHA.117.032380. Epub 2018 Feb 15.'},\n", + " {'ReferencePMID': '15897343',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Ferrario CM, Jessup J, Chappell MC, Averill DB, Brosnihan KB, Tallant EA, Diz DI, Gallagher PE. Effect of angiotensin-converting enzyme inhibition and angiotensin II receptor blockers on cardiac angiotensin-converting enzyme 2. Circulation. 2005 May 24;111(20):2605-10. Epub 2005 May 16.'},\n", + " {'ReferencePMID': '15165741',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Turner AJ, Hiscox JA, Hooper NM. ACE2: from vasopeptidase to SARS virus receptor. Trends Pharmacol Sci. 2004 Jun;25(6):291-4. Review.'}]},\n", + " 'SeeAlsoLinkList': {'SeeAlsoLink': [{'SeeAlsoLinkLabel': 'A Novel Coronavirus From Patients With Pneumonia in China, 2019',\n", + " 'SeeAlsoLinkURL': 'https://pubmed.ncbi.nlm.nih.gov/31978945/?from_single_result=31978945'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M2858',\n", + " 'InterventionBrowseLeafName': 'Antihypertensive Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2715',\n", + " 'InterventionBrowseLeafName': 'Angiotensin-Converting Enzyme Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000006973',\n", + " 'ConditionMeshTerm': 'Hypertension'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000014652',\n", + " 'ConditionAncestorTerm': 'Vascular Diseases'},\n", + " {'ConditionAncestorId': 'D000002318',\n", + " 'ConditionAncestorTerm': 'Cardiovascular Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8607',\n", + " 'ConditionBrowseLeafName': 'Hypertension',\n", + " 'ConditionBrowseLeafAsFound': 'Hypertension',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M15983',\n", + " 'ConditionBrowseLeafName': 'Vascular Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC14',\n", + " 'ConditionBrowseBranchName': 'Heart and Blood Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", + " {'Rank': 8,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04318418',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'DEP_012020'},\n", + " 'Organization': {'OrgFullName': 'Neuromed IRCCS', 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'ACE Inhibitors, Angiotensin II Type-I Receptor Blockers and Severity of COVID-19',\n", + " 'OfficialTitle': 'ACE Inhibitors, Angiotensin II Type-I Receptor Blockers and Severity of COVID-19',\n", + " 'Acronym': 'CODIV-ACE'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 23, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 10, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'April 30, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 19, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 19, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 24, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 19, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 24, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Augusto Di Castelnuovo',\n", + " 'ResponsiblePartyInvestigatorTitle': 'MSc, PhD',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Neuromed IRCCS'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Neuromed IRCCS',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Hypothesis Very recent evidences supports the hypothesis that the novel coronavirus 2019 (2019-nCoV) uses the SARS-1 coronavirus receptor angiotensin converting enzyme 2 (ACE2) for entry into target cells. The epidemiological association between Angiotensin receptor-blocker (ARB) or ACE inhibitors (ACE-I) use and severe sequelae of 2109-nCoV infection disease COVID-19 has not been yet conclusively demonstrated, but may have important consequences for population health.\\n\\nAim To retrospectively test whether 2019-nCoV patients treated with ACE-I or ARB, in comparison with patients who not, are at higher risk of having severe COVID-19 (including death).\\n\\nPopulation Hospitalized patients with confirmed COVID-19 infection (any type).\\n\\nStudy design Patients will be divided in two groups, a) controls: individuals who did not develop severe COVID-19 respiratory disease (including individuals who recovered from the infection) and b) cases: individuals who developed severe COVID-19 disease (including fatal events). Treatment with ACE-I or ARB, together with possible confounding will be assessed retrospectively.\\n\\nExposure Treatment for ACE-I or ARB.',\n", + " 'DetailedDescription': 'Background Very recent evidences support the hypothesis that the novel coronavirus 2019 (2019-nCoV) uses the SARS-1 coronavirus receptor ACE2 for gains entry into target cells. Angiotensin receptor-blocker (ARB) drugs, one of the most commonly used antihypertensive drug, typically increase ACE2 expression, often very markedly. With SARS-CoV-2 infection increased ACE2 expression very definitely would not be beneficial, and could be adverse. However, augmented ACE2 expression with ARBs has been demonstrated in the kidneys and heart but has not been tested in the lungs. So, the hypothesis that using of ARBS or ACE inhibitors (ACE-I) drugs during the COVID-19 may possibly be harmful is urgently to be verified in epidemiological studies.\\n\\nAim To retrospectively test whether 2019-nCoV patients treated with ARB or ACE-I, in comparison with patients who not, are at higher risk of having severe COVID-19 (including death).\\n\\nPopulation Hospitalized patients with confirmed COVID-19 infection (any type).\\n\\nOutcome The project will retrospectively collect data on the most severe manifestation of COVID-19 occurred in 2019-nCoV infected patients during hospitalization. Severity will be classified as: hospital discharge with healing, asymptomatic, mild complications but not pneumonia, not severe pneumonia, severe pneumonia, acute respiratory distress syndrome (ARDS) and death. Classification of pneumonia will follow WHO criteria. Data on severity will be obtained from medical record at one-point time (at the moment of inclusion in the study).\\n\\nExposure Treatment for ARB or ACE-I. When available, type of drugs will be recorded.\\n\\nStudy design Patients will be divided in two groups, a) controls: individuals who did not develop severe COVID-19 respiratory disease (including individuals who recovered from the infection) and b) cases: individuals who developed severe COVID-19 disease (including fatal events). Association between use of ACE-I or ARB and severity of COVID-19 will be assessed by using of multivariable logistic regression analysis. Data on potential confounders will be obtained by medical records: age, sex, time intervals from hospital admission to worse manifestation of COVID-19 and to eventual death or recovering, smoking, body mass index, history of myocardial infarction, diabetes, hypertension, cancer, respiratory disease, other morbidities, creatinine, insulin, glomerular filtration rate together with use of Tocilizumab, anti-aldosterone agents, diuretics, Kaletra, cortisone, Remdesevir, Chloroquine, Sacubitril or Valsartan.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", + " 'KeywordList': {'Keyword': ['Angiotensin receptor-blocker and ACE inhibitors drugs']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Case-Control']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Retrospective']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '5000',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Cases',\n", + " 'ArmGroupDescription': 'Patients who developed severe COVID-19 disease (including fatal events)'},\n", + " {'ArmGroupLabel': 'Controls',\n", + " 'ArmGroupDescription': 'Infected patients who did not develop severe COVID-19 respiratory disease (including individuals who recovered from the infection)'}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Severe COVID-19',\n", + " 'PrimaryOutcomeDescription': 'Severity pneumonia or acute respiratory distress syndrome by COVID-19',\n", + " 'PrimaryOutcomeTimeFrame': '1 month'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Death',\n", + " 'SecondaryOutcomeDescription': 'Death by COVID-19',\n", + " 'SecondaryOutcomeTimeFrame': '1 month'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nPatients hospitalized for COVID-19\\n\\nExclusion Criteria:\\n\\nnone',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'Hospitalized patients with confirmed COVID-19 infection (any type), recruited in Italian hospital',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Augusto Di Castelnuovo, MSc, PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '3289035621',\n", + " 'CentralContactEMail': 'dicastel@ngi.it'},\n", + " {'CentralContactName': 'Licia Iacoviello, MD, PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactEMail': 'licia.iacoviello@uninsubria.it'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Augusto Di Castelnuovo, MSc, PhD',\n", + " 'OverallOfficialAffiliation': 'IRCCS Neuromed',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'IRCCS Neuromed, Department of Epidemiology and Prevention',\n", + " 'LocationCity': 'Pozzilli',\n", + " 'LocationZip': '86077',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Augusto Di Castelnuovo',\n", + " 'LocationContactRole': 'Contact'},\n", + " {'LocationContactName': 'Licia Iacoviello',\n", + " 'LocationContactRole': 'Contact'}]}}]}}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000000804',\n", + " 'InterventionMeshTerm': 'Angiotensin II'},\n", + " {'InterventionMeshId': 'C000627694',\n", + " 'InterventionMeshTerm': 'Giapreza'},\n", + " {'InterventionMeshId': 'D000000806',\n", + " 'InterventionMeshTerm': 'Angiotensin-Converting Enzyme Inhibitors'},\n", + " {'InterventionMeshId': 'D000000808',\n", + " 'InterventionMeshTerm': 'Angiotensinogen'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000011480',\n", + " 'InterventionAncestorTerm': 'Protease Inhibitors'},\n", + " {'InterventionAncestorId': 'D000004791',\n", + " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000014662',\n", + " 'InterventionAncestorTerm': 'Vasoconstrictor Agents'},\n", + " {'InterventionAncestorId': 'D000015842',\n", + " 'InterventionAncestorTerm': 'Serine Proteinase Inhibitors'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M27503',\n", + " 'InterventionBrowseLeafName': 'Angiotensin Receptor Antagonists',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2715',\n", + " 'InterventionBrowseLeafName': 'Angiotensin-Converting Enzyme Inhibitors',\n", + " 'InterventionBrowseLeafAsFound': 'ACE inhibitor',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M2713',\n", + " 'InterventionBrowseLeafName': 'Angiotensin II',\n", + " 'InterventionBrowseLeafAsFound': 'Angiotensin II',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M269574',\n", + " 'InterventionBrowseLeafName': 'Giapreza',\n", + " 'InterventionBrowseLeafAsFound': 'Angiotensin II',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M2716',\n", + " 'InterventionBrowseLeafName': 'Angiotensinogen',\n", + " 'InterventionBrowseLeafAsFound': 'Angiotensin II',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M18192',\n", + " 'InterventionBrowseLeafName': 'HIV Protease Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M12926',\n", + " 'InterventionBrowseLeafName': 'Protease Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M15992',\n", + " 'InterventionBrowseLeafName': 'Vasoconstrictor Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M16974',\n", + " 'InterventionBrowseLeafName': 'Serine Proteinase Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'T18',\n", + " 'InterventionBrowseLeafName': 'Serine',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", + " {'InterventionBrowseBranchAbbrev': 'VaCoAg',\n", + " 'InterventionBrowseBranchName': 'Vasoconstrictor Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'AA',\n", + " 'InterventionBrowseBranchName': 'Amino Acids'}]}}}}},\n", + " {'Rank': 9,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04323800',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'IRB00245634'},\n", + " 'Organization': {'OrgFullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune Plasma) Among Adults Exposed to COVID-19',\n", + " 'OfficialTitle': 'Convalescent Plasma to Stem Coronavirus: A Randomized, Blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune Plasma) Among Adults Exposed to COVID-19',\n", + " 'Acronym': 'CSSC-001'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'December 31, 2022',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'January 2023',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 24, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 26, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 27, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 31, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No',\n", + " 'IsUSExport': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at day 28.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus',\n", + " 'Convalescence']},\n", + " 'KeywordList': {'Keyword': ['COVID-19']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 2']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignInterventionModelDescription': '1:1 ratio',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Triple',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", + " 'Care Provider',\n", + " 'Investigator']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '150',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'High titer anti-SARS-CoV-2 plasma',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Participants with High titer anti-SARS-CoV-2 plasma.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: Anti- SARS-CoV-2 Plasma']}},\n", + " {'ArmGroupLabel': 'SARS-CoV-2 non-immune plasma',\n", + " 'ArmGroupType': 'Active Comparator',\n", + " 'ArmGroupDescription': 'Participants with SARS-CoV-2 non-immune plasma.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: SARS-CoV-2 non-immune Plasma']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Biological',\n", + " 'InterventionName': 'Anti- SARS-CoV-2 Plasma',\n", + " 'InterventionDescription': 'SARS-CoV-2 convalescent plasma (1 unit; ~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and was found to have a titer of neutralizing antibody >1:64)',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['High titer anti-SARS-CoV-2 plasma']}},\n", + " {'InterventionType': 'Biological',\n", + " 'InterventionName': 'SARS-CoV-2 non-immune Plasma',\n", + " 'InterventionDescription': 'Standard plasma collected prior to December 2019',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['SARS-CoV-2 non-immune plasma']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Cumulative incidence of composite outcome of disease severity',\n", + " 'PrimaryOutcomeDescription': 'The cumulative incidence of composite outcome of disease severity will be used in assessing the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to COVID-19. This will be determined with the presence or occurrence of at least one of the following:\\n\\nDeath\\nRequiring mechanical ventilation and/or in ICU\\nnon-ICU hospitalization, requiring supplemental oxygen;\\nnon-ICU hospitalization, not requiring supplemental oxygen;\\nNot hospitalized, but with clinical and laboratory evidence of COVID-19 infection\\nNot hospitalized, no clinical evidence of COVID-19 infection, but with positive PCR for SARS-CoV-2',\n", + " 'PrimaryOutcomeTimeFrame': 'Day 28'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Anti-SARS-CoV-2 titers',\n", + " 'SecondaryOutcomeDescription': 'Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 0 (baseline).',\n", + " 'SecondaryOutcomeTimeFrame': 'Baseline'},\n", + " {'SecondaryOutcomeMeasure': 'Anti-SARS-CoV-2 titers',\n", + " 'SecondaryOutcomeDescription': 'Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 1.',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", + " {'SecondaryOutcomeMeasure': 'Anti-SARS-CoV-2 titers',\n", + " 'SecondaryOutcomeDescription': 'Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 3.',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", + " {'SecondaryOutcomeMeasure': 'Anti-SARS-CoV-2 titers',\n", + " 'SecondaryOutcomeDescription': 'Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 7.',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", + " {'SecondaryOutcomeMeasure': 'Anti-SARS-CoV-2 titers',\n", + " 'SecondaryOutcomeDescription': 'Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 14.',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 14'},\n", + " {'SecondaryOutcomeMeasure': 'Anti-SARS-CoV-2 titers',\n", + " 'SecondaryOutcomeDescription': 'Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 90.',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 90'},\n", + " {'SecondaryOutcomeMeasure': 'Rates of SARS-CoV-2 PCR positivity',\n", + " 'SecondaryOutcomeDescription': 'Compare the rates of SARS-CoV-2 PCR positivity (RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 and 28.',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to day 28'},\n", + " {'SecondaryOutcomeMeasure': 'Duration of SARS-CoV-2 PCR positivity',\n", + " 'SecondaryOutcomeDescription': 'Compare the duration (days) of SARS-CoV-2 PCR positivity (RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 and 28.',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to day 28'},\n", + " {'SecondaryOutcomeMeasure': 'Peak quantity levels of SARS-CoV-2 RNA',\n", + " 'SecondaryOutcomeDescription': 'Compare the peak quantity levels of SARS-CoV-2 RNA amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 days.',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to day 14'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nSubjects must be 18 years of age or older\\nClose contact* exposure to person with COVID-19 within 96 hours of enrollment (and 120 hours of receipt of plasma)\\n\\nIf female must not be pregnant and/or breastfeeding. Women of childbearing potential and men, must be willing to practice an effective contraceptive method or remain abstinent during the study period.\\n\\n*Close contact* is defined by the Centers for Disease Control and Prevention (CDC) as:\\n\\na) being within approximately 6 feet (2 meters) of a COVID-19 case for a prolonged period of time (without PPE); close contact can occur while caring for, living with, visiting, or sharing a healthcare waiting area or room with a COVID-19 case\\n\\nor -\\n\\nb) having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed on) without PPE\\n\\nExclusion Criteria:\\n\\nReceipt any blood product in past 120 days\\nPsychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance\\nSymptoms consistent with COVID-19 infection (fevers, acute onset cough, shortness of breath) at time of screening\\nNucleic acid testing evidence of COVID-19 infection at time of screening\\nHistory of prior reactions to transfusion blood products\\nInability to complete therapy with the study product within 24 hours after enrollment',\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Darin Ostrander, PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '410-614-6702',\n", + " 'CentralContactEMail': 'TOID_CRC@jhmi.edu'},\n", + " {'CentralContactName': 'Obi Ezennia, MPH',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '410-614-6702',\n", + " 'CentralContactEMail': 'TOID_CRC@jhmi.edu'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Darin Ostrander, PhD',\n", + " 'OverallOfficialAffiliation': 'Johns Hopkins University',\n", + " 'OverallOfficialRole': 'Study Director'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No',\n", + " 'IPDSharingDescription': 'Sharing is governed by Johns Hopkins University Institutional Guidelines'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M2806',\n", + " 'InterventionBrowseLeafName': 'Antibodies',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M8767',\n", + " 'InterventionBrowseLeafName': 'Immunoglobulins',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19718',\n", + " 'InterventionBrowseLeafName': 'Antibodies, Blocking',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", + " {'ConditionMeshId': 'D000003289',\n", + " 'ConditionMeshTerm': 'Convalescence'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'},\n", + " {'ConditionAncestorId': 'D000020969',\n", + " 'ConditionAncestorTerm': 'Disease Attributes'},\n", + " {'ConditionAncestorId': 'D000010335',\n", + " 'ConditionAncestorTerm': 'Pathologic Processes'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M5096',\n", + " 'ConditionBrowseLeafName': 'Convalescence',\n", + " 'ConditionBrowseLeafAsFound': 'Convalescence',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M21284',\n", + " 'ConditionBrowseLeafName': 'Disease Attributes',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 10,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04324463',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'PHRI.ACT.COVID19'},\n", + " 'Organization': {'OrgFullName': 'Population Health Research Institute',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Anti-Coronavirus Therapies to Prevent Progression of Coronavirus Disease 2019 (COVID-19) Trial',\n", + " 'OfficialTitle': 'Anti-Coronavirus Therapies to Prevent Progression of COVID-19, a Randomized Trial',\n", + " 'Acronym': 'ACT COVID19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'September 30, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 25, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 25, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 27, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 25, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 27, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Population Health Research Institute',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No',\n", + " 'IsUSExport': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'ACT is a randomized clinical trial to assess therapies to reduce the clinical progression of COVID-19.',\n", + " 'DetailedDescription': 'The ACT COVID-19 program consists of two parallel trials evaluating azithromycin and chloroquine therapy (ACT) versus usual care in outpatients and inpatients who have tested positive for COVID-19. The trial is an open-label, parallel group, randomized controlled trial with an adaptive design. Adaptive design features include adaptive intervention arms and adaptive sample size based on new and emerging data.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus',\n", + " 'Severe Acute Respiratory Syndrome']},\n", + " 'KeywordList': {'Keyword': ['COVID-19',\n", + " 'chloroquine',\n", + " 'azithromycin',\n", + " 'coronavirus']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 3']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignInterventionModelDescription': 'Open-label, parallel group randomized controlled trial',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '1500',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Azithromycin and Chloroquine Therapy (ACT)',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Chloroquine (Adults with a bodyweight ≥ 50 kg: 500 mg twice daily for 7 days; Adults with a bodyweight < 50 kg: 500 mg twice daily on days 1 and 2, followed by 500 mg once daily for days 3-7), plus Azithromycin (500 mg on day 1 followed by 250 mg daily for 4 days)',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Azithromycin',\n", + " 'Drug: Chloroquine']}},\n", + " {'ArmGroupLabel': 'Standard of Care',\n", + " 'ArmGroupType': 'No Intervention',\n", + " 'ArmGroupDescription': 'No constraints for treating physicians on the therapies within the standard of care arm. All key co-interventions will be documented.'}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Azithromycin',\n", + " 'InterventionDescription': 'oral medication',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Azithromycin and Chloroquine Therapy (ACT)']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Chloroquine',\n", + " 'InterventionDescription': 'oral medication',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Azithromycin and Chloroquine Therapy (ACT)']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Outpatients: Hospital Admission or Death',\n", + " 'PrimaryOutcomeDescription': 'In outpatients with COVID-19, the occurrence of hospital admission or death',\n", + " 'PrimaryOutcomeTimeFrame': 'Up to 6 weeks post randomization'},\n", + " {'PrimaryOutcomeMeasure': 'Inpatients: Invasive mechanical ventilation or mortality',\n", + " 'PrimaryOutcomeDescription': 'Patients intubated or requiring imminent intubation at the time of randomization will only be followed for the primary outcome of death.',\n", + " 'PrimaryOutcomeTimeFrame': 'Up to 6 weeks post randomization'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAge ≥ 18 years of age\\nInformed consent\\nCOVID-19 confirmed by established testing\\n\\nExclusion Criteria:\\n\\nKnown glucose-6-phosphate dehydrogenase (G6PD) deficiency\\nContra-indication to chloroquine or azithromycin\\nAlready receiving chloroquine or azithromycin',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'ACT COVID-19 Study Coordinator',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '905-297-3479',\n", + " 'CentralContactEMail': 'ACT.ProjectTeam@PHRI.ca'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Richard Whitlock, MD PhD',\n", + " 'OverallOfficialAffiliation': 'Population Health Research Institute',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Emilie Belley-Cote, MD PhD',\n", + " 'OverallOfficialAffiliation': 'Population Health Research Institute',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Hamilton Health Sciences',\n", + " 'LocationCity': 'Hamilton',\n", + " 'LocationState': 'Ontario',\n", + " 'LocationZip': 'L8L2X2',\n", + " 'LocationCountry': 'Canada',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'ACT COVID-19 Study Coordinator',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactEMail': 'ACT.ProjectTeam@PHRI.ca'}]}}]}},\n", + " 'IPDSharingStatementModule': 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'ConditionBrowseLeafAsFound': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 11,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04329559',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'CHESS2002'},\n", + " 'Organization': {'OrgFullName': 'Hepatopancreatobiliary Surgery Institute of Gansu Province',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'COVID-19 in Patients With Pre-existing Cirrhosis (COVID-Cirrhosis-CHESS2002): A Multicentre Observational Study',\n", + " 'OfficialTitle': 'Clinical Characteristics of COVID-19 in Patients With Pre-existing Cirrhosis (COVID-Cirrhosis-CHESS2002): A Multicentre Observational Study'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 30, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'June 29, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'June 29, 2021',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 29, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 29, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 29, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Xiaolong Qi',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Chief, Institute of Portal Hypertension',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Hepatopancreatobiliary Surgery Institute of Gansu Province',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Renmin Hospital of Wuhan University',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'LanZhou University',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'Minda Hospital Affiliated to Hubei University for Nationalities',\n", + " 'CollaboratorClass': 'UNKNOWN'},\n", + " {'CollaboratorName': 'Wuhan Union Hospital, China',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture',\n", + " 'CollaboratorClass': 'UNKNOWN'},\n", + " {'CollaboratorName': \"Tianjin Second People's Hospital\",\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'Sixth People’s Hospital of Shenyang',\n", + " 'CollaboratorClass': 'UNKNOWN'},\n", + " {'CollaboratorName': 'Guangxi Zhuang Autonomous Region',\n", + " 'CollaboratorClass': 'UNKNOWN'},\n", + " {'CollaboratorName': \"Shenzhen Third People's Hospital\",\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'Ankang Central Hospital',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': \"Xingtai People's Hospital\",\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'Dalian Sixth People’s Hospital',\n", + " 'CollaboratorClass': 'UNKNOWN'},\n", + " {'CollaboratorName': 'The Central Hospital of Lishui City',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'The Affiliated Third Hospital of Jiangsu University',\n", + " 'CollaboratorClass': 'UNKNOWN'},\n", + " {'CollaboratorName': 'Suizhou Hospital, Hubei University of Medicine',\n", + " 'CollaboratorClass': 'UNKNOWN'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'COVID-19 pandemic with SARS-CoV-2 infection has become a global challenge. Though most cases of COVID-19 are mild, the disease can also be fatal. Patients with liver cirrhosis are more susceptible to damage from SARS-CoV-2 infection considering their immunocompromised status. The spectrum of disease and factors that influence the disease course in COVID-19 cases with liver cirrhosis are incompletely defined. This muilticentre observational study (COVID-Cirrhosis-CHESS2002) aims to study the clinical characteristics and risk factors associated with specific outcomes in COVID-19 patients with pre-existing liver cirrhosis.',\n", + " 'DetailedDescription': 'Coronavirus disease 2019 (COVID-19) pandemic with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has become a global challenge. Though most cases of COVID-19 are mild, the disease can also be fatal. Patients with liver cirrhosis are more susceptible to damage from SARS-CoV-2 infection considering their immunocompromised status. The spectrum of disease and factors that influence the disease course in COVID-19 cases with liver cirrhosis are incompletely defined. This muilticentre observational study (COVID-Cirrhosis-CHESS2002) aims to study the clinical characteristics and risk factors associated with specific outcomes in COVID-19 patients with pre-existing liver cirrhosis.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", + " 'Liver Cirrhosis']},\n", + " 'KeywordList': {'Keyword': ['COVID-19',\n", + " 'Liver cirrhosis',\n", + " 'Clinical outcome']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'Yes',\n", + " 'TargetDuration': '1 Year',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Cross-Sectional']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '50',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'All-cause mortality of COVID-19 patients with liver cirrhosis',\n", + " 'PrimaryOutcomeDescription': '7-day, 28-day, 60-day, 180-day and 365-day all-cause mortality of COVID-19 patients with liver cirrhosis',\n", + " 'PrimaryOutcomeTimeFrame': 'From illness onset of COVID-19 to death from any cause, up to 365 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Liver-related mortality of COVID-19 patients with liver cirrhosis',\n", + " 'SecondaryOutcomeDescription': '7-day, 28-day, 60-day, 180-day and 365-day liver-related mortality of COVID-19 patients with liver cirrhosis',\n", + " 'SecondaryOutcomeTimeFrame': 'From illness onset of COVID-19 to death from liver-related cause, up to 365 days'},\n", + " {'SecondaryOutcomeMeasure': 'Risk factors associated with specific outcomes of COVID-19 patients with liver cirrhosis',\n", + " 'SecondaryOutcomeDescription': 'Risk factors (laboratory findings, imaging findings, etc.) associated with specific outcomes (death, etc.) of COVID-19 patients with liver cirrhosis',\n", + " 'SecondaryOutcomeTimeFrame': 'From hospital admission to death, up to 365 days'},\n", + " {'SecondaryOutcomeMeasure': 'Baseline characteristics of COVID-19 patients with liver cirrhosis',\n", + " 'SecondaryOutcomeDescription': 'Baseline characteristics (laboratory findings, imaging findings, etc.) of COVID-19 patients with liver cirrhosis',\n", + " 'SecondaryOutcomeTimeFrame': '1 Day'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\n1) Aged 18 or above;\\n2) Laboratory-confirmed COVID-19 infection;\\n3) Pre-existing liver cirrhosis based on liver biopsy or clinical findings.\\n\\nExclusion Criteria:\\n\\n1) Pregnancy or unknown pregnancy status.',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'Patients with COVID-19 infection with pre-existing liver cirrhosis',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Xiaolong Qi, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+86-18588602600',\n", + " 'CentralContactPhoneExt': '+8618588602600',\n", + " 'CentralContactEMail': 'qixiaolong@vip.163.com'},\n", + " {'CentralContactName': 'Yanna Liu, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+86-15625076784',\n", + " 'CentralContactPhoneExt': '+8615625076784',\n", + " 'CentralContactEMail': 'lauyenna@126.com'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Mingkai Chen, MD',\n", + " 'OverallOfficialAffiliation': 'Renmin Hospital of Wuhan University',\n", + " 'OverallOfficialRole': 'Study Chair'},\n", + " {'OverallOfficialName': 'Xiaolong Qi, MD',\n", + " 'OverallOfficialAffiliation': 'LanZhou University',\n", + " 'OverallOfficialRole': 'Study Chair'},\n", + " {'OverallOfficialName': 'Fengmei Wang, MD',\n", + " 'OverallOfficialAffiliation': \"Tianjin Second People's Hospital\",\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Ye Gu, MD',\n", + " 'OverallOfficialAffiliation': 'Sixth People’s Hospital of Shenyang',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Zicheng Jiang, MD',\n", + " 'OverallOfficialAffiliation': 'Ankang Central Hospital',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Guo Zhang, MD',\n", + " 'OverallOfficialAffiliation': 'Guangxi Zhuang Autonomous Region',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Yong Zhang, MD',\n", + " 'OverallOfficialAffiliation': 'Dalian Sixth People’s Hospital',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Dengxiang Liu, MD',\n", + " 'OverallOfficialAffiliation': \"Xingtai People's Hospital\",\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Qing He, MD',\n", + " 'OverallOfficialAffiliation': \"Shenzhen Third People's Hospital\",\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Hua Yang, MD',\n", + " 'OverallOfficialAffiliation': 'Minda Hospital Affiliated to Hubei University for Nationalities',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Zhengyan Wang, MD',\n", + " 'OverallOfficialAffiliation': 'Suizhou Hospital, Hubei University of Medicine',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Bin Xiong, MD',\n", + " 'OverallOfficialAffiliation': 'Wuhan Union Hospital, China',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Xiaodan Li, MD',\n", + " 'OverallOfficialAffiliation': 'The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Hongguang Zhang, MD',\n", + " 'OverallOfficialAffiliation': 'The Affiliated Third Hospital of Jiangsu University',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Chuxiao Shao, MD',\n", + " 'OverallOfficialAffiliation': 'The Central Hospital of Lishui City',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Hongmei Yue, MD',\n", + " 'OverallOfficialAffiliation': 'LanZhou University',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': \"Dalian Sixth People's Hospital\",\n", + " 'LocationStatus': 'Not yet recruiting',\n", + " 'LocationCity': 'Dalian',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Yong Zhang, MD',\n", + " 'LocationContactRole': 'Contact'}]}},\n", + " {'LocationFacility': 'Minda Hospital Affiliated to Hubei University for Nationalities',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Enshi',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Hua Yang, MD',\n", + " 'LocationContactRole': 'Contact'}]}},\n", + " {'LocationFacility': 'The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Enshi',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Xiaodan Li, MD',\n", + " 'LocationContactRole': 'Contact'}]}},\n", + " {'LocationFacility': 'The First Hospital of Lanzhou University',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Lanzhou',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Hongmei Yue, MD',\n", + " 'LocationContactRole': 'Contact'}]}},\n", + " {'LocationFacility': 'The Central Hospital of Lishui City',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Lishui',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Chuxiao Shao, MD',\n", + " 'LocationContactRole': 'Contact'}]}},\n", + " {'LocationFacility': 'Guangxi Zhuang Autonomous Region',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Nanning',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Guo Zhang, MD',\n", + " 'LocationContactRole': 'Contact'}]}},\n", + " {'LocationFacility': 'The Sixth Peoples Hospital of Shenyang',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Shenyang',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Ye Gu, MD',\n", + " 'LocationContactRole': 'Contact'}]}},\n", + " {'LocationFacility': \"Shenzhen Third People's Hospital\",\n", + " 'LocationStatus': 'Not yet recruiting',\n", + " 'LocationCity': 'Shenzhen',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Qing He, MD',\n", + " 'LocationContactRole': 'Contact'}]}},\n", + " {'LocationFacility': 'Suizhou Hospital, Hubei University of Medicine',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Suizhou',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Zhengyan Wang, MD',\n", + " 'LocationContactRole': 'Contact'}]}},\n", + " {'LocationFacility': \"Tianjin Second People's Hospital\",\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Tianjin',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Fengmei Wang, MD',\n", + " 'LocationContactRole': 'Contact'}]}},\n", + " {'LocationFacility': 'Ankang Central Hospital',\n", + " 'LocationStatus': 'Not yet recruiting',\n", + " 'LocationCity': 'Wuhan',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Zicheng Jiang, MD',\n", + " 'LocationContactRole': 'Contact'}]}},\n", + " {'LocationFacility': 'Renmin Hospital of Wuhan University',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Wuhan',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Mingkai Chen, MD',\n", + " 'LocationContactRole': 'Contact'}]}},\n", + " {'LocationFacility': 'Wuhan Union Hospital',\n", + " 'LocationStatus': 'Not yet recruiting',\n", + " 'LocationCity': 'Wuhan',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Bin Xiong, MD',\n", + " 'LocationContactRole': 'Contact'}]}},\n", + " {'LocationFacility': \"Xingtai People's Hospital\",\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Xingtai',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Dengxiang Liu, MD',\n", + " 'LocationContactRole': 'Contact'}]}},\n", + " {'LocationFacility': 'The Affiliated Third Hospital of Jiangsu University',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Zhenjiang',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Hongguang Zhang, MD',\n", + " 'LocationContactRole': 'Contact'}]}}]}},\n", + " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '32091533',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648. [Epub ahead of print]'},\n", + " {'ReferencePMID': '32109013',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMoa2002032. [Epub ahead of print]'},\n", + " {'ReferencePMID': '32145190',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Zhang C, Shi L, Wang FS. Liver injury in COVID-19: management and challenges. Lancet Gastroenterol Hepatol. 2020 Mar 4. pii: S2468-1253(20)30057-1. doi: 10.1016/S2468-1253(20)30057-1. [Epub ahead of print]'},\n", + " {'ReferencePMID': '32203680',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Bangash MN, Patel J, Parekh D. COVID-19 and the liver: little cause for concern. Lancet Gastroenterol Hepatol. 2020 Mar 20. pii: S2468-1253(20)30084-4. doi: 10.1016/S2468-1253(20)30084-4. [Epub ahead of print]'},\n", + " {'ReferencePMID': '32170806',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Xu L, Liu J, Lu M, Yang D, Zheng X. Liver injury during highly pathogenic human coronavirus infections. Liver Int. 2020 Mar 14. doi: 10.1111/liv.14435. [Epub ahead of print] Review.'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M9693',\n", + " 'InterventionBrowseLeafName': 'Liver Extracts',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Hemat',\n", + " 'InterventionBrowseBranchName': 'Hematinics'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000008103',\n", + " 'ConditionMeshTerm': 'Liver Cirrhosis'},\n", + " {'ConditionMeshId': 'D000005355', 'ConditionMeshTerm': 'Fibrosis'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000010335',\n", + " 'ConditionAncestorTerm': 'Pathologic Processes'},\n", + " {'ConditionAncestorId': 'D000008107',\n", + " 'ConditionAncestorTerm': 'Liver Diseases'},\n", + " {'ConditionAncestorId': 'D000004066',\n", + " 'ConditionAncestorTerm': 'Digestive System Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M9686',\n", + " 'ConditionBrowseLeafName': 'Liver Cirrhosis',\n", + " 'ConditionBrowseLeafAsFound': 'Cirrhosis',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M7068',\n", + " 'ConditionBrowseLeafName': 'Fibrosis',\n", + " 'ConditionBrowseLeafAsFound': 'Cirrhosis',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M9690',\n", + " 'ConditionBrowseLeafName': 'Liver Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M7466',\n", + " 'ConditionBrowseLeafName': 'Gastrointestinal Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M5838',\n", + " 'ConditionBrowseLeafName': 'Digestive System Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC06',\n", + " 'ConditionBrowseBranchName': 'Digestive System Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'}]}}}}},\n", + " {'Rank': 12,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04298814',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'COVEI'},\n", + " 'Organization': {'OrgFullName': 'Tongji Hospital', 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Safety Related Factors of Endotracheal Intubation in Patients With Severe Covid-19 Pneumonia',\n", + " 'OfficialTitle': 'Analysis of Safety Related Factors of Endotracheal Intubation in Patients With Severe Covid-19 Pneumonia'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 7, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 30, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'July 30, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'February 26, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 4, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 6, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 4, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 6, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'aijun xu',\n", + " 'ResponsiblePartyInvestigatorTitle': 'associate professor',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Tongji Hospital'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Tongji Hospital',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'To analyze the intubation with severe covid-19 pneumonia, the infection rate of anesthesiologist after intubation, and summarizes the experience of how to avoid the infection of anesthesiologist and ensure the safety of patients with severe covid-19 pneumonia.',\n", + " 'DetailedDescription': 'To analyze the intubation time, intubation condition, intubation process, intubation times and success rate of patients with severe covid-19 pneumonia, the infection rate of anesthesiologist after intubation, the degree of respiratory improvement and survival rate of patients, and summarizes the experience of how to avoid the infection of anesthesiologist and ensure the safety of patients with severe covid-19 pneumonia.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", + " 'Endotracheal Intubation']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Case-Only']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '120',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", + " 'InterventionName': 'severe covid-19 pneumonia with ET',\n", + " 'InterventionDescription': 'severe covid-19 pneumonia undergoing endotracheal intubation'}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Success rate of intubation',\n", + " 'PrimaryOutcomeDescription': 'The data of Success rate of intubation with severe COVID-19 pneumonia patients',\n", + " 'PrimaryOutcomeTimeFrame': 'the time span between 1hour before intubation and 24h after intubation'},\n", + " {'PrimaryOutcomeMeasure': 'Infection rate of Anesthesiologist',\n", + " 'PrimaryOutcomeDescription': 'Infection rate of Anesthesiologist who performed the endotracheal intubation for severe COVID-19 pneumonia patients',\n", + " 'PrimaryOutcomeTimeFrame': 'the time span between 1hour before intubation and 14days after intubation'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Extubation time',\n", + " 'SecondaryOutcomeDescription': 'Extubation time of intubated severe COVID-19 pneumonia patients',\n", + " 'SecondaryOutcomeTimeFrame': 'the time span between 1hour before intubation and 30days after intubation'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\nWuhan residents;\\nnovel coronavirus pneumonia was found to be characterized by fever and cough. Laboratory tests revealed leukocyte or lymphocyte decrease, chest CT examination showed viral pneumonia changes, and was diagnosed as COVID-19 pneumonia according to the national health and Health Committee's new coronavirus pneumonia diagnosis and treatment plan (trial version fifth Revision).\\nSevere and critical patients with covid-19 pneumonia in urgent need of tracheal intubation;\\nSign informed consent.\\n\\nExclusion Criteria:\\n\\nSuspected patients with covid-19 pneumonia;\\nPatients who need emergency endotracheal intubation due to other causes of respiratory failure;\\nThe family refused to sign the informed consent.\",\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '90 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'Severe and critical patients with covid-19 pneumonia in urgent need of tracheal intubation',\n", + " 'SamplingMethod': 'Non-Probability Sample'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000011014',\n", + " 'ConditionMeshTerm': 'Pneumonia'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000008171',\n", + " 'ConditionAncestorTerm': 'Lung Diseases'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M12487',\n", + " 'ConditionBrowseLeafName': 'Pneumonia',\n", + " 'ConditionBrowseLeafAsFound': 'Pneumonia',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M9751',\n", + " 'ConditionBrowseLeafName': 'Lung Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'}]}}}}},\n", + " {'Rank': 13,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04325061',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '2020-001278-31'},\n", + " 'Organization': {'OrgFullName': 'Dr. Negrin University Hospital',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Efficacy of Dexamethasone Treatment for Patients With ARDS Caused by COVID-19',\n", + " 'OfficialTitle': 'Efficacy of Dexamethasone Treatment for Patients With ARDS Caused by COVID-19',\n", + " 'Acronym': 'DEXA-COVID19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'October 30, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'October 30, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 25, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 26, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 27, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 31, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Jesus Villar',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Senior scientist',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Dr. Negrin University Hospital'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Dr. Negrin University Hospital',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Li Ka Shing Knowledge Institute',\n", + " 'CollaboratorClass': 'UNKNOWN'},\n", + " {'CollaboratorName': 'Consorcio Centro de Investigación Biomédica en Red, M.P.',\n", + " 'CollaboratorClass': 'OTHER_GOV'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Background: There are no proven therapies specific for Covid-19. The full spectrum of Covid-19 ranges from asymptomatic disease to mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. The efficacy of corticosteroids in viral ARDS remains controversial.\\n\\nMethods: This is an internationally (Spain, Canada, China, USA) designed multicenter, randomized, controlled, open-label clinical trial testing dexamethasone in mechanically ventilated adult patients with established moderate-to-severe ARDS caused by confirmed Covid-19 infection, admitted in a network of Spanish ICUs. Eligible patients will be randomly assigned to receive either dexamethasone plus standard intensive care, or standard intensive care alone. Patients in the dexamethasone group will receive an intravenous dose of 20 mg once daily from day 1 to day 5, followed by 10 mg once daily from day 6 to day 10. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days at 28 days. All analyses will be done according to the intention-to-treat principle.',\n", + " 'DetailedDescription': 'The acute respiratory distress syndrome (ARDS) is a catastrophic illness of multifactorial etiology characterized by a diffuse, severe inflammatory process of the lung leading to acute hypoxemic respiratory failure requiring mechanical ventilation (MV). Pulmonary infections are the leading causes of ARDS. Clinical and experimental research has established a strong association between dysregulated systemic and pulmonary inflammation and progression or delayed resolution of ARDS.\\n\\nThe COVID-19 pandemic is a critical moment for the world. Severe pneumonia is the main condition leading to ARDS requiring weeks of MV with high mortality (40-60%) in COVID-19 patients. There is no specific therapy for Covid-19, although patients are receiving drugs that are already approved for treating other diseases. There has been great interest in the role of corticosteroids to attenuate the pulmonary and systemic damage in ARDS patients because of their potent anti-inflammatory and antifibrotic properties. However, the efficacy of corticosteroids in viral ARDS remains controversial.\\n\\nWe justify the need of this study based on the positive results of a recent clinical trial by our group, showing that dexamethasone for 10 days was able to reduce the duration of mechanical ventilation (MV) and increase hospital survival in patients with ARDS from multiple causes (Villar J et al. Lancet Respir Med 2020). Dexamethasone has never been evaluated in viral ARDS in a randomized controlled fashion. Our goal in this study is to examine the effects of dexamethasone on hospital mortality and on ventilator-free days in patients with moderate-to-severe ARDS due to confirmed COVID-19 infection admitted into a network of Spanish intensive care units (ICUs).'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Acute Respiratory Distress Syndrome Caused by COVID-19']},\n", + " 'KeywordList': {'Keyword': ['ARDS',\n", + " 'COVID-19',\n", + " 'multiple system organ failure']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 4']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignInterventionModelDescription': 'Multicenter, randomized, controlled, open-label trial involving mechanically ventilated adult patients with ARDS caused by confirmed COVID-19 infection',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '200',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Control group',\n", + " 'ArmGroupType': 'No Intervention',\n", + " 'ArmGroupDescription': 'Patients will be treated with standard intensive care'},\n", + " {'ArmGroupLabel': 'Dexamethasone',\n", + " 'ArmGroupType': 'Active Comparator',\n", + " 'ArmGroupDescription': 'Standard intensive care plus dexamethasone',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Dexamethasone']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Dexamethasone',\n", + " 'InterventionDescription': 'Dexamethasone (20 mg/iv/daily/from Day 1 of randomization during 5 days, followed by 10 mg/iv/daily from Day 6 to 10 of randomization',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Dexamethasone']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['dexamethasone Indukern']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': '60-day mortality',\n", + " 'PrimaryOutcomeDescription': 'All-cause mortality at 60 days after enrollment',\n", + " 'PrimaryOutcomeTimeFrame': '60 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Ventilator-free days',\n", + " 'SecondaryOutcomeDescription': 'Number of ventilator-free days (VFDs) at Day 28 (defined as days being alive and free from mechanical ventilation at day 28 after enrollment, For patients ventilated 28 days or longer and for subjects who die, VFD is 0.',\n", + " 'SecondaryOutcomeTimeFrame': '28 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\nage 18 years or older;\\npositive reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay for COVID-19 in a respiratory tract sample;\\nintubated and mechanically ventilated;\\nacute onset of ARDS, as defined by Berlin criteria as moderate-to-severe ARDS,3 which includes: (i) having pneumonia or worsening respiratory symptoms, (ii) bilateral pulmonary infiltrates on chest imaging (x-ray or CT scan), (iii) absence of left atrial hypertension, pulmonary capillary wedge pressure <18 mmHg, or no clinical signs of left heart failure, and (iv) hypoxemia, as defined by a PaO2/FiO2 ratio of ≤200 mmHg on positive end-expiratory pressure (PEEP) of ≥5 cmH2O, regardless of FiO2.\\n\\nExclusion Criteria:\\n\\nPatients with a known contraindication to corticosteroids,\\nDecision by a physician that involvement in the trial is not in the patient's best interest,\\nPregnancy and breast-feeding.\",\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Jesús Villar, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+34606860027',\n", + " 'CentralContactEMail': 'jesus.villar54@gmail.com'},\n", + " {'CentralContactName': 'Arthur Slutsky, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+14168244000',\n", + " 'CentralContactEMail': 'SLUTSKYA@smh.ca'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Jesús Villar, MD',\n", + " 'OverallOfficialAffiliation': 'Hospital Universitario Dr. Negrin',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Department of Anesthesia, Hospital Universitario de Cruces',\n", + " 'LocationCity': 'Barakaldo',\n", + " 'LocationState': 'Vizcaya',\n", + " 'LocationZip': '48903',\n", + " 'LocationCountry': 'Spain',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Gonzalo Tamayo, MD, PhD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+34655740637',\n", + " 'LocationContactEMail': 'gonzalotamayo@gmail.com'},\n", + " {'LocationContactName': 'Alberto Martínez-Ruiz, MD, PhD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+34610494664',\n", + " 'LocationContactEMail': 'alberto.martinezruiz@osakidetza.net'},\n", + " {'LocationContactName': 'Iñaki Bilbao-Villasante',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'Intensive Care Unit, Hospital Universitario de Cruces',\n", + " 'LocationCity': 'Barakaldo',\n", + " 'LocationState': 'Vizcaya',\n", + " 'LocationZip': '48903',\n", + " 'LocationCountry': 'Spain',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Tomás Muñoz, MD, PhD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+34619440485',\n", + " 'LocationContactEMail': 'tomas.munozmartinez@osakidetza.net'},\n", + " {'LocationContactName': 'Pablo 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Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC16',\n", + " 'ConditionBrowseBranchName': 'Diseases and Abnormalities at or Before Birth'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC26',\n", + " 'ConditionBrowseBranchName': 'Wounds and Injuries'},\n", + " {'ConditionBrowseBranchAbbrev': 'BXS',\n", + " 'ConditionBrowseBranchName': 'Urinary Tract, Sexual Organs, and Pregnancy Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 14,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04321811',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'XC-PCOR-COVID19'},\n", + " 'Organization': {'OrgFullName': 'xCures', 'OrgClass': 'INDUSTRY'},\n", + " 'BriefTitle': 'Behavior, Environment And Treatments for Covid-19',\n", + " 'OfficialTitle': 'A PATIENT-CENTRIC OUTCOMES REGISTRY OF PATIENTS WITH KNOWN OR SUSPECTED NOVEL CORONAVIRUS INFECTION SARS-COV-2 (COVID-19)',\n", + " 'Acronym': 'BEAT19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 21, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 20, 2021',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'March 20, 2022',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 23, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 24, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 25, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 30, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'xCures',\n", + " 'LeadSponsorClass': 'INDUSTRY'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Genetic Alliance',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'LunaDNA', 'CollaboratorClass': 'UNKNOWN'},\n", + " {'CollaboratorName': 'Cancer Commons', 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'REDCap Cloud',\n", + " 'CollaboratorClass': 'UNKNOWN'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Background: During the current COVID-19 pandemic there is urgent need for information about the natural history of the infection in non-hospitalized patients, including the severity and duration of symptoms, and outcome from early in the infection, among different subgroups of patients. In addition, a large, real-world data registry can provide information about how different concomitant medications may differentially affect symptoms among patient subgroups. Such information can be invaluable for clinicians managing chronic diseases during this pandemic, as well as identify interventions undertaken in a naturalistic setting that have differential effects. Such factors may include patient diet, over the counter or prescription medications, and herbal and alternative treatments, among others. Identifying the natural disease history in patients from different demographic and disease subgroups will be important for identifying at-risk patients and effectiveness of interventions undertaken in the community.\\n\\nObjectives: The purpose of this study is to understand at the population level the symptomatic course of known or suspected COVID-19 patients while sheltering-in-place or under quarantine. Symptoms will be measured using a daily report derived from the CTCAE-PRO as well as free response. Outcomes will be assessed based on the duration and severity of infection, hospitalization, lost-to-follow-up, or death. As a patient-centric registry, patients themselves may propose, suggest, and/or submit evidence or ideas for relevant collection.',\n", + " 'DetailedDescription': \"Patients will be registered for through the study Web site. Following Web site registration, patients will receive an electronic informed consent form. Informed consent is a process that is initiated prior to the individual's agreeing to participate in the study and continues throughout the individual's study participation. Consent forms will be Institutional Review Board (IRB)-approved and the participant will read and review the document electronically. Participants must sign the informed consent document prior to participating in the registry. Participants will be informed that participation is voluntary and that they may withdraw from the study at any time, without prejudice by emailing the study team.\\n\\nAs a real-world data registry, any adult men and women currently in the United States and willing to provide written informed consent and:\\n\\nwho are feeling sick but have not tested positive for COVID-19, or\\nwho are feeling sick and have tested positive for COVID-19, or\\nwho are not feeling sick but want to participate can enroll\\n\\nPatients unwilling or unable to provide informed consent will be excluded.\\n\\nDATA MANAGEMENT A registry database will be maintained with identified registry data elements captured into the REDCap Cloud EDC system, a commercial eClinical Platform that is 21 CFR Part 11 Validated, HIPAA & FISMA compliant, and WHODrug and MedDRA certified. All access and activity in the system is tracked and can easily be monitored by the Administrator. The system has a login audit feature that tracks who has logged into the system, the date and time of login, and the IP address of the connection. The system also tracks failed logins and automatically locks a user's account after several failed attempts. The REDCap Cloud system has a robust audit trail that shows all changes to any records within the system including who made the change, the date and time of the change, the field that was changed, the old value of the field and the new value of the field. Access can be monitored via a dashboard or email alerts. Data management activities will follow standard operating procedures.\\n\\nSTUDY RECORDS RETENTION In the event that patient authorize the collection of additional medical records, those records will be maintained in xCures' HIPAA compliant box storage platform hosted on Amazon's HIPAA-compliant cloud servers. Source information, including medical records will be abstracted into a study database and not made available in their original format outside the study team. Study data including source records and case reports forms will be maintained in electronic format indefinitely. De-identified databases derived from the study records may be made available to other researchers and may be retained by those organizations indefinitely based on the terms of the agreement under which the data was provided.\\n\\nSOURCE DOCUMENTS Source data can include clinical findings and observations, or other information incorporated into the registry database to support analysis of data. Source data is all information from which information in the registry database is derived in original form (or certified copies of an original record). Examples of these original documents and records include but are not limited to the following: electronic medical records, clinical and office charts, laboratory notes, memoranda, correspondence, subjects' diaries or patient-reported questionnaires, data from automated instruments, such as ECG machines, photographs and other imaging (DICOM) files, slides, pharmacy records, and the reports documenting medical interpretation of those files.\\n\\nData may be entered into the eCRF either manually by the study team performing data abstraction from the EMR or electronically using direct entry of data into the or from an electronic import of data. Patients may also enter information directly into the eCRF using a patient-facing survey functionality either over the Web or using a smartphone app. Data elements originating in EMR may be automatically transmitted directly into the eCRF using a suitable API. Source data derived in that manner may have an intervening process, such as abstraction by third-party including software including processing using machine learning algorithms prior to transferring to the eCRF. xCures will retain source records in a secure that will be maintained separately and securely from the eCRF. However, metadata tagging may be employed to electronically map source data back from the eCRF to the source data record to create an audit trail.\\n\\nDISCONTINUATION OF PARTICIPATION\\n\\nParticipants can withdraw from the registry at any time by sending a written request to xCures. Withdrawal from the study means that no additional data will be collected from the patient and does not constitute revocation of the right to use the data collected prior to withdrawal for the purposes described herein. xCures may discontinue the study at any time for any reason. In the event the registry is discontinued enrolled participants may receive an email notification and a public posting on the study Web site will be made, if possible.\"},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus']},\n", + " 'KeywordList': {'Keyword': ['Coronavirus',\n", + " 'COVID19',\n", + " 'SARS-CoV-2',\n", + " 'COVID-19']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'Yes',\n", + " 'TargetDuration': '1 Year',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '100000',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Participants',\n", + " 'ArmGroupDescription': 'Adult men and women currently in the United States and willing to provide written informed consent and:\\n\\nwho are feeling sick but have not tested positive for COVID-19\\nwho are feeling sick and have tested positive for COVID-19\\nPeople who are not feeling sick but want to participate',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: Observation of patients with known, suspected, or at risk for COVID-19 infection']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", + " 'InterventionName': 'Observation of patients with known, suspected, or at risk for COVID-19 infection',\n", + " 'InterventionDescription': 'Participants will receive daily diary surveys to track the symptomatic course of known or suspected COVID-19 patients as well as use of any interventions or treatments.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Participants']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Define Natural Symptom Course',\n", + " 'PrimaryOutcomeDescription': 'Daily survey of symptoms known or reported to be associated with COVID-19 infection based including:\\n\\nHeadache, Sore throat, Runny nose, Stuffy nose, Gritty/itch eyes, Watery eyes, Nausea, Vomiting, Diarrhea, Sneezing, Coughing, Shortness of breath, Difficulty breathing, Pain or pressure in your chest, Fever, Chills, Body aches, Fatigue, or other issues. Symptoms are rated by participants on a scale of none, mild, moderate, severe, or very severe.',\n", + " 'PrimaryOutcomeTimeFrame': 'Cumulative symptom score from first onset of symptoms to resolution of symptoms (realistic timeframe of 14 days)'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Time to Hospitalization',\n", + " 'SecondaryOutcomeDescription': 'Time (in days) from onset of symptoms to hospitalization',\n", + " 'SecondaryOutcomeTimeFrame': 'Realistic timeframe of 14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Time to Symptomatic Recovery',\n", + " 'SecondaryOutcomeDescription': 'Time (in days) from onset of symptoms to resolution of symptoms',\n", + " 'SecondaryOutcomeTimeFrame': 'Realistic timeframe of 14 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nPeople who are feeling sick and have tested positive for COVID-19\\nPeople who are feeling sick but have not tested positive for COVID-19\\nPeople who are not feeling sick but want to participate\\n\\nExclusion Criteria:\\n\\n• People who are unwilling or unable to provide informed consent',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'Adults currently in the United States who may be infected or are at risk of infection with novel cornoavirus SARS-CoV-2 during the current pandemic.',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'BEAT19.org',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '(415) 754-9290',\n", + " 'CentralContactEMail': 'info@beat19.org'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Mark Shapiro',\n", + " 'OverallOfficialAffiliation': 'xCures',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'BEAT19.org',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'San Francisco',\n", + " 'LocationState': 'California',\n", + " 'LocationZip': '94022',\n", + " 'LocationCountry': 'United States',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'BEAT19.org',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactEMail': 'info@beat19.org'}]}}]}},\n", + " 'ReferencesModule': {'SeeAlsoLinkList': {'SeeAlsoLink': [{'SeeAlsoLinkLabel': 'Main registration page',\n", + " 'SeeAlsoLinkURL': 'http://www.beat19.org'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No',\n", + " 'IPDSharingDescription': 'De-identified datasets will be made available to qualified researchers in accordance with the study protocol.'}},\n", + " 'DocumentSection': {'LargeDocumentModule': {'LargeDocList': {'LargeDoc': [{'LargeDocTypeAbbrev': 'Prot_ICF',\n", + " 'LargeDocHasProtocol': 'Yes',\n", + " 'LargeDocHasSAP': 'No',\n", + " 'LargeDocHasICF': 'Yes',\n", + " 'LargeDocLabel': 'Study Protocol and Informed Consent Form',\n", + " 'LargeDocDate': 'March 20, 2020',\n", + " 'LargeDocUploadDate': '03/26/2020 16:27',\n", + " 'LargeDocFilename': 'Prot_ICF_000.pdf'}]}}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 15,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04316728',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'VivaDiag-2020'},\n", + " 'Organization': {'OrgFullName': 'Centro Studi Internazionali, Italy',\n", + " 'OrgClass': 'NETWORK'},\n", + " 'BriefTitle': 'Clinical Performance of the VivaDiag ™ COVID-19 lgM / IgG Rapid Test in Early Detecting the Infection of COVID-19',\n", + " 'OfficialTitle': 'Clinical Performance of the VivaDiag ™ COVID-19 lgM / IgG Rapid Test in a Cohort of Negative Patients for Coronavirus Infection for the Early Detection of Positive Antibodies for COVID-19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'September 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'November 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 14, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 19, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 20, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 19, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 20, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Centro Studi Internazionali, Italy',\n", + " 'LeadSponsorClass': 'NETWORK'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'VivaChek Laboratories, Inc.',\n", + " 'CollaboratorClass': 'UNKNOWN'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'This study aim to evaluate the immune response of negative patients during a COVID-19 outbreak.\\n\\nPatients are serially tested with a VivaDiag ™ COVID-19 lgM / IgG Rapid Test to evaluate the immune response in negative patients and the reliability of the test in those patients who develop clinical signs of COVID-19 during the trial.',\n", + " 'DetailedDescription': 'This study aim to evaluate the immune response of negative patients during a COVID-19 outbreak in patients with no symptoms and with no known exposure to the COVID-19.\\n\\nPatients are tested with a VivaDiag ™ COVID-19 lgM / IgG Rapid Test at day 0, day 7 and day 14. The investigators expect test to be negative on all the measurements in those patients that do not develop symptoms and that continue to have no known history of exposure to COVID-19\\n\\nPatients that develop symptoms (cough, fever or respiratory distress) and a possible contact with people positive for COVID-19 OR patients that show a positive VivaDiag test during the time frame of the test are asked to attend the COVID-19 RT - PCR &CT.\\n\\nSubsequently, the investigators will continue, repeating two tests seven days apart every 30 days (predefined times 0-7-14, then 30-37, 60-67) for the next six months. The investigators can evaluate to stop the test however before the six months if there are no new cases of COVID-19 for at least 21 days in the region where the enrolled patients live.\\n\\nThe test in use is the VivaDiag ™ COVID-19 lgM / IgG\\n\\nProcedure (as per the protocol in use for the administration of the test)\\n\\ntake out the test kit and leave it at least 30 minutes in the room where the test will be performed.\\nplace the test equipment on a clean and dust-free surface\\nFirst insert 10µL of whole blood or serum or plasma in the area reserved for blood (in the well) present on the test, then apply 2 drops of buffer.\\nread the result after 15 minutes\\n\\nInterpretation of test results\\n\\nPositive result\\n\\nThe anti-COVID-19 lgM antibody is detected if: the quality control band C and the lgM band are both colored and the lgG band does not stain. This means that the anti-COVID-19 lgM antibody is positive.\\nThe anti-COVID-19 lgG antibody is detected if: the quality control band C and the lgG band are both colored and the lgM band does not stain. This means that the COVID-19 lgG antibody is positive.\\nThe lgG and lgM anti-COVID-19 antibodies are detected if: the C band, the lgG band and the lgM band are all three colored. This means that the anti-COVID-19 lgG and lgM antibodies are both positive.\\n\\nNegative result The anti-COVID-19 lgG and lgM antibodies are not detected if only the quality control C band is stained but the lgG and lgM bands are not colored, this means that the test is negative.\\n\\nInvalid result\\n\\nIf the quality control band C does not color, regardless of whether the lgG and lgM bands are colored or not, the result is invalid and the test must be started again.\\n\\nSpecs of the test\\n\\nProduct Name VivaDiag™ COVID-19 IgM/IgG Rapid Test Test Principle Colloidal gold Sample Type Whole blood (from vein or fingertip), serum or plasma Sample Volume 10 μL Test Time 15 min Operation Temperature 18-25ºC Storage Temperature 2-30ºC Shelf Life (Unopened) 12 months'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus Infections']},\n", + " 'KeywordList': {'Keyword': ['COVID-19', 'IgM Test', 'IgG Test']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Not Applicable']},\n", + " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", + " 'DesignPrimaryPurpose': 'Diagnostic',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '200',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'negative Patients',\n", + " 'ArmGroupType': 'Other',\n", + " 'ArmGroupDescription': 'Adult HCWs with no signs or symptom of coronavirus infection and no known previous history of contact with patients positive for COVID-19, working in a primary care setting and Adult patients with at least 2 chronic medical conditions routinely attending a General Practioner (GP) practice or an outpatients departments or a primary care facility',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Device: VivaDiag™ COVID-19 lgM/IgG Rapid Test']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Device',\n", + " 'InterventionName': 'VivaDiag™ COVID-19 lgM/IgG Rapid Test',\n", + " 'InterventionDescription': 'VivaDiag™ COVID-19 lgM/IgG Rapid Test is an in vitro diagnostic for the qualitative determination of COVID-19 IgM and IgG antibodies in human whole blood (from vein or fingertip), serum or plasma',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['negative Patients']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Number of patients with constant negative results',\n", + " 'PrimaryOutcomeDescription': 'Number of patients with negative results in the three measurements, compared to the number of patients with at least one positive test',\n", + " 'PrimaryOutcomeTimeFrame': '30 days'},\n", + " {'PrimaryOutcomeMeasure': 'Number of patients with positive test with a positive PCR for COVID-19',\n", + " 'PrimaryOutcomeDescription': 'Number of patients that present at least one positive VivaDiag test that when subsequently tested with PCR remain positive',\n", + " 'PrimaryOutcomeTimeFrame': '30 days'},\n", + " {'PrimaryOutcomeMeasure': 'Overall Number of patients positive for COVID-19',\n", + " 'PrimaryOutcomeDescription': 'Where available, number of patients positive for COVID-19 IgG and IgM and positive for COVID-19 PCR',\n", + " 'PrimaryOutcomeTimeFrame': 'six months'},\n", + " {'PrimaryOutcomeMeasure': 'Overall Number of patients negative for COVID-19',\n", + " 'PrimaryOutcomeDescription': 'Where available, number of patients negative for COVID-19 IgG and IgM and negative for COVID-19 PCR',\n", + " 'PrimaryOutcomeTimeFrame': 'six months'},\n", + " {'PrimaryOutcomeMeasure': 'Number of patients with contrasting results',\n", + " 'PrimaryOutcomeDescription': 'Where available, number of patients positive for COVID-19 IgG and IgM and negative for COVID-19 PCR, or negative for COVID-19 IgG and IgM and positive for COVID-19 PCR',\n", + " 'PrimaryOutcomeTimeFrame': '30 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Reliability of the test',\n", + " 'SecondaryOutcomeDescription': 'Number of Invalid results',\n", + " 'SecondaryOutcomeTimeFrame': '30 days'},\n", + " {'SecondaryOutcomeMeasure': 'Positive HCW',\n", + " 'SecondaryOutcomeDescription': 'Number of healthcare workers that become positive for COVID-19 IgM or IgG',\n", + " 'SecondaryOutcomeTimeFrame': '60 days'},\n", + " {'SecondaryOutcomeMeasure': 'Number of Chronic Patients',\n", + " 'SecondaryOutcomeDescription': 'Number of Chronic Patients that become positive for COVID-19 IgM or IgG',\n", + " 'SecondaryOutcomeTimeFrame': '60 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAdults healthcare workers (HCW) OR\\nChronic patients with at least 2 chronic medical conditions\\n\\nExclusion Criteria:\\n\\nPeople that have been in contact with people positive for COVID-19 in the previous 14 days\\nPeople with body temperature >37.5°C\\nPeople with Dry cough\\nPeople with Respiratory distress (Respiratory Rate >25/min or O2 Saturation <92%)',\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Antonio V Gaddi, MD, MSc',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+393920039246',\n", + " 'CentralContactEMail': 'antonio.gaddi@ehealth.study'},\n", + " {'CentralContactName': 'Fabio V Capello, MD, PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactEMail': 'fabio.capello@ehealth.study'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Maurizio Cipolla, MD',\n", + " 'OverallOfficialAffiliation': 'Medical director of UCCP CATANZARO, Italy',\n", + " 'OverallOfficialRole': 'Study Director'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': \"Unità' Complesse di cure primarie (UCCP), ASP Catanzaro\",\n", + " 'LocationCity': 'Catanzaro',\n", + " 'LocationZip': '88100',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Maurizio Cipolla, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactEMail': 'maurizio.cipolla@ehealth.study'}]}}]}},\n", + " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '32035538',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Zarocostas J. What next for the coronavirus response? Lancet. 2020 Feb 8;395(10222):401. doi: 10.1016/S0140-6736(20)30292-0.'},\n", + " {'ReferencePMID': '31986257',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Wang C, Horby PW, Hayden FG, Gao GF. A novel coronavirus outbreak of global health concern. Lancet. 2020 Feb 15;395(10223):470-473. doi: 10.1016/S0140-6736(20)30185-9. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 29;:.'},\n", + " {'ReferencePMID': '31991079',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Phan LT, Nguyen TV, Luong QC, Nguyen TV, Nguyen HT, Le HQ, Nguyen TT, Cao TM, Pham QD. Importation and Human-to-Human Transmission of a Novel Coronavirus in Vietnam. N Engl J Med. 2020 Feb 27;382(9):872-874. doi: 10.1056/NEJMc2001272. Epub 2020 Jan 28.'},\n", + " {'ReferencePMID': '31978944',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Perlman S. Another Decade, Another Coronavirus. N Engl J Med. 2020 Feb 20;382(8):760-762. doi: 10.1056/NEJMe2001126. Epub 2020 Jan 24.'},\n", + " {'ReferencePMID': '31986264',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:.'},\n", + " {'ReferencePMID': '32109013',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMoa2002032. [Epub ahead of print]'},\n", + " {'ReferencePMID': '31991541',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Gralinski LE, Menachery VD. Return of the Coronavirus: 2019-nCoV. Viruses. 2020 Jan 24;12(2). pii: E135. doi: 10.3390/v12020135.'},\n", + " {'ReferencePMID': '32035509',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Ronco C, Navalesi P, Vincent JL. Coronavirus epidemic: preparing for extracorporeal organ support in intensive care. Lancet Respir Med. 2020 Mar;8(3):240-241. doi: 10.1016/S2213-2600(20)30060-6. Epub 2020 Feb 6.'},\n", + " {'ReferencePMID': '32105304',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Lan L, Xu D, Ye G, Xia C, Wang S, Li Y, Xu H. Positive RT-PCR Test Results in Patients Recovered From COVID-19. JAMA. 2020 Feb 27. doi: 10.1001/jama.2020.2783. [Epub ahead of print]'},\n", + " {'ReferencePMID': '32098019',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Kobayashi T, Jung SM, Linton NM, Kinoshita R, Hayashi K, Miyama T, Anzai A, Yang Y, Yuan B, Akhmetzhanov AR, Suzuki A, Nishiura H. Communicating the Risk of Death from Novel Coronavirus Disease (COVID-19). J Clin Med. 2020 Feb 21;9(2). pii: E580. doi: 10.3390/jcm9020580.'},\n", + " {'ReferencePMID': '32132196',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Chan JF, Yip CC, To KK, Tang TH, Wong SC, Leung KH, Fung AY, Ng AC, Zou Z, Tsoi HW, Choi GK, Tam AR, Cheng VC, Chan KH, Tsang OT, Yuen KY. Improved molecular diagnosis of COVID-19 by the novel, highly sensitive and specific COVID-19-RdRp/Hel real-time reverse transcription-polymerase chain reaction assay validated in vitro and with clinical specimens. J Clin Microbiol. 2020 Mar 4. pii: JCM.00310-20. doi: 10.1128/JCM.00310-20. [Epub ahead of print]'},\n", + " {'ReferencePMID': '32083985',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Zu ZY, Jiang MD, Xu PP, Chen W, Ni QQ, Lu GM, Zhang LJ. Coronavirus Disease 2019 (COVID-19): A Perspective from China. Radiology. 2020 Feb 21:200490. doi: 10.1148/radiol.2020200490. [Epub ahead of print]'},\n", + " {'ReferencePMID': '32145766',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Xiao Y, Torok ME. Taking the right measures to control COVID-19. Lancet Infect Dis. 2020 Mar 5. pii: S1473-3099(20)30152-3. doi: 10.1016/S1473-3099(20)30152-3. [Epub ahead of print]'},\n", + " {'ReferencePMID': '32096564',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Wang Y, Kang H, Liu X, Tong Z. Combination of RT-qPCR testing and clinical features for diagnosis of COVID-19 facilitates management of SARS-CoV-2 outbreak. J Med Virol. 2020 Feb 25. doi: 10.1002/jmv.25721. [Epub ahead of print]'},\n", + " {'ReferencePMID': '32130038',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Li Y, Xia L. Coronavirus Disease 2019 (COVID-19): Role of Chest CT in Diagnosis and Management. AJR Am J Roentgenol. 2020 Mar 4:1-7. doi: 10.2214/AJR.20.22954. [Epub ahead of print]'},\n", + " {'ReferencePMID': '32101510',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Ai T, Yang Z, Hou H, Zhan C, Chen C, Lv W, Tao Q, Sun Z, Xia L. Correlation of Chest CT and RT-PCR Testing in Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases. Radiology. 2020 Feb 26:200642. doi: 10.1148/radiol.2020200642. [Epub ahead of print]'},\n", + " {'ReferencePMID': '32097725',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Zhang S, Diao M, Yu W, Pei L, Lin Z, Chen D. Estimation of the reproductive number of novel coronavirus (COVID-19) and the probable outbreak size on the Diamond Princess cruise ship: A data-driven analysis. Int J Infect Dis. 2020 Feb 22;93:201-204. doi: 10.1016/j.ijid.2020.02.033. [Epub ahead of print]'},\n", + " {'ReferencePMID': '32119647',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Lippi G, Plebani M. Laboratory abnormalities in patients with COVID-2019 infection. Clin Chem Lab Med. 2020 Mar 3. pii: /j/cclm.ahead-of-print/cclm-2020-0198/cclm-2020-0198.xml. doi: 10.1515/cclm-2020-0198. [Epub ahead of print]'},\n", + " {'ReferencePMID': '32077933',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Binnicker MJ. Emergence of a Novel Coronavirus Disease (COVID-19) and the Importance of Diagnostic Testing: Why Partnership between Clinical Laboratories, Public Health Agencies, and Industry Is Essential to Control the Outbreak. Clin Chem. 2020 Feb 20. pii: hvaa071. doi: 10.1093/clinchem/hvaa071. [Epub ahead of print]'},\n", + " {'ReferencePMID': '32061311',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Habibi R, Burci GL, de Campos TC, Chirwa D, Cinà M, Dagron S, Eccleston-Turner M, Forman L, Gostin LO, Meier BM, Negri S, Ooms G, Sekalala S, Taylor A, Yamin AE, Hoffman SJ. Do not violate the International Health Regulations during the COVID-19 outbreak. Lancet. 2020 Feb 29;395(10225):664-666. doi: 10.1016/S0140-6736(20)30373-1. 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It will also be of utmost importance in tiring times of public health emergencies and will help understand practice variability and outcomes during COVID-19 pandemic.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus']},\n", + " 'KeywordList': {'Keyword': ['COVID19']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Other']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '50000',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'COVID19 test positive/pending or high clinical suspicion',\n", + " 'ArmGroupDescription': 'COVID19 test positive/pending/high clinical suspicion- patient admitted to hospital',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: 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'SecondaryOutcomeTimeFrame': '30 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nCOVID-19 PCR positive (within 7 days)\\nCOVID-19 PCR pending\\nCOVID-19 high clinical suspicion\\n\\nExclusion Criteria:\\n\\nPatient without Prior Research Authorization (applicable to Mayo Clinic sites)\\nNon COVID-19 related admissions\\nRepeated Admission to ICUs/Hospital',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'COVID-19 Hospitalized patients',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Rahul Kashya, MBBS',\n", + " 'OverallOfficialAffiliation': 'Mayo Clinic',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Mayo Clinic in Arizona',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Scottsdale',\n", + " 'LocationState': 'Arizona',\n", + " 'LocationZip': '85259',\n", + " 'LocationCountry': 'United States',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Ayan Sen, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '480-342-2000',\n", + " 'LocationContactEMail': 'sen.ayan@mayo.edu'}]}},\n", + " {'LocationFacility': 'Mayo Clinic in Florida',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Jacksonville',\n", + " 'LocationState': 'Florida',\n", + " 'LocationZip': '32224',\n", + " 'LocationCountry': 'United States',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Devang Sanghavi, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '904-956-3331',\n", + " 'LocationContactEMail': 'Sanghavi.Devang@mayo.edu'}]}},\n", + " {'LocationFacility': 'Society of Critical Care Medicine (150+ sites)',\n", + " 'LocationStatus': 'Not yet recruiting',\n", + " 'LocationCity': 'Chicago',\n", + " 'LocationState': 'Illinois',\n", + " 'LocationZip': '60056',\n", + " 'LocationCountry': 'United States',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Vishakha Kumar, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '847-827-6869',\n", + " 'LocationContactEMail': 'vkumar@sccm.org'}]}},\n", + " {'LocationFacility': 'Rahul Kashyap',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Rochester',\n", + " 'LocationState': 'Minnesota',\n", + " 'LocationZip': '55905',\n", + " 'LocationCountry': 'United States',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Rahul Kashyap',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '507-255-7196',\n", + " 'LocationContactEMail': 'Kashyap.Rahul@mayo.edu'},\n", + " {'LocationContactName': 'Ognjen Gajic, MD',\n", + " 'LocationContactRole': 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'Organization': {'OrgFullName': 'University of Calgary',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Hydroxychloroquine to Prevent Covid19 Pneumonia (ALBERTA HOPE-Covid19)',\n", + " 'OfficialTitle': 'A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Oral Hydroxychloroquine for the Treatment of SARS-CoV-2 Positive Patients for the Prevention of Severe COVID-19 Disease'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 8, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'July 31, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'August 31, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 29, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 31, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", + " 'LastUpdatePostDateType': 'Estimate'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor-Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Dr. Michael Hill',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Co-Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'University of Calgary'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Dr. Michael Hill',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Albertans with COVID-19 are at risk of deteriorating and developing severe illness. Those over age 40 and those with comorbid illness, including those with immunosuppressed states may be at highest risk.\\n\\nParticipants will be informed of the study by public health when they are tested for COVID-19. The study description and consent form will also be posted on the Alberta Covid-19 website for all Albertans to be aware of. Patients being tested for COVID-19 according to the guidance developed by Alberta Public Health will be referred to this website and those who indicate they do not have access to this information will be provided with written information at the time of testing.\\n\\nParticipants will be informed that they are potentially eligible for the study when a positive COVID-19 test is confirmed. They will be asked by public health for consent to be contacted by a study coordinator and their email address and phone number will be obtained. These will then be shared with the investigators. Potential participants will be reminded to review the study information and informed consent form on the website if possible.\\n\\nThe investigators will then initiate contact with potential participants by email (preferred) or telephone. The study requirements will be reviewed, and the potential participant will have an opportunity to ask questions. Consent for participation will preferably be obtained electronically; those without internet access may provide consent by telephone.\\n\\nParticipants will then be screened for inclusion and exclusion criteria by electronic questionnaire or telephone interview and Alberta Netcare medical record review. Follow-up questions to confirm eligibility by email or telephone may be required.\\n\\nThose who are eligible will be randomized to receive hydroxychloroquine or placebo for a total duration of 5 days. Those who are not eligible will be informed and the reasons for ineligibility will be explained why (generally it will be a safety exclusion and they should be aware). Study drug will be delivered to their residence by courier.\\n\\nOutcomes will be collected by electronic questionnaire, administrative data and review of Alberta Netcare. If follow-up questionnaires are not completed within 24 hours telephone follow-up will be attempted. Those completing the study who do not have internet access will be followed by telephone. Administrative data, and information on Alberta Netcare will also be used for follow-up. The duration of the followup is 30 days.',\n", + " 'DetailedDescription': 'This double-blind placebo-controlled, randomized clinical trial will determine if hydroxychloroquine for 5 days, initiated within 72 hours of a confirmed diagnosis of COVID-19, reduces the occurrence of severe COVID-19 disease. Severe disease is defined as the composite of mechanical ventilation or death at 30 days. This trial will enrol consenting Albertans who are not hospitalized, are over age 40, have no contraindication to treatment with hydroxychloroquine, who do not have a severe underlying comorbidity where treatment is not likely to be beneficial to the patient.\\n\\nSecondary outcomes will be the proportion requiring invasive mechanical ventilation, diagnosis of acute respiratory distress syndrome (ARDS), use of vasopressors, receipt of ECMO/ECLS, diagnosis of median length of stay, in-hospital and 30-day mortality, EQ5D at 30 days, disposition at 30 days.\\n\\nRandomization will be stratified by risk of severe disease. A pre-specified risk tool that includes classification by immunosuppression status will define patient strata.\\n\\nAlberta has a single publicly funded health care system with processes and administrative data that will allow complete capture of health system encounters and resource utilization. The population is ethnically diverse (ref) and most Albertans have internet access to allow electronic enrolment and data capture.\\n\\nThe current COVID-19 epidemic has also paused most ongoing research, thus providing access to a large number of experienced researchers and highly trained research staff.\\n\\nLack of any proven treatments for this severe condition makes it imperative that we use the resources we have to try to improve the lives of Albertans and determine if there is evidence for the use of hydroxychloroquine for confirmed COVID-19 disease, overall, and in high risk participants.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", + " 'KeywordList': {'Keyword': ['SARS-Cov2', 'viral pneumonia']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 3']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Single Group Assignment',\n", + " 'DesignInterventionModelDescription': 'Randomization will be stratified by risk of severe disease. A pre-specified risk tool that includes classification by immunosuppression status will define patient strata.\\n\\nIt is predicted that patients will want treatment. Further, immunosuppressed patients may be at the highest risk of fatal outcomes. Therefore, we will use 2:1 randomization (hydroxychloroquine: placebo), stratified by risk status (which includes immune status).\\n\\nRandomization will use a stratified minimal sufficient balance algorithm to ensure balance on age, provincial zone/geographic location',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Triple',\n", + " 'DesignMaskingDescription': 'A randomized, double-blind, placebo-controlled trial - trial staff and patients will all be blinded to the treatment allocation.',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", + " 'Care Provider',\n", + " 'Investigator']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '1660',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'hydroxychloroquine',\n", + " 'ArmGroupType': 'Active Comparator',\n", + " 'ArmGroupDescription': 'hydroxychloroquine 400 mg po bid loading dose for 1 day followed by 200 mg po twice daily for 4 days',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine']}},\n", + " {'ArmGroupLabel': 'Placebo',\n", + " 'ArmGroupType': 'Placebo Comparator',\n", + " 'ArmGroupDescription': 'Matching Placebo',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Hydroxychloroquine',\n", + " 'InterventionDescription': 'COVID19',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Placebo',\n", + " 'hydroxychloroquine']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['plaquenil']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Composite of hospitalization, invasive mechanical ventilation or death within 30 days',\n", + " 'PrimaryOutcomeDescription': 'The aim of this intervention is to prevent severe COVID-19 disease.\\n\\nThis trial aims to confirm that severe COVID-19 disease can be reduced by a relative risk reduction of 50% by the use of hydroxychloroquine.The aim of this intervention is to prevent severe COVID-19 disease.\\n\\nThis trial aims to confirm that severe COVID-19 disease can be reduced by a relative risk reduction of 50% by the use of hydroxychloroquine.The aim of this intervention is to prevent severe COVID-19 disease.\\n\\nThis trial aims to confirm that severe COVID-19 disease can be reduced by a relative risk reduction of 50% by the use of hydroxychloroquine.',\n", + " 'PrimaryOutcomeTimeFrame': 'Within 30 days of randomization'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'composite of invasive mechanical ventilation or death within 30 days',\n", + " 'SecondaryOutcomeDescription': 'Following patients admitted to ICU for mechanical ventilation for symptoms of COVID19',\n", + " 'SecondaryOutcomeTimeFrame': 'Within 30 days of randomization'},\n", + " {'SecondaryOutcomeMeasure': 'hospitalization within 30 days',\n", + " 'SecondaryOutcomeDescription': 'Admission to hospital as an inpatient within 30 days of randomization',\n", + " 'SecondaryOutcomeTimeFrame': 'Within 30 days of randomization'},\n", + " {'SecondaryOutcomeMeasure': 'mortality',\n", + " 'SecondaryOutcomeDescription': 'Mortality within 30 days of randomization',\n", + " 'SecondaryOutcomeTimeFrame': 'Within 30 days of randomization'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\nInclusion Criteria\\n\\nAll patients with a confirmed SARS-CoV-2 infection, defined as RT-PCR provincial laboratory confirmation.\\nSelf-reported symptoms of SARS-CoV-2 infection including any of the following: fever ≥37.5'C, cough, dyspnea, chest tightness, malaise, sore throat, myalgias, or coryza.\\nTime from being notified of a positive test result to day 1 of treatment < 96 hours\\nTime from patient reported first symptoms to day 1 of treatment <12 days\\nAdults, age 18 and over, with any risk factor for severe disease as per Table 1\\nResident of Alberta or if not a resident of Alberta able to provide complete follow-up data\\nInformed consent\\n\\nExclusion Criteria\\n\\nCurrently or imminently planned admission to hospital.\\nAny contraindication to hydroxychloroquine\\nParticipation in an ongoing interventional clinical trial within the previous 30 days.\\nCurrent treatment with hydroxychloroquine (Plaquenil), chloroquine, lumefantrine, mefloquine, or quinine.\\nInability to swallow pills or any other reason that compliance with the medical regimen is not likely.\\nPregnancy.\\nSevere underlying disease where treatment is not likely to be beneficial to the patient. This includes people requiring care in designated supported living facilities (SL4, nursing homes) and severe dementia.\",\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Dr. L Metz, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '403-944-4241',\n", + " 'CentralContactEMail': 'luanne.metz@ahs.ca'},\n", + " {'CentralContactName': 'Dr. M Hill, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '403-210-7786',\n", + " 'CentralContactEMail': 'michael.hill@ucalgary.ca'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Luanne Metz, MD',\n", + " 'OverallOfficialAffiliation': 'University of Calgary',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Michael D Hill, MD',\n", + " 'OverallOfficialAffiliation': 'University of Calgary',\n", + " 'OverallOfficialRole': 'Study Director'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'University of Calgary/Foothills Medical Centre',\n", + " 'LocationCity': 'Calgary',\n", + " 'LocationState': 'Alberta',\n", + " 'LocationZip': 'T2N 2T9',\n", + " 'LocationCountry': 'Canada',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Carol C Kenney, RN, CCRP',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '403-944-4286',\n", + " 'LocationContactEMail': 'ckenney@ucalgary.ca'},\n", + " {'LocationContactName': 'Michael D Hill, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '403-210-7786',\n", + " 'LocationContactEMail': 'michael.hill@ucalgary.ca'},\n", + " {'LocationContactName': 'Luanne M Metz, MD, FRCPC',\n", + " 'LocationContactRole': 'Principal Investigator'},\n", + " {'LocationContactName': 'Michael D Hill, MD.FRCPC',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", + " 'IPDSharingInfoTypeList': {'IPDSharingInfoType': ['Study Protocol',\n", + " 'Statistical Analysis Plan (SAP)',\n", + " 'Informed Consent Form (ICF)',\n", + " 'Clinical Study Report (CSR)',\n", + " 'Analytic Code']},\n", + " 'IPDSharingTimeFrame': '24 months after study close out.',\n", + " 'IPDSharingAccessCriteria': 'pending.'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", + " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", + " 'InterventionAncestorTerm': 'Antimalarials'},\n", + " {'InterventionAncestorId': 'D000000981',\n", + " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", + " {'InterventionAncestorId': 'D000000977',\n", + " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", + " {'InterventionAncestorId': 'D000000890',\n", + " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", + " {'InterventionAncestorId': 'D000004791',\n", + " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000018501',\n", + " 'InterventionAncestorTerm': 'Antirheumatic Agents'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", + " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M2861',\n", + " 'InterventionBrowseLeafName': 'Antimalarials',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2879',\n", + " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2875',\n", + " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2795',\n", + " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19188',\n", + " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000011014',\n", + " 'ConditionMeshTerm': 'Pneumonia'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000008171',\n", + " 'ConditionAncestorTerm': 'Lung Diseases'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M12487',\n", + " 'ConditionBrowseLeafName': 'Pneumonia',\n", + " 'ConditionBrowseLeafAsFound': 'Pneumonia',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M12497',\n", + " 'ConditionBrowseLeafName': 'Pneumonia, Viral',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M9751',\n", + " 'ConditionBrowseLeafName': 'Lung Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'}]}}}}},\n", + " {'Rank': 18,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04331834',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'PrEP_COVID'},\n", + " 'Organization': {'OrgFullName': 'Barcelona Institute for Global Health',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic',\n", + " 'OfficialTitle': 'Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic: A Unicentric, Double-Blinded Randomized Controlled Trial',\n", + " 'Acronym': 'PrEP_COVID'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 3, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'October 3, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'October 30, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'April 1, 2020',\n", + " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 2, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Barcelona Institute for Global Health',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Hospital Clinic of Barcelona',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'Laboratorios Rubió',\n", + " 'CollaboratorClass': 'UNKNOWN'}]}},\n", + " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No',\n", + " 'IsUSExport': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'The investigators aim to evaluate the efficacy of pre-exposure prophylaxis with hydroxychloroquine in healthcare workers with high-risk of SARS-CoV-2 infection.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", + " 'KeywordList': {'Keyword': ['PrEP']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 3']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Prevention',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Quadruple',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", + " 'Care Provider',\n", + " 'Investigator',\n", + " 'Outcomes Assessor']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '440',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Pre-exposure prophylaxis of SARS-CoV-2',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Participants will receive hydroxychloroquine 400 mg daily during the first 4 days, followed by 400 mg weekly during 6 months',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine']}},\n", + " {'ArmGroupLabel': 'Control group with placebo',\n", + " 'ArmGroupType': 'Placebo Comparator',\n", + " 'ArmGroupDescription': 'Participants will receive placebo 400 mg daily during the first 4 days, followed by 400 mg weekly during 6 months',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebos']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Hydroxychloroquine',\n", + " 'InterventionDescription': 'Hydroxychloroquine with the following dosage:\\n\\nday 0: 400 mg (2 tablets)\\nday 1: 400 mg (2 tablets)\\nday 2: 400 mg (2 tablets)\\nday 3: 400 mg (2 tablets)\\nweekly: 400 mg (2 tablets) for a period of six months',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Pre-exposure prophylaxis of SARS-CoV-2']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Placebos',\n", + " 'InterventionDescription': 'Placebo with the following dosage:\\n\\nday 0: 400 mg (2 tablets)\\nday 1: 400 mg (2 tablets)\\nday 2: 400 mg (2 tablets)\\nday 3: 400 mg (2 tablets)\\nweekly: 400 mg (2 tablets) for a period of six months',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Control group with placebo']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Confirmed cases of a COVID-19',\n", + " 'PrimaryOutcomeDescription': 'Confirmed cases of a COVID-19 (defined by symptoms compatible with COVID-19 and/or a positive PCR for SARS-CoV-2) in the PrEP group compared to the placebo group at any time during the 6 months of the follow-up in healthcare workers with negative PCR for SARS-CoV-2 at day 0.',\n", + " 'PrimaryOutcomeTimeFrame': 'Up to 6 months after start of treatment'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'SARS-CoV-2 seroconversion',\n", + " 'SecondaryOutcomeDescription': 'SARS-CoV-2 seroconversion in the PrEP group compared to placebo in during 6 months of follow-up in healthcare workers with negative serology at day 0.',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 6 months after start of treatment'},\n", + " {'SecondaryOutcomeMeasure': 'Occurrence of any adverse event related with hydroxychloroquine treatment',\n", + " 'SecondaryOutcomeDescription': 'Incidence of clinical and/or laboratory adverse events will be compared in the PrEP group and in the placebo arm.',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 6 months after start of treatment'},\n", + " {'SecondaryOutcomeMeasure': 'Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers',\n", + " 'SecondaryOutcomeDescription': 'Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers will be estimated by the number of healthcare workers diagnosed with COVID-19 in the placebo group, among the total of healthcare workers included in the non-PrEP group during the study period.',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 6 months after start of treatment'},\n", + " {'SecondaryOutcomeMeasure': 'Risk ratio for the different clinical, analytical and microbiological conditions to develop COVID-19',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 6 months after start of treatment'},\n", + " {'SecondaryOutcomeMeasure': 'COVID-19 Biobank',\n", + " 'SecondaryOutcomeDescription': 'A repository (biobank) of serum samples obtained from healthcare workers confirmed COVID-19 cases for future research on blood markers to predict SARS-CoV-2 infection.',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 6 months after start of treatment'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAge ≥ 18 years\\nNegative PCR and negative serology at day 0\\nHealthcare worker at Hospital Clínic de Barcelona\\nFemale participants: negative for pregnancy test\\nWilling to participate in the study\\nAble to sign the informed consent form\\n\\nExclusion Criteria:\\n\\nAge <18 years\\nPregnancy or breastfeeding\\nOngoing antiviral or antiretroviral treatment or HIV positive\\nOngoing anti-inflammatory treatment (NSAID, corticosteroids)\\nOngoing chloroquine or hydroxychloroquine treatment\\nConfirmed case of SARS-CoV-2 infection (positive PCR) at day 0\\nPositive serology for SARS-CoV-1 infection at day 0\\nImpossibility of signing the informed consent form\\nRejection of participation\\nWorking less than 5 days a week in the Hospital Clinic of Barcelona.\\n\\nAny contraindication for hydroxychloroquine treatment:\\n\\nHydroxychloroquine hypersensitivity or 4-aminoquinoline hypersensitivity\\nRetinopathy, visual field or visual acuity disturbances\\nQT prolongation, bradycardia (<50bpm), ventricular tachycardia, other arrhythmias, as determined on day 0 ECG or medical history\\nPotassium < 3 mEq/L or AST or ALT > 5 upper normal limit, as determined on day 0 blood test\\nPrevious myocardial infarction\\nMyasthenia gravis\\nPsoriasis or porphyria\\nGlomerular clearance < 10ml/min\\nPrevious history of severe hypoglycaemia\\nOngoing treatment with: antimalarials, antiarrhythmic, tricyclic antidepressants, natalizumab, quinolones, macrolides, agalsidase alfa and beta.',\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Jose Muñoz Gutiérrez, MD, PhD',\n", + " 'OverallOfficialAffiliation': 'Barcelona Institute for Global Health',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'ISGlobal',\n", + " 'LocationCity': 'Barcelona',\n", + " 'LocationZip': '08036',\n", + " 'LocationCountry': 'Spain'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", + " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", + " 'InterventionAncestorTerm': 'Antimalarials'},\n", + " {'InterventionAncestorId': 'D000000981',\n", + " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", + " {'InterventionAncestorId': 'D000000977',\n", + " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", + " {'InterventionAncestorId': 'D000000890',\n", + " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", + " {'InterventionAncestorId': 'D000004791',\n", + " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000018501',\n", + " 'InterventionAncestorTerm': 'Antirheumatic Agents'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", + " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M2861',\n", + " 'InterventionBrowseLeafName': 'Antimalarials',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2879',\n", + " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2875',\n", + " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2795',\n", + " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19188',\n", + " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}}}}},\n", + " {'Rank': 19,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04299724',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'GIMI-IRB-20002'},\n", + " 'Organization': {'OrgFullName': 'Shenzhen Geno-Immune Medical Institute',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Safety and Immunity of Covid-19 aAPC Vaccine',\n", + " 'OfficialTitle': 'Safety and Immunity Evaluation of A Covid-19 Coronavirus Artificial Antigen Presenting Cell Vaccine'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'February 15, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'July 31, 2023',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2024',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 5, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 6, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 9, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 6, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 9, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Lung-Ji Chang',\n", + " 'ResponsiblePartyInvestigatorTitle': 'President',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Shenzhen Geno-Immune Medical Institute'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Shenzhen Geno-Immune Medical Institute',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': \"Shenzhen Third People's Hospital\",\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': \"Shenzhen Second People's Hospital\",\n", + " 'CollaboratorClass': 'OTHER'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'In December 2019, viral pneumonia (Covid-19) caused by a novel beta-coronavirus (SARS-CoV-2) broke out in Wuhan, China. Some patients rapidly progressed and suffered severe acute respiratory failure and died, making it imperative to develop a safe and effective vaccine to treat and prevent severe Covid-19 pneumonia. Based on detailed analysis of the viral genome and search for potential immunogenic targets, a synthetic minigene has been engineered based on conserved domains of the viral structural proteins and a polyprotein protease. The infection of Covid-19 is mediated through binding of the Spike protein to the ACEII receptor, and the viral replication depends on molecular mechanisms of all of these viral proteins. This trial proposes to develop universal vaccine and test innovative Covid-19 minigenes engineered based on multiple viral genes, using an efficient lentiviral vector system (NHP/TYF) to express viral proteins and immune modulatory genes to modify artificial antigen presenting cells (aAPC) and to activate T cells. In this study, the safety and immune reactivity of this aAPC vaccine will be investigated.',\n", + " 'DetailedDescription': 'Background:\\n\\nThe 2019 discovered new coronavirus, SARS-CoV-2, is an enveloped positive strand single strand RNA virus. The number of SARS-CoV-2 infected people has increased rapidly and WHO has warned that the pandemic spread of Covid-19 is imminent and would have disastrous outcomes. Covid-19 could pose a serious threat to human health and the global economy. There is no vaccine available or clinically approved antiviral therapy as yet. This study aims to evaluate the safety and immune reactivity of a genetically modified aAPC universal vaccine to treat and prevent Covid-19.\\n\\nObjective:\\n\\nPrimary study objectives: Injection of Covid-19/aAPC vaccine to volunteers to evaluate the safety.\\n\\nSecondary study objectives: To evaluate the anti- Covid-19 reactivity of the Covid-19/aAPC vaccine.\\n\\nDesign:\\n\\nBased on the genomic sequence of the new coronavirus SARS-CoV-2, select conserved and critical structural and protease protein domains to engineer lentiviral minigenes to express SARS-CoV-2 antigens.\\nThe Covid-19/aAPC vaccine is prepared by applying lentivirus modification including immune modulatory genes and the viral minigenes, to the artificial antigen presenting cells (aAPCs). The Covid-19/aAPCs are then inactivated for proliferation and extensively safety tested.\\nThe subjects receive a total of 5x10^ 6 cells each time by subcutaneous injection at 0, 14 and 28 days. The subjects are followed-up with peripheral blood tests at 0, 14, 21, 28 and 60 days until the end of the test.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Treat and Prevent Covid-19 Infection']},\n", + " 'KeywordList': {'Keyword': ['Lentiviral vector, Covid-19/aAPC vaccine']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 1']},\n", + " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '100',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Injection of Covid-19/aAPC vaccine',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: Pathogen-specific aAPC']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Biological',\n", + " 'InterventionName': 'Pathogen-specific aAPC',\n", + " 'InterventionDescription': 'The subjects will receive three injections of 5x10^6 each Covid-19/aAPC vaccine via subcutaneous injections.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Injection of Covid-19/aAPC vaccine']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Frequency of vaccine events',\n", + " 'PrimaryOutcomeDescription': 'Frequency of vaccine events such as fever, rash, and abnormal heart function.',\n", + " 'PrimaryOutcomeTimeFrame': 'Measured from Day 0 through Day 28'},\n", + " {'PrimaryOutcomeMeasure': 'Frequency of serious vaccine events',\n", + " 'PrimaryOutcomeDescription': 'Frequency of serious vaccine events',\n", + " 'PrimaryOutcomeTimeFrame': 'Measured from Day 0 through Day 28'},\n", + " {'PrimaryOutcomeMeasure': 'Proportion of subjects with positive T cell response',\n", + " 'PrimaryOutcomeTimeFrame': '14 and 28 days after randomization'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': '28-day mortality',\n", + " 'SecondaryOutcomeDescription': 'Number of deaths during study follow-up',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured from Day 0 through Day 28'},\n", + " {'SecondaryOutcomeMeasure': 'Duration of mechanical ventilation if applicable',\n", + " 'SecondaryOutcomeDescription': 'Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured from Day 0 through Day 28'},\n", + " {'SecondaryOutcomeMeasure': 'Proportion of patients in each category of the 7-point scale',\n", + " 'SecondaryOutcomeDescription': 'Proportion of patients in each category of the 7-point scale, the 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death)',\n", + " 'SecondaryOutcomeTimeFrame': '7,14 and 28 days after randomization'},\n", + " {'SecondaryOutcomeMeasure': 'Proportion of patients with normalized inflammation factors',\n", + " 'SecondaryOutcomeDescription': 'Proportion of patients with different inflammation factors in normalization range',\n", + " 'SecondaryOutcomeTimeFrame': '7 and 14 days after randomization'},\n", + " {'SecondaryOutcomeMeasure': 'Clinical improvement based on the 7-point scale if applicable',\n", + " 'SecondaryOutcomeDescription': 'A decline of 2 points on the 7-point scale from admission means better outcome. The 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death)',\n", + " 'SecondaryOutcomeTimeFrame': '28 days after randomization'},\n", + " {'SecondaryOutcomeMeasure': 'Lower Murray lung injury score if applicable',\n", + " 'SecondaryOutcomeDescription': 'Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition',\n", + " 'SecondaryOutcomeTimeFrame': '7 days after randomization'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nHealthy and Covid-19-positive volunteers\\nThe interval between the onset of symptoms and randomized is within 7 days in Covid-19 patients. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used;\\nWhite blood cells ≥ 3,500/μl, lymphocytes ≥ 750/μl;\\nHuman immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or tuberculosis (TB) test negative;\\nSign the Informed Consent voluntarily;\\n\\nExclusion Criteria:\\n\\nSubject with active HCV, HBV or HIV infection.\\nSubject is albumin-intolerant.\\nSubject with life expectancy less than 4 weeks.\\nSubject participated in other investigational vaccine therapies within the past 60 days.\\nSubject with positive pregnancy test result.\\nResearchers consider unsuitable.',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '6 Months',\n", + " 'MaximumAge': '80 Years',\n", + " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Lung-Ji Chang',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+86(755)8672 5195',\n", + " 'CentralContactEMail': 'c@szgimi.org'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Lung-Ji Chang',\n", + " 'OverallOfficialAffiliation': 'Shenzhen Geno-Immune Medical Institute',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Shenzhen Geno-immune Medical Institute',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Shenzhen',\n", + " 'LocationState': 'Guangdong',\n", + " 'LocationZip': '518000',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Lung-Ji Chang',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '86-755-86725195',\n", + " 'LocationContactEMail': 'c@szgimi.org'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000014612',\n", + " 'InterventionMeshTerm': 'Vaccines'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000007155',\n", + " 'InterventionAncestorTerm': 'Immunologic Factors'},\n", + " {'InterventionAncestorId': 'D000045505',\n", + " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M15943',\n", + " 'InterventionBrowseLeafName': 'Vaccines',\n", + " 'InterventionBrowseLeafAsFound': 'Vaccine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M8784',\n", + " 'InterventionBrowseLeafName': 'Immunologic Factors',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", + " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'}]}}}}},\n", + " {'Rank': 20,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04322682',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'MHIPS-2020-001'},\n", + " 'Organization': {'OrgFullName': 'Montreal Heart Institute',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)',\n", + " 'OfficialTitle': 'Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)',\n", + " 'Acronym': 'COVID-19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 23, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'September 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'September 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 23, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 25, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 26, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 26, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 27, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Montreal Heart Institute',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'DACIMA Software',\n", + " 'CollaboratorClass': 'UNKNOWN'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No',\n", + " 'IsUSExport': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'This is a phase 3, multi-center, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of colchicine in adult patients diagnosed with COVID-19 infection and have at least one high-risk criterion. Approximately 6000 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either colchicine or placebo tablets for 30 days.',\n", + " 'DetailedDescription': 'The primary objective of this study is to determine whether short-term treatment with colchicine reduces the rate of death and lung complications related to COVID-19. The secondary objective is to determine the safety of treatment with colchicine in this patient population.\\n\\nApproximately 6000 patients will be enrolled to receive either colchicine or placebo (1:1 allocation ratio) for 30 days. Follow-up assessments will occur at 15 and 30 days following randomization for evaluation of the occurrence of any trial endpoints or other adverse events.\\n\\nSafety and efficacy will be based on data from randomized patients. An independent data and safety monitoring board (DSMB) will periodically review study results as well as the overall conduct of the study, and will make recommendations to the study Executive Steering Committee (ESC) to continue, stop or modify the study protocol.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Corona Virus Infection']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 3']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignInterventionModelDescription': 'This will be a randomized, double-blind, placebo-controlled, multi-center study. Following signature of the informed consent form, approximately 6000 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either colchicine or placebo (1:1 allocation ratio) for 30 days. Follow-up phone or video assessments will occur at 15 and 30 days following randomization for evaluation of the occurrence of any trial endpoints or other adverse events.',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Single',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '6000',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Colchicine 0.5 mg',\n", + " 'ArmGroupType': 'Active Comparator',\n", + " 'ArmGroupDescription': 'Patients will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Colchicine']}},\n", + " {'ArmGroupLabel': 'Placebo',\n", + " 'ArmGroupType': 'Placebo Comparator',\n", + " 'ArmGroupDescription': 'Patients will receive a placebo per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo oral tablet']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Colchicine',\n", + " 'InterventionDescription': 'Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Colchicine 0.5 mg']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Immuno-modulatory']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Placebo oral tablet',\n", + " 'InterventionDescription': 'Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Placebo']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Number of participants who die or require hospitalization due to COVID-19 infection',\n", + " 'PrimaryOutcomeDescription': 'The primary endpoint will be the composite of death or the need for hospitalization due to COVID-19 infection in the first 30 days after randomization.',\n", + " 'PrimaryOutcomeTimeFrame': '30 days post randomization'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Number of participants who die',\n", + " 'SecondaryOutcomeDescription': 'The secondary endpoint is the occurrence of death in the 30 days following randomization.',\n", + " 'SecondaryOutcomeTimeFrame': '30 days post randomization'},\n", + " {'SecondaryOutcomeMeasure': 'Number of participants requiring hospitalization due to COVID-19 infection',\n", + " 'SecondaryOutcomeDescription': 'The secondary endpoint is the need for hospitalization due to COVID-19 infection in the 30 days following randomization.',\n", + " 'SecondaryOutcomeTimeFrame': '30 days post randomization'},\n", + " {'SecondaryOutcomeMeasure': 'Number of participants requiring mechanical ventilation',\n", + " 'SecondaryOutcomeDescription': 'The secondary endpoint is the need for mechanical ventilation in the 30 days following randomization.',\n", + " 'SecondaryOutcomeTimeFrame': '30 days post randomization'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\nMales and females, at least 40 years of age, capable and willing to provide informed consent;\\nPatient must have received a diagnosis of COVID-19 infection within the last 24 hours;\\nOutpatient setting (not currently hospitalized or under immediate consideration for hospitalization);\\nPatient must possess at least one of the following high-risk criteria: 70 years or more of age, diabetes mellitus, uncontrolled hypertension (systolic blood pressure ≥150 mm Hg), known respiratory disease (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary disease, fever of ≥38.4°C within the last 48 hours, dyspnea at the time of presentation, bicytopenia, pancytopenia, or the combination of high neutrophil count and low lymphocyte count;\\nFemale patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing at least one method of contraception and preferably two complementary forms of contraception including a barrier method (e.g. male or female condoms, spermicides, sponges, foams, jellies, diaphragm, intrauterine device (IUD)) throughout the study and for 30 days after study completion;\\nPatient must be able and willing to comply with the requirements of this study protocol.\\n\\nExclusion Criteria:\\n\\nPatient currently hospitalized or under immediate consideration for hospitalization;\\nPatient currently in shock or with hemodynamic instability;\\nPatient with inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption;\\nPatient with pre-existent progressive neuromuscular disease;\\nEstimated Glomerular filtration rate (eGFR), using the MDRD equation for all subjects being considered for enrollment, with a cut-off of < 30 mL/m in/1.73m2;\\nPatient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease;\\nFemale patient who is pregnant, or breast-feeding or is considering becoming pregnant during the study or for 6 months after the last dose of study medication;\\nPatient currently taking colchicine for other indications (mainly chronic indications represented by Familial Mediterranean Fever or gout);\\nPatient with a history of an allergic reaction or significant sensitivity to colchicine;\\nPatient undergoing chemotherapy for cancer;\\nPatient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.\",\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '40 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Jean-Claude Tardif, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '514-376-3330',\n", + " 'CentralContactPhoneExt': '3612',\n", + " 'CentralContactEMail': 'jean-claude.tardif@icm-mhi.org'},\n", + " {'CentralContactName': 'Zohar Bassevitch, B.SC.',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '514-461-1300',\n", + " 'CentralContactPhoneExt': '2214',\n", + " 'CentralContactEMail': 'zohar.bassevitch@mhicc.org'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Jean-Claude Tardif, MD',\n", + " 'OverallOfficialAffiliation': 'Montreal Heart Institute',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Zohar Bassevitch, B.SC.',\n", + " 'OverallOfficialAffiliation': 'Montreal Health Innovations Coordinating Center',\n", + " 'OverallOfficialRole': 'Study Director'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Montreal Heart Institute',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Montreal',\n", + " 'LocationState': 'Quebec',\n", + " 'LocationZip': 'H1T 1C8',\n", + " 'LocationCountry': 'Canada',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Chantal Lacoste',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '514 376-3330',\n", + " 'LocationContactPhoneExt': '3604',\n", + " 'LocationContactEMail': 'chantal.lacoste@icm-mhi.org'},\n", + " {'LocationContactName': 'Jean-Claude Tardif, M.D',\n", + " 'LocationContactRole': 'Principal Investigator'}]}}]}}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000003078',\n", + " 'InterventionMeshTerm': 'Colchicine'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000006074',\n", + " 'InterventionAncestorTerm': 'Gout Suppressants'},\n", + " {'InterventionAncestorId': 'D000018501',\n", + " 'InterventionAncestorTerm': 'Antirheumatic Agents'},\n", + " {'InterventionAncestorId': 'D000050257',\n", + " 'InterventionAncestorTerm': 'Tubulin Modulators'},\n", + " {'InterventionAncestorId': 'D000050256',\n", + " 'InterventionAncestorTerm': 'Antimitotic Agents'},\n", + " {'InterventionAncestorId': 'D000050258',\n", + " 'InterventionAncestorTerm': 'Mitosis Modulators'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000000970',\n", + " 'InterventionAncestorTerm': 'Antineoplastic Agents'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M4890',\n", + " 'InterventionBrowseLeafName': 'Colchicine',\n", + " 'InterventionBrowseLeafAsFound': 'Colchicine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M19188',\n", + " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M24783',\n", + " 'InterventionBrowseLeafName': 'Antimitotic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'ANeo',\n", + " 'InterventionBrowseBranchName': 'Antineoplastic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic 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[{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 21,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04312464',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'MD-COVID-19'},\n", + " 'Organization': {'OrgFullName': 'Wuhan Union Hospital, China',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Myocardial Damage in COVID-19',\n", + " 'OfficialTitle': 'Retrospective Study of Myocardial Damage in COVID-19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Enrolling by invitation',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'January 1, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 15, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'March 18, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 4, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 13, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 18, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 13, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 18, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Xiang Cheng',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Professor',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Wuhan Union Hospital, China'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Wuhan Union Hospital, China',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'This study aims to investigate the clinical characteristics, the incidence of myocardial injury, and the influence of myocardial injury on the prognosis in COVID-19 patients. There is no additional examination and treatment for this project.',\n", + " 'DetailedDescription': 'The epidemic of the COVID-19 has expanded from Wuhan through out China, and is being exported to a growing number of countries. Recently, investigators have revealed that acute myocardial injury is existed in 7.2% patients with COVID-19, and this proportion in patients admitted to the ICU (22.2%) is higher than patients not treated in the ICU (2.0%). Thus, cardiac troponin I (cTNI), the biomarker of cardiac injury, might be a clinical predictor of COVID-19 patient outcomes. This study aims to investigate the clinical characteristics, the incidence of myocardial injury, and the influence of myocardial injury on the prognosis in COVID-19 patients.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", + " 'Cardiovascular Diseases']},\n", + " 'KeywordList': {'Keyword': ['COVID-19', 'myocardial injury']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Case-Control']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Retrospective']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '500',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Discharged group',\n", + " 'ArmGroupDescription': 'The individual which is defined as patient discharged from hospital',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: non']}},\n", + " {'ArmGroupLabel': 'Dead group',\n", + " 'ArmGroupDescription': 'The individual which is defined as patient with all-cause death',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: non']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", + " 'InterventionName': 'non',\n", + " 'InterventionDescription': 'no intervention',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Dead group',\n", + " 'Discharged group']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'The myocardial injury incidence',\n", + " 'PrimaryOutcomeDescription': 'The myocardial injury incidence of COVID-19 patients',\n", + " 'PrimaryOutcomeTimeFrame': '75 days'},\n", + " {'PrimaryOutcomeMeasure': 'The risk factors analysis for the death',\n", + " 'PrimaryOutcomeDescription': 'The risk factors analysis for the death of COVID-19 patients',\n", + " 'PrimaryOutcomeTimeFrame': '75 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Clinical characteristics',\n", + " 'SecondaryOutcomeDescription': 'The clinical characteristics description of COVID-19 patients',\n", + " 'SecondaryOutcomeTimeFrame': '75 days'},\n", + " {'SecondaryOutcomeMeasure': 'Clinical course',\n", + " 'SecondaryOutcomeDescription': 'The clinical course description of COVID-19 patients',\n", + " 'SecondaryOutcomeTimeFrame': '75 days'},\n", + " {'SecondaryOutcomeMeasure': 'Cardiovascular comorbidity',\n", + " 'SecondaryOutcomeDescription': 'The clinical characteristics and prognosis analysis in different cardiovascular comorbidity of COVID-19 patients',\n", + " 'SecondaryOutcomeTimeFrame': '75 days'},\n", + " {'SecondaryOutcomeMeasure': 'Analysis of causes of death',\n", + " 'SecondaryOutcomeDescription': 'Analysis of causes of death in COVID-19 patients',\n", + " 'SecondaryOutcomeTimeFrame': '75 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\n(1) Age ≥18 years. (2) Laboratory (RT-PCR) confirmed infection with SARS-CoV-2. (3) Lung involvement confirmed with chest imaging.\\n\\nExclusion Criteria:\\n\\nNo cTnI test on admission',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'The laboratory-confirmed patients with confirmed COVID-19 admitted to headquarters, west campus and cancer center of Union Hospital, Tongji Medical College, Huazhong University of science and technology, from January 1st to March 15th, 2020',\n", + " 'SamplingMethod': 'Probability Sample'},\n", + " 'ContactsLocationsModule': {'LocationList': {'Location': [{'LocationFacility': 'Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology',\n", + " 'LocationCity': 'Wuhan',\n", + " 'LocationState': 'Hubei',\n", + " 'LocationZip': '430022',\n", + " 'LocationCountry': 'China'}]}}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000002318',\n", + " 'ConditionMeshTerm': 'Cardiovascular Diseases'}]}}}}},\n", + " {'Rank': 22,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04333225',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '020-132'},\n", + " 'Organization': {'OrgFullName': 'Baylor Research Institute',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Hydroxychloroquine in the Prevention of COVID-19 Infection in Healthcare Workers',\n", + " 'OfficialTitle': 'A Prospective Clinical Study of Hydroxychloroquine in the Prevention of SARS- CoV-2 (COVID-19) Infection in Healthcare Workers After High-risk Exposures'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 3, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'July 30, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'July 30, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'April 1, 2020',\n", + " 'StudyFirstSubmitQCDate': 'April 2, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 3, 2020',\n", + " 'StudyFirstPostDateType': 'Estimate'},\n", + " 'LastUpdateSubmitDate': 'April 2, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", + " 'LastUpdatePostDateType': 'Estimate'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Baylor Research Institute',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'Yes',\n", + " 'IsFDARegulatedDevice': 'No',\n", + " 'IsUSExport': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'In order to assess the efficacy of hydroxychloroquine treatment weekly for a total of 7 weeks in the prevention of COVID-19 infection, three hundred sixty (360) Healthcare workers with high risk exposure to patients infected with COVID-19 will be tested for COVID-19 infection via nasopharyngeal (NP) swab once weekly for 7 weeks. Of those, one hundred eighty (180) will receive weekly doses of hydroxychloroquine for the duration of the study. Subjects who opt not to receive the study drug will form the control group.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", + " 'KeywordList': {'Keyword': ['hydroxychloroquine']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 2']},\n", + " 'DesignInfo': {'DesignAllocation': 'Non-Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Prevention',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '360',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Treatment',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Oral hydroxychloroquine 400 mg twice a day (two 200 mg tabs twice a day) on day 1 followed by two 200 mg tablets once a week for a total of 7 weeks.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine']}},\n", + " {'ArmGroupLabel': 'Control',\n", + " 'ArmGroupType': 'No Intervention',\n", + " 'ArmGroupDescription': 'Subjects who opt not to receive the study drug will undergo all procedures to form the control group'}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Hydroxychloroquine',\n", + " 'InterventionDescription': 'Weekly treatment in individuals at high risk',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Treatment']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Rate of COVID-19 positive conversion',\n", + " 'PrimaryOutcomeDescription': 'Rate of COVID-19 positive conversion on weekly nasopharyngeal (NP) sampling',\n", + " 'PrimaryOutcomeTimeFrame': '7 weeks'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Time-to-first clinical event',\n", + " 'SecondaryOutcomeDescription': 'Time-to-first clinical event consisting of a persistent change for any of the following:\\n\\nOne positive NP sample\\nCommon clinical symptoms of COVID-19 infection including fever, cough, and shortness of breath\\nLess common signs and symptoms of COVID-19 infection including headache, muscle pain, abdominal pain, sputum production, and sore throat',\n", + " 'SecondaryOutcomeTimeFrame': '7 weeks'}]},\n", + " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'Time-to-first clinical worsening event',\n", + " 'OtherOutcomeDescription': 'Time-to-first clinical worsening event consisting of any of the following:\\n\\nHospitalization for COVID-19 infection\\nIntensive care unit admission for COVID-19 infection\\nAll cause death',\n", + " 'OtherOutcomeTimeFrame': '7 weeks'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAdult male and female healthcare workers ≥ 18 to ≤ 75 years of age upon study consent\\n\\nHealthcare workers with\\n\\n• One day or more of exposure to suspect and/or positive COVID-19 patients, including but not limited to those working in the Emergency Department or Intensive Care Unit.\\n\\nOR\\n\\n• Unprotected exposure to a known positive COVID-19 patient within 72 hours of screening.\\n\\nAfebrile with no constitutional symptoms\\nWilling and able to comply with scheduled visits, treatment plan, and other study procedures\\nEvidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures\\n\\nExclusion Criteria:\\n\\nParticipation in other investigational clinical trials for the treatment or prevention of SARS-COV-2 infection within 30days\\nUnwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) during Screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested Note: the following criteria follow standard clinical practice for FDA approved indications of this medication\\nHaving a prior history of blood disorders such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia\\nHaving a prior history of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency\\nHaving dermatitis, psoriasis or porphyria\\nTaking Digoxin, Mefloquine, methotrexate, cyclosporine, praziquantel, antacids and kaolin, cimetidine, ampicillin, Insulin or antidiabetic drugs, arrhythmogenic drugs, antiepileptic drugs, loop, thiazide, and related diuretics, laxatives and enemas, amphotericin B, high dose corticosteroids, and proton pump inhibitors, neostigmine, praziquantel, Pyridostigmine, tamoxifen citrate\\nAllergies: 4-Aminoquinolines\\nPre-existing retinopathy of the eye\\nHas a chronic liver disease or cirrhosis, including hepatitis B and/or untreated hepatitis\\nUntreated or uncontrolled active bacterial, fungal infection\\nKnown or suspected active drug or alcohol abuse, per investigator judgment\\nWomen who are pregnant or breastfeeding\\nKnown hypersensitivity to any component of the study drug\\nA known history of prolonged QT syndrome or history of additional risk factors for torsades de pointe (e.g., heart failure, requires a lab test , family history of Long QT Syndrome), or the use of concomitant medications that prolong the QT/QTc interval',\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '75 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Laura Clariday, CCRC',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '214-820-7224',\n", + " 'CentralContactEMail': 'Laura.Clariday@BSWHealth.org'},\n", + " {'CentralContactName': 'Rebecca Baker, MSN, APRN',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '214-820-7965',\n", + " 'CentralContactEMail': 'Rebecca.Baker2@BSWHealth.org'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Peter A McCullough, MD, MPH',\n", + " 'OverallOfficialAffiliation': 'Baylor Health Care System',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Baylor University Medical Center',\n", + " 'LocationCity': 'Dallas',\n", + " 'LocationState': 'Texas',\n", + " 'LocationZip': '75226',\n", + " 'LocationCountry': 'United States',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Laura Clariday, CCRC',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '214-820-7224',\n", + " 'LocationContactEMail': 'Laura.Clariday@BSWHealth.org'},\n", + " {'LocationContactName': 'Rebecca Baker, MSN, APRN',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '214-820-7965',\n", + " 'LocationContactEMail': 'Rebecca.Baker2@BSWHealth.org'},\n", + " {'LocationContactName': 'Peter A McCullough, MD, MPH',\n", + " 'LocationContactRole': 'Principal Investigator'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", + " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", + " 'InterventionAncestorTerm': 'Antimalarials'},\n", + " {'InterventionAncestorId': 'D000000981',\n", + " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", + " {'InterventionAncestorId': 'D000000977',\n", + " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", + " {'InterventionAncestorId': 'D000000890',\n", + " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", + " {'InterventionAncestorId': 'D000004791',\n", + " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000018501',\n", + " 'InterventionAncestorTerm': 'Antirheumatic Agents'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", + " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M2861',\n", + " 'InterventionBrowseLeafName': 'Antimalarials',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2879',\n", + " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2875',\n", + " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2795',\n", + " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19188',\n", + " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", + " 'ConditionMeshTerm': 'Infection'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafAsFound': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", + " {'Rank': 23,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04333355',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'PC-TecSalud Fase I'},\n", + " 'Organization': {'OrgFullName': 'Hospital San Jose Tec de Monterrey',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Safety in Convalescent Plasma Transfusion to COVID-19',\n", + " 'OfficialTitle': 'Phase 1 Study to Evaluate the Safety of Convalescent Plasma as an Adjuvant Therapy in Patients With SARS-CoV-2 Infection'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 15, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'December 20, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'April 30, 2021',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 31, 2020',\n", + " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 3, 2020',\n", + " 'StudyFirstPostDateType': 'Estimate'},\n", + " 'LastUpdateSubmitDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", + " 'LastUpdatePostDateType': 'Estimate'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Servando Cardona-Huerta',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Director of Clinical Research',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Hospital San Jose Tec de Monterrey'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Hospital San Jose Tec de Monterrey',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Tecnologico de Monterrey',\n", + " 'CollaboratorClass': 'OTHER'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'There is currently no specific vaccine or treatment to treat critically ill patients with COVID-19. Different therapies are still under investigation and are use in different health institutions, however, a significant proportion of patients do not respond to these treatments, so it is important to seek new treatments. One of these alternatives is the use of convalescent plasma. The investigator will use plasma obtained from convalescent individuals with proven novel SARS-CoV-2 virus infection, diagnosed with coronavirus-19-induced disease and symptom-free for a period of not less than 10 days since they recovered from the disease. This plasma will be infused in patients affected by the same virus, but who have developed respiratory complications that have not responded favorably to usual treatment such as chloroquine, hydroxychloroquine, azithromycin, and other antivirals. The investigator will evaluate the safety of this procedure by accounting for any adverse event.',\n", + " 'DetailedDescription': 'There is currently no specific vaccine or treatment to treat critically ill patients with COVID-19. Different therapies are still under investigation and are use in different health institutions, however, a significant proportion of patients do not respond to these treatments, so it is important to seek new treatments. One of these alternatives is the use of convalescent plasma.\\n\\nThe investigator will use plasma obtained from convalescent individuals with proven novel SARS-CoV-2 virus infection, diagnosed with coronavirus-19-induced disease and symptom-free for a period of not less than 10 days since they recovered from the disease. Donors will be screened for infectious diseases including sARS-CoV-2 and will be programmed for apheresis the next day. The investigaotr will process one plasmatic volume per donor and this will be guarded in the blood bank until required by the principal investigator.\\n\\nPatients or receptors will be screened and selected by the research team according to eligibility criteria, including severe disease refractory to treatment such as chloroquine, hydroxychloroquine, azithromycin, and other antivirals. Plasma will be fractioned in 250ml. Infusion will start after a clinical evaluation and blood sampling. Patients will remain under careful observation. If no adverse event is present, infusion will be repeated after 24 hours and the investigator will evaluate patients again 48 hours after the second transfusion. A final evaluation will be performed at day 14. The investigator will evaluate the safety of this procedure by accounting for any adverse event.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", + " 'KeywordList': {'Keyword': ['COVID-19',\n", + " 'SARS-CoV-2',\n", + " 'Convalescent plasma']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 1']},\n", + " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '20',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'COVID-19 patients receiving Convalescent Plasma',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Convalescent Plasma from patients who recently recover from COVID-19',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: Convalescent Plasma']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Biological',\n", + " 'InterventionName': 'Convalescent Plasma',\n", + " 'InterventionDescription': 'Along with the administration of convalescent plasma, patients will continue to receive supportive standard care.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['COVID-19 patients receiving Convalescent Plasma']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Supportive standard care']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Side effects',\n", + " 'PrimaryOutcomeDescription': 'Identify possible adverse effects after the administration of convalescent plasma',\n", + " 'PrimaryOutcomeTimeFrame': '14 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Heart Failure',\n", + " 'SecondaryOutcomeDescription': 'Development of heart failure during convalescent plasma transfusion or after it.',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Pulmonary Edema',\n", + " 'SecondaryOutcomeDescription': 'Development of pulmonary edema during convalescent plasma transfusion or after it.',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Allergic Reaction',\n", + " 'SecondaryOutcomeDescription': 'Development of any allergic reaction during convalescent plasma transfusion or after it.',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Lung infiltrates',\n", + " 'SecondaryOutcomeDescription': 'Thorax Computer tomography',\n", + " 'SecondaryOutcomeTimeFrame': '48 hours'},\n", + " {'SecondaryOutcomeMeasure': 'Lung infiltrates',\n", + " 'SecondaryOutcomeDescription': 'Thorax Computer tomography',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Viral load of SARS-CoV-2',\n", + " 'SecondaryOutcomeDescription': 'RT PCR SARS-CoV-2',\n", + " 'SecondaryOutcomeTimeFrame': '48 hrs'},\n", + " {'SecondaryOutcomeMeasure': 'Viral load of SARS-CoV-2',\n", + " 'SecondaryOutcomeDescription': 'RT PCR SARS-CoV-2',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria\\n\\nPatients 18 years and older\\nConfirmed SARS-CoV-2 Infection by RT-PCR.\\n\\nSerious or life-threatening infection defined as:\\n\\nSerious:\\n\\nDyspnea\\nRespiratory rate greater than or equal to 30 cycles / minute.\\nBlood oxygen saturation less than or equal to 93% with an oxygen supply greater than 60%.\\nPartial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300\\n\\nA 50% increase in pulmonary infiltrates defined by computer tomography scans in 24 to 48 hours.\\n\\nLife-threatening infection:\\n\\nrespiratory failure.\\nseptic shock.\\ndysfunction or multiple organ failure.\\nRefractory to treatment with azithromycin / hydroxychloroquine or chloroquine / ritonavir / lopinavir defined as: 48 hours with no improvement in the modified parameters such as serious or clinically imminent infection.\\nSigned Informed consent by the patient or by the person responsible for the patient in the case of critically ill patients (spouse or parents).\\n\\nExclusion Criteria:\\n\\nPatients with a history of allergic reaction to any type of previous transfusion.\\nHeart failure patients at risk of volume overload.\\nPatients with a history of chronic kidney failure in the dialysis phase.\\nPatients with previous hematological diseases (anemia less than 10 grams of hemoglobin, platelets greater than 100,000 / µl).\\nAny case where the investigator decides that the patient is not suitable for the protocol.',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Servando Cardona-Huerta, MD., Ph. D.',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+5218112121946',\n", + " 'CentralContactEMail': 'servandocardona@tec.mx'},\n", + " {'CentralContactName': 'Sylvia De la Rosa, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+5218111832730',\n", + " 'CentralContactEMail': 'sylvia.delarosa@tec.mx'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'José Fe Castilleja-Leal, MD.',\n", + " 'OverallOfficialAffiliation': 'Hospital San José',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Hospital San José',\n", + " 'LocationCity': 'Monterrey',\n", + " 'LocationState': 'Nuevo Leon',\n", + " 'LocationZip': '64718',\n", + " 'LocationCountry': 'Mexico'}]}},\n", + " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '32167489',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Mar 13. pii: 138003. doi: 10.1172/JCI138003. [Epub ahead of print]'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", + " {'Rank': 24,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04323228',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'ONS_COVID-19'},\n", + " 'Organization': {'OrgFullName': 'King Saud University',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Anti-inflammatory/Antioxidant Oral Nutrition Supplementation in COVID-19',\n", + " 'OfficialTitle': 'Anti-inflammatory/Antioxidant Oral Nutrition Supplementation on the Cytokine Storm and Progression of COVID-19: A Randomized Controlled Trial',\n", + " 'Acronym': 'ONSCOVID19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'October 1, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'October 30, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 23, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 24, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 26, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 25, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 27, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Mahmoud Abulmeaty, M.D., FACN.',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Associate Professor',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'King Saud University'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'King Saud University',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'COVID-19 pandemic threatens patients, societies and healthcare systems around the world. The host immunity determines the progress of the disease and its lethality. The associated cytokine storm mainly affects the lungs; leading to acute lung injury with variable degrees. Modulation of cytokine production using Immunonutrition is a novel concept that has been applied to other diseases. Using specific nutrients such as n3- fatty acids and antioxidant vitamins in extraordinary doses modulate the host immune response and ameliorate the cytokine storm associated with viral diseases such as COVID-19. In this proposal, we will conduct a prospective double-blinded controlled trial for 14 days on 30 SARS-CoV-2 positive cases. The participant will be randomly assigned to two groups (n=15/each); intervention (IG) and placebo (PG) groups. The IG group will be provided with an anti-inflammatory and antioxidant oral nutrition supplement (ONS) on a daily basis, while the PG will be given an isocaloric placebo. Basal and weekly nutritional screening, as well as recording of anthropometric, clinical and biochemical parameters, will be done. The main biochemical parameters include serum ferritin level, cytokine storm parameters (interleukin-6, Tumor necrosis factor-α, and monocyte chemoattractant protein 1), C-reactive protein, total leukocyte count, differential lymphocytic count and neutrophil to lymphocyte ratio. It is expected that the anti-inflammatory-antioxidant ONS might help in the reduction of the COVID-19 severity with more preservation of the nutritional status of infected cases.',\n", + " 'DetailedDescription': \"Subjects: A total of 30 participants will be enrolled in this double-blinded prospective, randomized controlled trial. All participants will sign a written consent after details of the study have been fully explained to them. Later on, they will be randomly allocated into two study groups; intervention group (IG, n=15) and placebo group (PG, n=15). Computer-generated random numbers will be used to randomize the participants into one of two intervention groups. The study protocol will be approved by the IRB committee in King Khalid University Hospital, King Saud University Medical city. This clinical trial will be registered in the clinicaltrials.gov registry.\\n\\nSettings: All participants will be SARS-CoV-2 positive cases admitted to King Khalid University Hospital.\\n\\nStudy protocol: All study participants will be instructed to either consume 8 fl oz oral nutrition supplement (ONS) enriched in eicosapentaenoic acid, gamma-linolenic acid and antioxidants (Oxepa, Abbott Nutrition, Abbott Laboratories) or iso-caloric -isonitrogenous product (by the same manufacture). The ONS will be served in opaque glasses of the same shape and color and should be ingested in the morning under the supervision of a nurse. The ONS should not be consumed at the time of a meal. The composition of one can of the intervention-ONS includes: 14.8 g protein, 22.2 g fat, 25 g carbohydrate, 355 kcal, 1.1 g EPA, 450 mg DHA, 950 mg GLA, 2840 IU vitamin A as 1.2 mg β-carotene, 205 mg Vitamin C, 75 IU vitamin E, 18 ug Selenium, and 5.7 mg Zinc. The composition of the control-ONS will have the same macronutrient composition, calorie density, and normal concentrations of vitamin A, C, E, Selenium and zinc.\\n\\nAll participants will be assessed at the start and reassessed again after 1 week and after 14-days period. The assessment will include nutritional screening by Nutritional risk screening 2002 (NRS-2002), anthropometric measurements, clinical assessment, and biochemical data.\\n\\nStatistical analysis: The Statistical Package for the Social Sciences (SPSS) version 25 will be used for analysis. The descriptive statistics for continuous variables will be presented as mean ± standard deviation, while other categorical variables as percentages. The independent sample t-test will be used for comparison between the IG and PG groups. For repeated measures at multiple points of time will be tested by Friedman's two-way ANOVA. The Pearson correlation coefficient will be applied to correlate some relevant variables. All these tests were performed with 80% power and a 5% level of significance.\"},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", + " 'KeywordList': {'Keyword': ['COVID-19',\n", + " 'Anti-inflammatory, and antioxidant ONS',\n", + " 'Cytokine storm']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 4']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignInterventionModelDescription': 'Participants will be randomly allocated into two study groups; intervention group (IG, n=15) and placebo group (PG, n=15). Computer-generated random numbers will be used to randomize the participants into one of two intervention groups.',\n", + " 'DesignPrimaryPurpose': 'Supportive Care',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Double',\n", + " 'DesignMaskingDescription': 'The intervention-ONS and isocaloric-NOS will be served in opaque glasses of the same shape and color. the care providers (nurses, dietitians) will not know members of each groups or the nature or composition of the ONS.',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", + " 'Care Provider']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '30',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Intervention',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'the intervention groups will receive daily oral nutrition supplement (ONS) enriched in eicosapentaenoic acid, gamma-linolenic acid and antioxidants. The composition of one can (8 fl oz) of the intervention-ONS includes: 14.8 g protein, 22.2 g fat, 25 g carbohydrate, 355 kcal, 1.1 g EPA, 450 mg DHA, 950 mg GLA, 2840 IU vitamin A as 1.2 mg β-carotene, 205 mg Vitamin C, 75 IU vitamin E, 18 ug Selenium, and 5.7 mg Zinc.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Dietary Supplement: oral nutrition supplement (ONS) enriched in eicosapentaenoic acid, gamma-linolenic acid and antioxidants']}},\n", + " {'ArmGroupLabel': 'Placebo',\n", + " 'ArmGroupType': 'Placebo Comparator',\n", + " 'ArmGroupDescription': 'iso-caloric -isonitrogenous product (by the same manufacture) and served in cans with the same color and shape.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Dietary Supplement: isocaloric/isonutrigenous ONS']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Dietary Supplement',\n", + " 'InterventionName': 'oral nutrition supplement (ONS) enriched in eicosapentaenoic acid, gamma-linolenic acid and antioxidants',\n", + " 'InterventionDescription': 'the intervention group will receive a commercially available anti-inflammatory/antioxidant ONS, which will be given to patients with COVID-19 in the morning 3 hours after breakfast.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Intervention']}},\n", + " {'InterventionType': 'Dietary Supplement',\n", + " 'InterventionName': 'isocaloric/isonutrigenous ONS',\n", + " 'InterventionDescription': 'The placebo group will receive an isocaloric/isonutrigenous ONS at the same time in the same shape/size/color of the cans.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Placebo']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Change from baseline score of Nutrition risk screening-2002 (NRS-2002) at end of the trial',\n", + " 'PrimaryOutcomeDescription': 'Changes in scores of the NRS-2002 for patients with COVID-19 at the end of the study, from 0 to 7 scores, with those scores < 3 means no risk of malnutrition and >= 3 means malnutrition.',\n", + " 'PrimaryOutcomeTimeFrame': 'up to 3 months'},\n", + " {'PrimaryOutcomeMeasure': 'Change from baseline Serum ferritin level at end of the trial',\n", + " 'PrimaryOutcomeDescription': 'Change in serum ferritin at the end of the trial as ferritin is considered as a COVID-19 fatality predictor.',\n", + " 'PrimaryOutcomeTimeFrame': 'up to 3 months'},\n", + " {'PrimaryOutcomeMeasure': 'Change from baseline serum Interleukin-6 concentration at end of the trial',\n", + " 'PrimaryOutcomeDescription': 'Change in IL-6 at the end of the trial as it represent the cytokine storm and it is considered as a COVID-19 fatality predictor',\n", + " 'PrimaryOutcomeTimeFrame': 'up to 3 months'},\n", + " {'PrimaryOutcomeMeasure': 'Change from baseline serum C-reactive protein concentration at end of the trial',\n", + " 'PrimaryOutcomeDescription': 'Change in C-reactive protein in the serum at the end of the trial which reflect the acute phase',\n", + " 'PrimaryOutcomeTimeFrame': 'up to 3 months'},\n", + " {'PrimaryOutcomeMeasure': 'Change from baseline serum Tumor necrosis factor-α concentration at end of the trial',\n", + " 'PrimaryOutcomeDescription': 'Change in the TNF a in the serum at the end of study as it represent severity of the cytokine storm',\n", + " 'PrimaryOutcomeTimeFrame': 'up to 3 months'},\n", + " {'PrimaryOutcomeMeasure': 'Change from baseline serum monocyte chemoattractant protein 1 (MCP-1) at end of the trial',\n", + " 'PrimaryOutcomeDescription': 'plasma MCP-1 represent severity of the cytokine storm',\n", + " 'PrimaryOutcomeTimeFrame': 'up to 3 months'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Change from baseline Weight at end of the trial',\n", + " 'SecondaryOutcomeDescription': 'Body weight in Kg',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 3 months'},\n", + " {'SecondaryOutcomeMeasure': 'Height',\n", + " 'SecondaryOutcomeDescription': 'stature in cm',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 1 month'},\n", + " {'SecondaryOutcomeMeasure': 'Change from baseline BMI at end of the trial',\n", + " 'SecondaryOutcomeDescription': 'Claculation of BMI according to weight / square Height',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 3 months'},\n", + " {'SecondaryOutcomeMeasure': 'Change from baseline mid arm circumference at end of the trial',\n", + " 'SecondaryOutcomeDescription': 'changes of MAC in cm',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 3 months'},\n", + " {'SecondaryOutcomeMeasure': 'Change from baseline triceps skin-fold thickness at end of the trial',\n", + " 'SecondaryOutcomeDescription': 'changes of TSF in mm',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 3 months'},\n", + " {'SecondaryOutcomeMeasure': 'Change from baseline MAMA at end of the trial',\n", + " 'SecondaryOutcomeDescription': '). The mid-arm muscle area (MAMA) will be calculated according to the following equation: {MAMA= (MAC - π x TSF)2 / 4π}.',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 3 months'},\n", + " {'SecondaryOutcomeMeasure': 'Change from baseline percentage of peripheral O2 saturation at end of the trial',\n", + " 'SecondaryOutcomeDescription': 'changes in the percentage of peripheral O2 saturation by an oximeter',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 3 months'},\n", + " {'SecondaryOutcomeMeasure': 'Change from baseline degree of body temperature at end of the trial',\n", + " 'SecondaryOutcomeDescription': 'changes in the degree of body temperature by infrared thermometer',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 3 months'},\n", + " {'SecondaryOutcomeMeasure': 'Change from baseline count the total leukocyte at end of the trial',\n", + " 'SecondaryOutcomeDescription': 'change in the count from complete blood counts',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 3 months'},\n", + " {'SecondaryOutcomeMeasure': 'Change from baseline differential lymphocytic count at end of the trial',\n", + " 'SecondaryOutcomeDescription': 'change in the count from complete blood counts',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 3 months'},\n", + " {'SecondaryOutcomeMeasure': 'Change from baseline Neutrophil count at end of the trial',\n", + " 'SecondaryOutcomeDescription': 'change in the count from complete blood counts',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 3 months'},\n", + " {'SecondaryOutcomeMeasure': 'Change from baseline neutrophil to lymphocyte ratio at end of the trial',\n", + " 'SecondaryOutcomeDescription': 'change in the rations calculated by division of the neutrophil count by the lymphocyte count',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 3 months'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nConfirmed SARS-CoV-2 infection\\nCOVID-19 patient in stable condition (i.e., not requiring ICU admission).\\n\\nExclusion Criteria:\\n\\nTube feeding or parenteral nutrition.\\nPregnant or lactating women\\nAdmission to ICU > 24 hours\\nparticipation in another study including any forms of supplementation or disease specific ONS.',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '65 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Mahmoud M.A. Abulmeaty, M.D., FACN',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '00966548155983',\n", + " 'CentralContactEMail': 'mabulmeaty@ksu.edu.sa'}]}},\n", + " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '28397943',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Abulmeaty MM, Almajwal AM, Almadani NK, Aldosari MS, Alnajim AA, Ali SB, Hassan HM, Elkatawy HA. Anthropometric and central obesity indices as predictors of long-term cardiometabolic risk among Saudi young and middle-aged men and women. Saudi Med J. 2017 Apr;38(4):372-380. doi: 10.15537/smj.2017.4.18758.'},\n", + " {'ReferencePMID': '11895145',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Grimm H, Calder PC. Immunonutrition. Br J Nutr. 2002 Jan;87 Suppl 1:S1.'},\n", + " {'ReferencePMID': '17922951',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Calder PC. Immunonutrition in surgical and critically ill patients. Br J Nutr. 2007 Oct;98 Suppl 1:S133-9. Review.'},\n", + " {'ReferencePMID': '32150360',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Cascella M, Rajnik M, Cuomo A, Dulebohn SC, Di Napoli R. Features, Evaluation and Treatment Coronavirus (COVID-19). 2020 Mar 8. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/'},\n", + " {'ReferencePMID': '28877163',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Das SK, Chisti MJ, Sarker MHR, Das J, Ahmed S, Shahunja KM, Nahar S, Gibbons N, Ahmed T, Faruque ASG, Rahman M, J Fuchs G 3rd, Al Mamun A, John Baker P. Long-term impact of changing childhood malnutrition on rotavirus diarrhoea: Two decades of adjusted association with climate and socio-demographic factors from urban Bangladesh. PLoS One. 2017 Sep 6;12(9):e0179418. doi: 10.1371/journal.pone.0179418. eCollection 2017.'},\n", + " {'ReferencePMID': '30655992',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Harada K, Minami H, Ferdous T, Kato Y, Umeda H, Horinaga D, Uchida K, Park SC, Hanazawa H, Takahashi S, Ohota M, Matsumoto H, Maruta J, Kakutani H, Aritomi S, Shibuya K, Mishima K. The Elental(®) elemental diet for chemoradiotherapy-induced oral mucositis: A prospective study in patients with oral squamous cell carcinoma. Mol Clin Oncol. 2019 Jan;10(1):159-167. doi: 10.3892/mco.2018.1769. Epub 2018 Nov 16.'},\n", + " {'ReferencePMID': '31986264',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:.'},\n", + " {'ReferencePMID': '22028151',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Kim H. Glutamine as an immunonutrient. Yonsei Med J. 2011 Nov;52(6):892-7. doi: 10.3349/ymj.2011.52.6.892. Review.'},\n", + " {'ReferencePMID': '12880610',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Kondrup J, Allison SP, Elia M, Vellas B, Plauth M; Educational and Clinical Practice Committee, European Society of Parenteral and Enteral Nutrition (ESPEN). ESPEN guidelines for nutrition screening 2002. Clin Nutr. 2003 Aug;22(4):415-21.'},\n", + " {'ReferencePMID': '12663270',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'McCowen KC, Bistrian BR. Immunonutrition: problematic or problem solving? Am J Clin Nutr. 2003 Apr;77(4):764-70. Review.'},\n", + " {'ReferencePMID': '26315574',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Mariette C. Immunonutrition. J Visc Surg. 2015 Aug;152 Suppl 1:S14-7. doi: 10.1016/S1878-7886(15)30005-9. Review. Erratum in: J Visc Surg. 2016 Feb;153(1):83.'},\n", + " {'ReferencePMID': '29878555',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'McCarthy MS, Martindale RG. Immunonutrition in Critical Illness: What Is the Role? Nutr Clin Pract. 2018 Jun;33(3):348-358. doi: 10.1002/ncp.10102.'},\n", + " {'ReferencePMID': '32125452',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 Mar 3. doi: 10.1007/s00134-020-05991-x. [Epub ahead of print]'},\n", + " {'ReferencePMID': '22390970',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Tisoncik JR, Korth MJ, Simmons CP, Farrar J, Martin TR, Katze MG. Into the eye of the cytokine storm. Microbiol Mol Biol Rev. 2012 Mar;76(1):16-32. doi: 10.1128/MMBR.05015-11. Review.'},\n", + " {'ReferencePMID': '25516320',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Teo BW, Toh QC, Chan XW, Xu H, Li JL, Lee EJ. Assessment of muscle mass and its association with protein intake in a multi-ethnic Asian population: relevance in chronic kidney disease. Asia Pac J Clin Nutr. 2014;23(4):619-25. doi: 10.6133/apjcn.2014.23.4.01.'}]},\n", + " 'SeeAlsoLinkList': {'SeeAlsoLink': [{'SeeAlsoLinkLabel': 'Immunonutrition: Interactions of Diet, Genetics, and Inflammation - Google Books. In Immunonutrition: Interactions of Diet, Genetics, and Inflammation',\n", + " 'SeeAlsoLinkURL': 'https://books.google.com.sa/books?id=d2HvAgAAQBAJ&pg=PA17&lpg=PA17&dq=immunonutrition+virus&source=bl&ots=VUneSrxucb&sig=ACfU3U0bKU0mAdShOEvzIAMifj7SNE47Lw&hl=en&sa=X&redir_esc=y#v=onepage&q=immunonutrition%20virus&f=false'},\n", + " {'SeeAlsoLinkLabel': 'COVID-19: consider cytokine storm syndromes and immunosuppression',\n", + " 'SeeAlsoLinkURL': 'https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30628-0/fulltext'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", + " 'IPDSharingDescription': 'all IPD that underlie results in a publication will be shared',\n", + " 'IPDSharingInfoTypeList': {'IPDSharingInfoType': ['Study Protocol',\n", + " 'Statistical Analysis Plan (SAP)',\n", + " 'Clinical Study Report (CSR)']},\n", + " 'IPDSharingTimeFrame': 'starting 6 months after publication.',\n", + " 'IPDSharingAccessCriteria': 'Access will be available for any researcher interested in this type of research on considerable consent.'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'C000028498',\n", + " 'InterventionMeshTerm': 'Evening primrose oil'},\n", + " {'InterventionMeshId': 'D000000893',\n", + " 'InterventionMeshTerm': 'Anti-Inflammatory Agents'},\n", + " {'InterventionMeshId': 'D000000975',\n", + " 'InterventionMeshTerm': 'Antioxidants'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000020011',\n", + " 'InterventionAncestorTerm': 'Protective Agents'},\n", + " {'InterventionAncestorId': 'D000045505',\n", + " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", + " {'InterventionAncestorId': 'D000000894',\n", + " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents, Non-Steroidal'},\n", + " {'InterventionAncestorId': 'D000018712',\n", + " 'InterventionAncestorTerm': 'Analgesics, Non-Narcotic'},\n", + " {'InterventionAncestorId': 'D000000700',\n", + " 'InterventionAncestorTerm': 'Analgesics'},\n", + " {'InterventionAncestorId': 'D000018689',\n", + " 'InterventionAncestorTerm': 'Sensory System Agents'},\n", + " {'InterventionAncestorId': 'D000018373',\n", + " 'InterventionAncestorTerm': 'Peripheral Nervous System Agents'},\n", + " {'InterventionAncestorId': 'D000018501',\n", + " 'InterventionAncestorTerm': 'Antirheumatic Agents'},\n", + " {'InterventionAncestorId': 'D000000960',\n", + " 'InterventionAncestorTerm': 'Hypolipidemic Agents'},\n", + " {'InterventionAncestorId': 'D000000963',\n", + " 'InterventionAncestorTerm': 'Antimetabolites'},\n", + " {'InterventionAncestorId': 'D000057847',\n", + " 'InterventionAncestorTerm': 'Lipid Regulating Agents'},\n", + " {'InterventionAncestorId': 'D000003879',\n", + " 'InterventionAncestorTerm': 'Dermatologic Agents'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M16141',\n", + " 'InterventionBrowseLeafName': 'Vitamins',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2798',\n", + " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents',\n", + " 'InterventionBrowseLeafAsFound': 'Anti-inflammatory',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M16351',\n", + " 'InterventionBrowseLeafName': 'Zinc',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M3094',\n", + " 'InterventionBrowseLeafName': 'Ascorbic Acid',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M16127',\n", + " 'InterventionBrowseLeafName': 'Vitamin A',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M4174',\n", + " 'InterventionBrowseLeafName': 'Carotenoids',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M268321',\n", + " 'InterventionBrowseLeafName': 'Evening primrose oil',\n", + " 'InterventionBrowseLeafAsFound': 'Gamma-linolenic acid',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M2873',\n", + " 'InterventionBrowseLeafName': 'Antioxidants',\n", + " 'InterventionBrowseLeafAsFound': 'Antioxidant',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M16136',\n", + " 'InterventionBrowseLeafName': 'Vitamin E',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M21556',\n", + " 'InterventionBrowseLeafName': 'Tocopherols',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M21559',\n", + " 'InterventionBrowseLeafName': 'Tocotrienols',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M21553',\n", + " 'InterventionBrowseLeafName': 'alpha-Tocopherol',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M217588',\n", + " 'InterventionBrowseLeafName': 'Retinol palmitate',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M14038',\n", + " 'InterventionBrowseLeafName': 'Selenium',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M20453',\n", + " 'InterventionBrowseLeafName': 'Protective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2799',\n", + " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents, Non-Steroidal',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2613',\n", + " 'InterventionBrowseLeafName': 'Analgesics',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19370',\n", + " 'InterventionBrowseLeafName': 'Analgesics, Non-Narcotic',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19188',\n", + " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2859',\n", + " 'InterventionBrowseLeafName': 'Hypolipidemic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2862',\n", + " 'InterventionBrowseLeafName': 'Antimetabolites',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M27470',\n", + " 'InterventionBrowseLeafName': 'Lipid Regulating Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M5657',\n", + " 'InterventionBrowseLeafName': 'Dermatologic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'T437',\n", + " 'InterventionBrowseLeafName': 'Ascorbic Acid',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'T477',\n", + " 'InterventionBrowseLeafName': 'Vitamin C',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'T462',\n", + " 'InterventionBrowseLeafName': 'Retinol',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'T415',\n", + " 'InterventionBrowseLeafName': 'Omega 3 Fatty Acid',\n", + " 'InterventionBrowseLeafAsFound': 'Eicosapentaenoic acid',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'T480',\n", + " 'InterventionBrowseLeafName': 'Vitamin E',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'T466',\n", + " 'InterventionBrowseLeafName': 'Tocopherol',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'T467',\n", + " 'InterventionBrowseLeafName': 'Tocotrienol',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'T468',\n", + " 'InterventionBrowseLeafName': 'Vitamin A',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'T152',\n", + " 'InterventionBrowseLeafName': 'Evening Primrose',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Micro',\n", + " 'InterventionBrowseBranchName': 'Micronutrients'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", + " {'InterventionBrowseBranchAbbrev': 'Infl',\n", + " 'InterventionBrowseBranchName': 'Anti-Inflammatory Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'Analg',\n", + " 'InterventionBrowseBranchName': 'Analgesics'},\n", + " {'InterventionBrowseBranchAbbrev': 'Derm',\n", + " 'InterventionBrowseBranchName': 'Dermatologic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'Lipd',\n", + " 'InterventionBrowseBranchName': 'Lipid Regulating Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ANeo',\n", + " 'InterventionBrowseBranchName': 'Antineoplastic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'Vi',\n", + " 'InterventionBrowseBranchName': 'Vitamins'},\n", + " {'InterventionBrowseBranchAbbrev': 'Ot',\n", + " 'InterventionBrowseBranchName': 'Other Dietary Supplements'},\n", + " {'InterventionBrowseBranchAbbrev': 'HB',\n", + " 'InterventionBrowseBranchName': 'Herbal and Botanical'}]}},\n", + " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19143',\n", + " 'ConditionBrowseLeafName': 'Disease Progression',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", + " {'Rank': 25,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04330586',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'KUMC-COVID-19'},\n", + " 'Organization': {'OrgFullName': 'Korea University Guro Hospital',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'A Trial of Ciclesonide in Adults With Mild COVID-19',\n", + " 'OfficialTitle': 'A Trial of Ciclesonide Alone or in Combination With Hydroxychloroquine for Adults With Mild COVID-19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'June 30, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'September 30, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 31, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 31, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 31, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Woo Joo Kim',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Professor',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Korea University Guro Hospital'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Korea University Guro Hospital',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'According to In vitro studies, ciclesonide showed good antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although some cases were reported for the clinical effectiveness of ciclesonide in the treatment of COVID-19, there is no clinical trial to evaluate the antiviral effect on the reduction of viral load in patients with COVID-19. In this study, we aimed to investigate whether ciclesonide alone or in combination with hydroxychloroquine could eradicate SARS-CoV-2 from respiratory tract earlier in patients with mild COVID-19.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", + " 'KeywordList': {'Keyword': ['SARS-CoV-2',\n", + " 'Ciclesonide',\n", + " 'Hydroxychloroquine',\n", + " 'Viral load',\n", + " 'Coronavirus']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 2']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignInterventionModelDescription': 'This multicenter study is an open-labelled, randomized clinical trial for 1:1:1 ratio of ciclesonide, ciclesonide plus hydroxychloroquine or control arm',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '141',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Ciclesonide',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Ciclesonide 320ug oral inhalation q12h for 14 days',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Ciclesonide Metered Dose Inhaler [Alvesco]']}},\n", + " {'ArmGroupLabel': 'Ciclesonide plus hydroxychloroquine',\n", + " 'ArmGroupType': 'Active Comparator',\n", + " 'ArmGroupDescription': 'Ciclesonide 320ug oral inhalation q12h for 14 days\\n\\nHydroxychloroquine 400mg QD for 10 days',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Ciclesonide Metered Dose Inhaler [Alvesco]',\n", + " 'Drug: Hydroxychloroquine']}},\n", + " {'ArmGroupLabel': 'Control',\n", + " 'ArmGroupType': 'No Intervention',\n", + " 'ArmGroupDescription': 'No ciclesonide and hydroxychloroquine'}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Ciclesonide Metered Dose Inhaler [Alvesco]',\n", + " 'InterventionDescription': 'Ciclesonide 320ug oral inhalation q12h for 14 days',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Ciclesonide',\n", + " 'Ciclesonide plus hydroxychloroquine']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Hydroxychloroquine',\n", + " 'InterventionDescription': 'Hydroxychloroquine 400mg QD for 10 days',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Ciclesonide plus hydroxychloroquine']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Rate of SARS-CoV-2 eradication at day 14 from study enrollment',\n", + " 'PrimaryOutcomeDescription': 'Viral load',\n", + " 'PrimaryOutcomeTimeFrame': 'Hospital day 14'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Rate of SARS-CoV-2 eradication at day 7 from study enrollment',\n", + " 'SecondaryOutcomeDescription': 'Viral load',\n", + " 'SecondaryOutcomeTimeFrame': 'Hospital day 7'},\n", + " {'SecondaryOutcomeMeasure': 'Time to SARS-CoV-2 eradication (days)',\n", + " 'SecondaryOutcomeDescription': 'Viral load',\n", + " 'SecondaryOutcomeTimeFrame': 'Hospital day 1, 4, 7, 10, 14, 21'},\n", + " {'SecondaryOutcomeMeasure': 'Viral load area-under-the-curve (AUC) reduction versus control',\n", + " 'SecondaryOutcomeDescription': 'Viral load change',\n", + " 'SecondaryOutcomeTimeFrame': 'Hospital day 1, 4, 7, 10, 14, 21'},\n", + " {'SecondaryOutcomeMeasure': 'Time to clinical improvement (days)',\n", + " 'SecondaryOutcomeDescription': 'Resolution of all systemic and respiratory symptoms for ≥2 consecutive days',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 28 days'},\n", + " {'SecondaryOutcomeMeasure': 'Proportion of clinical failure',\n", + " 'SecondaryOutcomeDescription': 'ICU admission, mechanical ventilation or death',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 28 days'}]},\n", + " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'Safety and tolerability of study drug',\n", + " 'OtherOutcomeDescription': 'Number of adverse events, proportion of early discontinuance',\n", + " 'OtherOutcomeTimeFrame': 'Up to 28 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nPatients with mild COVID-19 (NEWS scoring system 0-4)\\nPatient within 7 days from symptom onset or Patient within 48 hous after laboratory diagnosis (SARS-CoV-2 RT-PCR)\\n\\nExclusion Criteria:\\n\\nUnable to take oral medication\\nUnable to use inhaler\\nPregnancy or breast feeding\\nImmunocompromising conditions\\nModerate/severe renal dysfunction : creatinine clearance (CCL) < 30 mL/min\\nModerate/severe liver dysfunction: AST or ALT > 5 times upper normal limit\\nAsthma or chronic obstructive lung disease',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '80 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Joon Young Song, MD, PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '82-2-2626-3052',\n", + " 'CentralContactEMail': 'infection@korea.ac.kr'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'C000120481',\n", + " 'InterventionMeshTerm': 'Ciclesonide'},\n", + " {'InterventionMeshId': 'D000006886',\n", + " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", + " 'InterventionAncestorTerm': 'Antimalarials'},\n", + " {'InterventionAncestorId': 'D000000981',\n", + " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", + " {'InterventionAncestorId': 'D000000977',\n", + " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", + " {'InterventionAncestorId': 'D000000890',\n", + " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", + " {'InterventionAncestorId': 'D000004791',\n", + " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000018501',\n", + " 'InterventionAncestorTerm': 'Antirheumatic Agents'},\n", + " {'InterventionAncestorId': 'D000005938',\n", + " 'InterventionAncestorTerm': 'Glucocorticoids'},\n", + " {'InterventionAncestorId': 'D000006728',\n", + " 'InterventionAncestorTerm': 'Hormones'},\n", + " {'InterventionAncestorId': 'D000006730',\n", + " 'InterventionAncestorTerm': 'Hormones, Hormone Substitutes, and Hormone Antagonists'},\n", + " {'InterventionAncestorId': 'D000045505',\n", + " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", + " {'InterventionAncestorId': 'D000018926',\n", + " 'InterventionAncestorTerm': 'Anti-Allergic Agents'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", + " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M228767',\n", + " 'InterventionBrowseLeafName': 'Ciclesonide',\n", + " 'InterventionBrowseLeafAsFound': 'Ciclesonide',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M2861',\n", + " 'InterventionBrowseLeafName': 'Antimalarials',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2879',\n", + " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2875',\n", + " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2795',\n", + " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19188',\n", + " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M7630',\n", + " 'InterventionBrowseLeafName': 'Glucocorticoids',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M8372',\n", + " 'InterventionBrowseLeafName': 'Hormones',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M8371',\n", + " 'InterventionBrowseLeafName': 'Hormone Antagonists',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19546',\n", + " 'InterventionBrowseLeafName': 'Anti-Allergic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", + " {'InterventionBrowseBranchAbbrev': 'AAll',\n", + " 'InterventionBrowseBranchName': 'Anti-Allergic Agents'}]}},\n", + " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", + " {'Rank': 26,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04327531',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'turkishcovid19'},\n", + " 'Organization': {'OrgFullName': 'Kanuni Sultan Suleyman Training and Research Hospital',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Evaluation of Covid 19 Knowledge Anxiety and Expectation Levels of Turkish Physicians, Survey Study',\n", + " 'OfficialTitle': 'Evaluation of Covid 19 Knowledge Anxiety and Expectation Levels of Turkish Physicians, Survey Study'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Active, not recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 26, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 26, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'April 28, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 27, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 27, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 31, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 31, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Pınar Yalcin bahat',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Kanuni Sultan Suleyman Training and Research Hospital',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'It is aimed to measure the general health information of Turkish physicians about covid 19 pandemic, to evaluate anxiety levels and to evaluate future expectations in this period.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", + " 'Physician-Patient Relations']},\n", + " 'KeywordList': {'Keyword': ['covid-19', 'turkish physicians']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Ecologic or Community']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '200',\n", + " 'EnrollmentType': 'Actual'}},\n", + " 'ArmsInterventionsModule': {'InterventionList': {'Intervention': [{'InterventionType': 'Behavioral',\n", + " 'InterventionName': 'turkish physicians',\n", + " 'InterventionDescription': 'turkish physicians, who work active in pandemic hospital.'}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Evaluation of covid-19 knowledge level of turkish physicians',\n", + " 'PrimaryOutcomeDescription': 'beck depression scale\\n\\nThe BDI inventory has maximum of 63 and minimum of 0 scores:\\n\\n(0-10): Are considered normal ups and downs (11-16): Mild mood disturbance (17-20): Borderline clinical depression (21-30): Moderate depression, (31-40): Severe depression, Over 40: Extreme depression. A persistent score of !17, requires psychiatric treatment',\n", + " 'PrimaryOutcomeTimeFrame': '1 month'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'what they think about the future',\n", + " 'SecondaryOutcomeDescription': 'Turkish physicians write their thoughts about the health system after covid 19 with their own sentences',\n", + " 'SecondaryOutcomeTimeFrame': '1 month'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nturkish physicians\\nwork active in pandemic hospital\\n\\nExclusion Criteria:\\n\\nwork in another country\\nretired physicians',\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '25 Years',\n", + " 'MaximumAge': '55 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult']},\n", + " 'StudyPopulation': 'turkish physicians, who work active in pandemic hospital',\n", + " 'SamplingMethod': 'Probability Sample'},\n", + " 'ContactsLocationsModule': {'LocationList': {'Location': [{'LocationFacility': 'Pinar Yalcin Bahat',\n", + " 'LocationCity': 'Istanbul',\n", + " 'LocationState': 'İ̇stanbul',\n", + " 'LocationZip': '34000',\n", + " 'LocationCountry': 'Turkey'}]}}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M2905',\n", + " 'ConditionBrowseLeafName': 'Anxiety Disorders',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BXM',\n", + " 'ConditionBrowseBranchName': 'Behaviors and Mental Disorders'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", + " {'Rank': 27,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04318314',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '130852'},\n", + " 'Organization': {'OrgFullName': 'University College, London',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'COVID-19: Healthcare Worker Bioresource: Immune Protection and Pathogenesis in SARS-CoV-2',\n", + " 'OfficialTitle': 'COVID-19: Healthcare Worker Bioresource: Immune Protection and Pathogenesis in SARS-CoV-2',\n", + " 'Acronym': 'COVID19-HCW'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 18, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'December 31, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2021',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 17, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 19, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 23, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 25, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 26, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'University College, London',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': \"St. Bartholomew's Hospital\",\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'Royal Free Hospital NHS Foundation Trust',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'UCLH', 'CollaboratorClass': 'UNKNOWN'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Modelling repurposed from pandemic influenza is currently informing all strategies for SARS-CoV-2 and the disease COVID-19. A customized disease specific understanding will be important to understand subsequent disease waves, vaccine development and therapeutics. For this reason, ISARIC (the International Severe Acute Respiratory and Emerging Infection Consortium) was set up in advance. This focuses on hospitalised and convalescent serum samples to understand severe illness and associated immune response. However, many subjects are seroconverting with mild or even subclinical disease. Information is needed about subclinical infection, the significance of baseline immune status and the earliest immune changes that may occur in mild disease to compare with those of SARS-CoV-2. There is also a need to understand the vulnerability and response to COVID-19 of the NHS workforce of healthcare workers (HCWs). HCW present a cohort with likely higher exposure and seroconversion rates than the general population, but who can be followed up with potential for serial testing enabling an insight into early disease and markers of risk for disease severity. We have set up \"COVID-19: Healthcare worker Bioresource: Immune Protection and Pathogenesis in SARS-CoV-2\". This urgent fieldwork aims to secure significant (n=400) sampling of healthcare workers (demographics, swabs, blood sampling) at baseline, and weekly whilst they are well and attending work, with acute sampling (if hospitalised, via ISARIC, if their admission hospital is part of the ISARIC network) and convalescent samples post illness. These will be used to address specific questions around the impact of baseline immune function, the earliest immune responses to infection, and the biology of those who get non-hospitalized disease for local research and as a national resource. The proposal links directly with other ongoing ISARIC and community COVID projects sampling in children and the older age population. Reasonable estimates suggest the usable window for baseline sampling of NHS HCW is closing fast (e.g. baseline sampling within 3 weeks).',\n", + " 'DetailedDescription': \"The proposed study is a prospective observational cohort design which will be carried out across three different trusts: Barts Health NHS Trust (St Bartholomew's Hospital, The Royal London Hospital, Whipps Cross Hospital and Newham Hospital), Royal Free London NHS Foundation Trust (Royal Free Hospital) and University College London Hospitals NHS Foundation Trust (UCLH).\\n\\nParticipants will be asymptomatic front-facing HCWs who carry out their tasks in different areas of the corresponding hospital: Accident and Emergency, Adult Medical Admissions Unit, Medical and Surgical Wards and Intensive Care Units.\\n\\nThis study substantially uses existing infrastructure: Recruits into this study who are subsequently suspected to have COVID-19 can be co-recruited into ISARIC using ISARIC Ethics Ref: 13/SC/0149 (Oxford C Research Ethics Committee, UK CRN /CPMS ID 14152 IRAS ID126600 for acute samples and data collection. Sampling can be delivered via existing research personnel from furloughed projects (CLRN nurses, research fellows, Barts Bioresource). Convalescent sampling will be via an otherwise inactive Clinical Trials unit. It\"},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Health Care Worker Patient Transmission',\n", + " 'Coronavirus',\n", + " 'Coronavirus Infections',\n", + " 'Immunological Abnormality']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'Yes',\n", + " 'TargetDuration': '6 Months',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'BioSpec': {'BioSpecRetention': 'Samples With DNA',\n", + " 'BioSpecDescription': 'Blood samples Nasal and oropharygeal swabs'},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '400',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Healthy and asymptomatic healthcare workers',\n", + " 'ArmGroupDescription': 'Healthy and asymptomatic healthcare workers',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Diagnostic Test: COPAN swabbing and blood sample collection']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Diagnostic Test',\n", + " 'InterventionName': 'COPAN swabbing and blood sample collection',\n", + " 'InterventionDescription': 'COPAN swabbing of nostrils and/or oropharynx and blood sample collection',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Healthy and asymptomatic healthcare workers']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Seroconversion to SARS-CoV-2 positivity',\n", + " 'PrimaryOutcomeDescription': 'Home-isolation or hospital admission',\n", + " 'PrimaryOutcomeTimeFrame': 'Within 6 months'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nhealthy asymptomatic healthcare workers attending hospital (place of work)\\n\\nExclusion Criteria:\\n\\nSARS-CoV-2 positive or symptomatic healthcare workers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': \"Healthy asymptomatic healthcare workers attending their usual place of work that can be St Bartholomew's Hospital, Royal Free London or UCLH.\",\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'James C Moon, MD MBBS MRCP',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '07570911438',\n", + " 'CentralContactEMail': 'bartshealth.covid-hcw@nhs.net'},\n", + " {'CentralContactName': 'Mahdad Noursadeghi',\n", + " 'CentralContactRole': 'Contact'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'James C Moon',\n", + " 'OverallOfficialAffiliation': 'BHC & UCL',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Gabriella Captur',\n", + " 'OverallOfficialAffiliation': 'RFH & UCL',\n", + " 'OverallOfficialRole': 'Study Director'},\n", + " {'OverallOfficialName': 'Charlotte Manisty',\n", + " 'OverallOfficialAffiliation': 'BHC & UCL',\n", + " 'OverallOfficialRole': 'Study Director'},\n", + " {'OverallOfficialName': \"Ben O'Brien\",\n", + " 'OverallOfficialAffiliation': 'BHC & QMUL',\n", + " 'OverallOfficialRole': 'Study Chair'},\n", + " {'OverallOfficialName': 'Hugh Montgomery',\n", + " 'OverallOfficialAffiliation': 'UCL',\n", + " 'OverallOfficialRole': 'Study Chair'},\n", + " {'OverallOfficialName': 'Steffen Petersen',\n", + " 'OverallOfficialAffiliation': 'BHC & QMUL',\n", + " 'OverallOfficialRole': 'Study Chair'},\n", + " {'OverallOfficialName': 'Thomas Treibel',\n", + " 'OverallOfficialAffiliation': 'Barts Heart Center',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Barts Heart Center',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'London',\n", + " 'LocationCountry': 'United Kingdom',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'James Moon',\n", + " 'LocationContactRole': 'Contact'},\n", + " {'LocationContactName': 'James Moon',\n", + " 'LocationContactRole': 'Principal Investigator'}]}},\n", + " {'LocationFacility': 'Royal Free London NHS Foundation Trust',\n", + " 'LocationStatus': 'Active, not recruiting',\n", + " 'LocationCity': 'London',\n", + " 'LocationCountry': 'United Kingdom'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", + " 'IPDSharingDescription': 'Publication of results in open access journals; sharing of results in scientific databases.',\n", + " 'IPDSharingInfoTypeList': {'IPDSharingInfoType': ['Study Protocol',\n", + " 'Statistical Analysis Plan (SAP)',\n", + " 'Informed Consent Form (ICF)']}}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", + " {'ConditionMeshId': 'D000045169',\n", + " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M12',\n", + " 'ConditionBrowseLeafName': 'Congenital Abnormalities',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M14938',\n", + " 'ConditionBrowseLeafName': 'Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC16',\n", + " 'ConditionBrowseBranchName': 'Diseases and Abnormalities at or Before Birth'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 28,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04331860',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'C19REG'},\n", + " 'Organization': {'OrgFullName': 'RAD-AID International',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'COVID-19 Public Image Registry',\n", + " 'OfficialTitle': 'COVID-19 Public Image Registry',\n", + " 'Acronym': 'C19REG'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 30, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 30, 2025',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'March 30, 2025',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 30, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 31, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 2, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 31, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'RAD-AID International',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'BioClinica, Inc.',\n", + " 'CollaboratorClass': 'INDUSTRY'},\n", + " {'CollaboratorName': 'Google Inc.',\n", + " 'CollaboratorClass': 'INDUSTRY'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'The COVID-19 Public Image Registry is a global de-identified medical image registry for patients suspected/confirmed to have Covid-19 infection.',\n", + " 'DetailedDescription': \"This project is an observational registry where the patient's images are already acquired as part of standard clinical care. The data undergoes 100% de-identification with multiple confirmation steps. Therefore ,no patient identifiers will be collected and the images cannot be linked back to the patient.\\n\\nThe image repository will be made an open public health resource for researchers under a Creative Commons license similar to the ACR's various National Radiology Data Registries. There are no commercial aspects to this project. All sponsors are donating their services as a humanitarian effort.\"},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", + " 'KeywordList': {'Keyword': ['covid-19',\n", + " 'coronavirus',\n", + " 'registry',\n", + " 'imaging']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'Yes',\n", + " 'TargetDuration': '5 Years',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Other']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '500000',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", + " 'InterventionName': 'No intervention',\n", + " 'InterventionDescription': 'There is no intervention, this is an observational registry'}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'CT or Xray images from COVID-19 patients',\n", + " 'PrimaryOutcomeDescription': 'DICOM format, de-identified images',\n", + " 'PrimaryOutcomeTimeFrame': 'through study completion, an average of 2 years'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\n18 years or older\\nSuspected or known Covid-19 infection (currently or previously)\\nImage procedure performed as part of a Covid-19 exam with the images available in DICOM format\\n\\nExclusion Criteria:\\n\\n• Under age 18',\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '100 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'Suspected or known Covid-19 infection (currently or previously), 18 or over, undergoing a medical imaging exam',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Dan Gebow, PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '415-244-1481',\n", + " 'CentralContactEMail': 'dgebow@gmail.com'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Daniel Mollura, MD',\n", + " 'OverallOfficialAffiliation': 'Rad-AID',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'To be determined',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'San Francisco',\n", + " 'LocationState': 'California',\n", + " 'LocationZip': '94960',\n", + " 'LocationCountry': 'United States',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'TBD TBD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '415-244-1481',\n", + " 'LocationContactEMail': 'TBD@TBD.com'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No',\n", + " 'IPDSharingDescription': 'All data will be shared, but in a de-identified state.'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", + " {'Rank': 29,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04329507',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '282014'},\n", + " 'Organization': {'OrgFullName': 'NHS Lothian', 'OrgClass': 'OTHER_GOV'},\n", + " 'BriefTitle': 'Non-invasive Detection of Pneumonia in Context of Covid-19 Using Gas Chromatography - Ion Mobility Spectrometry (GC-IMS)',\n", + " 'OfficialTitle': 'Non-invasive Detection of Pneumonia in Context of Covid-19 Using Gas Chromatography - Ion Mobility Spectrometry (GC-IMS)'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 25, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 25, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'March 25, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 26, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 30, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 30, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'NHS Lothian',\n", + " 'LeadSponsorClass': 'OTHER_GOV'}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'On Dec 31, 2019, a number of viral pneumonia cases were reported in China. The virus causing pneumonia was then identified as a new coronavirus called SARS-CoV-2. Since this time, the infection called coronavirus disease 2019 (COVID-19) has spread around the world, causing huge stress for health care systems. To diagnose this infection, throat and nose swabs are taken. Unfortunately, the results often take more than 24 hrs to return from a laboratory. Speeding diagnosis up would be of great help.\\n\\nThis study aims to look at the breath to find signs that might allow clinicians to diagnose the coronavirus infection at the bedside, without needing to send samples to the laboratory. To do this, the team will be using a machine called a BreathSpec which has been adapted to fit in the hospital for this purpose.',\n", + " 'DetailedDescription': 'Analysis of volatile organic compounds (VOCs) in exhaled breath is of increasing interest in the diagnosis of lung infection. Over 2,000 VOCs can be detected through gas chromatography and mass spectrometry (GC-MS); patterns of VOC detected can offer information on chronic obstructive pulmonary disease, asthma, lung cancer and interstitial lung disease. Unfortunately, GC-MS while highly sensitive cannot be done at the bedside and at best takes hours to prepare samples, run the analysis and then interpret the results.\\n\\nCompared with other methods of breath analysis, ion mobility spectrometry (IMS) offers a tenfold higher detection rate of VOCs. By coupling an ion mobility spectrometer with a GC column, GC-IMS offers immediate twofold separation of VOCs with visualisation in a three-dimensional chromatogram. The total analysis time is about 300 seconds and the equipment has been miniaturised to allow bedside analysis.\\n\\nThe BreathSpec machine has been previously used to study both radiation injury in patients undergoing radiotherapy at the Edinburgh Cancer Centre (REC ref 16-SS-0059, as part of the H2020 TOXI-triage project, http://www.toxi-triage.eu/) and pneumonia in patients presenting to the ED of the Royal Infirmary of Edinburgh (REC ref 18-LO-1029). This work has developed artificial intelligence methodology that allows rapid analysis of the vast amount of data collected from these breath samples to identify signatures that may indicate a particular pathological process such as pneumonia or radiation injury.\\n\\nThe TOXI-triage project showed that the BreathSpec GC-IMS could rapidly triage individuals to identify those who had been exposed to particular volatile liquids in a mass casualty situation (http://www.toxi-triage.eu/).\\n\\nA pilot trial assessed chest infections at the Acute Medical Unit of the Royal Liverpool University Hospital. The final diagnostic model permitted fair discrimination between bacterial chest infections and chest infections due to other agents with an area under the receiver operator characteristic curve (AUC-ROC) of 0.73 (95% CI 0.61-0.86). The summary test characteristics were a sensitivity of 62% (95% CI 41-80%) and specificity of 80% (95% CI 64 - 91%) [8].\\n\\nThis was expanded in the EU H2020 funded \"Breathspec Study\" which aimed to differentiate breath samples from patients with bacterial or viral upper or lower respiratory tract infection. Over 1220 patients were recruited, with 191 patients identified as definitely bacterial infection and 671 classed as definitely not bacterial. Virology was undertaken on all patients, with 259 patients confirmed viral infection. Date processing is still on going to determine how well they can be distinguished using this methodology. More than 100 patients were recruited to this study in Edinburgh. Since then, artificial intelligence has been incorporated into our analytical processes, permitting faster and more refined analysis.\\n\\nOur ambition is that this technology will identify a signature of Covid-19 pneumonia or within 10 min in non-invasively collected breath samples to allow triage of patients into high and low risk categories for Covid-19. This will allow targeting of scarce resources and complex protocols associated with high risk patients including personal protective equipment (PPE), cohorting, and dedicated medical and nursing personel.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", + " 'Respiratory Disease']},\n", + " 'KeywordList': {'Keyword': ['COVID-19']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '200',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'InterventionList': {'Intervention': [{'InterventionType': 'Diagnostic Test',\n", + " 'InterventionName': 'Breath test',\n", + " 'InterventionDescription': 'collection of an exhaled breath sample'}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'To perform a study in patients with clinical features of pneumonia/chest infection to identify a signature of Covid-19 pneumonia in patients exposed to SARS-CoV-2, compared to unexposed patients or those without.',\n", + " 'PrimaryOutcomeDescription': 'breath sample collection',\n", + " 'PrimaryOutcomeTimeFrame': 'up to daily during hospital admission'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Detection of markers of Covid-19 pneumonia in non-invasive breath samples.',\n", + " 'SecondaryOutcomeDescription': 'breath sample collection',\n", + " 'SecondaryOutcomeTimeFrame': 'daily until the patient has ben discharged from hospital or it is deemed inappropriate to continue'},\n", + " {'SecondaryOutcomeMeasure': 'Relationship of this biomarker signature to the presence of SARS-CoV-2 in nasal and throat swabs.',\n", + " 'SecondaryOutcomeDescription': 'breath sample collection',\n", + " 'SecondaryOutcomeTimeFrame': 'daily until the patient has ben discharged from hospital or it is deemed inappropriate to continue'},\n", + " {'SecondaryOutcomeMeasure': \"Subsequently, the signature's relationship to other biomarkers of SARS-CoV-2 infection which are currently being explored\",\n", + " 'SecondaryOutcomeDescription': 'breath sample collection',\n", + " 'SecondaryOutcomeTimeFrame': 'daily until the patient has ben discharged from hospital or it is deemed inappropriate to continue'},\n", + " {'SecondaryOutcomeMeasure': 'In a smaller group of participants, ideally daily non-invasive breath samples will be collected to determine if there are changes between SARS-CoV-2 positive patients and those that are negative until hospital discharge or undue participant burden .',\n", + " 'SecondaryOutcomeDescription': 'breath sample collection',\n", + " 'SecondaryOutcomeTimeFrame': 'daily until the patient has ben discharged from hospital or it is deemed inappropriate to continue'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\n≥18 years old with clinical features consistent with pneumonia or chest infection due to SARS-CoV-2 AND\\n\\npresenting to the Royal Infirmary of Edinburgh where they are swabbed and triaged for Covid-19.\\n\\nExclusion Criteria:\\n\\nInability to provide informed consent\\nAge 17 years or less',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'Patients presenting to hospital with respiratory signs and tested for SARS-CoV-2',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Michael Eddleston',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '0131 242 3867',\n", + " 'CentralContactEMail': 'm.eddleston@ed.ac.uk'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided',\n", + " 'IPDSharingDescription': 'no plan made as yet - this research needs to be expedited during the pandemic'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000011014',\n", + " 'ConditionMeshTerm': 'Pneumonia'},\n", + " {'ConditionMeshId': 'D000012120',\n", + " 'ConditionMeshTerm': 'Respiration Disorders'},\n", + " {'ConditionMeshId': 'D000012140',\n", + " 'ConditionMeshTerm': 'Respiratory Tract Diseases'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000008171',\n", + " 'ConditionAncestorTerm': 'Lung Diseases'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M12487',\n", + " 'ConditionBrowseLeafName': 'Pneumonia',\n", + " 'ConditionBrowseLeafAsFound': 'Pneumonia',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M13540',\n", + " 'ConditionBrowseLeafName': 'Respiration Disorders',\n", + " 'ConditionBrowseLeafAsFound': 'Respiratory Disease',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafAsFound': 'Respiratory Disease',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M9751',\n", + " 'ConditionBrowseLeafName': 'Lung Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'}]}}}}},\n", + " {'Rank': 30,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04328285',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '20PH061'},\n", + " 'SecondaryIdInfoList': {'SecondaryIdInfo': [{'SecondaryId': '2020-001188-96',\n", + " 'SecondaryIdType': 'EudraCT Number'}]},\n", + " 'Organization': {'OrgFullName': 'Centre Hospitalier Universitaire de Saint Etienne',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers',\n", + " 'OfficialTitle': 'Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers : A Randomized Double-blind Placebo-controlled Clinical Trial',\n", + " 'Acronym': 'COVIDAXIS'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 30, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'November 30, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'November 30, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 25, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 27, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 31, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 27, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 31, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Centre Hospitalier Universitaire de Saint Etienne',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Institut Pasteur',\n", + " 'CollaboratorClass': 'INDUSTRY'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Since December 2019, the emergence of a new coronavirus named SARS-Cov-2 in the city of Wuhan in China has been responsible for a major epidemic of respiratory infections, including severe pneumonia. Within weeks, COVID-19 became a pandemic.\\n\\nIn the absence of specific antiviral treatment, a special attention should be given to prevention. Personal protection equipments may be insufficiently protective, including in healthcare workers, a significant proportion of whom (around 4%) having been infected in the outbreaks described in China and more recently in Italy. Infection in healthcare workers could result from the contact with COVID-19 people in community or with infected colleagues or patients.\\n\\nAs it will take at least a year before vaccines against SARS-CoV-2 becomes available, chemoprophylaxis is an option that should be considered in this setting where prevention of SARS-CoV-2 infection in Health Care Workers.\\n\\nThe COVIDAXIS trial evaluates a chemoprophylaxis of SARS-CoV-2 infection in Health Care Workers. This trial is divided into two distinct studies that could start independently each with its own randomization process: COVIDAXIS 1 will study Hydroxychloroquine (HCQ) versus placebo; COVIDAXIS 2 will study Lopinavir/ritonavir (LPV/r) versus placebo.\\n\\nUpon randomization healthcare workers (HCWs) involved in the management of suspected or confirmed COVID-19 cases will be assigned to one of the following 2 treatment groups:',\n", + " 'DetailedDescription': 'The study COVIDAXIS 1( Hydroxychloroquine (HCQ) versus placebo) will be realized on 600 participants and will be implemented first in as many centers as possible.\\n\\nUpon randomization healthcare workers involved in the management of suspected or confirmed COVID-19 cases will be assigned to one of the following 2 treatment groups:\\n\\nGroup 1.1: HCQ 400 mg, 2 tablets twice daily at Day 1 and 200 mg, 1 tablet once daily afterwards\\nGroup 1.2: Placebo of HCQ, 2 tablets twice daily at Day 1 and 1 tablet once daily afterwards).\\n\\nCOVIDAXIS 1\\n\\nThe COVIDAXIS 2 (Lopinavir/ritonavir (LPV/r) versus placebo will be realized on 600 participants and will be implemented in already participating and newer centers in a second step (when LPV/r becomes available).\\n\\nUpon randomization healthcare workers involved in the management of suspected or confirmed COVID-19 cases will be assigned to one of the following 2 treatment groups:\\n\\nGroup 2.1: LPV/r 400/100 mg, 2 tablets twice daily\\nGroup 2.2: Placebo of LPV/r, 2 tablets twice daily\\n\\nParticipants will receive the randomized treatment for 2 months and will be followed upon a 2.5 months period.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", + " 'KeywordList': {'Keyword': ['SARS-CoV-2',\n", + " 'COVID-19',\n", + " 'nasopharyngeal swab',\n", + " 'pneumonia',\n", + " 'Hydroxychloroquine',\n", + " 'Lopinavir/ritonavir']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 3']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignInterventionModelDescription': 'A randomized double-blind placebo-controlled clinical trial',\n", + " 'DesignPrimaryPurpose': 'Prevention',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Triple',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", + " 'Investigator',\n", + " 'Outcomes Assessor']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '1200',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Hydroxychloroquine (HCQ) vs Placebo',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Group 1.1: HCQ 400 mg, 2 tablets twice daily at Day 1 and 200 mg, 1 tablet once daily afterwards\\n\\nGroup 1.2: Placebo of HCQ, 2 tablets twice daily at Day 1 and 1 tablet once daily afterwards.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine',\n", + " 'Drug: Placebo of Hydroxychloroquine']}},\n", + " {'ArmGroupLabel': 'Lopinavir/ritonavir (LPV/r) vs Placebo',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Group 2.1: LPV/r 400/100 mg, 2 tablets twice daily\\n\\nGroup 2.2: Placebo of LPV/r, 2 tablets twice daily',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Lopinavir and ritonavir',\n", + " 'Drug: Placebo of LPV/r Tablets']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Hydroxychloroquine',\n", + " 'InterventionDescription': 'Hydroxychloroquine Oral Tablets',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Hydroxychloroquine (HCQ) vs Placebo']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Plaquenil']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Placebo of Hydroxychloroquine',\n", + " 'InterventionDescription': 'Placebo of Hydroxychloroquine Oral Tablets Placebo manufactured to mimic Hydroxychloroquine tablets',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Hydroxychloroquine (HCQ) vs Placebo']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Lopinavir and ritonavir',\n", + " 'InterventionDescription': 'LPV/r Oral Tablets',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Lopinavir/ritonavir (LPV/r) vs Placebo']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Kaletra']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Placebo of LPV/r Tablets',\n", + " 'InterventionDescription': 'Placebo of LPV/r Oral Tablets Placebo manufactured to mimic LPV/r tablets',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Lopinavir/ritonavir (LPV/r) vs Placebo']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Occurrence of an symptomatic or asymptomatic SARS-CoV-2 infection among healthcare workers (HCWs)',\n", + " 'PrimaryOutcomeDescription': 'An infection by SARS-CoV-2 is defined by either:\\n\\na positive specific Reverse Transcription - Polymerase Chain Reaction (RT-PCR) on periodic systematic nasopharyngeal swab during follow-up OR\\na positive specific RT-PCR on a respiratory sample in case of onset of symptoms consistent with COVID-19 during follow-up OR\\na seroconversion to SARS-CoV-2 after randomization.',\n", + " 'PrimaryOutcomeTimeFrame': 'Up to 2.5 months'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Evaluation of the occurrence of adverse events in each arm,',\n", + " 'SecondaryOutcomeDescription': 'Number of adverse events expected or unexpected, related and unrelated to the treatment, notably grades 2, 3 and 4 (moderate, severe and lifethreatening, according to the Adverse National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0) in each arm.',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 2.5 months'},\n", + " {'SecondaryOutcomeMeasure': 'Evaluation of the discontinuation rates of the investigational drug in each arm,',\n", + " 'SecondaryOutcomeDescription': 'Number of treatment discontinuations in each arm',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 2 months'},\n", + " {'SecondaryOutcomeMeasure': 'Evaluation of the adherence of participants to study drug,',\n", + " 'SecondaryOutcomeDescription': 'Treatment adherence rate will be assessed by:\\n\\nmeasurement of LPV and HCQ plasma concentrations using LC-MS/MS or LC-Fluorimetric detection\\nthe count of returned drugs at each visit.',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 2 months'},\n", + " {'SecondaryOutcomeMeasure': 'Evaluation of the incidence of symptomatic cases of SARS-CoV-2 infection in each arm,',\n", + " 'SecondaryOutcomeDescription': 'Number of incident cases of symptomatic SARS-CoV-2 infections among HCWs in each arm.\\n\\nSymptomatic infection is defined as :\\n\\na positive specific RT-PCR on a respiratory or non respiratory sample OR\\na thoracic CT scan with imaging abnormalities consistent with COVID-19.\\n\\nThese investigations being performed in case of signs/symptoms consistent with COVID-19 during follow-up.',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 2.5 months'},\n", + " {'SecondaryOutcomeMeasure': 'Evaluation of the incidence of asymptomatic cases of SARS-CoV-2 infection in each arm',\n", + " 'SecondaryOutcomeDescription': 'Number of incident cases of asymptomatic SARS-CoV-2 infection among HCWs in each randomization arm.\\n\\nAsymptomatic infection is defined as :\\n\\na positive specific RT-PCR on periodic systematic nasopharyngeal swab during clinical follow-up without consistent clinical signs/symptoms during follow-up OR\\nas seroconversion to SARS-CoV-2 between start and end of the study in HCWs that did not reported any consistent clinical symptoms during follow-up',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 2.5 months'},\n", + " {'SecondaryOutcomeMeasure': 'Evaluation of the incidence of severe cases of SARS-CoV-2 infection in each arm.',\n", + " 'SecondaryOutcomeDescription': 'Number of incident cases of severe SARS-CoV-2 infections among HCWs in each randomization arm, defined as :\\n\\na positive specific RT-PCR on a respiratory sample OR\\na thoracic CT scan with imaging abnormalities consistent with COVID-19 performed in case of onset of symptoms consistent with COVID-19 during follow-up in a participant who need to be hospitalized for respiratory distress. Respiratory distress defined as dyspnea with a respiratory frequency > 30/min, blood oxygen saturation <93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300 and/or lung infiltrates >50% (1).',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 2.5 months'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAdult healthcare workers (HCWs) (physicians, nurses, assistant nurses, dentists, physiotherapists, and midwives)\\nHCW involved at the time of enrolment in the care of patients with confirmed or suspected SARS-CoV-2 infection in hospital settings, in outpatient care settings or in geriatric long-term care facilities\\nHCW tested negative for HIV\\nHCW affiliated to the French health insurance system\\nHCW women of childbearing age with an effective contraception (ethinylestradiol-containing contraceptive pills are not regarded as effective in the context of LPV/r treatment)\\nWilling to comply to study design and the follow-up\\n\\nExclusion Criteria:\\n\\nHCW with positive SARS-CoV-2 RT-PCR of nasopharyngeal swab at the inclusion visit.\\nHCW with past history of confirmed SARS-CoV-2 infection\\nHCW with positive SARS-CoV-2 serology at the inclusion visit (if the serology is available at inclusion time, if SARS-CoV-2 serology is not available, it will be a secondary exclusion criteria)\\nHCW with comorbidities such as chronic hepatitis C virus (HCV) infection treated by direct antiviral drugs or with hypothyroidism that need hormonal substitution, or retinopathy, or known to have hypercholesterolemia hypertriglyceridemia\\nPregnant HCW\\nBreastfeeding HCW\\nHCW taking comedications known to have interactions with HCQ according to the official characteristics of the product',\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Arnauld Garcin',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '33 4 77 12 02 85',\n", + " 'CentralContactEMail': 'Arnauld.Garcin@chu-st-etienne.fr'},\n", + " {'CentralContactName': 'Nathalie Jolly',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '33 1 40 61 38 74',\n", + " 'CentralContactEMail': 'nathalie.jolly@pasteur.fr'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Elisabeth Botelho-Nevers, MD, PhD',\n", + " 'OverallOfficialAffiliation': 'CHU de Saint-Etienne',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Bruno Hoen, MD, PhD',\n", + " 'OverallOfficialAffiliation': 'Institut Pasteur',\n", + " 'OverallOfficialRole': 'Study Director'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': \"CHU d'Angers\",\n", + " 'LocationCity': 'Angers',\n", + " 'LocationCountry': 'France',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Vincent DUBEE',\n", + " 'LocationContactRole': 'Contact'},\n", + " {'LocationContactName': 'Vincent DUBEE',\n", + " 'LocationContactRole': 'Principal Investigator'},\n", + " {'LocationContactName': 'Marc-Antoine CUSTAUD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Isabelle PELLIER',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'AP-HP - Hôpital Bichat',\n", + " 'LocationCity': 'Paris',\n", + " 'LocationCountry': 'France',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Xavier DUVAL',\n", + " 'LocationContactRole': 'Contact'},\n", + " {'LocationContactName': 'Xavier DUVAL',\n", + " 'LocationContactRole': 'Principal Investigator'}]}},\n", + " {'LocationFacility': 'CHU de Saint-Etienne',\n", + " 'LocationCity': 'Saint-Étienne',\n", + " 'LocationCountry': 'France',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Elisabeth BOTELHO-NEVERS',\n", + " 'LocationContactRole': 'Contact'},\n", + " {'LocationContactName': 'Elisabeth BOTELHO-NEVERS',\n", + " 'LocationContactRole': 'Principal Investigator'},\n", + " {'LocationContactName': 'Bernard TARDY',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Amandine GAGNEUX-BRUNON',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Sandrine ACCASSAT',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000019438',\n", + " 'InterventionMeshTerm': 'Ritonavir'},\n", + " {'InterventionMeshId': 'D000061466',\n", + " 'InterventionMeshTerm': 'Lopinavir'},\n", + " {'InterventionMeshId': 'D000006886',\n", + " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000017320',\n", + " 'InterventionAncestorTerm': 'HIV Protease Inhibitors'},\n", + " {'InterventionAncestorId': 'D000011480',\n", + " 'InterventionAncestorTerm': 'Protease Inhibitors'},\n", + " {'InterventionAncestorId': 'D000004791',\n", + " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000019380',\n", + " 'InterventionAncestorTerm': 'Anti-HIV Agents'},\n", + " {'InterventionAncestorId': 'D000044966',\n", + " 'InterventionAncestorTerm': 'Anti-Retroviral Agents'},\n", + " {'InterventionAncestorId': 'D000000998',\n", + " 'InterventionAncestorTerm': 'Antiviral Agents'},\n", + " {'InterventionAncestorId': 'D000000890',\n", + " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", + " {'InterventionAncestorId': 'D000065692',\n", + " 'InterventionAncestorTerm': 'Cytochrome P-450 CYP3A Inhibitors'},\n", + " {'InterventionAncestorId': 'D000065607',\n", + " 'InterventionAncestorTerm': 'Cytochrome P-450 Enzyme Inhibitors'},\n", + " {'InterventionAncestorId': 'D000000962',\n", + " 'InterventionAncestorTerm': 'Antimalarials'},\n", + " {'InterventionAncestorId': 'D000000981',\n", + " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", + " {'InterventionAncestorId': 'D000000977',\n", + " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", + " {'InterventionAncestorId': 'D000018501',\n", + " 'InterventionAncestorTerm': 'Antirheumatic Agents'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", + " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M19978',\n", + " 'InterventionBrowseLeafName': 'Ritonavir',\n", + " 'InterventionBrowseLeafAsFound': 'Ritonavir',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M28424',\n", + " 'InterventionBrowseLeafName': 'Lopinavir',\n", + " 'InterventionBrowseLeafAsFound': 'Lopinavir',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M18192',\n", + " 'InterventionBrowseLeafName': 'HIV Protease Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M12926',\n", + " 'InterventionBrowseLeafName': 'Protease Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19934',\n", + " 'InterventionBrowseLeafName': 'Anti-HIV Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M24015',\n", + " 'InterventionBrowseLeafName': 'Anti-Retroviral Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2895',\n", + " 'InterventionBrowseLeafName': 'Antiviral Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2795',\n", + " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M29151',\n", + " 'InterventionBrowseLeafName': 'Cytochrome P-450 CYP3A Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M29124',\n", + " 'InterventionBrowseLeafName': 'Cytochrome P-450 Enzyme Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2861',\n", + " 'InterventionBrowseLeafName': 'Antimalarials',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2879',\n", + " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2875',\n", + " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19188',\n", + " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", + " 'ConditionMeshTerm': 'Infection'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafAsFound': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M12487',\n", + " 'ConditionBrowseLeafName': 'Pneumonia',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'}]}}}}},\n", + " {'Rank': 31,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04324489',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'DAS181-SARS-CoV-2'},\n", + " 'Organization': {'OrgFullName': 'Renmin Hospital of Wuhan University',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'DAS181 for Severe COVID-19: Compassionate Use',\n", + " 'OfficialTitle': 'DAS181 for Severe COVID-19: Compassionate Use'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 6, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 25, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'April 30, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 25, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 25, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 27, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 31, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Gong Zuojiong',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Director, Department of Infectious Disease',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Renmin Hospital of Wuhan University'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Renmin Hospital of Wuhan University',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Ansun Biopharma, Inc.',\n", + " 'CollaboratorClass': 'INDUSTRY'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No',\n", + " 'IsUSExport': 'Yes'},\n", + " 'DescriptionModule': {'BriefSummary': 'The objective of the study is to investigate the safety and potential efficacy of DAS181 for the treatment of severe COVID-19.',\n", + " 'DetailedDescription': 'Each eligible subject is treated with DAS181 for 10 days and observed for 28 days from the first day of administration.\\n\\nFrom day 1 to 10, once or twice a day, for 10 consecutive days, a total of 9 mg (7 ml) nebulized DAS181 is given. If DAS181 is given by twice a day, one vial containing 4.5 mg (3.5m1) DAS181 should be delivered with about 12-hour interval.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", + " 'KeywordList': {'Keyword': ['COVID-19',\n", + " 'SARS-CoV-2',\n", + " 'DAS181',\n", + " 'Hypoxemia']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Not Applicable']},\n", + " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '4',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'DAS181 Treatment',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Nebulized DAS181 9mg/day (4.5 mg bid/day) for 10 days',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: DAS181']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'DAS181',\n", + " 'InterventionDescription': 'Patient receives nebulized DAS181 (4.5 mg BID/day, a total 9 mg/day) for 10 days.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['DAS181 Treatment']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Improved clinical status',\n", + " 'PrimaryOutcomeDescription': 'Percent of subjects with improved clinical status',\n", + " 'PrimaryOutcomeTimeFrame': 'Day 14'},\n", + " {'PrimaryOutcomeMeasure': 'Return to room air',\n", + " 'PrimaryOutcomeDescription': 'Percent of subjects return to room air',\n", + " 'PrimaryOutcomeTimeFrame': 'Day 14'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'SARS-CoV-2 RNA',\n", + " 'SecondaryOutcomeDescription': 'time to SARS-CoV-2 RNA in the respiratory specimens being undetectable',\n", + " 'SecondaryOutcomeTimeFrame': '28 days'},\n", + " {'SecondaryOutcomeMeasure': 'Discharge',\n", + " 'SecondaryOutcomeDescription': 'Percent of patients discharge from hospital',\n", + " 'SecondaryOutcomeTimeFrame': 'Days 14, 21, 28'},\n", + " {'SecondaryOutcomeMeasure': 'Death',\n", + " 'SecondaryOutcomeDescription': 'All-cause mortality rate',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 14, 21, 28'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Key Inclusion Criteria:\\n\\nPositive for RNA of SARS-CoV-2 from respiratory specimens or blood specimens\\nHypoxemic\\nSevere COVID-19\\nIf female, subject must not be pregnant or nursing.\\nNon-vasectomized males are required to practice effective birth control methods\\nCapable of understanding and complying with procedures as outlined in the protocol as judged by the Investigator and able to sign informed consent form prior to the initiation of any screening or study-specific procedures.\\n\\nExclusion Criteria:\\n\\nALT or AST> 8 x ULN\\n(ALT or AST> 3 x ULN) and (Total bilirubin> 2.5 x ULN or INR> 2.0 x ULN)\\nFemale subjects who have a positive pregnancy test and are breastfeeding\\nSubjects using any other investigational antiviral drugs during the hospitalization before enrollment.\\nSubjects participating in other clinical trials\\nSubjects may be transferred to a non-participating hospital within 72 hours\\nPeople who cannot cooperate well due to mental illness, have no self-control, and cannot express clearly\\nSevere underlying diseases affecting survival\\nCritical COVID-19 requiring mechanical ventilator at the time enrolled',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '70 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Zuojiong Gong, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '027-88999120',\n", + " 'CentralContactEMail': 'zjgong@163.com'},\n", + " {'CentralContactName': 'Ke Hu, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '027-88999120',\n", + " 'CentralContactEMail': 'hukejx@163.com'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Zuojiong Gong, MD',\n", + " 'OverallOfficialAffiliation': 'Renmin Hospital of Wuhan University',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Renmin Hospital of Wuhan University',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Wuhan',\n", + " 'LocationState': 'Hubei',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Zuojiong Guong, MD',\n", + " 'LocationContactRole': 'Contact'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'}}}},\n", + " {'Rank': 32,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04312243',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'NOpreCOVID-19'},\n", + " 'Organization': {'OrgFullName': 'Massachusetts General Hospital',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'NO Prevention of COVID-19 for Healthcare Providers',\n", + " 'OfficialTitle': 'Nitric Oxide Gas Inhalation for Prevention of COVID-19 in Healthcare Providers',\n", + " 'Acronym': 'NOpreventCOVID'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 2, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 20, 2021',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'March 20, 2022',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 15, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 16, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 18, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", + " 'LastUpdatePostDateType': 'Estimate'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Lorenzo Berra, MD',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Massachusetts General Hospital'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Massachusetts General Hospital',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'IsFDARegulatedDrug': 'Yes',\n", + " 'IsFDARegulatedDevice': 'No',\n", + " 'IsUSExport': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Thousands of healthcare workers have been infected with SARS-CoV-2 and contracted COVID-19 despite their best efforts to prevent contamination. No proven vaccine is available to protect healthcare workers against SARS-CoV-2.\\n\\nThis study will enroll 470 healthcare professionals dedicated to care for patients with proven SARS-CoV-2 infection. Subjects will be randomized either in the observational (control) group or in the inhaled nitric oxide group. All personnel will observe measures on strict precaution in accordance with WHO and the CDC regulations.',\n", + " 'DetailedDescription': 'In their efforts to provide care for patients with novel coronavirus (SARS-CoV-2) disease (COVID-19) infection, many healthcare workers around the globe exposed to SARS-CoV-2 got infected and died over the past two months. Quarantined nurses and physicians have become the norm in regions with COVID-19 patients, putting at risk the overall functionality of the regional healthcare system. Other than strict contact-precautions, no proven vaccination or targeted therapy is available to prevent COVID-19 in healthcare workers. Inhaled nitric oxide gas (NO) has shown in a small clinical study to have antiviral activity against a Coronavirus during the 2003 SARS outbreak. We have designed this study to assess whether intermittent inhaled NO in healthcare workers might prevent their infection with SARS-CoV-2.\\n\\nBackground: After almost two months of fight against COVID-19 infection, on February 24, more than 3,000 physicians and nurses were reported as contracting COVID-19 disease in Wuhan (China). Fatalities among those healthcare workers were reported to be related to SARS-CoV-2 infection. Implementation of strict contact protections for all healthcare personnel is essential to decrease and contain the risks of exposure. However, despite best efforts, dozens of thousands of healthcare providers have been quarantined for at least 14 consecutive days in Wuhan alone. Similarly data have been reported in Italy, several healthcare providers have been quarantined, developed pneumonia and died. Most recent information from Italy reported that 12% of healthcare workers are infected.\\n\\nThe shortage of hospital personnel, especially in the critical care and anesthesiology domains, led many hospitals to postpone indefinitely scheduled surgical procedures, including cardiac surgery or oncological procedures. Only urgent and emergent cases are performed in patients without symptoms (i.e., absence of fever, cough or dyspnea), no signs (i.e., negative chest CT for consolidations, normal complete blood count) and a negative test on SARS-CoV-2 reverse transcriptase (rt)-PCR. If time does not allow for thorough screening (i.e., after traumatic injury), such patients are considered to be infected and medical staff in the OR are fully protected with third degree protections (i.e., N95 masks, goggles, protective garments and a gown and double gloving).\\n\\nRationale. In 2004 in a collaborative study between the virology laboratory at the University of Leuven (Belgium), the Clinical Physiology Laboratory of Uppsala University (Sweden) and the General Airforce Hospital of China (Beijing, China), nitric oxide (NO) donors (e.g. S-nitroso-N-acetylpenicillamine) greatly increased the survival rate of infected eukaryotic cells with the coronavirus responsible for SARS (SARS-CoV-1), suggesting direct antiviral effects of NO. These authors suggest that oxidation is the antiviral mechanism of nitric oxide. A later work by Akerstrom and colleagues showed that NO or its derivatives reduce palmitoylation SARS-CoV spike (S) protein affecting its fusion with angiotensin converting enzyme 2. Furthermore, NO or its derivatives reduce viral RNA synthesis in the infected cells. Future in-vitro studies should confirm that NO donors are equally effective against SARS-CoV-2, as the current virus shares 88% of its genome with the SARS-CoV [3]. However, at present it is reasonable to assess that a high dose of inhaled NO might be anti-viral against SARS-CoV-2 in the lung. The virus is transmitted by human-to-human contact and occurs primarily via respiratory droplets from coughs and sneezes within a range of about 1.5 meters. The incubation period ranges from 1 to 14 days with an estimated median incubation period of 5 to 6 days according to the World Health Organization [1]. COVID-19 disease is mainly a respiratory system disease, but in the most severe forms can progress to impair also other organ function (i.e., kidneys, liver, heart). Nitric oxide gas inhalation has been successfully and safely used for decades (since 1990) in thousands of newborns and adults to decrease pulmonary artery pressure and improve systemic oxygenation.\\n\\nRecently at the Massachusetts General Hospital, a high dose of inhaled NO (160 ppm) for 30 - 60 minutes was delivered twice a day to an adolescent with cystic fibrosis and pulmonary infection due to multi-resistant Burkholderia cepacia. There were no adverse events to this patient, blood methemoglobin remained below 5% and lung function and overall well-being improved.\\n\\nClinical Gap. Thousands of healthcare workers have been infected with SARS-CoV-2 and contracted COVID-19 despite their best efforts to prevent contamination. No proven vaccine is available to protect healthcare workers against SARS-CoV-2.\\n\\nHypothesis. Due to genetic similarities with the Coronavirus responsible for SARS, it is expected that inhaled NO gas retains potent antiviral activity against the SARS-CoV-2 responsible for COVID-19.\\n\\nAim. To assess whether intermittent delivery of inhaled NO gas in air at a high dose may protect healthcare workers from SARS-CoV-2 infection.\\n\\nObservational group: daily symptoms and body temperature monitoring. SARS-CoV-2 RT-PCR test will be performed if fever or COVID-19 symptoms.\\n\\nTreatment group: the subjects will breathe NO at 160 parts per million (ppm) for two cycles of 15 minutes each at the beginning of each shift and before leaving the hospital. Daily symptoms and body temperature monitoring. SARS-CoV-2 RT-PCR test will be performed if fever or COVID-19 symptoms. Safety: Oxygenation and methemoglobin levels will be monitored via a non-invasive CO-oximeter. If methemoglobin levels rise above 5% at any point of the gas delivery, inhaled NO will be stopped. NO2 gas will be monitored and maintained below 5 ppm.\\n\\nBlinding. The treatment is not masked.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus Infections',\n", + " 'Healthcare Associated Infection']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 2']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Prevention',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '470',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Treatment Group',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Inhaled NO (160 ppm) before and after the work shift. Daily monitoring of body temperature and symptoms. SARS-CoV-2 RT-PCR test if fever or COVID-19 symptoms.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Inhaled nitric oxide gas']}},\n", + " {'ArmGroupLabel': 'Control Group',\n", + " 'ArmGroupType': 'No Intervention',\n", + " 'ArmGroupDescription': 'Daily monitoring of body temperature and symptoms. SARS-CoV-2 RT-PCR test if fever or COVID-19 symptoms.'}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Inhaled nitric oxide gas',\n", + " 'InterventionDescription': 'Control group: a SARS-CoV2 rt-PCR will be performed if symptoms arise. Treatment group: the subjects will breathe NO at the beginning of the shift and before leaving the hospital. Inspired NO will be delivered at 160 parts per million (ppm) for 15 minutes in each cycle. A SARS-CoV-2 rt-PCR will be performed if symptoms arise. Safety: Oxygenation and methemoglobin levels will be monitored via a non-invasive CO-oximeter. If methemoglobin levels rise above 5% at any point of the gas delivery, inhaled NO will be halvened. NO2 gas will be monitored and maintained below 5 ppm.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Treatment Group']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'COVID-19 diagnosis',\n", + " 'PrimaryOutcomeDescription': 'Percentage of subjects with COVID-19 diagnosis in the two groups',\n", + " 'PrimaryOutcomeTimeFrame': '14 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Positive SARS-CoV-2 rt-PCR test',\n", + " 'SecondaryOutcomeDescription': 'Percentage of subjects with a positive test in the two groups',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'}]},\n", + " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'Total number of quarantine days',\n", + " 'OtherOutcomeDescription': 'Mean/ Median in the two groups',\n", + " 'OtherOutcomeTimeFrame': '14 days'},\n", + " {'OtherOutcomeMeasure': 'Proportion of healthcare providers requiring quarantine',\n", + " 'OtherOutcomeDescription': 'Percentage in the two groups',\n", + " 'OtherOutcomeTimeFrame': '14 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAge ≥18 years\\nScheduled to work with SARS-CoV-2 infected patients for at least 3 days in a week.\\n\\nExclusion Criteria:\\n\\nPrevious documented SARS-CoV-2 infections and subsequent negative SARS-CoV-2 rt-PCR test.\\nPregnancy\\nKnown hemoglobinopathies.\\nKnown anemia',\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '99 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Lorenzo Berra, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+16176437733',\n", + " 'CentralContactEMail': 'lberra@mgh.harvard.edu'}]}},\n", + " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '19800091',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Akerström S, Gunalan V, Keng CT, Tan YJ, Mirazimi A. Dual effect of nitric oxide on SARS-CoV replication: viral RNA production and palmitoylation of the S protein are affected. Virology. 2009 Dec 5;395(1):1-9. doi: 10.1016/j.virol.2009.09.007. Epub 2009 Oct 1.'},\n", + " {'ReferencePMID': '15234326',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Keyaerts E, Vijgen L, Chen L, Maes P, Hedenstierna G, Van Ranst M. Inhibition of SARS-coronavirus infection in vitro by S-nitroso-N-acetylpenicillamine, a nitric oxide donor compound. Int J Infect Dis. 2004 Jul;8(4):223-6.'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000009569',\n", + " 'InterventionMeshTerm': 'Nitric Oxide'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000001993',\n", + " 'InterventionAncestorTerm': 'Bronchodilator Agents'},\n", + " {'InterventionAncestorId': 'D000001337',\n", + " 'InterventionAncestorTerm': 'Autonomic Agents'},\n", + " {'InterventionAncestorId': 'D000018373',\n", + " 'InterventionAncestorTerm': 'Peripheral Nervous System Agents'},\n", + " {'InterventionAncestorId': 'D000045505',\n", + " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", + " {'InterventionAncestorId': 'D000018927',\n", + " 'InterventionAncestorTerm': 'Anti-Asthmatic Agents'},\n", + " {'InterventionAncestorId': 'D000019141',\n", + " 'InterventionAncestorTerm': 'Respiratory System Agents'},\n", + " {'InterventionAncestorId': 'D000016166',\n", + " 'InterventionAncestorTerm': 'Free Radical Scavengers'},\n", + " {'InterventionAncestorId': 'D000000975',\n", + " 'InterventionAncestorTerm': 'Antioxidants'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000018377',\n", + " 'InterventionAncestorTerm': 'Neurotransmitter Agents'},\n", + " {'InterventionAncestorId': 'D000045462',\n", + " 'InterventionAncestorTerm': 'Endothelium-Dependent Relaxing Factors'},\n", + " {'InterventionAncestorId': 'D000014665',\n", + " 'InterventionAncestorTerm': 'Vasodilator Agents'},\n", + " {'InterventionAncestorId': 'D000064426',\n", + " 'InterventionAncestorTerm': 'Gasotransmitters'},\n", + " {'InterventionAncestorId': 'D000020011',\n", + " 'InterventionAncestorTerm': 'Protective Agents'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M11090',\n", + " 'InterventionBrowseLeafName': 'Nitric Oxide',\n", + " 'InterventionBrowseLeafAsFound': 'Nitric Oxide',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M3851',\n", + " 'InterventionBrowseLeafName': 'Bronchodilator Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M3219',\n", + " 'InterventionBrowseLeafName': 'Autonomic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19547',\n", + " 'InterventionBrowseLeafName': 'Anti-Asthmatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19721',\n", + " 'InterventionBrowseLeafName': 'Respiratory System Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M17210',\n", + " 'InterventionBrowseLeafName': 'Free Radical Scavengers',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2873',\n", + " 'InterventionBrowseLeafName': 'Antioxidants',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19088',\n", + " 'InterventionBrowseLeafName': 'Neurotransmitter Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M15995',\n", + " 'InterventionBrowseLeafName': 'Vasodilator Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M20453',\n", + " 'InterventionBrowseLeafName': 'Protective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'VaDiAg',\n", + " 'InterventionBrowseBranchName': 'Vasodilator Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'Resp',\n", + " 'InterventionBrowseBranchName': 'Respiratory System Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", + " 'ConditionMeshTerm': 'Infection'},\n", + " {'ConditionMeshId': 'D000003141',\n", + " 'ConditionMeshTerm': 'Communicable Diseases'},\n", + " {'ConditionMeshId': 'D000003428',\n", + " 'ConditionMeshTerm': 'Cross Infection'},\n", + " {'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", + " {'ConditionMeshId': 'D000045169',\n", + " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", + " {'ConditionAncestorId': 'D000007049',\n", + " 'ConditionAncestorTerm': 'Iatrogenic Disease'},\n", + " {'ConditionAncestorId': 'D000020969',\n", + " 'ConditionAncestorTerm': 'Disease Attributes'},\n", + " {'ConditionAncestorId': 'D000010335',\n", + " 'ConditionAncestorTerm': 'Pathologic Processes'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafAsFound': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafAsFound': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M25724',\n", + " 'ConditionBrowseLeafName': 'Respiratory Aspiration',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M5225',\n", + " 'ConditionBrowseLeafName': 'Cross Infection',\n", + " 'ConditionBrowseLeafAsFound': 'Healthcare Associated Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M14938',\n", + " 'ConditionBrowseLeafName': 'Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M8682',\n", + " 'ConditionBrowseLeafName': 'Iatrogenic Disease',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M21284',\n", + " 'ConditionBrowseLeafName': 'Disease Attributes',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 33,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04331899',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '55619'},\n", + " 'Organization': {'OrgFullName': 'Stanford University',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Mild COVID-19 Peginterferon Lambda',\n", + " 'OfficialTitle': 'A Phase 2 Randomized, Open Label Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19',\n", + " 'Acronym': 'COVID-Lambda'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 15, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 31, 2021',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'May 31, 2022',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 27, 2020',\n", + " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 2, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Upinder Singh',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Professor (Medicine -Infectious Diseases)',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Stanford University'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Stanford University',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'Yes',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'To evaluate the efficacy of subcutaneous injections of 180 ug of Peginterferon Lambda-1a once weekly, for up to two weeks (2 injections at most), compared with standard supportive care, in reducing the duration of oral shedding of SARS-CoV-2 virus in patients with uncomplicated COVID-19 disease.',\n", + " 'DetailedDescription': 'Patients will attend up to 8 study visits over a period of up to 28 days.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 2']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Single Group Assignment',\n", + " 'DesignInterventionModelDescription': 'An open-label randomized controlled trial. Study participants will be randomly assigned 1:1 to a single subcutaneous dose of Peginterferon Lambda-1a or standard of care.',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '120',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Study drug Peginterferon Lambda-1a',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Study participants assigned to study drug will receive a single subcutaneous dose of Peginterferon Lambda-1a in addition to standard of care treatment.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Peginterferon Lambda-1a',\n", + " 'Other: Standard of Care Treatment']}},\n", + " {'ArmGroupLabel': 'Standard of care',\n", + " 'ArmGroupType': 'Active Comparator',\n", + " 'ArmGroupDescription': 'Study participants will receive standard of care treatment.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: Standard of Care Treatment']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Peginterferon Lambda-1a',\n", + " 'InterventionDescription': 'Peginterferon Lambda-1a (180 ug subcutaneous injection) single dose',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Study drug Peginterferon Lambda-1a']}},\n", + " {'InterventionType': 'Other',\n", + " 'InterventionName': 'Standard of Care Treatment',\n", + " 'InterventionDescription': 'Standard of Care Treatment for COVID-19 Infection',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Standard of care',\n", + " 'Study drug Peginterferon Lambda-1a']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Duration of Viral shedding of SARS-CoV-2 by qRT-PCR',\n", + " 'PrimaryOutcomeDescription': 'Time to first of two consecutive negative respiratory secretions obtained by nasopharyngeal and/or oropharyngeal and/or salivary swabs tests for SARS-CoV-2 by qRT-PCR.',\n", + " 'PrimaryOutcomeTimeFrame': '28 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAge ≥ 18 years and ≤ 64 years at the time of the assessment\\nAble and willing to understand the study, adhere to all study procedures, and provide written informed consent\\nInitial diagnosis of COVID-19 disease as defined by a FDA-cleared molecular diagnostic assay positive for SARS-CoV-2\\nDisplay symptoms of COVID respiratory infection without respiratory distress\\n\\nExclusion Criteria:\\n\\nPatients who are hospitalized for inpatient treatment or currently being evaluated for potential hospitalization at the time of initiation of informed consent\\n\\nPatients with a known allergy to Peginterferon Lambda-1a or any component thereof\\nRoom air oxygen saturation of <92%\\nParticipation in a clinical trial with or use of any investigational agent within 30 days before screening, or treatment with interferons (IFN) or immunomodulators within 12 months before screening\\nPrevious use of Peginterferon Lambda-1a\\nHistory or evidence of any intolerance or hypersensitivity to IFNs or other substances contained in the study medication.\\nFemale patients who are pregnant or breastfeeding. Male patients must confirm that their female sexual partners are not pregnant.\\nCurrent or previous history of decompensated liver disease (Child-Pugh Class B or C) or hepatocellular carcinoma\\nCo-infected with human immunodeficiency virus (HIV) or hepatitis C virus (HCV)\\nSignificant abnormal laboratory test results at screening.\\nSignificant concurrent illnesses and other comorbidities that may require intervention during the study\\n\\nConcurrent use of any of the following medications:\\n\\nTherapy with an immunomodulatory agent\\nCurrent use of heparin or Coumadin\\nReceived blood products within 30 days before study randomization\\nUse of hematologic growth factors within 30 days before study randomization\\nSystemic antibiotics, antifungals, or antivirals for treatment of active infection within 14 days before study randomization\\nAny prescription or herbal product that is not approved by the investigator\\nLong-term treatment (> 2 weeks) with agents that have a high risk for nephrotoxicity or hepatotoxicity unless it is approved by the medical monitor\\nReceipt of systemic immunosuppressive therapy within 3 months before screening',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '64 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Upinder Singh',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '6507234045',\n", + " 'CentralContactEMail': 'usingh@stanford.edu'},\n", + " {'CentralContactName': 'Julie Parsonnet',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '6507254561',\n", + " 'CentralContactEMail': 'parsonnt@stanford.edu'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Upinder Singh',\n", + " 'OverallOfficialAffiliation': 'Professor (Medicine -Infectious Diseases)',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No',\n", + " 'IPDSharingDescription': 'No current plan to share the data.'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'}}}},\n", + " {'Rank': 34,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04320017',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'CIC1421-20-05'},\n", + " 'Organization': {'OrgFullName': 'Groupe Hospitalier Pitie-Salpetriere',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Joint Use of Electrocardiogram and Transthoracic Echocardiography in an Observational Study to Monitor Cardio-vascular Events in Patients Diagnosed With COVID-19',\n", + " 'OfficialTitle': 'Joint Use of Electrocardiogram and Transthoracic Echocardiography in an Observational Study to Monitor Cardio-vascular Events in Patients Diagnosed With COVID-19',\n", + " 'Acronym': 'JOCOVID'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 20, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 20, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'May 20, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 20, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 23, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 24, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 23, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 24, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Joe Elie Salem',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Head of Investigations in Clinical Investigation Centers Paris-Est',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Groupe Hospitalier Pitie-Salpetriere'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Groupe Hospitalier Pitie-Salpetriere',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'COVID-19 outbreak is often lethal. Morality has been associated with several cardio-vascular risk factors such as diabetes, obesity, hypertension and tobacco use. Furthermore, cases of myocarditis have been reported with COVID-19.\\n\\nCardio-vascular events have possibly been highly underestimated. The study proposes to systematically collect cardio-vascular data to study the incidence of myocarditis and coronaropathy events during COVID-19 infection.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", + " 'Myocardial Injury',\n", + " 'Myocarditis']},\n", + " 'KeywordList': {'Keyword': ['Coronavirus',\n", + " 'Heart conditions',\n", + " 'Cardio-vascular outcomes']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '500',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'COVID-19 patients',\n", + " 'ArmGroupDescription': 'Patients diagnosed with COVID-19 by PCR done on nasal sample.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Diagnostic Test: Electrocardiogram and transthoracic echocardiography']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Diagnostic Test',\n", + " 'InterventionName': 'Electrocardiogram and transthoracic echocardiography',\n", + " 'InterventionDescription': '12 derivations electrocardiogram done at baseline transthoracic echocardiography',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['COVID-19 patients']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Incidence of acute myocardial events in COVID-19 population at baseline and during hospital stay',\n", + " 'PrimaryOutcomeDescription': 'Viral myocarditis or myocardial infarction or stenosis detected with ST segment elevation or depression associated with troponine elevation and transthoracic echocardiography',\n", + " 'PrimaryOutcomeTimeFrame': 'ECG and concomitant troponine at day 1 after admission and twice a week after admission and until patient is discharged, transthoracic echocardiography at day 1 and day 7, t'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Description of cardiovascular outcomes in the cohort',\n", + " 'SecondaryOutcomeDescription': 'Cardio-vascular events including but not limited to: myocardial infarction or stenosis, stroke, pulmonary embolism, deep vein thrombosis, ventricular dysfunctio, conduction disorders and sudden death',\n", + " 'SecondaryOutcomeTimeFrame': 'During hospital admission'},\n", + " {'SecondaryOutcomeMeasure': 'Prognosis role of baseline cardio-vascular caracteristics on patients survival',\n", + " 'SecondaryOutcomeDescription': 'Biological biomarkers including but not limited to: baseline troponine T, D-dimers, NT-proBNP, creatinine phosphokinase, creatininemia, ionogram, renine-angiotensin aldosterone system profiling, glycemia (fasting), HbA1c, steroid profiling, lipid profiling',\n", + " 'SecondaryOutcomeTimeFrame': '1st day of admission'},\n", + " {'SecondaryOutcomeMeasure': 'Prediction of cardio-vascular events with baseline characteristics',\n", + " 'SecondaryOutcomeTimeFrame': 'Baseline on first day of admission'},\n", + " {'SecondaryOutcomeMeasure': 'Characterization of inflammation on cardio-vascular outcomes',\n", + " 'SecondaryOutcomeDescription': 'Biological markers including but not limited to: C reactive protein, procalcitonine, fibrinogen, interleukin-6',\n", + " 'SecondaryOutcomeTimeFrame': 'Baseline and every 2 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\n- COVID-19 positive patients admitted in a ward identified by positive PCR on nasal swab samples\\n\\nExclusion Criteria:\\n\\n- Patients for which electrocardiogram or transthoracic echocardiography is not technically feasible',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '16 Years',\n", + " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'All patients admitted in Pitié-Salpêtrière hospital will be eligible, if the electrocardiogram and the transthoracic echocardiography is technically feasible.',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Joe-Elie Salem, MD-PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '01 42 17 85 31',\n", + " 'CentralContactPhoneExt': '+33',\n", + " 'CentralContactEMail': 'joe-elie.salem@aphp.fr'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Clinical Investigation Center Pitié-Salpêtrière',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Paris',\n", + " 'LocationZip': '75013',\n", + " 'LocationCountry': 'France',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Joe-Elie Salem, MD-PhD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '01 42 17 85 31',\n", + " 'LocationContactPhoneExt': '+33',\n", + " 'LocationContactEMail': 'joe-elie.salem@aphp.fr'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000009205',\n", + " 'ConditionMeshTerm': 'Myocarditis'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000009202',\n", + " 'ConditionAncestorTerm': 'Cardiomyopathies'},\n", + " {'ConditionAncestorId': 'D000006331',\n", + " 'ConditionAncestorTerm': 'Heart Diseases'},\n", + " {'ConditionAncestorId': 'D000002318',\n", + " 'ConditionAncestorTerm': 'Cardiovascular Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M10740',\n", + " 'ConditionBrowseLeafName': 'Myocarditis',\n", + " 'ConditionBrowseLeafAsFound': 'Myocarditis',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M10737',\n", + " 'ConditionBrowseLeafName': 'Cardiomyopathies',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M8002',\n", + " 'ConditionBrowseLeafName': 'Heart Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T4031',\n", + " 'ConditionBrowseLeafName': 'Myocarditis',\n", + " 'ConditionBrowseLeafAsFound': 'Myocarditis',\n", + " 'ConditionBrowseLeafRelevance': 'high'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC14',\n", + " 'ConditionBrowseBranchName': 'Heart and Blood Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 35,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04331509',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'COVID-19 Symptom tracker'},\n", + " 'Organization': {'OrgFullName': \"King's College London\",\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'COVID-19 Symptom Tracker',\n", + " 'OfficialTitle': 'COVID-19 Symptom Tracker'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 23, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 23, 2022',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'March 23, 2022',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 31, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 31, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 2, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 31, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': \"King's College London\",\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Zoe Global Limited',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'Massachusetts General Hospital',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'Harvard School of Public Health',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'Stanford University',\n", + " 'CollaboratorClass': 'OTHER'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': \"The viral Covid-19 outbreak is now considered a pandemic according to the World Health Organisation (WHO). A free monitoring app 'COVID-19 Symptom Tracker' has been developed to record and monitor the symptoms of the COVID-19 coronavirus infection; tracking in real time how the disease progresses. The app also records how measures aimed at controlling the pandemic including self-isolation and distancing are affecting the mental health and well-being of participants. The data from the study will reveal important information about the symptoms and progress of COVID-19 infection in different people, and why some go on to develop more severe or fatal disease while others have only mild symptoms do not.\",\n", + " 'DetailedDescription': \"A free monitoring app 'COVID-19 Symptom Tracker' has been developed by health technology company Zoe Global Limited in collaboration with scientists at King's College London, Harvard Medical School, Massachusetts General Hospital and Stanford University. A web-based equivalent is being developed for those unable to download this app. This new app records and monitors the symptoms of COVID-19 coronavirus infection; tracking in real time how the disease progresses. The app also records how measures aimed at controlling the pandemic including self-isolation and distancing affect the mental health and well-being of participants. The app also allows self-reporting where no symptoms are experienced such that it records any users that feel healthy and normal.\\n\\nThe app, has been launched in both the UK and the US. Researchers in other countries are encouraged to obtain the required approvals from Apple and Google to make the app available in their territories.\\n\\nThe data from the study will reveal important information about the symptoms and progress of COVID-19 infection in different people, and why some go on to develop more severe or fatal disease while others have only mild symptoms do not.\\n\\nIt is also hoped that the data generated from this study will help the urgent clinical need to distinguish mild coronavirus symptoms from seasonal coughs and colds, which may be leading people to unnecessarily self-isolate when they aren't infected or inadvertently go out and spread the disease when they are.\\n\\nUsers download the free app COVID-19 Symptom Tracker and record information about their health on a daily basis, including temperature, tiredness and symptoms such as coughing, breathing problems or headaches.\\n\\nThe app is available internationally to the general population and will also be used in two large epidemiological cohorts: The TwinsUK cohort (n=15,000) and Nurses Health Study (n=280,000).\\n\\nThe app will allow scientists to study the spread and development of symptoms across whole populations, both in the UK and abroad, as well as detailed genetic and other studies, particularly with the twins cohort\\n\\nAny data gathered from the app and study will be used strictly for public health or academic research and will not be used commercially or sold.\"},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", + " 'KeywordList': {'Keyword': ['COVID-19',\n", + " 'Coronovirus',\n", + " 'Symptom tracker',\n", + " 'Virus',\n", + " 'Pandemic']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '10000000',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Symptom tracker users',\n", + " 'ArmGroupDescription': 'No Intervention',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: No Intervention']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", + " 'InterventionName': 'No Intervention',\n", + " 'InterventionDescription': 'No Intervention',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Symptom tracker users']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Physical health symptoms',\n", + " 'PrimaryOutcomeDescription': 'Self reported as physically healthy',\n", + " 'PrimaryOutcomeTimeFrame': '1 day'},\n", + " {'PrimaryOutcomeMeasure': 'Lack of physical health symptoms',\n", + " 'PrimaryOutcomeDescription': 'Self reported as physically not feeling healthy',\n", + " 'PrimaryOutcomeTimeFrame': '1 day'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Fever',\n", + " 'SecondaryOutcomeDescription': 'Self reported remperature',\n", + " 'SecondaryOutcomeTimeFrame': '1 day'}]},\n", + " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'Cough',\n", + " 'OtherOutcomeDescription': 'Self reported cough',\n", + " 'OtherOutcomeTimeFrame': '1 day'},\n", + " {'OtherOutcomeMeasure': 'Fatigue',\n", + " 'OtherOutcomeDescription': 'Self reported fatigue',\n", + " 'OtherOutcomeTimeFrame': '1 day'},\n", + " {'OtherOutcomeMeasure': 'Headache',\n", + " 'OtherOutcomeDescription': 'Self reported headache',\n", + " 'OtherOutcomeTimeFrame': '1 day'},\n", + " {'OtherOutcomeMeasure': 'Shortness of breath',\n", + " 'OtherOutcomeDescription': 'Self reported shortness of breath',\n", + " 'OtherOutcomeTimeFrame': '1 day'},\n", + " {'OtherOutcomeMeasure': 'Sore throat',\n", + " 'OtherOutcomeDescription': 'Self reported sore throat',\n", + " 'OtherOutcomeTimeFrame': '1 day'},\n", + " {'OtherOutcomeMeasure': 'Loss of smell/ taste',\n", + " 'OtherOutcomeDescription': 'Self reported loss of smell/ taste',\n", + " 'OtherOutcomeTimeFrame': '1 day'},\n", + " {'OtherOutcomeMeasure': 'Hoarse voice',\n", + " 'OtherOutcomeDescription': 'Self reported hoarse voice',\n", + " 'OtherOutcomeTimeFrame': '1 day'},\n", + " {'OtherOutcomeMeasure': 'Chest pain or tightness',\n", + " 'OtherOutcomeDescription': 'Self reported chest pain or tightness',\n", + " 'OtherOutcomeTimeFrame': '1 day'},\n", + " {'OtherOutcomeMeasure': 'Abdominal pain',\n", + " 'OtherOutcomeDescription': 'Self reported abdominal pain',\n", + " 'OtherOutcomeTimeFrame': '1 day'},\n", + " {'OtherOutcomeMeasure': 'Diarrhoea',\n", + " 'OtherOutcomeDescription': 'Self reported diarrhoea',\n", + " 'OtherOutcomeTimeFrame': '1 day'},\n", + " {'OtherOutcomeMeasure': 'Confusion',\n", + " 'OtherOutcomeDescription': 'Self reported confusion',\n", + " 'OtherOutcomeTimeFrame': '1 day'},\n", + " {'OtherOutcomeMeasure': 'Skipping meals',\n", + " 'OtherOutcomeDescription': 'Self reported skipping meals',\n", + " 'OtherOutcomeTimeFrame': '1 day'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAdults of 18 years and above, both in the UK and internationally where the app has been approved for download from the Apple App store and Google Play. The web-based equivalent to the app will also be made available via a link for those unable to download.\\n\\nExclusion Criteria:\\n\\nAnyone below the age of 18; anyone unable to provide informed consent.',\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'Anyone who is able to download the app or use the web-based equivalent tool to self-report their symptoms.',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Victoria Vazquez',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '02071886765',\n", + " 'CentralContactEMail': 'victoria.vazquez@kcl.ac.uk'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Tim D Spector',\n", + " 'OverallOfficialAffiliation': \"King's College London\",\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Massachusetts General Hospital',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Boston',\n", + " 'LocationState': 'Massachusetts',\n", + " 'LocationZip': '02114',\n", + " 'LocationCountry': 'United States',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'David A Drew, PhD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactEMail': 'predict@mgh.harvard.edu'},\n", + " {'LocationContactName': 'Andrew T. Chan, MD',\n", + " 'LocationContactRole': 'Contact'},\n", + " {'LocationContactName': 'Andrew Chan',\n", + " 'LocationContactRole': 'Principal Investigator'}]}},\n", + " {'LocationFacility': \"King's College London\",\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'London',\n", + " 'LocationZip': 'SE1 7EH',\n", + " 'LocationCountry': 'United Kingdom',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Victoria Vazquez',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '020 7188 6765',\n", + " 'LocationContactEMail': 'victoria.vazquez@kcl.ac.uk'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", + " 'IPDSharingDescription': 'Access to the COVID-19 Symptom Tracker data will be given to members of the clinical or scientific community as outlined below in accordance with the following privacy policies:\\n\\nhttps://covid.joinzoe.com/privacy-notice\\n\\nhttps://storage.googleapis.com/covid-symptom-tracker-public/privacy-policy-us.pdf',\n", + " 'IPDSharingTimeFrame': 'Immediately',\n", + " 'IPDSharingAccessCriteria': 'Request to access the COVID-19 Symptom Tracker data should made by submitting an online Data Access Application Form. The form is available on the TwinsUK website.\\n\\nhttps://dtr.eu.qualtrics.com/jfe/form/SV_81U9lmshTofiFeZ\\n\\nDecision Process & Outcome:\\n\\nUpon submission of the Covid-19 Data Application Form, the TwinsUK data management team will review the application forms received and information on the outcome will be provided within a week. Decisions on the most complex applications will be overseen by the TwinsUK Resource Executive Committee.\\n\\nAll applicants must belong to the clinical or scientific community, present a valid rationale and must have\\n\\nA healthcare email address\\nAn educational email address\\nA track of peer reviewed publications',\n", + " 'IPDSharingURL': 'https://dtr.eu.qualtrics.com/jfe/form/SV_81U9lmshTofiFeZ'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", + " {'Rank': 36,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04318015',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'ProfilaxisCOVID'},\n", + " 'Organization': {'OrgFullName': 'National Institute of Respiratory Diseases, Mexico',\n", + " 'OrgClass': 'OTHER_GOV'},\n", + " 'BriefTitle': 'Hydroxychloroquine Chemoprophylaxis in Healthcare Personnel in Contact With COVID-19 Patients (PHYDRA Trial)',\n", + " 'OfficialTitle': 'Chemoprophylaxis With Hydroxychloroquine in Healthcare Personnel in Contact With COVID-19 Patients: A Randomized Controlled Trial (PHYDRA Trial)',\n", + " 'Acronym': 'PHYDRA'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'December 31, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'March 31, 2021',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 19, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 19, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 23, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 19, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 23, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'National Institute of Respiratory Diseases, Mexico',\n", + " 'LeadSponsorClass': 'OTHER_GOV'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Sanofi',\n", + " 'CollaboratorClass': 'INDUSTRY'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': \"Triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) aiming to prove hydroxychloroquine's security and efficacy as prophylaxis treatment for healthcare personnel exposed to COVID-19 patients.\",\n", + " 'DetailedDescription': 'Healthcare personnel infection with COVID-19 is a major setback in epidemiological emergencies. Hydroxychloroquine has proven to inhibit coronavirus in-vitro but no data to date has proven in-vivo effects. Nevertheless, hydroxychloroquine is a low cost, limited toxicity and broadly used agent. Since there is currently no treatment for COVID-19 exposure prophylaxis, the investigators will implement a triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) for 60 days.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", + " 'Severe Acute Respiratory Syndrome']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 3']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignInterventionModelDescription': 'Triple blinded, randomized controlled trial',\n", + " 'DesignPrimaryPurpose': 'Prevention',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Quadruple',\n", + " 'DesignMaskingDescription': 'Randomization will happen after previous assignment of recruited individual to high-risk or low-risk exposure according to he or her activities. An independent member of the team will randomly assign treatment or placebo following a computer based program. Blinding will end in case elimination criteria are met.',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", + " 'Care Provider',\n", + " 'Investigator',\n", + " 'Outcomes Assessor']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '400',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'High-risk Treatment',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Hydroxychloroquine 200mg per day for 60 days.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine']}},\n", + " {'ArmGroupLabel': 'High-risk Placebo',\n", + " 'ArmGroupType': 'Placebo Comparator',\n", + " 'ArmGroupDescription': 'Placebo tablet per day for 60 days.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo oral tablet']}},\n", + " {'ArmGroupLabel': 'Low-risk Treatment',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Hydroxychloroquine 200mg per day for 60 days',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine']}},\n", + " {'ArmGroupLabel': 'Low-risk Placebo',\n", + " 'ArmGroupType': 'Placebo Comparator',\n", + " 'ArmGroupDescription': 'Placebo tablet per day for 60 days.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo oral tablet']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Hydroxychloroquine',\n", + " 'InterventionDescription': 'All treatment will be administered orally.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['High-risk Treatment',\n", + " 'Low-risk Treatment']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Plaquenil']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Placebo oral tablet',\n", + " 'InterventionDescription': 'All placebo will be administered orally',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['High-risk Placebo',\n", + " 'Low-risk Placebo']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Placebo']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Symptomatic COVID-19 infection rate',\n", + " 'PrimaryOutcomeDescription': 'Symptomatic infection rate by COVID-19 defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive COVID-19 real-time polymerase chain reaction test.',\n", + " 'PrimaryOutcomeTimeFrame': 'From date of randomization until the appearance of symptoms or study completion 60 days after treatment start'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Symptomatic non-COVID viral infection rate',\n", + " 'SecondaryOutcomeDescription': 'Symptomatic infection rate by other non-COVID-19 viral etiologies defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive viral real time polymerase chain reaction test.',\n", + " 'SecondaryOutcomeTimeFrame': 'From date of randomization until the appearance of symptoms or study completion 60 days after treatment start'},\n", + " {'SecondaryOutcomeMeasure': 'Days of labor absenteeism',\n", + " 'SecondaryOutcomeDescription': 'Number of days absent from labor due to COVID-19 symptomatic infection',\n", + " 'SecondaryOutcomeTimeFrame': 'From date of randomization until study completion 60 days after treatment start'},\n", + " {'SecondaryOutcomeMeasure': 'Rate of labor absenteeism',\n", + " 'SecondaryOutcomeDescription': 'Absenteeism from labor rate due to COVID-19 symptomatic infection',\n", + " 'SecondaryOutcomeTimeFrame': 'From date of randomization until study completion 60 days after treatment start'},\n", + " {'SecondaryOutcomeMeasure': 'Rate of severe respiratory COVID-19 disease in healthcare personnel',\n", + " 'SecondaryOutcomeDescription': 'Rate of severe respiratory COVID-19 disease in healthcare personnel',\n", + " 'SecondaryOutcomeTimeFrame': 'From date of randomization until the appearance of symptoms or study completion 60 days after treatment start'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\n18 years old upon study start\\nHealthcare personnel exposed to patients with COVID-19 respiratory disease: physicians, nurses, chemists, pharmacists, janitors, stretcher-bearer, administrative and respiratory therapists.\\nSigned consent for randomization to any study arm.\\n\\nExclusion Criteria:\\n\\nKnown hypersensitivity to hydroxychloroquine manifested as anaphylaxis\\nCurrent treatment to chloroquine or hydroxychloroquine\\nWomen with last menstruation date farther than a month without negative pregnancy test.\\nWomen with positive pregnancy test\\nBreastfeeding women\\nChronic hepatic disease history (Child-Pugh B or C)\\nChronic renal disease (GFR less or equal to 30)',\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Felipe Camacho-Jurado, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+52 55871700',\n", + " 'CentralContactPhoneExt': '5305',\n", + " 'CentralContactEMail': 'lfjcamacho@comunidad.unam.mx'},\n", + " {'CentralContactName': 'Rogelio Perez-Padilla, MD. PhD.',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+52 55871700',\n", + " 'CentralContactPhoneExt': '5305',\n", + " 'CentralContactEMail': 'perezpad@gmail.com'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Jorge Rojas-Serrano, MD, PhD.',\n", + " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Rogelio Perez-Padilla, MD',\n", + " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", + " 'OverallOfficialRole': 'Study Director'},\n", + " {'OverallOfficialName': 'Felipe Jurado-Camacho, MD. MSc',\n", + " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", + " 'OverallOfficialRole': 'Study Director'},\n", + " {'OverallOfficialName': 'Ireri Thirion-Romero, MD, MSc',\n", + " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", + " 'OverallOfficialRole': 'Study Chair'},\n", + " {'OverallOfficialName': 'Sebastian Rodríguez-Llamazares, MD, MPH',\n", + " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", + " 'OverallOfficialRole': 'Study Chair'},\n", + " {'OverallOfficialName': 'Carmen Hernandez Cárdenas, MD, MSc',\n", + " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", + " 'OverallOfficialRole': 'Study Chair'},\n", + " {'OverallOfficialName': 'Cristobal Guadarrama-Pérez, MD',\n", + " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", + " 'OverallOfficialRole': 'Study Chair'},\n", + " {'OverallOfficialName': 'Alejandra Ramírez-Venegas, MD, MSc',\n", + " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", + " 'OverallOfficialRole': 'Study Chair'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", + " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", + " 'InterventionAncestorTerm': 'Antimalarials'},\n", + " {'InterventionAncestorId': 'D000000981',\n", + " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", + " {'InterventionAncestorId': 'D000000977',\n", + " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", + " {'InterventionAncestorId': 'D000000890',\n", + " 'InterventionAncestorTerm': 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'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 37,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04303507',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'VIR20001'},\n", + " 'Organization': {'OrgFullName': 'University of Oxford',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting',\n", + " 'OfficialTitle': 'Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting; a Randomised, Placebo-controlled Prophylaxis Study (COPCOV)',\n", + " 'Acronym': 'COPCOV'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 2021',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'April 2021',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 6, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 10, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 11, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 25, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 27, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'University of Oxford',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'The study is a double-blind, randomised, placebo-controlled trial that will be conducted in health care settings. After obtaining fully informed consent, the investigator will recruit healthcare workers, or other individuals at significant risk who can be followed reliably for 5 months. 40,000 participants will be recruited and the investigator predict an average of 400-800 participants per site in 50-100 sites.\\n\\nThe participant will be randomised to receive either chloroquine/ hydroxychloroquine or placebo (1:1 randomisation). A loading dose of 10mg base/kg, followed by 155 mg daily (250mg chloroquine phosphate salt or 200mg hydroxychloroquine sulphate) will be taken for 3 months. Subsequent episodes of symptomatic respiratory illness, including symptomatic COVID-19, clinical outcomes, and asymptomatic infection with the virus causing COVID-19 will be recorded during the follow-up period. If they are diagnosed with COVID-19 during the period of prophylaxis, they will continue their prophylaxis unless advised to do so by their healthcare professional until they run out of their current supply of chloroquine/ hydroxychloroquine or placebo at home. They will not collect more. They will be followed up for 28 days (up until a maximum of 60 days if not recovered at 28 days).'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID19',\n", + " 'Coronavirus',\n", + " 'Acute Respiratory Illnesses']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Not Applicable']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Prevention',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Double',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", + " 'Investigator']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '40000',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Chloroquine or Hydroxychloroquine',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'In Asia, the participant will receive chloroquine.\\n\\nIn Europe, the participant will receive hydroxychloroquine',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Chloroquine or Hydroxychloroquine']}},\n", + " {'ArmGroupLabel': 'Placebo',\n", + " 'ArmGroupType': 'Placebo Comparator',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Chloroquine or Hydroxychloroquine',\n", + " 'InterventionDescription': 'A loading dose of 10 mg base/ kg followed by 155 mg daily (250mg chloroquine phosphate salt or 200mg of or hydroxychloroquine sulphate) will be taken for 3 months',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Chloroquine or Hydroxychloroquine']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Placebo',\n", + " 'InterventionDescription': 'Placebo',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Placebo']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Number of symptomatic COVID-19 infections',\n", + " 'PrimaryOutcomeDescription': 'Number of symptomatic COVID-19 infections will be compared between the chloroquine or hydroxychloroquine and placebo groups',\n", + " 'PrimaryOutcomeTimeFrame': 'Approximately 100 days'},\n", + " {'PrimaryOutcomeMeasure': 'Symptoms severity of COVID-19',\n", + " 'PrimaryOutcomeDescription': 'Symptoms severity of COVID-19 will be compared between the two groups using a respiratory severity score.',\n", + " 'PrimaryOutcomeTimeFrame': 'Approximately 100 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Number of asymptomatic cases of COVID-19',\n", + " 'SecondaryOutcomeDescription': 'Number of asymptomatic cases of COVID-19 will be determined by comparing acute and convalescent serology in the two groups.',\n", + " 'SecondaryOutcomeTimeFrame': 'Approximately 100 days'},\n", + " {'SecondaryOutcomeMeasure': 'Number of symptomatic acute respiratory illnesses',\n", + " 'SecondaryOutcomeDescription': 'Number of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.',\n", + " 'SecondaryOutcomeTimeFrame': 'Approximately 100 days'},\n", + " {'SecondaryOutcomeMeasure': 'Severity of symptomatic acute respiratory illnesses',\n", + " 'SecondaryOutcomeDescription': 'Severity of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.',\n", + " 'SecondaryOutcomeTimeFrame': 'Approximately 100 days'}]},\n", + " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, ARI and disease severity.',\n", + " 'OtherOutcomeDescription': 'Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, ARI and disease severity.',\n", + " 'OtherOutcomeTimeFrame': 'Approximately 100 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Study Participants\\n\\nThese are of two types:\\n\\nA. Adult volunteers (exact age is dependent on countries) working as a healthcare worker or frontline (i.e. patient contact) in a healthcare facility or similar institution\\n\\nB. Provided that they are willing to participate in the trial and can be followed adequately for up to 5 months, we may also enrol hospitalised patients or relatives exposed or potentially exposed to the SARS-CoV-2 virus or other high-risk groups\\n\\nInclusion Criteria:\\n\\nParticipant is willing and able to give informed consent for participation in the study and agrees with the study and its conduct\\nAgrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals\\nAdults (exact age is dependent on countries)\\nNot previously diagnosed with COVID-19\\nNot currently symptomatic with an Acute Respiratory Infection\\nParticipant A. works in healthcare facility or other well characterised high-risk environment, OR B. is an inpatient or relative of a patient in a participating hospital and likely exposed to COVID-19 infection or another high-risk group\\nPossesses an internet-enabled smartphone (Android or iOS)\\n\\nExclusion Criteria:\\n\\nHypersensitivity 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203-6333',\n", + " 'CentralContactEMail': 'William@tropmedres.ac'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", + " 'IPDSharingDescription': \"With participant's consent, suitably anonymised clinical data and results from blood analyses stored in the database may be shared according to the terms defined in the MORU data sharing policy with other researchers to use in the future.\",\n", + " 'IPDSharingURL': 'https://www.tropmedres.ac/units/moru-bangkok/bioethics-engagement/data-sharing'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", + " 'InterventionMeshTerm': 'Hydroxychloroquine'},\n", + " {'InterventionMeshId': 'D000002738',\n", + " 'InterventionMeshTerm': 'Chloroquine'},\n", + " {'InterventionMeshId': 'C000023676',\n", + " 'InterventionMeshTerm': 'Chloroquine diphosphate'}]},\n", + " 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'Analg',\n", + " 'InterventionBrowseBranchName': 'Analgesics'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 38,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04331600',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'QUARANTINE2020'},\n", + " 'Organization': {'OrgFullName': 'Wroclaw Medical University',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'ChloroQUine As antiviRal treAtmeNT In coroNavirus infEction 2020',\n", + " 'OfficialTitle': 'Multicenter, Randomized, Open-label, Non-commercial, Investigator-initiated Study to Evaluate the Effectiveness and Safety of Chloroquine Phosphate in Combination With Telemedicine in the Reduction of Risk of Disease-related Hospitalization or Death, in Ambulatory Patients With COVID-19 at Particular Risk of Serious Complications',\n", + " 'Acronym': 'QUARANTINE2020'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 6, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'September 30, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 30, 2020',\n", + " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 2, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Wroclaw Medical University',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No',\n", + " 'IsUSExport': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'The aim of the study is to evaluate whether the therapy with chloroquine phosphate (CQ, in combination with telemedical approach) in addition to standard care is effective and safe in reducing composite endpoint of COVID-19-related hospitalization or all cause death, in ambulatory patients with SARS-SoV-2 infection at particular risk of serious complications due to advanced age and/or comorbid conditions (in comparison with subjects not treated with CQ but receiving standard care and supervised telemedically).',\n", + " 'DetailedDescription': 'Until now there are no evidence-based, good-quality data from sufficiently powered clinical trials supporting the use of any antiviral medicines or immunomodulatory therapies in the management or prophylaxis of COVID-19; however there are currently being initiated studies in Europe and U.S., and a few registered studies are ongoing in China. Currently two groups of medicines are hypothesized to be effective therapeutic options in COVID-19: (1) classical antiviral drugs interfering with pathogen dissemination / replication, and (2) compounds inhibiting host inflammatory reactions, especially (and potentially selectively) in respiratory tract / system (cytokine inhibitors and specific antibodies). Special hopes are placed in quinoline derivatives such as chloroquine (CQ), based on some unpublished data from China and a few experiments in vitro. CQ is an old antimalarial drug that has been used for more than 50 years in the therapy and prevention of this parasitosis. Anti-inflammatory features of quinolone derivatives such as CQ or hydroxychloroquine have also been used in rheumatology (for the therapy of lupus erythematosus or rheumatoid arthritis) due to the inhibition of the production of proinflammatory cytokines. The effectiveness (and safety) of CQ in COVID-19 has not been investigated in sufficiently powered RCTs until now.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", + " 'KeywordList': {'Keyword': ['COVID-19']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 4']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '400',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'CHLOROQUINE',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Standard of care + chloroquine phosphate + telemedical approach.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Chloroquine phosphate',\n", + " 'Other: Telemedicine']}},\n", + " {'ArmGroupLabel': 'CONTROL GROUP',\n", + " 'ArmGroupType': 'Other',\n", + " 'ArmGroupDescription': 'Standard of care + telemedical approach.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: Telemedicine']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Chloroquine phosphate',\n", + " 'InterventionDescription': 'Oral chloroquine phosphate for 14 days',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['CHLOROQUINE']}},\n", + " {'InterventionType': 'Other',\n", + " 'InterventionName': 'Telemedicine',\n", + " 'InterventionDescription': 'Telemedical supervision for 42 days',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['CHLOROQUINE',\n", + " 'CONTROL GROUP']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'COVID-19-related hospitalization or all-cause death',\n", + " 'PrimaryOutcomeDescription': 'Composite endpoint of COVID-19-related hospitalization or all-cause death',\n", + " 'PrimaryOutcomeTimeFrame': '15 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Decrease in COVID-19 symptoms',\n", + " 'SecondaryOutcomeDescription': 'Decrease in self-reported symptoms of novel coronavirus infection. Non-dichotomous symptoms (e.g. syncope is dichotomous - yes or no) such as dyspnoea will be self-evaluated by patients using the 0-3 scale with the severity increasing with the punctation (0-no symptoms, 1-mild symptoms, 2-moderate symptoms, 3-severe symptoms).',\n", + " 'SecondaryOutcomeTimeFrame': '15 days and 42 days'},\n", + " {'SecondaryOutcomeMeasure': 'Development of pneumonia',\n", + " 'SecondaryOutcomeDescription': 'Based on X-ray, microbiology and laboratory results',\n", + " 'SecondaryOutcomeTimeFrame': '42 days'},\n", + " {'SecondaryOutcomeMeasure': 'Development of coronavirus infection-related complications',\n", + " 'SecondaryOutcomeDescription': 'Acute respiratory distress syndrome, bacterial infection, shock, sepsis, etc',\n", + " 'SecondaryOutcomeTimeFrame': '42 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'INCLUSION CRITERIA\\n\\nage >=60 years OR age 18-59 years with one of the following conditions:\\n\\nchronic lung disease\\nchronic cardiovascular disease\\ndiabetes\\nmalignancy diagnosed within 5 years prior to enrollment\\nchronic kidney disease\\nSARS-CoV-2 infection confirmed in RT-PCR (nasopharyngeal swab)\\nHospitalization not required based on clinical judgement\\nAbility to participate in telemedical care\\n\\nEXCLUSION CRITERIA\\n\\nLack of written informed consent\\nPossible failure to comply with the protocol\\nChloroquine, hydroxychloroquine or other antiviral therapy within 3 months prior to enrollment\\nContraindications to chloroquine (pregnancy, breast-feeding, severe renal insufficiency, amiodarone or anticolvunsants therapy, alcohol disease, haematological disorders, epilepsia, porphyria, liver disease/cirrhosis, retinopathy, fainting/syncope, myasthenia)\\nHIV infection\\nConcurrent participation in another interventional clinical trial\\nHypersensitivity to chloroquine or drug excipients\\nOther relevant circumstances/conditions based on clinical judgement',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Marta Duda-Sikula, MBA',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '48 71 784 00 34',\n", + " 'CentralContactEMail': 'marta.duda-sikula@umed.wroc.pl'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000002738',\n", + " 'InterventionMeshTerm': 'Chloroquine'},\n", + " {'InterventionMeshId': 'C000023676',\n", + " 'InterventionMeshTerm': 'Chloroquine diphosphate'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000563',\n", + " 'InterventionAncestorTerm': 'Amebicides'},\n", + " {'InterventionAncestorId': 'D000000981',\n", + " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", + " {'InterventionAncestorId': 'D000000977',\n", + " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", + " {'InterventionAncestorId': 'D000000890',\n", + " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", + " {'InterventionAncestorId': 'D000000962',\n", + " 'InterventionAncestorTerm': 'Antimalarials'},\n", + " {'InterventionAncestorId': 'D000018501',\n", + " 'InterventionAncestorTerm': 'Antirheumatic Agents'},\n", + " {'InterventionAncestorId': 'D000000894',\n", + " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents, Non-Steroidal'},\n", + " {'InterventionAncestorId': 'D000018712',\n", + " 'InterventionAncestorTerm': 'Analgesics, Non-Narcotic'},\n", + " {'InterventionAncestorId': 'D000000700',\n", + " 'InterventionAncestorTerm': 'Analgesics'},\n", + " {'InterventionAncestorId': 'D000018689',\n", + " 'InterventionAncestorTerm': 'Sensory System Agents'},\n", + " {'InterventionAncestorId': 'D000018373',\n", + " 'InterventionAncestorTerm': 'Peripheral Nervous System Agents'},\n", + " {'InterventionAncestorId': 'D000045505',\n", + " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", + " {'InterventionAncestorId': 'D000000893',\n", + " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents'},\n", + " {'InterventionAncestorId': 'D000005369',\n", + " 'InterventionAncestorTerm': 'Filaricides'},\n", + " {'InterventionAncestorId': 'D000000969',\n", + " 'InterventionAncestorTerm': 'Antinematodal Agents'},\n", + " {'InterventionAncestorId': 'D000000871',\n", + " 'InterventionAncestorTerm': 'Anthelmintics'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M4562',\n", + " 'InterventionBrowseLeafName': 'Chloroquine',\n", + " 'InterventionBrowseLeafAsFound': 'Chloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M151035',\n", + " 'InterventionBrowseLeafName': 'Chloroquine diphosphate',\n", + " 'InterventionBrowseLeafAsFound': 'Chloroquine phosphate',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M2895',\n", + " 'InterventionBrowseLeafName': 'Antiviral Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2879',\n", + " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2875',\n", + " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2795',\n", + " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2861',\n", + " 'InterventionBrowseLeafName': 'Antimalarials',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19188',\n", + " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2798',\n", + " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2799',\n", + " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents, Non-Steroidal',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2613',\n", + " 'InterventionBrowseLeafName': 'Analgesics',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19370',\n", + " 'InterventionBrowseLeafName': 'Analgesics, Non-Narcotic',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2777',\n", + " 'InterventionBrowseLeafName': 'Anthelmintics',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", + " {'InterventionBrowseBranchAbbrev': 'Infl',\n", + " 'InterventionBrowseBranchName': 'Anti-Inflammatory Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'Analg',\n", + " 'InterventionBrowseBranchName': 'Analgesics'}]}},\n", + " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M5428',\n", + " 'ConditionBrowseLeafName': 'Death',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 39,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04323514',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '3143'},\n", + " 'Organization': {'OrgFullName': 'University of Palermo',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Use of Ascorbic Acid in Patients With COVID 19',\n", + " 'OfficialTitle': 'Use of Ascorbic Acid in Patients With COVID 19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 13, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 13, 2021',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'March 13, 2021',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 18, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 24, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 26, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 24, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 26, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Salvatore Corrao, MD',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Professor',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'University of Palermo'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'University of Palermo',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Different studies showed that ascorbic acid (vitaminC) positively affects the development and maturation of T-lymphocytes, in particular NK (natural Killer) cells involved in the immune response to viral agents. It also contributes to the inhibition of ROS production and to the remodulation of the cytokine network typical of systemic inflammatory syndrome.\\n\\nRecent studies have also demonstrated the effectiveness of vitamin C administration in terms of reducing mortality, in patients with sepsis hospitalized in intensive care wards.\\n\\nGiven this background, in the light of the current COVID-19 emergency, since the investigators cannot carry out a randomized controlled trial, it is their intention to conduct a study in the cohort of hospitalized patients with covid-19 pneumonia, administering 10 gr of vitamin C intravenously in addition to conventional therapy.',\n", + " 'DetailedDescription': 'The Sars-COV-2, has spread all over the world, in two months after its discovery in China. Outbreaks have been reported in more than 50 countries with more than 118,223 confirmed cases and 4,291 deaths worldwide. In Italy, the scenario is progressively worsening with 8514 confirmed cases and 631 deaths at 10/3/2020.\\n\\nAlong with the spread of this new virus there has been an increase in the number of pneumonia identified with the term novel coronavirus (2019-nCoV)-infected pneumonia (NCIP), which are characterized by fever, asthenia, dry cough, lymphopenia, prolonged prothrombin time, elevated lactic dehydrogenase, and a tomographic imaging indicative of interstitial pneumonia (ground glass and patchy shadows).\\n\\nRecent studies have shown the efficacy of vitamin C and thiamine administration in patients hospitalized for sepsis in the setting of intensive wards in terms of mortality reduction. The use of intravenously vitamin C arises from the experimental evidence of its anti-inflammatory and antioxidant properties. Vitamin C causes a greater proliferation of natural killers without affecting their functionality. Moreover, the vitamin C reduces the production of ROS (reactive oxygen species) that contribute to the activation of the inflammosomi and, in particular, the NLRP3 that affetcs the maturation and secretion of cytokines such as IL1beta and IL-18 that are involved in the inflammatory systemic syndrome that characterized sepsis. Vitamin C blocks the expression of ICAM-1 and activation of NFKappaB that are involved in inflammatory, neoplastic, and apoptotic processes by the inhibition of TNFalfa.\\n\\nFor this reason, the use of vitamin C could be effective in terms of mortality and secondary outcomes in the cohort of patients with covid-19 pneumonia.\\n\\nIn view of the emergency of SARS-VOC-2 and the impossibility of carrying out a randomized controlled study, it is their intention to conduct an intervention protocol (administration of 10 grams of vitamin C intravenously in addition to conventional therapy) involving the cohort of hospitalized patients with covid-19 pneumonia.\\n\\nMethods:\\n\\nAn uncontrolled longitudinal study will be conducted at the Arnas Civico-di Cristina-Benfratelli National Relevance Hospital in Palermo. This study will include all patients consecutively hospitalized with positive swab test of SARS-CoV-2 and interstitial pneumonia or with interstitial pneumonia with indication of intubation. At the admission, data will be collected: personal and anamnestic information, clinical and laboratory findings such as Gender, Age, Ethnicity, Comorbidities, Drugs, blood urea nitrogen, Creatinine, Electrolytes, Blood cell count, Clearance of the lactates, PCR, PCT, SOFA score, liver function, Coagulation, Blood gas analysis, Systolic and Diastolic Blood Pressure, Sp02, Glycaemia, Body Mass Index (BMI). Length of hospital stay will be recorded. After written informed consent, 10 grams of vitamin C in 250 ml of saline to infuse at a rate of 60 drops / minute will be administered. In-hospital mortality, reduction of PCR levels > 50% in comparison with PCR levels at the admission within 72 hours after the administration, lactate clearance, length of hospital stay, resolution of symptoms, duration of positive swab (days). Resolution of the CT imaging will be analysed. Stata Statistical Software: Release 14.1. College Station, TX: StataCorp LP) was used for database management and analysis.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Hospitalized Patients With Covid-19 Pneumonia']},\n", + " 'KeywordList': {'Keyword': ['pneumonia',\n", + " 'covid-19',\n", + " 'hospitalized patients',\n", + " 'vitamin C']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Not Applicable']},\n", + " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '500',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Patients with COVID-19 pneumonia',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Consecutive patients with COVID-19 pneumonia admitted to ARNAS Civico-Di Cristina-Benfratelli, Palermo',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Dietary Supplement: Vitamin C']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Dietary Supplement',\n", + " 'InterventionName': 'Vitamin C',\n", + " 'InterventionDescription': '10 gr of vitamin C intravenously in addition to conventional therapy.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Patients with COVID-19 pneumonia']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'In-hospital mortality',\n", + " 'PrimaryOutcomeDescription': 'Change of hospital mortality',\n", + " 'PrimaryOutcomeTimeFrame': '72 hours'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'PCR levels',\n", + " 'SecondaryOutcomeDescription': 'Reduction of PCR levels > 50% in comparison with PCR levels at the admission, within 72 hours after the administration',\n", + " 'SecondaryOutcomeTimeFrame': '72 hours'},\n", + " {'SecondaryOutcomeMeasure': 'Lactate clearance',\n", + " 'SecondaryOutcomeDescription': 'Change of the lactate clearance',\n", + " 'SecondaryOutcomeTimeFrame': '72 hours'},\n", + " {'SecondaryOutcomeMeasure': 'Hospital stay',\n", + " 'SecondaryOutcomeDescription': 'Change of hospital stay days',\n", + " 'SecondaryOutcomeTimeFrame': '72 hours'},\n", + " {'SecondaryOutcomeMeasure': 'Symptoms',\n", + " 'SecondaryOutcomeDescription': 'Resolution of symptoms (Fever, Cough, Shortness of breath or difficulty breathing)',\n", + " 'SecondaryOutcomeTimeFrame': '72 hours'},\n", + " {'SecondaryOutcomeMeasure': 'Positive swab',\n", + " 'SecondaryOutcomeDescription': 'Change of duration of positive swab (nasopharynx and throat)',\n", + " 'SecondaryOutcomeTimeFrame': '72 hours'},\n", + " {'SecondaryOutcomeMeasure': 'Tomography imaging',\n", + " 'SecondaryOutcomeDescription': 'Resolution of tomography imaging (example, patches located in the subpleural regions of the lung)',\n", + " 'SecondaryOutcomeTimeFrame': '72 hours'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nIn case of doubt of interstitial pneumonia with indications for intubation\\nPositive swab test of SARS-CoV-2\\nInterstitial pneumonia\\nSignature of informed consent\\n\\nExclusion Criteria:\\n\\nUnsigned informed consent\\nNegative swab test of SARS-CoV-2',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Salvatore Corrao, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+390916662717',\n", + " 'CentralContactEMail': 's.corrao@tiscali.it'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'A.R.N.A.S. Civico - Di Cristina - Benfratelli',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Palermo',\n", + " 'LocationZip': '90127',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Salvatore Corrao, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+390916662717',\n", + " 'LocationContactEMail': 's.corrao@tiscali.it'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DocumentSection': {'LargeDocumentModule': {'LargeDocList': {'LargeDoc': [{'LargeDocTypeAbbrev': 'Prot_SAP_ICF',\n", + " 'LargeDocHasProtocol': 'Yes',\n", + " 'LargeDocHasSAP': 'Yes',\n", + " 'LargeDocHasICF': 'Yes',\n", + " 'LargeDocLabel': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form',\n", + " 'LargeDocDate': 'March 12, 2020',\n", + " 'LargeDocUploadDate': '03/24/2020 05:48',\n", + " 'LargeDocFilename': 'Prot_SAP_ICF_000.pdf'}]}}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000014815',\n", + " 'InterventionMeshTerm': 'Vitamins'},\n", + " {'InterventionMeshId': 'D000001205',\n", + " 'InterventionMeshTerm': 'Ascorbic Acid'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000018977',\n", + " 'InterventionAncestorTerm': 'Micronutrients'},\n", + " {'InterventionAncestorId': 'D000078622',\n", + " 'InterventionAncestorTerm': 'Nutrients'},\n", + " {'InterventionAncestorId': 'D000006133',\n", + " 'InterventionAncestorTerm': 'Growth Substances'},\n", + " {'InterventionAncestorId': 'D000045505',\n", + " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", + " {'InterventionAncestorId': 'D000000975',\n", + " 'InterventionAncestorTerm': 'Antioxidants'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000020011',\n", + " 'InterventionAncestorTerm': 'Protective Agents'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M16141',\n", + " 'InterventionBrowseLeafName': 'Vitamins',\n", + " 'InterventionBrowseLeafAsFound': 'Vitamin',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M3094',\n", + " 'InterventionBrowseLeafName': 'Ascorbic Acid',\n", + " 'InterventionBrowseLeafAsFound': 'Vitamin C',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M15468',\n", + " 'InterventionBrowseLeafName': 'Trace Elements',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19593',\n", + " 'InterventionBrowseLeafName': 'Micronutrients',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M1986',\n", + " 'InterventionBrowseLeafName': 'Nutrients',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2873',\n", + " 'InterventionBrowseLeafName': 'Antioxidants',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M20453',\n", + " 'InterventionBrowseLeafName': 'Protective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'T437',\n", + " 'InterventionBrowseLeafName': 'Ascorbic Acid',\n", + " 'InterventionBrowseLeafAsFound': 'Ascorbic acid',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'T477',\n", + " 'InterventionBrowseLeafName': 'Vitamin C',\n", + " 'InterventionBrowseLeafAsFound': 'Vitamin C',\n", + " 'InterventionBrowseLeafRelevance': 'high'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Micro',\n", + " 'InterventionBrowseBranchName': 'Micronutrients'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", + " {'InterventionBrowseBranchAbbrev': 'Vi',\n", + " 'InterventionBrowseBranchName': 'Vitamins'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000011014',\n", + " 'ConditionMeshTerm': 'Pneumonia'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000008171',\n", + " 'ConditionAncestorTerm': 'Lung Diseases'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M12487',\n", + " 'ConditionBrowseLeafName': 'Pneumonia',\n", + " 'ConditionBrowseLeafAsFound': 'Pneumonia',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M9751',\n", + " 'ConditionBrowseLeafName': 'Lung Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'}]}}}}},\n", + " {'Rank': 40,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04292327',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'KY-2020-24.01'},\n", + " 'Organization': {'OrgFullName': 'Fujian Provincial Hospital',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Clinical Progressive Characteristics and Treatment Effects of 2019-novel Coronavirus',\n", + " 'OfficialTitle': 'Clinical Progressive Characteristics and Treatment Effects of 2019-novel Coronavirus(2019-nCoV)',\n", + " 'Acronym': '2019-nCoV'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'February 2020',\n", + " 'OverallStatus': 'Active, not recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'January 1, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 30, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'July 31, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'February 23, 2020',\n", + " 'StudyFirstSubmitQCDate': 'February 29, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 3, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'February 29, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 3, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Xiuling Shang',\n", + " 'ResponsiblePartyInvestigatorTitle': 'associate chief physician',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Fujian Provincial Hospital'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Fujian Provincial Hospital',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': \"Objects: The purpose of this study was to observe the characteristics of morbidity, disease progression and therapeutic effects of 2019-novel coronavirus pneumonia patients with different clinical types.\\n\\nMethod: A single center, retrospective and observational study was used to collect COVID-19 patients admitted to Wuhan Infectious Diseases Hospital (Wuhan JinYinTan Hospital) from January 2020 to March 2020. The general information, first clinical symptoms, hospitalization days, laboratory examination, CT examination, antiviral drugs, immune enhancers, traditional Chinese medicine treatment and other clinical intervention measures were recorded, and the nutritional status and prognosis of the patients were recorded. confirm COVID-19 's disease progression, clinical characteristics, disease severity and treatment effects. To compare the characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19.\\n\\nOutcomes: The characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19.\\n\\nConclusion: The characteristics of disease progression, clinical features and therapeutic effect of different types of COVID-19.\",\n", + " 'DetailedDescription': \"Since December 2019, patients with unexplained pneumonia have appeared in some medical institutions in Wuhan, China. Nucleic acid testing was completed on January 10, 2020, which was confirmed to be caused by 2019-novel coronavirus. In 2020, the World Health Organization(WHO) named the virus 2019-novel coronavirus(2019-nCoV). The WHO announced that the pneumonia caused by 2019-nCoV is officially called COVID-19. Today, more than 70,000 cases have been confirmed and more than 2,000 patients have died.\\n\\nAt present, the epidemiological characteristics, laboratory indicators, imaging features and clinical treatment effects of COVID-19 should be reported, but the sample size is small. Large sample studies are still needed to further confirm COVID-19 's disease progression, clinical characteristics, disease severity and treatment effects, so as to provide a scientific basis for future clinical treatment. Therefore, it is particularly important to further review the relationship between the characteristics and prognosis of such patients.\"},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Pneumonia Caused by Human Coronavirus']},\n", + " 'KeywordList': {'Keyword': ['2019-novel coronavirus', 'Pneumonia']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Other']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Retrospective']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '400',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'The ordinary COVID-19',\n", + " 'ArmGroupDescription': 'Consistent with the diagnosis of ordinary COVID-19.'},\n", + " {'ArmGroupLabel': 'The heavy COVID-19.',\n", + " 'ArmGroupDescription': 'Consistent with the diagnosis of heavy COVID-19.'},\n", + " {'ArmGroupLabel': 'The critical COVID-19',\n", + " 'ArmGroupDescription': 'Consistent with the diagnosis of critical COVID-19'}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Mortality',\n", + " 'PrimaryOutcomeDescription': 'The mortality of COVID-19 in 28 days',\n", + " 'PrimaryOutcomeTimeFrame': '28 day'},\n", + " {'PrimaryOutcomeMeasure': 'The time interval of Nucleic acid detection become negative',\n", + " 'PrimaryOutcomeDescription': 'The time interval of COVID-19 form nucleic acid confirmed to the nucleic acid detection turn into negative.',\n", + " 'PrimaryOutcomeTimeFrame': '28 day'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion criteria.\\n\\n2019-nCov (SARA-Cov-2) nucleic acid positive detected by PCR.\\nOlder than 18 years old and younger than 75 years old.\\nMeet the diagnostic criteria of COVID-19 for different types (including ordinary type, heavy type and critical type)\\n\\nExclusion criteria.\\n\\nthe age is less than 18 years old;\\npregnant or lactating women;\\nsevere underlying diseases, such as advanced malignant tumor, end-stage lung disease, etc.',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '75 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'Collect COVID-19 patients admitted to Wuhan Infectious Diseases Hospital (Wuhan JinYinTan Hospital) from January 2020 to March 2020',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Xiuling Shang',\n", + " 'OverallOfficialAffiliation': 'Fujian Provincial Hospital',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Fujian Provincial Hospital',\n", + " 'LocationCity': 'Fuzhou',\n", + " 'LocationState': 'Fujian',\n", + " 'LocationZip': '350000',\n", + " 'LocationCountry': 'China'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", + " {'ConditionMeshId': 'D000011014', 'ConditionMeshTerm': 'Pneumonia'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000008171',\n", + " 'ConditionAncestorTerm': 'Lung Diseases'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", + " {'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M12487',\n", + " 'ConditionBrowseLeafName': 'Pneumonia',\n", + " 'ConditionBrowseLeafAsFound': 'Pneumonia',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M9751',\n", + " 'ConditionBrowseLeafName': 'Lung Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 41,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04313023',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'PUL-042-501'},\n", + " 'Organization': {'OrgFullName': 'Pulmotect, Inc.',\n", + " 'OrgClass': 'INDUSTRY'},\n", + " 'BriefTitle': 'The Use PUL-042 Inhalation Solution to Prevent COVID-19 in Adults Exposed to SARS-CoV-2',\n", + " 'OfficialTitle': 'A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing COVID-19 Infection in Adults Exposed to COVID-19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'September 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'October 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 16, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 16, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 18, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 22, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 24, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Pulmotect, Inc.',\n", + " 'LeadSponsorClass': 'INDUSTRY'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'Yes',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Subjects who have documented exposure to SARS-CoV-2 (COVID-19) and test negative for SARS-CoV-2 infection will receive 4 doses of PUL-042 Inhalation Solution or 4 doses of a placebo solution by inhalation over 2 weeks. Subjects must be under quarantine in a controlled facility or hospital (home quarantine is not sufficient). Subjects will be under observation and tested for infection with SARS-CoV-2 over a 14 day period.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 2']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Prevention',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Quadruple',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", + " 'Care Provider',\n", + " 'Investigator',\n", + " 'Outcomes Assessor']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '200',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'PUL-042 Inhalation Solution',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'PUL-042 Inhalation Solution given by nebulization on study days 1,3, 6, and 10',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: PUL-042 Inhalation Solution']}},\n", + " {'ArmGroupLabel': 'Sterile normal saline for inhalation',\n", + " 'ArmGroupType': 'Placebo Comparator',\n", + " 'ArmGroupDescription': 'Sterile normal saline for inhalation given by nebulization on study days 1, 3, 6, and 10',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'PUL-042 Inhalation Solution',\n", + " 'InterventionDescription': '20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042) PUL-042 Inhalation Solution will be given by nebulization on study days 1, 3, 6, and 10',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['PUL-042 Inhalation Solution']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Placebo',\n", + " 'InterventionDescription': 'Sterile normal saline for inhalation',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Sterile normal saline for inhalation']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Prevention of COVID-19',\n", + " 'PrimaryOutcomeDescription': 'Difference in the incidence of infection with SARS-CoV-2',\n", + " 'PrimaryOutcomeTimeFrame': '14 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\n1. Subjects must have documented exposure to COVID-19 and have a documented negative test for the virus within 72 hours of the administration of study drug\\n2. Subjects must be free of clinical symptoms (fever, cough, shortness of breath) of a potential COVID-19 infection\\n3. Subjects must be under quarantine in a controlled facility or hospital (home quarantine is not sufficient)\\n4. Spirometry (forced expiratory volume in one second [FEV1] and forced vital capacity [FVC]) ≥70% of predicted value\\n5. If female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception must be: practicing two effective methods of birth control (acceptable methods include intrauterine device, spermicide, barrier, male partner surgical sterilization, and hormonal contraception) during the study and through 30 days after completion of the study. Abstinence is not classified as an effective method of birth control.\\n6. If female, must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study. A pregnancy test must be negative at the Screening Visit, prior to dosing on Day 1.\\n7. If male, must be surgically sterile or willing to practice two effective methods of birth control (acceptable methods include barrier, spermicide, or female partner surgical sterilization) during the study and through 30 days after completion of the study. Abstinence is not classified as an effective method of birth control.\\n8. Ability to understand and give informed consent.\\n\\nExclusion Criteria:\\n\\n1. Documented infection with COVID-19\\n2. Clinical signs and symptoms consistent with COVID-19 infection (fever, cough, shortness of breath) at the time of screening\\n3. Known history of chronic pulmonary disease (e.g., asthma [including atopic asthma, exercise-induced asthma, or asthma triggered by respiratory infection], chronic pulmonary disease, pulmonary fibrosis, COPD), pulmonary hypertension, or heart failure.\\n4. Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints.\\n5. Previous exposure to PUL-042 Inhalation Solution',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Colin Broom, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '713-579-9226',\n", + " 'CentralContactEMail': 'clinicaltrials@pulmotect.com'},\n", + " {'CentralContactName': 'Brenton Scott, Ph D',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '713-579-9226',\n", + " 'CentralContactEMail': 'clincaltrials@pulmotect.com'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Colin Broom, MD',\n", + " 'OverallOfficialAffiliation': 'Pulmotect, Inc.',\n", + " 'OverallOfficialRole': 'Study Director'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'C000627946',\n", + " 'InterventionMeshTerm': 'PUL-042'},\n", + " {'InterventionMeshId': 'D000019999',\n", + " 'InterventionMeshTerm': 'Pharmaceutical Solutions'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000019141',\n", + " 'InterventionAncestorTerm': 'Respiratory System Agents'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M20444',\n", + " 'InterventionBrowseLeafName': 'Pharmaceutical Solutions',\n", + " 'InterventionBrowseLeafAsFound': 'Solution',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M266568',\n", + " 'InterventionBrowseLeafName': 'PUL-042',\n", + " 'InterventionBrowseLeafAsFound': 'PUL-042',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M19721',\n", + " 'InterventionBrowseLeafName': 'Respiratory System Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", + " {'InterventionBrowseBranchAbbrev': 'Resp',\n", + " 'InterventionBrowseBranchName': 'Respiratory System Agents'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000053120',\n", + " 'ConditionMeshTerm': 'Respiratory Aspiration'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000012120',\n", + " 'ConditionAncestorTerm': 'Respiration Disorders'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", + " {'ConditionAncestorId': 'D000010335',\n", + " 'ConditionAncestorTerm': 'Pathologic Processes'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M25724',\n", + " 'ConditionBrowseLeafName': 'Respiratory Aspiration',\n", + " 'ConditionBrowseLeafAsFound': 'Inhalation',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M13540',\n", + " 'ConditionBrowseLeafName': 'Respiration Disorders',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'}]}}}}},\n", + " {'Rank': 42,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04313322',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'COVID-19'},\n", + " 'Organization': {'OrgFullName': 'Stem Cells Arabia',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': \"Treatment of COVID-19 Patients Using Wharton's Jelly-Mesenchymal Stem Cells\",\n", + " 'OfficialTitle': \"Treatment of COVID-19 Patients Using Wharton's Jelly-Mesenchymal Stem Cells\"},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 16, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'June 30, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'September 30, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 15, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 15, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 18, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 15, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 18, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Adeeb Al Zoubi',\n", + " 'ResponsiblePartyInvestigatorTitle': 'President, Chief Scientific Officer',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Stem Cells Arabia'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Stem Cells Arabia',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': \"The purpose of this study is to investigate the potential use of Wharton's Jelly Mesenchymal stem cells (WJ-MSCs) for treatment of patient diagnosed with Corona Virus SARS-CoV-2 infection, and showing symptoms of COVID-19.\",\n", + " 'DetailedDescription': 'COVID-19 is a condition caused by infection with Coronoa Virus (SARS-CoV-2). This virus has a high transmission rate and is spreading at very high rates. causing a worldwide pandemic. Patients diagnosed with COVID-19 and confirmed positive with the virus, will be given three IV doses of WJ-MSCs consisting of 1X10e6/kg. The three doses will be 3 days apart form each other.\\n\\nPatients will be followed up for a period of three weeks to assess the severity of the condition and measure the viral titers.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Use of Stem Cells for COVID-19 Treatment']},\n", + " 'KeywordList': {'Keyword': ['Stem Cells, COVID-19, SARS CoV2, WJ MSCs, Immunomodulation,']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 1']},\n", + " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", + " 'DesignInterventionModelDescription': 'Patients positively diagnosed with COVID-19',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)',\n", + " 'DesignMaskingDescription': 'None. This is a direct study for the potential effects of WJ-MSCs on COVID-19 outcome.'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '5',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'WJ-MSCs',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'WJ-MSCs will be derived from cord tissue of newborns, screened for HIV1/2, HBV, HCV, CMV, Mycoplasma, and cultured to enrich for MSCs.\\n\\nWJ-MSCs will be counted and suspended in 25 ml of Saline solution containing 0.5% human serum Albumin, and will be given to patient intravenously.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: WJ-MSCs']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Biological',\n", + " 'InterventionName': 'WJ-MSCs',\n", + " 'InterventionDescription': 'WJ-MSCs will be derived from cord tissue of newborns, screened for HIV1/2, HBV, HCV, CMV, Mycoplasma, and cultured to enrich for MSCs.\\n\\nWJ-MSCs will be counted and suspended in 25 ml of Saline solution containing 0.5% human serum Albumin, and will be given to patient intravenously.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['WJ-MSCs']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Clinical outcome',\n", + " 'PrimaryOutcomeDescription': 'Improvement of clinical symptoms including duration of fever, respiratory destress, pneumonia, cough, sneezing, diarrhea.',\n", + " 'PrimaryOutcomeTimeFrame': '3 weeks'},\n", + " {'PrimaryOutcomeMeasure': 'CT Scan',\n", + " 'PrimaryOutcomeDescription': 'Side effects measured by Chest Readiograph',\n", + " 'PrimaryOutcomeTimeFrame': '3 weeks'},\n", + " {'PrimaryOutcomeMeasure': 'RT-PCR results',\n", + " 'PrimaryOutcomeDescription': 'Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative',\n", + " 'PrimaryOutcomeTimeFrame': '3 weeks'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'RT-PCR results',\n", + " 'SecondaryOutcomeDescription': 'Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative',\n", + " 'SecondaryOutcomeTimeFrame': '8 weeks'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nCOVID-19 positive according to diagnosis and clinical management of COVID-19 criteria.\\n\\nExclusion Criteria:\\n\\nParticipants in other clinical trials\\npatients with malignant tumors\\npregnant and lactating women\\nco-infection with other infectious viruses or bacteria\\nHistory of several allergies\\nPatients with history of pulmonary embolism\\nany liver or kidney diseases\\nHIV positive patients\\nConsidered by researchers to be not suitable to participate in this clinical trial\\nChronic heart failure with ejection fraction less than 30%.',\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Adeeb M AlZoubi, Ph.D.',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+962795337575',\n", + " 'CentralContactEMail': 'adeebalzoubi@stemcellsarabia.net'},\n", + " {'CentralContactName': 'Ahmad Y AlGhadi, M.Sc.',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+962796624217',\n", + " 'CentralContactEMail': 'ahmed.alghadi@stemcellsarabia.net'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Stem Cells Arabia',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Amman',\n", + " 'LocationZip': '11953',\n", + " 'LocationCountry': 'Jordan',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Adeeb M Alzoubi, Ph.D.',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+962795337575',\n", + " 'LocationContactEMail': 'adeebalzoubi@stemcellsarabia.net'},\n", + " {'LocationContactName': 'Ahmad AlGhadi, M.Sc.',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+962796624217',\n", + " 'LocationContactEMail': 'ahmed.alghadi@stemcellsarabia.net'},\n", + " {'LocationContactName': 'Ahmad Y AlGhadi, M.Sc.',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Sumaya H Aldajah, M.Sc.',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Marwa E Tapponi, Pharm.D.',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Sameh N AlBakheet, B.Sc.',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Mahasen Zalloum, B.Sc.',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M20444',\n", + " 'InterventionBrowseLeafName': 'Pharmaceutical Solutions',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}}}}},\n", + " {'Rank': 43,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04328961',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'STUDY00009750'},\n", + " 'Organization': {'OrgFullName': 'University of Washington',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Hydroxychloroquine for COVID-19 PEP',\n", + " 'OfficialTitle': 'Efficacy of Hydroxychloroquine for Post-exposure Prophylaxis (PEP) to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection Among Adults Exposed to Coronavirus Disease (COVID-19): a Blinded, Randomized Study'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'September 30, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'October 31, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 23, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 29, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 29, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Ruanne Barnabas',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Associate Professor, School of Medicine: Global Health',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'University of Washington'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'University of Washington',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'New York University',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'Bill and Melinda Gates Foundation',\n", + " 'CollaboratorClass': 'OTHER'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'Yes',\n", + " 'IsFDARegulatedDevice': 'No',\n", + " 'IsUSExport': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'This is a clinical study for the prevention of SARS-CoV-2 infection in adults exposed to the virus. This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) who are close contacts of persons with laboratory confirmed SARS-CoV-2 or clinically suspected COVID-19. Eligible participants will be enrolled and randomized to receive the intervention or placebo at the level of the household (all eligible participants in one household will receive the same intervention).',\n", + " 'DetailedDescription': 'This is a randomized, multi-center, placebo-equivalent (ascorbic acid) controlled, blinded study of Hydroxychloroquine (HCQ) post-exposure prophylaxis (PEP) for the prevention of SARS-CoV-2 infection in adults exposed to the virus.The overarching goal of this study is to assess the effectiveness of HCQ PEP on the incidence of SARS-CoV-2 detection by polymerase chain reaction (PCR) to inform public health control strategies.This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) at baseline who are close contacts of persons with PCR-confirmed SARS-CoV-2 or clinically suspected COVID-19 and a pending SARS-CoV-2 PCR test. Eligible participants will be enrolled and randomized 1:1 to HCQ or ascorbic acid at the level of the household (all eligible participants in one household will receive the same intervention). Participants will be counseled about the preliminary in vitro data on HCQ activity against SARS CoV-2 and equipoise regarding efficacy in humans.The duration of study participation will be approximately 28 days.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", + " 'Corona Virus Infection',\n", + " 'SARS (Severe Acute Respiratory Syndrome)']},\n", + " 'KeywordList': {'Keyword': ['novel coronavirus',\n", + " 'post-exposure prophylaxis']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 1']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Prevention',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Single',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '2000',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Ascorbic Acid',\n", + " 'ArmGroupType': 'Placebo Comparator',\n", + " 'ArmGroupDescription': 'Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Ascorbic Acid']}},\n", + " {'ArmGroupLabel': 'Hydroxychloroquine',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine Sulfate']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Hydroxychloroquine Sulfate',\n", + " 'InterventionDescription': 'Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Hydroxychloroquine']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['HCQ arm']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Ascorbic Acid',\n", + " 'InterventionDescription': 'Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Ascorbic Acid']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Placebo arm']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection',\n", + " 'PrimaryOutcomeDescription': 'Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected daily for 14 days',\n", + " 'PrimaryOutcomeTimeFrame': 'Day 1 through Day 14 after enrolment'},\n", + " {'PrimaryOutcomeMeasure': 'Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection',\n", + " 'PrimaryOutcomeDescription': 'Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected at study exit',\n", + " 'PrimaryOutcomeTimeFrame': 'Day 28 after enrolment'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Rate of participant-reported adverse events',\n", + " 'SecondaryOutcomeDescription': 'Safety and tolerability of Hydroxychloroquine as SARS-CoV-2 PEP in adults',\n", + " 'SecondaryOutcomeTimeFrame': '28 days from start of Hydroxychloroquine therapy'},\n", + " {'SecondaryOutcomeMeasure': 'Incidence rates of COVID-19 through study completion',\n", + " 'SecondaryOutcomeDescription': 'PCR-confirmed COVID-19 diagnosis',\n", + " 'SecondaryOutcomeTimeFrame': '28 days from enrolment'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nMen or women 18 to 80 years of age inclusive, at the time of signing the informed consent\\nWilling and able to provide informed consent\\n\\nHad a close contact of a person (index) with known PCR-confirmed SARS-CoV-2 infection or who is currently being assessed for COVID-19. Close contact defined as:\\n\\nHousehold contact (i.e., residing with the index case in the 14 days prior to index diagnosis)\\nMedical staff, first responders, or other care persons who cared for the index case without personal protection (mask and gloves)\\nLess than 4 days since last exposure (close contact with a person with SARS-CoV-2 infection) to the index case\\nBody weight < 100 kg (self-reported)\\nAccess to device and internet for Telehealth visits\\n\\nExclusion Criteria:\\n\\nKnown hypersensitivity to HCQ or other 4-aminoquinoline compounds\\nCurrently hospitalized\\nSymptomatic with subjective fever, cough, or sore throat\\nCurrent medications exclude concomitant use of HCQ\\nConcomitant use of other anti-malarial treatment or chemoprophylaxis\\nHistory of retinopathy of any etiology\\nPsoriasis\\nPorphyria\\nKnown bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes < 1500) or thrombocytopenia (< 100 K)\\nConcomitant use of digoxin, cyclosporin, cimetidine, or tamoxifen\\nKnown liver disease\\nKnown long QT syndrome\\nUse of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of the study drugs, or planned use during the study period',\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '80 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Meighan Krows',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '206-520-3833',\n", + " 'CentralContactEMail': 'meigs@uw.edu'},\n", + " {'CentralContactName': 'Justice Quame-Amaglo',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '206-520-3866',\n", + " 'CentralContactEMail': 'quamaglo@uw.edu'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Ruanne V. Barnabas, MBChB, DPhil',\n", + " 'OverallOfficialAffiliation': 'University of Washington',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Anna Bershteyn, PhD',\n", + " 'OverallOfficialAffiliation': 'NYU Langone Health',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'NYU Langone Health',\n", + " 'LocationCity': 'New York',\n", + " 'LocationState': 'New York',\n", + " 'LocationZip': '10016',\n", + " 'LocationCountry': 'United States',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Anna Bershteyn, PhD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactEMail': 'anna.bershteyn@nyulangone.org'},\n", + " {'LocationContactName': 'Anna Bershteyn, PhD',\n", + " 'LocationContactRole': 'Principal Investigator'}]}},\n", + " {'LocationFacility': 'University of Washington, Coordinating Center',\n", + " 'LocationCity': 'Seattle',\n", + " 'LocationState': 'Washington',\n", + " 'LocationZip': '98104',\n", + " 'LocationCountry': 'United States'},\n", + " {'LocationFacility': 'UW Virology Research Clinic',\n", + " 'LocationCity': 'Seattle',\n", + " 'LocationState': 'Washington',\n", + " 'LocationZip': '98104',\n", + " 'LocationCountry': 'United States',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Helen Stankiewicz Karita, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '206-520-4340',\n", + " 'LocationContactEMail': 'helensk@uw.edu'},\n", + " {'LocationContactName': 'Kirsten Hauge',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '206-520-4341',\n", + " 'LocationContactEMail': 'kahauge@uw.edu'},\n", + " {'LocationContactName': 'Christine Johnston, MD',\n", + " 'LocationContactRole': 'Principal Investigator'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", + " 'IPDSharingDescription': \"De-identified data from the study will be made available in accordance with the funder's open access policy.\",\n", + " 'IPDSharingInfoTypeList': {'IPDSharingInfoType': ['Study Protocol',\n", + " 'Informed Consent Form (ICF)',\n", + " 'Analytic Code']},\n", + " 'IPDSharingTimeFrame': 'Within 3 months of publication of primary results.',\n", + " 'IPDSharingAccessCriteria': \"De-identified data from the study will be made available in accordance with the funder's open access policy.\",\n", + " 'IPDSharingURL': 'https://www.gatesfoundation.org/how-we-work/general-information/open-access-policy'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000001205',\n", + " 'InterventionMeshTerm': 'Ascorbic Acid'},\n", + " {'InterventionMeshId': 'D000006886',\n", + " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", + " 'InterventionAncestorTerm': 'Antimalarials'},\n", + " {'InterventionAncestorId': 'D000000981',\n", + " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", + " {'InterventionAncestorId': 'D000000977',\n", + " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", + " {'InterventionAncestorId': 'D000000890',\n", + " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", + " {'InterventionAncestorId': 'D000004791',\n", + " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000018501',\n", + " 'InterventionAncestorTerm': 'Antirheumatic Agents'},\n", + " {'InterventionAncestorId': 'D000000975',\n", + " 'InterventionAncestorTerm': 'Antioxidants'},\n", + " {'InterventionAncestorId': 'D000020011',\n", + " 'InterventionAncestorTerm': 'Protective Agents'},\n", + " {'InterventionAncestorId': 'D000045505',\n", + " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", + " {'InterventionAncestorId': 'D000014815',\n", + " 'InterventionAncestorTerm': 'Vitamins'},\n", + " {'InterventionAncestorId': 'D000018977',\n", + " 'InterventionAncestorTerm': 'Micronutrients'},\n", + " {'InterventionAncestorId': 'D000078622',\n", + " 'InterventionAncestorTerm': 'Nutrients'},\n", + " {'InterventionAncestorId': 'D000006133',\n", + " 'InterventionAncestorTerm': 'Growth Substances'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", + " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M3094',\n", + " 'InterventionBrowseLeafName': 'Ascorbic Acid',\n", + " 'InterventionBrowseLeafAsFound': 'Ascorbic acid',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M2861',\n", + " 'InterventionBrowseLeafName': 'Antimalarials',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2879',\n", + " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2875',\n", + " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2795',\n", + " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19188',\n", + " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2873',\n", + " 'InterventionBrowseLeafName': 'Antioxidants',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M20453',\n", + " 'InterventionBrowseLeafName': 'Protective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M16141',\n", + " 'InterventionBrowseLeafName': 'Vitamins',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M15468',\n", + " 'InterventionBrowseLeafName': 'Trace Elements',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19593',\n", + " 'InterventionBrowseLeafName': 'Micronutrients',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M1986',\n", + " 'InterventionBrowseLeafName': 'Nutrients',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'T437',\n", + " 'InterventionBrowseLeafName': 'Ascorbic Acid',\n", + " 'InterventionBrowseLeafAsFound': 'Ascorbic acid',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'T477',\n", + " 'InterventionBrowseLeafName': 'Vitamin C',\n", + " 'InterventionBrowseLeafAsFound': 'Ascorbic acid',\n", + " 'InterventionBrowseLeafRelevance': 'high'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", + " {'InterventionBrowseBranchAbbrev': 'Micro',\n", + " 'InterventionBrowseBranchName': 'Micronutrients'},\n", + " {'InterventionBrowseBranchAbbrev': 'Vi',\n", + " 'InterventionBrowseBranchName': 'Vitamins'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", + " 'ConditionMeshTerm': 'Infection'},\n", + " {'ConditionMeshId': 'D000045169',\n", + " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'},\n", + " {'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", + " {'ConditionMeshId': 'D000013577', 'ConditionMeshTerm': 'Syndrome'},\n", + " {'ConditionMeshId': 'D000014777',\n", + " 'ConditionMeshTerm': 'Virus Diseases'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000004194',\n", + " 'ConditionAncestorTerm': 'Disease'},\n", + " {'ConditionAncestorId': 'D000010335',\n", + " 'ConditionAncestorTerm': 'Pathologic Processes'},\n", + " {'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafAsFound': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M14938',\n", + " 'ConditionBrowseLeafName': 'Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafAsFound': 'Virus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 44,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04304053',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'HCQ4COV19'},\n", + " 'SecondaryIdInfoList': {'SecondaryIdInfo': [{'SecondaryId': '2020-001031-27',\n", + " 'SecondaryIdType': 'EudraCT Number'}]},\n", + " 'Organization': {'OrgFullName': 'Fundacio Lluita Contra la SIDA',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts as Prevention',\n", + " 'OfficialTitle': 'Treatment of Non-severe Confirmed Cases of COVID-19 and Chemoprophylaxis of Their Contacts as Prevention Strategy: a Cluster Randomized Clinical Trial (PEP CoV-2 Study)',\n", + " 'Acronym': 'HCQ4COV19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 18, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'June 15, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'June 15, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 5, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 7, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 11, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 22, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 24, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Oriol Mitja',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Prof (Ass) Infectious Disease and Global Health',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Germans Trias i Pujol Hospital'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Fundacio Lluita Contra la SIDA',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Germans Trias i Pujol Hospital',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'Department of Health, Generalitat de Catalunya',\n", + " 'CollaboratorClass': 'OTHER_GOV'},\n", + " {'CollaboratorName': 'FUNDACIÓN FLS DE LUCHA CONTRA EL SIDA, LAS ENFERMEDADES INFECCIOSAS Y LA PROMOCIÓN DE LA SALUD Y LA CIENCIA',\n", + " 'CollaboratorClass': 'UNKNOWN'},\n", + " {'CollaboratorName': 'Laboratorios Gebro Pharma SA',\n", + " 'CollaboratorClass': 'UNKNOWN'},\n", + " {'CollaboratorName': 'Laboratorios Rubió',\n", + " 'CollaboratorClass': 'UNKNOWN'},\n", + " {'CollaboratorName': 'Institut Catala de Salut',\n", + " 'CollaboratorClass': 'OTHER_GOV'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': \"The investigators plan to evaluate the efficacy of the 'test and treat' strategy of infected patients and prophylactic chloroquine treatment to all contacts. The strategy entails decentralized COVID-19 testing and starting antiviral darunavir/cobicistat plus chloroquine treatment immediately in all who are found to be infected. As viral loads decline to undetectable levels, the probability of onward transmission is reduced to very low levels. Such evaluation will require prospective surveillance to assess the population-level effect of transmission prevention.\\n\\nDrug interventions in this protocol will follow the Spanish law about off-label use of medicines.\",\n", + " 'DetailedDescription': \"Previous research on influenza has indicated that antiviral drugs administered before o short after symptom onset can reduce infectiousness to others by reducing viral loads in the respiratory secretions of patients.\\n\\nLopinavir/ritonavir, a protease inhibitor used to treat HIV/AIDS, was found to block COVID-19 infection in vitro at low-micromolar concentration, with a half-maximal effective concentration (EC50) of 8.5 μM. China's guidelines were set up in January 2020 and treated hospitalized patients with lopinavir/ritonavir, either alone or with various combinations. Darunavir (DRV)/Cobicistat, is also a protease inhibitor used to treat and prevent HIV/AIDS. Its as effective as lopinavir/ritonavir for the treatment of HIV/AIDS and better tolerated because the adverse effects rate is lower (diarrhea 2% vs 27%).\\n\\nAnother promising drug is chloroquine, that showed excellent in vitro results and strong antiviral effects on SARS-CoV infection of primate cells. Results from n=100 patients have shown superiority to the control treatment in improving lung imaging findings, promoting virus reversion to negative and shortening the disease.\"},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 3']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignInterventionModelDescription': 'Cluster-randomized clinical trial',\n", + " 'DesignPrimaryPurpose': 'Prevention',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)',\n", + " 'DesignMaskingDescription': 'Open label'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '3040',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'No Intervention- SARS-CoV-2 surveillance',\n", + " 'ArmGroupType': 'Active Comparator',\n", + " 'ArmGroupDescription': 'Subjects exhibiting Acute Respiratory Infection (ARI) symptoms at a participating health care services complete a survey collecting demographic and clinical data and provide a swab for RT-PCR testing. Isolation of patient and contact tracing as per guidelines.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: Standard Public Health measures']}},\n", + " {'ArmGroupLabel': 'Testing, treatment and prophylaxis of SARS-CoV-2',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Subjects exhibiting ARI symptoms at a participating hospital complete a survey collecting demographic and clinical data and provide a swab to be tested on-site with a molecular assay. Isolation of patient and contact tracing as per guidelines. Case receive an antiviral if tested positive (Chloroquine and darunavir/cobicistat). Contacts receive Chloroquine prophylaxis',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Antiviral treatment and prophylaxis',\n", + " 'Other: Standard Public Health measures']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Antiviral treatment and prophylaxis',\n", + " 'InterventionDescription': 'darunavir 800 mg / cobicistat 150 mg tablets (oral, 1 tablet q24h, taking for 7 days) and hydroxychloroquine (200mg tablets) 800mg on day 1, and 400mg on days 2,3,4, 5, 6 and 7.\\n\\nContacts will be offered a prophylactic regimen of hydroxychloroquine (200mg tablets) 800mg on day 1, and 400mg on days 2,3,4.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Testing, treatment and prophylaxis of SARS-CoV-2']}},\n", + " {'InterventionType': 'Other',\n", + " 'InterventionName': 'Standard Public Health measures',\n", + " 'InterventionDescription': 'Isolation of patient and contact tracing as per national guidelines.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['No Intervention- SARS-CoV-2 surveillance',\n", + " 'Testing, treatment and prophylaxis of SARS-CoV-2']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Effectiveness of chemoprophylaxis assessed by incidence of secondary COVID-19 cases',\n", + " 'PrimaryOutcomeDescription': 'Incidence of secondary cases among contacts of a case and contacts of contacts',\n", + " 'PrimaryOutcomeTimeFrame': 'Up to 14 days after start of treatment'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at days 3',\n", + " 'SecondaryOutcomeTimeFrame': '3 days after start of treatment'},\n", + " {'SecondaryOutcomeMeasure': 'The mortality rate of subjects at weeks 2',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 14 days after start of treatment'},\n", + " {'SecondaryOutcomeMeasure': 'Proportion of participants that drop out of study',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 14 days after start of treatment'},\n", + " {'SecondaryOutcomeMeasure': 'Proportion of participants that show non-compliance with study drug',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 14 days after start of treatment'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria for a case:\\n\\nPatients who meet the requirements of the New Coronavirus Infection Diagnosis (Acute respiratory infection symptoms or acute cough alone and positive PCR)\\nAged ≥18 years male or female;\\nIn women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study.\\nWilling to take study medication\\nWilling to comply with all study procedures, including repeat nasal swab at day 3\\nAble to provide oral and written informed consent\\n\\nExclusion Criteria for a case:\\n\\nSerious condition meeting one of the following: (1) respiratory distress with respiratory rate >=30 breaths/min; (2) oxygen saturation<=93% on quiet status; (3) Arterial partial pressure of oxygen (PaO2)/oxygen concentration<=300mmHg;\\nCritically ill patients meeting one of the following: (1) Experience respiratory failure and need to receive mechanical ventilation; (2) Experience shock; (3) Complicated with other organs failure and need intensive care and therapy in ICU;\\nParticipants under treatment with medications likely to interfere with experimental drugs\\nUnable to take drugs by mouth;\\nWith significantly abnormal liver function (Child Pugh C)\\nNeed of dialysis treatment, or GFR≤30 mL/min/1.73 m2;\\nParticipants with psoriasis, myasthenia, haematopoietic and retinal diseases,CNS-related hearing loss or glucose-6-phosphate dehydrogenase deficit\\nParticipants with severe neurological and mental illness;\\nPregnant or lactating women;\\nInability to consent and/or comply with study protocol;\\nIndividuals with known hypersensitivity to the study drugs.\\nPersons already treated with any of the study drugs during the last 30 days.\\nConcomitant administration of enzyme inducers (such as carbamazepine) which could lead to ineffectiveness of darunavir; and those who receive CYP3A4 substrates (such as statins) because of the risk of increased toxicity.\\nHIV patients (because these are already on antiretroviral treatment)\\nAny contraindications as per the Data Sheet of Rezolsta or Hydroxychloroquine.\\n\\nInclusion Criteria for a contact:\\n\\nPatients who meet the definition of a contact according to the Catalan Public Health Department Guidelines\\nAged ≥18 years male or female;\\nIn women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study.\\nWilling to take study medication;\\nWilling to comply with all study procedures;\\nAble to provide oral, informed consent and/or assent.\\n\\nExclusion Criteria for a contact:\\n\\nWith known history of cardiac arrhythmia (or QT prolongation syndrome);\\nUnable to take drugs by mouth;\\nWith significantly abnormal liver function (Child Pugh C)\\nNeed of dialysis treatment, or GFR≤30 mL/min/1.73 m2;\\nParticipants with psoriasis, myasthenia, haematopoietic and retinal diseases,CNS-related hearing loss or glucose-6-phosphate dehydrogenase deficit;\\nPersons already treated with any of the study drugs during the last 30 days;\\nPregnant or lactating women;\\nAny contraindications as per the Data Sheet of Hydroxychloroquine.',\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'oriol Mitja, PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '0034 934651072',\n", + " 'CentralContactEMail': 'oriolmitja@hotmail.com'},\n", + " {'CentralContactName': 'Laia Bertran',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '0034 934651072'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'CAP II Sant Fèlix',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Sabadell',\n", + " 'LocationState': 'Barcelona',\n", + " 'LocationZip': '08204',\n", + " 'LocationCountry': 'Spain'},\n", + " {'LocationFacility': 'Gerència Territorial Catalunya Central',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Sant Fruitós De Bages',\n", + " 'LocationState': 'Barcelona',\n", + " 'LocationZip': '08272',\n", + " 'LocationCountry': 'Spain'},\n", + " {'LocationFacility': 'Centre de Salut Isabel Roig-Casernes de Sant Andreu',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Barcelona',\n", + " 'LocationZip': '08030',\n", + " 'LocationCountry': 'Spain'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000000998',\n", + " 'InterventionMeshTerm': 'Antiviral Agents'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000890',\n", + " 'InterventionAncestorTerm': 'Anti-Infective Agents'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M4562',\n", + " 'InterventionBrowseLeafName': 'Chloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M151035',\n", + " 'InterventionBrowseLeafName': 'Chloroquine diphosphate',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M8523',\n", + " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2895',\n", + " 'InterventionBrowseLeafName': 'Antiviral Agents',\n", + " 'InterventionBrowseLeafAsFound': 'Antiviral',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M459',\n", + " 'InterventionBrowseLeafName': 'Cobicistat',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M423',\n", + " 'InterventionBrowseLeafName': 'Darunavir',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2795',\n", + " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", + " {'InterventionBrowseBranchAbbrev': 'Infl',\n", + " 'InterventionBrowseBranchName': 'Anti-Inflammatory Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'Analg',\n", + " 'InterventionBrowseBranchName': 'Analgesics'}]}}}}},\n", + " {'Rank': 45,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04328129',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '2020-009'},\n", + " 'Organization': {'OrgFullName': 'Institut Pasteur',\n", + " 'OrgClass': 'INDUSTRY'},\n", + " 'BriefTitle': 'Household Transmission Investigation Study for COVID-19 in French Guiana',\n", + " 'OfficialTitle': 'Household Transmission Investigation Study for Coronavirus Disease 2019 (COVID-19) in French Guiana',\n", + " 'Acronym': 'EPI-COVID-19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 23, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 23, 2022',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'March 23, 2022',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 23, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 27, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 31, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 27, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 31, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Institut Pasteur',\n", + " 'LeadSponsorClass': 'INDUSTRY'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Institut Pasteur de la Guyane',\n", + " 'CollaboratorClass': 'UNKNOWN'},\n", + " {'CollaboratorName': 'Centre Hospitalier Andrée Rosemon de Cayenne',\n", + " 'CollaboratorClass': 'UNKNOWN'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'This study is a interventional study that present minimal risks and constraints to evaluate the presence of novel coronavirus (SARS-CoV-2) or antibodies among individuals living in households where there is a confirmed coronavirus case in order to provide useful information on the proportion of symptomatic forms and the extent of the virus transmission in a territory such as French Guiana.',\n", + " 'DetailedDescription': 'This study is a interventional study that present minimal risks and constraints to evaluate the presence of novel coronavirus (SARS-CoV-2) or antibodies among individuals living in households where there is a confirmed coronavirus case in order to provide useful information on the proportion of symptomatic forms and the extent of the virus transmission in a territory such as French Guiana.\\n\\nSubjects will be assessed (questionnaires and sampling) in their homes. Subjects will be asked to attend study visits at days 0, 7, 14 and 28.\\n\\nThe primary objective of the study is to evaluate the rate of intra-household secondary transmission of the virus.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus Infections',\n", + " 'Severe Acute Respiratory Syndrome',\n", + " 'SARS-CoV Infection']},\n", + " 'KeywordList': {'Keyword': ['SARS-CoV-2',\n", + " 'COVID-19',\n", + " 'Serology',\n", + " 'French Guiana']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Not Applicable']},\n", + " 'DesignInfo': {'DesignAllocation': 'Non-Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Screening',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '450',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Primary case',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Subject with laboratory-confirmed coronavirus SARS-CoV-2 infection by polymerase chain reaction (PCR)',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Procedure: Human biological samples']}},\n", + " {'ArmGroupLabel': 'Family contact',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Subject who lived in the household of the primary case while the primary case was symptomatic',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Procedure: Human biological samples']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Procedure',\n", + " 'InterventionName': 'Human biological samples',\n", + " 'InterventionDescription': 'Blood sample\\nNasopharyngeal swab.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Family contact',\n", + " 'Primary case']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Evaluation of the extent of the virus transmission within households',\n", + " 'PrimaryOutcomeDescription': 'The extent of the virus transmission within households will be assessed by evaluating the rate of intra-household secondary transmission of the virus',\n", + " 'PrimaryOutcomeTimeFrame': '2 years'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Characterization of the secondary cases',\n", + " 'SecondaryOutcomeDescription': 'The characterization of the secondary cases will be assessed by evaluating the proportion of asymptomatic forms within the household',\n", + " 'SecondaryOutcomeTimeFrame': '2 years'},\n", + " {'SecondaryOutcomeMeasure': 'Characterization of the secondary cases',\n", + " 'SecondaryOutcomeDescription': 'The characterization of the secondary cases will be assessed by characterizing the risk factors for coronavirus infection.',\n", + " 'SecondaryOutcomeTimeFrame': '2 years'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nPrimary case: laboratory-confirmed coronavirus SARS-CoV-2 infection by polymerase chain reaction (PCR), or Family contact: person who lived in the same household as the primary case of COVID-19 when the primary case was symptomatic. A household is defined as a group of people (2 or more) living in the same accommodation (excluding residential institutions such as boarding schools, dormitories, hostels, prisons, other communities hosting grouped people)\\nAffiliated or beneficiary of a social security system\\nInformed consent prior to initiation of any study procedures from subject (or legally authorized representative)\\nState of health compatible with a blood sample as defined in the protocol.\\n\\nExclusion Criteria:\\n\\nPregnant woman or breast feeding\\nInability to consent\\nPerson under guardianship or curatorship\\nKnown pathology or a health problem contraindicated with the collect of blood sample.',\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Claude Flamand, Phd',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+33 5 94 29 26 15',\n", + " 'CentralContactEMail': 'cflamand@pasteur-cayenne.fr'},\n", + " {'CentralContactName': 'Dominique Rousset, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+33 5 94 29 26 09',\n", + " 'CentralContactEMail': 'drousset@pasteur-cayenne.fr'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Claude Flamand, PhD',\n", + " 'OverallOfficialAffiliation': 'Institut Pasteur de la Guyane, Head of Epidemiology Unit',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Centre Hospitalier Andrée Rosemon',\n", + " 'LocationStatus': 'Enrolling by invitation',\n", + " 'LocationCity': 'Cayenne',\n", + " 'LocationCountry': 'French Guiana'},\n", + " {'LocationFacility': 'Institut Pasteur de la Guyane',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Cayenne',\n", + " 'LocationCountry': 'French Guiana',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Claude Flamand, PhD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+33 5 94 29 26 15',\n", + " 'LocationContactEMail': 'cflamand@pasteur-cayenne.fr'},\n", + " {'LocationContactName': 'Dominique Rousset, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+33 5 94 29 26 09',\n", + " 'LocationContactEMail': 'drousset@pasteur-cayenne.fr'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", + " 'ConditionMeshTerm': 'Infection'},\n", + " {'ConditionMeshId': 'D000003141',\n", + " 'ConditionMeshTerm': 'Communicable Diseases'},\n", + " {'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", + " {'ConditionMeshId': 'D000045169',\n", + " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafAsFound': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M14938',\n", + " 'ConditionBrowseLeafName': 'Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafAsFound': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 46,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04326036',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'GARM COVID19'},\n", + " 'Organization': {'OrgFullName': 'Healeon Medical Inc',\n", + " 'OrgClass': 'INDUSTRY'},\n", + " 'BriefTitle': 'Use of cSVF Via IV Deployment for Residual Lung Damage After Symptomatic COVID-19 Infection',\n", + " 'OfficialTitle': 'Use of cSVF For Residual Lung Damage (COPD/Fibrotic Lung Disease After Symptomatic COVID-19 Infection For Residual Pulmonary Injury or Post-Adult Respiratory Distress Syndrome Following Viral (SARS-Co-2) Infection',\n", + " 'Acronym': 'GARM-COVID19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Enrolling by invitation',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 25, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'November 1, 2021',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2021',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 26, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 26, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 30, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 30, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 31, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Healeon Medical Inc',\n", + " 'LeadSponsorClass': 'INDUSTRY'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Robert W. Alexander, MD',\n", + " 'CollaboratorClass': 'UNKNOWN'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'Yes',\n", + " 'IsFDARegulatedDevice': 'No',\n", + " 'IsUSExport': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure and functionality. A short review includes:\\n\\nEarly December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office.\\nJanuary 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern.\\nFebruary 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus.\\nFebruary 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19.\\nFebruary 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives..\\nMarch 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland.\\nMarch 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control.\" March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up..\\n\\nMarch 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New York-New Jersey, Washington, and California.\\n\\nImmediate attention is turned to testing, diagnosis, epidemiological containment, clinical trials for drug testing started, and work on a long-term vaccine started.\\n\\nThe recovering patients are presenting with mild to severe lung impairment as a result of the viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary function appears to be a permanent finding as a direct result of the interstitial lung damage and inflammatory changes that accompanied.\\n\\nThis Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascular fraction (cSVF) deployed intravenously to examine the anti-inflammatory and structural potential to improve the residual, permanent damaged alveolar tissues of the lungs.',\n", + " 'DetailedDescription': 'COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure and functionality. A short review includes:\\n\\nEarly December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office.\\nJanuary 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern.\\nFebruary 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus.\\nFebruary 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19.\\nFebruary 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives..\\nMarch 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland.\\nMarch 11th, 2020 - As of this date, Over 60% of all COVID-19 deaths in the U.S. can be traced to that single nursing home in Seattle.\\nMarch 11th, 2020 - Dr. Fauci from the National Institutes of Health (NIH) states, \"If you count all the estimated cases of people who may have it but haven\\'t been diagnosed yet, the mortality rate is probably closer to 1%,\" he said, \"which means it\\'s 10 times more lethal than the seasonal flu.\"\\nMarch 21st, 2020 - The U.S. has 24,105 active cases, 301 deaths, and 171 patients declared recovered, a number which has since massively increased within the United States and Globally.\\nMarch 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control.\" March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up..\\n\\nMarch 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New York-New Jersey, Washington, and California\\n\\nImmediate attention is turned to testing, diagnosis, epidemiological containment, clinical trials for drug testing started, and work on a long-term vaccine started.\\n\\nThe recovering patients are presenting with mild to severe lung impairment as a result of the viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary function appears to be a permanent finding as a direct result of the interstitial lung damage and inflammatory changes that accompanied.\\n\\nThis Phase 0, first-in-kind for humans, is use of autologous, cSVF deployed intravenously to examine the anti-inflammatory and structural potential to improve the residual damaged tissues.\\n\\nPrevious utilization of cSVF remains in Clinical Trials at this moment for uses in Chronic Obstructive Pulmonary Disease (COPD) and Idiopathic Pulmonary Fibrotic Lung disorders, showing encouraging safety profile and clinical efficacy. It is the intention of this study, driven by the ongoing pandemic as a direct causative etiology for permanent lung damage within the oxygen/carbon dioxide exchange resulting the the direct alveolar disruption and scarring reaction.\\n\\nThe inflammatory mediation, autoimmune modulatory capabilities, and revascularization potentials of the cSVF is becoming well recognized and documented in peer-reviewed literature and in scientific studies.\\n\\nDue to the urgency presented from the ongoing CoronaVirus pandemic, many patients that survive experience demonstrate direct pulmonary damage residua. There is available a relative new technology offered by Fluidda Inc in European Union (EU) known as \"Functional Respiratory Imaging (FRI) and examines pulmonary function and vascular capabilities in damaged lung tissues. This study examines the lung baseline (post-infection), and at 3 and 6 month intervals post-cSVF treatment to examine the functional airway configuration and efficiency at those intervals.\\n\\nSporadic reports of use of stem cells or stem/stromal cells have revealed some positive clinical outcomes, although not within a traditional randomized trial format at this point in time. This study proposed in the specific situation of permanent residual dysfunction created by the SARS-Co2 (Coronavirus) infection is felt to warrant a pilot study using the cSVF that is in current Clinical Trials, which, at this point presents a very good safety profile with the absence of adverse event (AE) or severe adverse events (SAE) as yet reported by the trials.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Pulmonary Alveolar Proteinosis',\n", + " 'COPD',\n", + " 'Idiopathic Pulmonary Fibrosis',\n", + " 'Viral Pneumonia',\n", + " 'Coronavirus Infection',\n", + " 'Interstitial Lung Disease']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Early Phase 1']},\n", + " 'DesignInfo': {'DesignAllocation': 'Non-Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '10',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Lipoaspiration',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Closed sterile, disposable microcannula of small volume adipose tissue, including the stromal vascular fraction (SVF) (cells and stromal tissue',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Procedure: Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF)']}},\n", + " {'ArmGroupLabel': 'Isolation & Concentration of cSVF',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Isolation & Concentration of cellular stromal vascular fraction (cSVF) using Healeon Centricyte 1000 Centrifuge, incubator and shaker plate with sterile Liberase enzyme (Roche Medical) per manufacturer protocols',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Device: Centricyte 1000',\n", + " 'Drug: Liberase Enzyme (Roche)']}},\n", + " {'ArmGroupLabel': 'Delivery cSVF via Intravenous',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'cSVF from Arm 2 is suspended in a 250 cc of sterile Normal Saline IV solution and deployed though 150 micron in-line filtration and intravenous route over 30-60 minute timeframe',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution',\n", + " 'Drug: Sterile Normal Saline for Intravenous Use']}},\n", + " {'ArmGroupLabel': 'Liberase TM',\n", + " 'ArmGroupType': 'Other',\n", + " 'ArmGroupDescription': 'Use of sterile Liberase TM enzyme to allow cSVF separation and isolation',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Device: Centricyte 1000',\n", + " 'Drug: Liberase Enzyme (Roche)']}},\n", + " {'ArmGroupLabel': 'Sterile Normal Saline',\n", + " 'ArmGroupType': 'Other',\n", + " 'ArmGroupDescription': '250 cc of sterile Normal Saline for Intravenous with sterile 150 micron in-line filtration for suspension of the concentrated cSVF and deployment IV',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution',\n", + " 'Drug: Sterile Normal Saline for Intravenous Use']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Procedure',\n", + " 'InterventionName': 'Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF)',\n", + " 'InterventionDescription': 'Use of Disposable Microcannula Closed System (Tulip Med, 2.2 mm) Harvest of Autologous Adipose Stroma and Stem/Stromal Cell Content',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Lipoaspiration']}},\n", + " {'InterventionType': 'Device',\n", + " 'InterventionName': 'Centricyte 1000',\n", + " 'InterventionDescription': 'Centricyte 1000 (Healeon Medical) Digestive (sterile Roche Liberase TM) Isolation/Concentration Protocol, Rinsing/Neutralization, and Pelletize the cSVF For Deployment Via Sterile Saline IV fluid Standard Protocol',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Isolation & Concentration of cSVF',\n", + " 'Liberase TM']}},\n", + " {'InterventionType': 'Procedure',\n", + " 'InterventionName': 'IV Deployment Of cSVF In Sterile Normal Saline IV Solution',\n", + " 'InterventionDescription': 'Sterile Normal Saline Suspension cSVF in 250cc for Intravenous Delivery Including Use of 150 micron in-line filtration',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Delivery cSVF via Intravenous',\n", + " 'Sterile Normal Saline']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Liberase Enzyme (Roche)',\n", + " 'InterventionDescription': 'Sterile Collagenase Blend to separate cSVF from the AD-SVF',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Isolation & Concentration of cSVF',\n", + " 'Liberase TM']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Proteolytic Emzyme']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Sterile Normal Saline for Intravenous Use',\n", + " 'InterventionDescription': 'Sterile Normal Saline IV solution to provide suspension of cSVF in 250 cc via standard IV line, including sterile 150 micron in-line standard filter',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Delivery cSVF via Intravenous',\n", + " 'Sterile Normal Saline']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Suspensory Fluid for cSVF']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Incidence of Treatment-Emergent Adverse Events',\n", + " 'PrimaryOutcomeDescription': 'Reporting of Adverse Events or Severe Adverse Events Assessed by CTCAE v4.0',\n", + " 'PrimaryOutcomeTimeFrame': '1 month'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Pulmonary Function Analysis',\n", + " 'SecondaryOutcomeDescription': 'High Resolution Computerized Tomography of Lung (HRCT Lung) for Fluidda Analysis comparative at baseline and 3 and 6 months post-treatment comparative analytics',\n", + " 'SecondaryOutcomeTimeFrame': 'baseline, 3 Month, 6 months'},\n", + " {'SecondaryOutcomeMeasure': 'Digital Oximetry',\n", + " 'SecondaryOutcomeDescription': 'Finger Pulse Oximetry taken before and after 6 minute walk on level ground, compare desaturation tendency',\n", + " 'SecondaryOutcomeTimeFrame': '3 months, 6 months'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nMust have confirmed and documented Coronaviral (COVID-19) infection history with involvement of lung tissues\\nMust be clear of any viral shed residual confirmed by negative viral testing protocol accepted by the Center for Disease Control (CDC) and/or the FDA\\nMust have discharge confirmation from infectious disease managing Provider declaring freedom of viral load or active infection\\nMust have a written Medical History of Physical and discharge summary (if hospitalized) from appropriate Center or Licensed Medical Provider\\nMust agree to provide a HRCT LUNG study done at baseline (before), 3 months and 6 months\\nMust be able to provide full Informed Consent (ICF)\\n\\nExclusion Criteria:\\n\\nActive or positive testing of COVID-19 With Clinical Report and Discharge Summary from Hospital or Treatment Facility\\nLung disorder without prior confirmation by approved test protocol of history of COVID-19\\nPatient health or condition deemed dangerous or inappropriate for transport, exceeding acceptable stress for transport or care needed to achieve access to the clinical facility, at the discretion of the Providers\\nExpected lifespan of < 6 months\\nSerious of life threatening co-morbidities, that in the opinion of the investigators, may compromise the safety or compliance with the study guidelines and tracking',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '90 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Robert W Alexander, MD',\n", + " 'OverallOfficialAffiliation': 'Global Alliance Regenerative Medicine',\n", + " 'OverallOfficialRole': 'Study Chair'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Robert W. Alexander, MD, FICS, LLC',\n", + " 'LocationCity': 'Stevensville',\n", + " 'LocationState': 'Montana',\n", + " 'LocationZip': '59870',\n", + " 'LocationCountry': 'United States'}]}},\n", + " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Alexander, Robert W., Overview of Cellular Stromal Vascular Fraction (cSVF) & Biocellular Uses of Stem/Stromal Cells & Matrix (tSVF + HD-PRP) in Regenerative Medicine, Aesthetic Medicine and Plastic Surgery. 2019, S1003, DOI: 10.24966/SRDT-2060/S1003.'},\n", + " {'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Alexander, Robert W., Understanding Adipose-Derived Stromal Vascular Fraction (AD-SVF) Cell Biology and Use on the Basis of Cellular, Chemical, Structural and Paracrine Components. (2012), J of Prolotherapy, 4: 855-869.'},\n", + " {'ReferencePMID': '32105632',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 Feb 24. pii: S2213-2600(20)30079-5. doi: 10.1016/S2213-2600(20)30079-5. [Epub ahead of print] Erratum in: Lancet Respir Med. 2020 Feb 28;:.'},\n", + " {'ReferencePMID': '32064853',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Novel Coronavirus Pneumonia Emergency Response Epidemiology Team. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 17;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. [Epub ahead of print] Chinese.'},\n", + " {'ReferencePMID': '32127666',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Li G, De Clercq E. Therapeutic options for the 2019 novel coronavirus (2019-nCoV). Nat Rev Drug Discov. 2020 Mar;19(3):149-150. doi: 10.1038/d41573-020-00016-0.'},\n", + " {'ReferencePMID': '22291007',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Wu K, Peng G, Wilken M, Geraghty RJ, Li F. Mechanisms of host receptor adaptation by severe acute respiratory syndrome coronavirus. J Biol Chem. 2012 Mar 16;287(12):8904-11. doi: 10.1074/jbc.M111.325803. Epub 2012 Jan 30.'},\n", + " {'ReferencePMID': '32015507',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3.'},\n", + " {'ReferencePMID': '15141376',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Ding Y, He L, Zhang Q, Huang Z, Che X, Hou J, Wang H, Shen H, Qiu L, Li Z, Geng J, Cai J, Han H, Li X, Kang W, Weng D, Liang P, Jiang S. Organ distribution of severe acute respiratory syndrome (SARS) associated coronavirus (SARS-CoV) in SARS patients: implications for pathogenesis and virus transmission pathways. J Pathol. 2004 Jun;203(2):622-30.'},\n", + " {'ReferencePMID': '22496216',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Kawase M, Shirato K, van der Hoek L, Taguchi F, Matsuyama S. Simultaneous treatment of human bronchial epithelial cells with serine and cysteine protease inhibitors prevents severe acute respiratory syndrome coronavirus entry. J Virol. 2012 Jun;86(12):6537-45. doi: 10.1128/JVI.00094-12. Epub 2012 Apr 11.'},\n", + " {'ReferencePMID': '25945397',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Zhang R, Pan Y, Fanelli V, Wu S, Luo AA, Islam D, Han B, Mao P, Ghazarian M, Zeng W, Spieth PM, Wang D, Khang J, Mo H, Liu X, Uhlig S, Liu M, Laffey J, Slutsky AS, Li Y, Zhang H. Mechanical Stress and the Induction of Lung Fibrosis via the Midkine Signaling Pathway. Am J Respir Crit Care Med. 2015 Aug 1;192(3):315-23. doi: 10.1164/rccm.201412-2326OC.'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No',\n", + " 'IPDSharingDescription': 'In discussion phase'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000019999',\n", + " 'InterventionMeshTerm': 'Pharmaceutical Solutions'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M20444',\n", + " 'InterventionBrowseLeafName': 'Pharmaceutical Solutions',\n", + " 'InterventionBrowseLeafAsFound': 'Solution',\n", + " 'InterventionBrowseLeafRelevance': 'high'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", + " 'ConditionMeshTerm': 'Infection'},\n", + " {'ConditionMeshId': 'D000003141',\n", + " 'ConditionMeshTerm': 'Communicable Diseases'},\n", + " {'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", + " {'ConditionMeshId': 'D000045169',\n", + " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'},\n", + " {'ConditionMeshId': 'D000011024',\n", + " 'ConditionMeshTerm': 'Pneumonia, Viral'},\n", + " {'ConditionMeshId': 'D000008171',\n", + " 'ConditionMeshTerm': 'Lung Diseases'},\n", + " {'ConditionMeshId': 'D000011658',\n", + " 'ConditionMeshTerm': 'Pulmonary Fibrosis'},\n", + " {'ConditionMeshId': 'D000054990',\n", + " 'ConditionMeshTerm': 'Idiopathic Pulmonary Fibrosis'},\n", + " {'ConditionMeshId': 'D000017563',\n", + " 'ConditionMeshTerm': 'Lung Diseases, Interstitial'},\n", + " {'ConditionMeshId': 'D000011649',\n", + " 'ConditionMeshTerm': 'Pulmonary Alveolar Proteinosis'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000011014',\n", + " 'ConditionAncestorTerm': 'Pneumonia'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", + " {'ConditionAncestorId': 'D000054988',\n", + " 'ConditionAncestorTerm': 'Idiopathic Interstitial Pneumonias'},\n", + " {'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafAsFound': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M14938',\n", + " 'ConditionBrowseLeafName': 'Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafAsFound': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M9751',\n", + " 'ConditionBrowseLeafName': 'Lung Diseases',\n", + " 'ConditionBrowseLeafAsFound': 'Lung Disease',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M13547',\n", + " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Newborn',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13548',\n", + " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Adult',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M12487',\n", + " 'ConditionBrowseLeafName': 'Pneumonia',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M26731',\n", + " 'ConditionBrowseLeafName': 'Acute Lung Injury',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M18396',\n", + " 'ConditionBrowseLeafName': 'Lung Diseases, Interstitial',\n", + " 'ConditionBrowseLeafAsFound': 'Interstitial Lung Disease',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M7068',\n", + " 'ConditionBrowseLeafName': 'Fibrosis',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M12497',\n", + " 'ConditionBrowseLeafName': 'Pneumonia, Viral',\n", + " 'ConditionBrowseLeafAsFound': 'Viral Pneumonia',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M26730',\n", + " 'ConditionBrowseLeafName': 'Lung Injury',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13095',\n", + " 'ConditionBrowseLeafName': 'Pulmonary Fibrosis',\n", + " 'ConditionBrowseLeafAsFound': 'Pulmonary Fibrosis',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M26576',\n", + " 'ConditionBrowseLeafName': 'Idiopathic Pulmonary Fibrosis',\n", + " 'ConditionBrowseLeafAsFound': 'Idiopathic Pulmonary Fibrosis',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M13086',\n", + " 'ConditionBrowseLeafName': 'Pulmonary Alveolar Proteinosis',\n", + " 'ConditionBrowseLeafAsFound': 'Pulmonary Alveolar Proteinosis',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M26574',\n", + " 'ConditionBrowseLeafName': 'Idiopathic Interstitial Pneumonias',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'T4953',\n", + " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Infant',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T191',\n", + " 'ConditionBrowseLeafName': 'Acute Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T3014',\n", + " 'ConditionBrowseLeafName': 'Idiopathic Pulmonary Fibrosis',\n", + " 'ConditionBrowseLeafAsFound': 'Idiopathic Pulmonary Fibrosis',\n", + " 'ConditionBrowseLeafRelevance': 'high'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC16',\n", + " 'ConditionBrowseBranchName': 'Diseases and Abnormalities at or Before Birth'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC26',\n", + " 'ConditionBrowseBranchName': 'Wounds and Injuries'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 47,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04320732',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'REK-124170'},\n", + " 'Organization': {'OrgFullName': 'Oslo University Hospital',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Risk Factors for Community- and Workplace Transmission of COVID-19',\n", + " 'OfficialTitle': 'Risk Factors for Community- and Workplace Transmission of COVID-19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 27, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 27, 2022',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'March 20, 2030',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 23, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 23, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 25, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 27, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 31, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Arne Vasli Lund Søraas',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Principal Investigator, MD, PhD',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Oslo University Hospital'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Oslo University Hospital',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Age Labs AS',\n", + " 'CollaboratorClass': 'UNKNOWN'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'The project is an epidemiological observational study based on an electronic questionnaire on risk factors for COVID-19 in the community and healthcare setting.',\n", + " 'DetailedDescription': 'Summary The data collected will identify real-life risk factors for getting the COVID-19 diagnosis.\\n\\nThe Oslo University Hospital/University of Oslo web-based solution \"nettskjema\" will be used to collect data and consent forms.\\n\\nThe impact of knowing the risk factors for COVID-19 is tremendous because it can enable governments to conduct more targeted public health measurements than today to reduce the spread of the virus.\\n\\nDetailed description Research into an ongoing COVID-19 outbreak is difficult because patients are isolated, and supplies of personal protective equipment (PPE) supplies are limited. The risk of transmission to study personal is non-negligible even when PPE is available.\\n\\nA study design based on an electronic questionnaire and consent from delivered from the Oslo University Hospital/University of Oslo, GDPR (General Data Protection Regulation) compliant \"TSD\" service has therefore been chosen.\\n\\nThe study will be a case-control study based on a combined electronic consent form and questionnaire that the participants will fill in using a smartphone and electronic identification.\\n\\nThe groups that will be included are:\\n\\nHospitalized and non-hospitalized patients/persons with COVID-19 at all stages of the disease and after the disease\\nHospitalized patients without COVID-19\\nHealthcare personal or other groups with an increased risk of COVID-19\\nHealthy volunteers\\n\\nParticipants may be followed with repeated questionnaires prospectively.\\n\\nBiological samples Biological samples may hold crucial information about the susceptibility to COVID-19 and for susceptibility to the progression of the disease. It is within the scope of the study to analyze such samples from a limited number of participants which will be asked to provide such samples or hospitalized patients that have surplus material. The material will be analyzed with non-genetic methods most suitable to provide such information.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Case-Control']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'BioSpec': {'BioSpecRetention': 'Samples With DNA',\n", + " 'BioSpecDescription': 'Blood and upper repiratory samples will be collected from some participants.'},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '50000',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Individuals with COVID-19 infection',\n", + " 'ArmGroupDescription': 'Confirmed by routine laboratory diagnosis. All types of COVID-19 disease from asymptomatic carriers to hospitalized patients can be included.\\n\\nOnly subjects >18 years old will be included in the study.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Behavioral: Observation of behavior and COVID-19 infection will be conducted.']}},\n", + " {'ArmGroupLabel': 'Individuals tested for COVID-19 infection with negative test',\n", + " 'ArmGroupDescription': 'Confirmed by routine laboratory diagnosis',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Behavioral: Observation of behavior and COVID-19 infection will be conducted.']}},\n", + " {'ArmGroupLabel': 'Healthy individuals',\n", + " 'ArmGroupDescription': 'Recruitet from the general population',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Behavioral: Observation of behavior and COVID-19 infection will be conducted.']}},\n", + " {'ArmGroupLabel': 'Risk groups for COVID-19 exposure',\n", + " 'ArmGroupDescription': 'Including, but not limited to healthcare workers.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Behavioral: Observation of behavior and COVID-19 infection will be conducted.']}},\n", + " {'ArmGroupLabel': 'Patients admitted to hospital',\n", + " 'ArmGroupDescription': 'Without COVID-19 infection.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Behavioral: Observation of behavior and COVID-19 infection will be conducted.']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Behavioral',\n", + " 'InterventionName': 'Observation of behavior and COVID-19 infection will be conducted.',\n", + " 'InterventionDescription': 'No intervention, only prospective observation of behavior will be conducted by a questionnaire.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Healthy individuals',\n", + " 'Individuals tested for COVID-19 infection with negative test',\n", + " 'Individuals with COVID-19 infection',\n", + " 'Patients admitted to hospital',\n", + " 'Risk groups for COVID-19 exposure']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Rate of COVID-19 infection',\n", + " 'PrimaryOutcomeDescription': 'Diagnosed with serology or direct viral detection',\n", + " 'PrimaryOutcomeTimeFrame': '1 year'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nNorwegian adult\\n\\nExclusion Criteria:\\n\\nUnable to consent',\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'The study will be a combined retrospective and prospective case-control study based on a combined electronic consent form and questionnaire that the study groups will fill in using a smartphone and electronic identification.\\n\\nThe groups that will be included are:\\n\\nHospitalized and non-hospitalized patients/persons with COVID-19 at all stages of the disease and after the disease\\nHospitalized patients without COVID-19\\nHealthcare personal or other groups with an increased risk of COVID-19\\nHealthy volunteers\\n\\nProbability sampling will be conducted, but not solely.',\n", + " 'SamplingMethod': 'Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Arne Søraas, MD, PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+4790652904',\n", + " 'CentralContactEMail': 'Arne.Vasli.Lund.Soraas@rr-research.no'},\n", + " {'CentralContactName': 'John Arne Dahl, PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactEMail': 'j.a.dahl@medisin.uio.no'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Oslo University Hospital',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Oslo',\n", + " 'LocationZip': '0424',\n", + " 'LocationCountry': 'Norway',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Arne Søraas, PhD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+4790652904',\n", + " 'LocationContactEMail': 'Arne.Vasli.Lund.Soraas@rr-research.no'},\n", + " {'LocationContactName': 'John A Dahl, PhD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+4741456596',\n", + " 'LocationContactEMail': 'j.a.dahl@medisin.uio.no'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No',\n", + " 'IPDSharingDescription': 'European GDPR regulations severely limits IPD, but the study will share data to the largest extent possible within GDPR.'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 48,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04323332',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '2020XLA015-1'},\n", + " 'Organization': {'OrgFullName': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Traditional Chinese Medicine for Severe COVID-19',\n", + " 'OfficialTitle': 'A Retrospective Cohort Study to Evaluate the Efficacy and Safety of Traditional Chinese Medicine as an Adjuvant Treatment for Patients With Severe COVID-19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'April 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 8, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 24, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 26, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 24, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 26, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Li Hao',\n", + " 'ResponsiblePartyInvestigatorTitle': 'professor',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': \"In December 2019, a new type of pneumonia, COVID-2019 outbroke in Wuhan ,China, and currently the infected has been reported in more than at least 75 countries.\\n\\nPatients with severe COVID-19 have rapid disease progression and high mortality rate. This may attribute to the excessive immune response caused by cytokine storm. Strategies based on anti-virus drugs and treatments against symptoms have now been employed. However, these managements can't effectively treat the lethal lung injury and uncontrolled immune responses, especially in the elderly with severe COVID-19. Traditional Chinese Medicine (TCM), which treats the disease from anther perspective, has achieved satisfactory results. National Health Commission of China released a series of policies to enhance the administration of TCM prescriptions.\\n\\nThis study is aimed to evaluate the efficacy and safety of Traditional Chinese Medicine as an adjuvant treatment for severe COVID-19.\"},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", + " 'KeywordList': {'Keyword': ['COVID-19',\n", + " 'Traditional Chinese Medicine',\n", + " 'Pneumonia',\n", + " 'Coronavirus']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 3']},\n", + " 'DesignInfo': {'DesignAllocation': 'Non-Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '50',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Traditional Chinese Medicine',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'TCM prescription and conventional treatments',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Traditional Chinese Medicine Prescription']}},\n", + " {'ArmGroupLabel': 'Control',\n", + " 'ArmGroupType': 'No Intervention',\n", + " 'ArmGroupDescription': 'conventional treatments'}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Traditional Chinese Medicine Prescription',\n", + " 'InterventionDescription': 'Traditional Chinese Medicine Prescriptions have been recommended according to the Guidelines for the treatment of COVID-19 issued by National Health Commission of the PRC.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Traditional Chinese Medicine']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Length of hospital stay (days)',\n", + " 'PrimaryOutcomeTimeFrame': 'First treatment date up to 3 months'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Duration (days) of supplemental oxygenation',\n", + " 'SecondaryOutcomeTimeFrame': 'First treatment date up to 3 months'},\n", + " {'SecondaryOutcomeMeasure': 'CT imaging changes',\n", + " 'SecondaryOutcomeTimeFrame': 'First treatment date up to 3 months'},\n", + " {'SecondaryOutcomeMeasure': 'Mortality rate',\n", + " 'SecondaryOutcomeTimeFrame': 'First treatment date up to 3 months'},\n", + " {'SecondaryOutcomeMeasure': 'Time to Clinical Improvement (TTCI)',\n", + " 'SecondaryOutcomeTimeFrame': 'First treatment date up to 3 months'},\n", + " {'SecondaryOutcomeMeasure': 'The pneumonia severity index scores',\n", + " 'SecondaryOutcomeDescription': 'The pneumonia severity index is a clinical tool helping in the risk stratification of patients with community-acquired pneumonia. It ranges from 0-395 scores and a higher score indicates higher death risk.',\n", + " 'SecondaryOutcomeTimeFrame': 'First treatment date up to 3 months'},\n", + " {'SecondaryOutcomeMeasure': 'Time to COVID-19 nucleic acid testing negativity in throat swab',\n", + " 'SecondaryOutcomeTimeFrame': 'First treatment date up to 3 months'},\n", + " {'SecondaryOutcomeMeasure': 'Blood immune cell count',\n", + " 'SecondaryOutcomeDescription': 'Changes in leukocyte, neutral, lymphocyte counts and absolute lymphocyte count from baseline',\n", + " 'SecondaryOutcomeTimeFrame': 'Baseline, 7 and/ or 14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Serum inflammatory markers',\n", + " 'SecondaryOutcomeDescription': 'Changes in blood interleukin-6, c-reactive protein,SS-A/Ro antibodies and serum ferritin from baseline.',\n", + " 'SecondaryOutcomeTimeFrame': 'Baseline, 7 and/ or 14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Erythrocyte sedimentation rate',\n", + " 'SecondaryOutcomeDescription': 'Changes in erythrocyte sedimentation rate from baseline.',\n", + " 'SecondaryOutcomeTimeFrame': 'Baseline, 7 and/ or 14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Platelet and D-dimer changes',\n", + " 'SecondaryOutcomeDescription': 'Changes in platelets and D-dimers from baseline.',\n", + " 'SecondaryOutcomeTimeFrame': 'Baseline, 7 and/ or 14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Creatinine changes',\n", + " 'SecondaryOutcomeDescription': 'Changes in serum creatinine from baseline.',\n", + " 'SecondaryOutcomeTimeFrame': 'Baseline, 7 and/ or 14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Muscle enzymes changes',\n", + " 'SecondaryOutcomeDescription': 'Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.',\n", + " 'SecondaryOutcomeTimeFrame': 'Baseline, 7 and/ or 14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Usage of antibiotics',\n", + " 'SecondaryOutcomeDescription': 'Dosing time and amounts of antibiotics；the categories of the antibiotics',\n", + " 'SecondaryOutcomeTimeFrame': 'First treatment date up to 3 months'},\n", + " {'SecondaryOutcomeMeasure': 'Usage of glucocorticoids',\n", + " 'SecondaryOutcomeDescription': 'Dosing time and amounts of glucocorticoids',\n", + " 'SecondaryOutcomeTimeFrame': 'First treatment date up to 3 months'},\n", + " {'SecondaryOutcomeMeasure': 'Frequency of adverse events',\n", + " 'SecondaryOutcomeTimeFrame': 'First treatment date up to 3 months'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Key Inclusion Criteria:\\n\\nPatients were diagnosed as severe COVID-19 according to the Coronavirus disease (COVID-19) Treatment Guidance (Six edition)\\nPatients received a combined treatment of TCM and conventional therapy, or only conventional therapy.\\n\\nKey Exclusion Criteria:\\n\\nAge ＞85 years\\nAfter cardiopulmonary resuscitation\\nPatients combined with other organ failure or conditions need ICU monitoring and treatment, such as severe liver disease, severe renal dysfunction, upper gastrointestinal hemorrhage, disseminated intravascular coagulation.\\nRespiratory failure and need mechanical ventilation',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MaximumAge': '85 Years',\n", + " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Hao Li, Professor',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+0086-133113382093',\n", + " 'CentralContactEMail': 'xyhplihao1965@126.com'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Hao Li, Professor',\n", + " 'OverallOfficialAffiliation': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences',\n", + " 'OverallOfficialRole': 'Study Chair'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Hao Li',\n", + " 'LocationCity': 'Beijing',\n", + " 'LocationState': 'Beijing',\n", + " 'LocationZip': '100091',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Hao Li, Prof.',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '01062835088',\n", + " 'LocationContactEMail': 'xyhplihao1965@126.com'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", + " 'IPDSharingInfoTypeList': {'IPDSharingInfoType': ['Study Protocol']}}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M12487',\n", + " 'ConditionBrowseLeafName': 'Pneumonia',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'}]}}}}},\n", + " {'Rank': 49,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04331665',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'U-DEPLOY: RUX-COVID'},\n", + " 'SecondaryIdInfoList': {'SecondaryIdInfo': [{'SecondaryId': '20-5315',\n", + " 'SecondaryIdType': 'Other Identifier',\n", + " 'SecondaryIdDomain': 'University Health Network'}]},\n", + " 'Organization': {'OrgFullName': 'University Health Network, Toronto',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Study of the Efficacy and Safety of Ruxolitinib to Treat COVID-19 Pneumonia',\n", + " 'OfficialTitle': 'A Single Arm Open-label Clinical Study to Investigate the Efficacy and Safety of Ruxolitinib for the Treatment of COVID-19 Pneumonia'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 6, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'October 30, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'January 31, 2021',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'April 1, 2020',\n", + " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 2, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'April 2, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", + " 'LastUpdatePostDateType': 'Estimate'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'University Health Network, Toronto',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'The purpose of this study is to determine the safety and efficacy of the drug ruxolitinib in people diagnosed with COVID-19 pneumonia by determining the number of people whose conditions worsen (requiring machines to help with breathing or needing supplemental oxygen) while receiving the drug.\\n\\nThis is a sub-study of the U-DEPLOY study: UHN Umbrella Trial Defining Coordinated Approach to Pandemic Trials of COVID-19 and Data Harmonization to Accelerate Discovery. U-DEPLOY helps to facilitate timely conduct of studies across the University Health Network and other centers.',\n", + " 'DetailedDescription': 'Multifocal interstitial pneumonia is the most common cause of deterioration in people with COVID-19. This is attributed to a severe reaction where releases too many cytokines (proteins that play an important role in immune responses) which rush into the lungs resulting in lung inflammation and fluid buildup. This can lead to damage to the lungs and leading to breathing problems. Ruxolitinib when given early in the disease, may prevent the overproduction of cytokines which, in turn, may prevent lung damage.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", + " 'Pneumonia']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Not Applicable']},\n", + " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '64',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Ruxolitinib to prevent COVID-19 pneumonia',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'All participants will receive ruxolitinib at at 10 mg, twice a day, for 14 days, followed by 5 mg, twice a day, for 2 days and 5 mg, once daily, for 1 day.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Ruxolitinib']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Ruxolitinib',\n", + " 'InterventionDescription': 'Ruxolitinib is an inhibitor of JAK1 and JAK2 (proteins important in cell signalling) approved for the treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Ruxolitinib to prevent COVID-19 pneumonia']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['JAKAVI']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Proportion of patients with COVID-19 pneumonia who become critically ill (defined as requiring mechanical ventilation and/or FiO2 of 60% of more)',\n", + " 'PrimaryOutcomeTimeFrame': '6 months'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'All cause mortality rate',\n", + " 'SecondaryOutcomeTimeFrame': '9 months'},\n", + " {'SecondaryOutcomeMeasure': 'Average duration of hospital stay',\n", + " 'SecondaryOutcomeTimeFrame': '9 months'},\n", + " {'SecondaryOutcomeMeasure': 'Number of occurrence of secondary infections',\n", + " 'SecondaryOutcomeTimeFrame': '9 months'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nCOVID-19 infection diagnosed by nasopharyngeal sample\\nNeed for supplemental oxygen to maintain oxygen saturation > 93%\\n12 years of age or older\\n\\nExclusion Criteria:\\n\\nNeutrophils < 1 x 10^9/L\\nPlatelets < 50 x 10^9/L\\nTotal bilirubin, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) > 5x upper limit of normal (ULN)\\nCreatinine clearance (CrCl) < 15 mL/minute\\nPregnant women\\nPatients requiring invasive mechanical ventilation. Patients requiring non-invasive mechanical ventilation (e.g., BiPAP) are eligible.\\nPatients who require supplemental oxygen support prior to COVID-19 infection.\\nPatients who are on ruxolitinib.',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '12 Years',\n", + " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Steven Chan, M.D.',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '416-946-4501',\n", + " 'CentralContactPhoneExt': '2253',\n", + " 'CentralContactEMail': 'steven.chan@uhn.ca'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Steven Chan, M.D.',\n", + " 'OverallOfficialAffiliation': 'Princess Margaret Cancer Centre',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Vikas Gupta, M.D.',\n", + " 'OverallOfficialAffiliation': 'Princess Margaret Cancer Centre',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Princess Margaret Cancer Centre',\n", + " 'LocationCity': 'Toronto',\n", + " 'LocationState': 'Ontario',\n", + " 'LocationZip': 'M5G 2M9',\n", + " 'LocationCountry': 'Canada',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Steven Chan, M.D.',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '416-946-4501',\n", + " 'LocationContactPhoneExt': '2253',\n", + " 'LocationContactEMail': 'steven.chan@uhn.ca'},\n", + " {'LocationContactName': 'Steven Chan, M.D.',\n", + " 'LocationContactRole': 'Principal Investigator'},\n", + " {'LocationContactName': 'Vikas Gupta, M.D.',\n", + " 'LocationContactRole': 'Principal Investigator'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000011014',\n", + " 'ConditionMeshTerm': 'Pneumonia'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000008171',\n", + " 'ConditionAncestorTerm': 'Lung Diseases'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M12487',\n", + " 'ConditionBrowseLeafName': 'Pneumonia',\n", + " 'ConditionBrowseLeafAsFound': 'Pneumonia',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M9751',\n", + " 'ConditionBrowseLeafName': 'Lung Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'}]}}}}},\n", + " {'Rank': 50,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04327505',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'K-2020-2611'},\n", + " 'SecondaryIdInfoList': {'SecondaryIdInfo': [{'SecondaryId': '2020-001349-37',\n", + " 'SecondaryIdType': 'EudraCT Number'},\n", + " {'SecondaryId': '4-1199/2020',\n", + " 'SecondaryIdType': 'Registry Identifier',\n", + " 'SecondaryIdDomain': 'Karolinska Institutet'}]},\n", + " 'Organization': {'OrgFullName': 'Karolinska University Hospital',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Safety and Efficacy of Hyperbaric Oxygen for ARDS in Patients With COVID-19',\n", + " 'OfficialTitle': 'Safety and Efficacy of Hyperbaric Oxygen for Improvement of Acute Respiratory Distress Syndrome in Adult Patients With COVID-19; a Randomized, Controlled, Open Label, Multicentre Clinical Trial',\n", + " 'Acronym': 'COVID-19-HBO'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 25, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'October 31, 2021',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2022',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 25, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 27, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 31, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 27, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 31, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Anders Kjellberg, MD',\n", + " 'ResponsiblePartyInvestigatorTitle': 'ICU Consultant, head of hyperbaric medicine',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Karolinska University Hospital'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Karolinska University Hospital',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Karolinska Institutet',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'University of California, San Diego',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'Blekinge County Council Hospital',\n", + " 'CollaboratorClass': 'OTHER'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'We hypothesize that hyperbaric oxygen (HBO) is safe for patients with COVID-19 and that HBO reduces the inflammatory reaction in Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19.\\n\\nAlso known as SARS-CoV-2, COVID-19 is declared a pandemic by World Health Organization (WHO). No specific treatment has been successful as of March 2020. Mortality rates in patients that develop ARDS is extremely high, 61.5-90%, almost double the mortality of ARDS of any cause. ARDS associated with COVID-19 is associated with pulmonary edema, rapidly progressing respiratory failure and fibrosis. The mechanism behind the rapid progress is still an enigma but theories have evolved around severe inflammatory involvement with a cytokine storm. Macrophage activation is involved in the early phase of ARDS and cytokine modulators have been tried in experimental settings without proven clinical benefits. HBO significantly reduces inflammatory cytokines and and oedema in other clinical settings. HBO has been used for almost a century, nowadays mainly used for its anti-inflammatory effects. Several randomized clinical trials show beneficial effects in variety of inflammatory diseases including diabetic foot ulcers and radiation injury. HBO is generally regarded as safe with very few adverse events and extensive experimental and clinical evidence suggest that HBO is a promising drug to ameliorate ARDS associated with COVID-19.',\n", + " 'DetailedDescription': 'COVID-19 also known as CoV-2 is declared a pandemic by WHO. More than 400 articles have been published and more than 160 clinical trials are registered but no specific treatment has been successful as of March 2020. Antiviral drugs Lopinavir-Ritonavir did not show any significant benefit compared to standard care in a Chinese randomized controlled study with 199 patients. Even though the overall mortality is low (0.2-7.2% the figures from critical care are fearsome. Mortality rates have been reported as high as 90% in patients developing Acute Respiratory Distress Syndrome (ARDS) in early reports from the Wuhan province and more recent reports has reported overall 28-d mortality rates of 61,5% in ICU patients with acute respiratory illness (ALI), almost double the mortality of ARDS of any cause. ARDS associated with COVID-19 differs from other described ARDS with rapidly progressing respiratory failure and fibrosis. The mechanism behind the rapid progress is still an enigma but theories have evolved around severe inflammatory involvement with a cytokine storm. Macrophage activation is involved in the early phase of ARDS and cytokine modulators such as Interleukin-6 (IL-6) inhibitors have been tried in experimental settings but no proper clinical trials have proven positive outcome. Hyperbaric oxygen (HBO) significantly reduces inflammatory cytokines including IL-1β, IL-6 and TNF-α through several transcription factors regulating inflammation, including Hypoxia Inducible Factor 1 (HIF-1), Nrf2 and NFkB. Hyperbaric oxygen (HBO) has been used for almost a century, initially for decompression sickness, but it nowadays mainly used for its anti-inflammatory effects. Several randomized clinical trials have been conducted on humans for a variety of inflammatory diseases including diabetic foot ulcers and radiation injury. HBO is generally regarded as safe with very few adverse events. The broad and physiological anti-inflammatory effects of HBO shown in extensive experimental and clinical evidence suggest that HBO is a promising drug to ameliorate ARDS associated with COVID-19.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)',\n", + " 'Cytokine Storm',\n", + " 'Infection Viral']},\n", + " 'KeywordList': {'Keyword': ['COVID-19',\n", + " 'Hyperbaric oxygen',\n", + " 'ARDS',\n", + " 'SARS-CoV-2']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 2', 'Phase 3']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignInterventionModelDescription': 'Randomized controlled, open label, multi-centre clinical trial',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '200',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Hyperbaric oxygen',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Hyperbaric oxygen 2.4 Bar for 30 minutes (with 5 min compression time and 5 minutes decompression time, according to local routines)',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hyperbaric oxygen']}},\n", + " {'ArmGroupLabel': 'Control',\n", + " 'ArmGroupType': 'No Intervention',\n", + " 'ArmGroupDescription': 'Standard care'}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Hyperbaric oxygen',\n", + " 'InterventionDescription': '2.4 Bar (2.4 ATA), 30 min (excluding compression/recompression)',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Hyperbaric oxygen']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['HBO']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'PO2/FiO2 (Safety)',\n", + " 'PrimaryOutcomeDescription': 'Oxygen requirement (Arterial bloodgas (pO2) and recorded Fraction inspired oxygen within 1 hour before and after HBO and 6 hours after each HBO treatment)',\n", + " 'PrimaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", + " {'PrimaryOutcomeMeasure': 'PO2/FiO2 (Efficacy)',\n", + " 'PrimaryOutcomeDescription': 'Oxygen requirement (Arterial bloodgas (pO2) and recorded Fraction inspired oxygen) At baseline, daily for 7 days, Day 14 and Day 30 (or last day in hospital if patient is discharged earlier, or at withdrawal) irrespective of HBO treatments.',\n", + " 'PrimaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", + " {'PrimaryOutcomeMeasure': 'Early Warning Score (NEWS) (Safety)',\n", + " 'PrimaryOutcomeDescription': 'NEWS within 1 hour before and after and 6h after HBO',\n", + " 'PrimaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", + " {'PrimaryOutcomeMeasure': 'Early Warning Score (NEWS) (Efficacy)',\n", + " 'PrimaryOutcomeDescription': 'Mean NEWS at baseline, daily for 7 days, Day 14 and Day 30 (or last day in hospital if patient is discharged earlier, or at withdrawal) irrespective of HBO treatments.',\n", + " 'PrimaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", + " {'PrimaryOutcomeMeasure': 'Immunological response (Efficacy)',\n", + " 'PrimaryOutcomeDescription': 'Measurement of clinically available markers; Baseline, daily for 7 days, Day 14, Day 30 or last day in ICU if patient have left ICU earlier, or at withdrawal)\\n\\nFull Blood cell count including WBC count + differentiation (number/ml)\\nC-Reactive protein\\nProcalcitonin\\nCytokines including but not limited to IL-6',\n", + " 'PrimaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", + " {'PrimaryOutcomeMeasure': 'Mechanical ventilation (Efficacy)',\n", + " 'PrimaryOutcomeDescription': 'Days free of invasive mechanical ventilation',\n", + " 'PrimaryOutcomeTimeFrame': 'Through study completion 30 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'SAE',\n", + " 'SecondaryOutcomeDescription': 'Serious Adverse Events (number of events)',\n", + " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", + " {'SecondaryOutcomeMeasure': 'Serious ADR',\n", + " 'SecondaryOutcomeDescription': 'Serious Adverse Drug Reaction (number of events)',\n", + " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", + " {'SecondaryOutcomeMeasure': 'AE',\n", + " 'SecondaryOutcomeDescription': 'Adverse Event (number of events )',\n", + " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", + " {'SecondaryOutcomeMeasure': 'Oxygen dose',\n", + " 'SecondaryOutcomeDescription': 'Mean oxygen dose/day including HBO and cumulative potential oxygen toxicity calculated as Oxygen Tolerance Units (OTU)',\n", + " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", + " {'SecondaryOutcomeMeasure': 'Pulmonary CT (low-dose CT)',\n", + " 'SecondaryOutcomeDescription': 'Changes in Pulmonary CT (low-dose CT), within before and after HBO and Day 0,7,14 and 28/30 (in selected patients if clinically indicated)',\n", + " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", + " {'SecondaryOutcomeMeasure': 'Chest X-ray',\n", + " 'SecondaryOutcomeDescription': 'Changes on Chest X-ray, before and after HBO and Day 0,7,14 and 28/30 (in selected patients if clinically indicated)',\n", + " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", + " {'SecondaryOutcomeMeasure': 'Chest ultrasound',\n", + " 'SecondaryOutcomeDescription': 'Changes in Chest ultrasound (Atelectasis/b-lines), before and after HBO, Day 0,7,14 and 28/30 (in selected patients when available)',\n", + " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", + " {'SecondaryOutcomeMeasure': 'Secondary infections',\n", + " 'SecondaryOutcomeDescription': 'Secondary infections (VAP, CLABSI, other) (number of events)',\n", + " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", + " {'SecondaryOutcomeMeasure': 'Mortality',\n", + " 'SecondaryOutcomeDescription': '30-day all-cause mortality',\n", + " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", + " {'SecondaryOutcomeMeasure': 'ICU free days',\n", + " 'SecondaryOutcomeDescription': 'Time not admitted to ICU during the study.',\n", + " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", + " {'SecondaryOutcomeMeasure': 'ICU mortality',\n", + " 'SecondaryOutcomeDescription': 'Mortality of any cause in ICU (% of patients admitted to ICU)',\n", + " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", + " {'SecondaryOutcomeMeasure': 'Hospital mortality',\n", + " 'SecondaryOutcomeDescription': 'Mortality of any cause in Hospital (% of patients admitted to Hospital)',\n", + " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", + " {'SecondaryOutcomeMeasure': 'Micro RNA plasma (Biomarker)',\n", + " 'SecondaryOutcomeDescription': 'Change in expression of Micro RNA in plasma (qPCR) Baseline, Day 3, Day 5, Day 7, Day 14, Day 30. First 20 patients.',\n", + " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", + " {'SecondaryOutcomeMeasure': 'MicroRNA/RNA PBMC (Explanatory)',\n", + " 'SecondaryOutcomeDescription': 'Change in gene expression and Micro RNA interactions in Peripheral Blood Mononuclear Cells (qPRC and Micro array) Baseline, Day 3, Day 5, Day 7, Day 14, Day 30. First 20 patients.',\n", + " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", + " {'SecondaryOutcomeMeasure': 'Immunological response (Explanatory)',\n", + " 'SecondaryOutcomeDescription': 'Immunological response, Baseline, Day 3, Day 5, Day 7. In first 20 patients Cytokines extended including (IL-1β, IL-2, IL-6, IL33 and TNFα) Lymphocyte profile Flowcytometry with identification of monocyte/lymphocyte sub sets including but not limited to CD3+/CD4+/CD8+ Monocyte proliferation markers',\n", + " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", + " {'SecondaryOutcomeMeasure': 'Viral load',\n", + " 'SecondaryOutcomeDescription': 'Viral load (quantitative PCR) (Baseline, Day 7, Day 14, Day 30)',\n", + " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'}]},\n", + " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'Staff safety',\n", + " 'OtherOutcomeDescription': 'SAE or AE in staff associated with treatment of patient',\n", + " 'OtherOutcomeTimeFrame': 'Through study completion 30 days'},\n", + " {'OtherOutcomeMeasure': 'HBO Feasibility',\n", + " 'OtherOutcomeDescription': 'Number of HBO treatments given/planned first 10 days\\nReceived HBO treatment within 24h of enrolment (Yes/No)',\n", + " 'OtherOutcomeTimeFrame': 'Through study completion 30 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAged 18-90 years\\nThe patient is likely to fulfill the ARDS criteria (Berlin definition) and need intubation, ventilator-assisted or ECMO-assisted treatment within 7 days of admission to hospital\\nSuspected or verified COVID-19 infection\\nAt least one risk factor for increased mortality in COVID-19: currently published e.g. Smoking, Hypertension, Diabetes, Cardiovascular disease\\nDocumented informed consent according to ICH-GCP and national regulations\\n\\nExclusion Criteria:\\n\\nARDS caused by other viral infections (negative SARS-CoV-2)\\nARDS caused by other non-viral infections or trauma\\nKnown pregnancy or positive pregnancy test in women\\nPatients with previous lung fibrosis\\nCT- or Spirometry-verified severe COPD with Emphysema\\nContraindication for HBO according to local guidelines\\nDo Not Resuscitate (DNR) or other restrictions in escalation of level of care',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'GenderBased': 'Yes',\n", + " 'GenderDescription': 'Adults, all genders',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '90 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Anders Kjellberg, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+46812375212',\n", + " 'CentralContactEMail': 'anders.kjellberg@ki.se'},\n", + " {'CentralContactName': 'Peter Lindholm, MD, PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactEMail': 'peter.lindholm@ki.se'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Anders Kjellberg, MD',\n", + " 'OverallOfficialAffiliation': 'Karolinska University Hospital (and karolinska Insitutet)',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000012127',\n", + " 'ConditionMeshTerm': 'Respiratory Distress Syndrome, Newborn'},\n", + " {'ConditionMeshId': 'D000012128',\n", + " 'ConditionMeshTerm': 'Respiratory Distress Syndrome, Adult'},\n", + " {'ConditionMeshId': 'D000055371',\n", + " 'ConditionMeshTerm': 'Acute Lung Injury'},\n", + " {'ConditionMeshId': 'D000055370', 'ConditionMeshTerm': 'Lung Injury'},\n", + " {'ConditionMeshId': 'D000013577', 'ConditionMeshTerm': 'Syndrome'},\n", + " {'ConditionMeshId': 'D000014777',\n", + " 'ConditionMeshTerm': 'Virus Diseases'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000004194',\n", + " 'ConditionAncestorTerm': 'Disease'},\n", + " {'ConditionAncestorId': 'D000010335',\n", + " 'ConditionAncestorTerm': 'Pathologic Processes'},\n", + " {'ConditionAncestorId': 'D000008171',\n", + " 'ConditionAncestorTerm': 'Lung Diseases'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", + " {'ConditionAncestorId': 'D000012120',\n", + " 'ConditionAncestorTerm': 'Respiration Disorders'},\n", + " {'ConditionAncestorId': 'D000007235',\n", + " 'ConditionAncestorTerm': 'Infant, Premature, Diseases'},\n", + " {'ConditionAncestorId': 'D000007232',\n", + " 'ConditionAncestorTerm': 'Infant, Newborn, Diseases'},\n", + " {'ConditionAncestorId': 'D000013898',\n", + " 'ConditionAncestorTerm': 'Thoracic Injuries'},\n", + " {'ConditionAncestorId': 'D000014947',\n", + " 'ConditionAncestorTerm': 'Wounds and Injuries'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M14938',\n", + " 'ConditionBrowseLeafName': 'Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13547',\n", + " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Newborn',\n", + " 'ConditionBrowseLeafAsFound': 'Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M13548',\n", + " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Adult',\n", + " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M26731',\n", + " 'ConditionBrowseLeafName': 'Acute Lung Injury',\n", + " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M26730',\n", + " 'ConditionBrowseLeafName': 'Lung Injury',\n", + " 'ConditionBrowseLeafAsFound': 'Lung Injury',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafAsFound': 'Infection Viral',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M9751',\n", + " 'ConditionBrowseLeafName': 'Lung Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13540',\n", + " 'ConditionBrowseLeafName': 'Respiration Disorders',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M24456',\n", + " 'ConditionBrowseLeafName': 'Premature Birth',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M8862',\n", + " 'ConditionBrowseLeafName': 'Infant, Premature, Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M8859',\n", + " 'ConditionBrowseLeafName': 'Infant, Newborn, Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M15240',\n", + " 'ConditionBrowseLeafName': 'Thoracic Injuries',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16268',\n", + " 'ConditionBrowseLeafName': 'Wounds and Injuries',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T4953',\n", + " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Infant',\n", + " 'ConditionBrowseLeafAsFound': 'Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'T191',\n", + " 'ConditionBrowseLeafName': 'Acute Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC16',\n", + " 'ConditionBrowseBranchName': 'Diseases and Abnormalities at or Before Birth'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC26',\n", + " 'ConditionBrowseBranchName': 'Wounds and Injuries'},\n", + " {'ConditionBrowseBranchAbbrev': 'BXS',\n", + " 'ConditionBrowseBranchName': 'Urinary Tract, Sexual Organs, and Pregnancy Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 51,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04256395',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'RWS-BTCH-002'},\n", + " 'Organization': {'OrgFullName': 'Beijing Tsinghua Chang Gung Hospital',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Efficacy of a Self-test and Self-alert Mobile Applet in Detecting Susceptible Infection of COVID-19',\n", + " 'OfficialTitle': 'Registry Study on the Efficacy of a Self-test and Self-alert Applet in Detecting Susceptible Infection of COVID-19 ——a Population Based Mobile Internet Survey',\n", + " 'Acronym': 'COVID-19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'February 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'February 1, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'July 31, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'July 31, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'February 1, 2020',\n", + " 'StudyFirstSubmitQCDate': 'February 3, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'February 5, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'February 18, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'February 20, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Beijing Tsinghua Chang Gung Hospital',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Institute for precision medicine of Tsinghua University',\n", + " 'CollaboratorClass': 'UNKNOWN'},\n", + " {'CollaboratorName': 'Institute for artificial intelligent of Tsinghua University',\n", + " 'CollaboratorClass': 'UNKNOWN'},\n", + " {'CollaboratorName': 'Chinese Medical Doctor Association',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'Institute for network behavior of Tsinghua University',\n", + " 'CollaboratorClass': 'UNKNOWN'},\n", + " {'CollaboratorName': 'school of clinical medicine of Tsinghua University',\n", + " 'CollaboratorClass': 'UNKNOWN'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'The \"COVID-19 infection self-test and alert system\" (hereinafter referred to as \"COVID-19 self-test applet\") jointly developed by Beijing Tsinghua Changgung Hospital, Institute for precision medicine, artificial intelligence of Tsinghua University was launched on February 1，2020. Residents , according to their actual healthy situation, after answering questions online, the system will conduct intelligent analysis, make disease risk assessment and give healthcare and medical guidance. Based on the Internet population survey, and referring to the diagnosis and screening standards of the National Health Commission of the People\\'s Republic of China, investigators carried out the mobile applet of Internet survey and registry study for the Internet accessible identifiable population, so as to screen the suspected population and guide the medical treatment.',\n", + " 'DetailedDescription': 'The \"COVID-19 infection self-test and alert system\" (hereinafter referred to as \"COVID-19 self-test applet\") jointly developed by Beijing Tsinghua Changgung Hospital, Institute for precision medicine, artificial intelligence of Tsinghua University was launched on February 1，2020. This survey was also advocated by Chinese Medical Doctor Association. Residents , or even oversea Chinese people，according to their actual healthy situation, after answering questions online, the system will conduct intelligent analysis, make disease risk assessment and give healthcare and medical guidance. Based on the Internet population survey, and referring to the diagnosis and screening standards of the National Health Commission of the People\\'s Republic of China, investigators carried out the mobile applet of Internet survey and registry study for the Internet accessible identifiable population, so as to screen the suspected population and guide the medical treatment.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Susceptibility to Viral and Mycobacterial Infection']},\n", + " 'KeywordList': {'Keyword': ['registry study',\n", + " 'novel coronavirus（COVID-19）',\n", + " 'mobile internet survey']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Other']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '300000',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", + " 'InterventionName': 'mobile internet survey on self-test',\n", + " 'InterventionDescription': '1. make a questionnaire, the content of which refers to the new coronavirus diagnosis and treatment guidelines released by the National Health Commission; 2. develop the mobile applet and carry out internet propagation; 3. background data could be identified according to computer technology, de duplication and de privacy; 4. once registered, the applet can automatically remind the self-test twice a day, and encourage to adhere to 14 days; 5. automatically compare with the standards and highly suspected population could be given medical guidance and encouraged to go to the fever clinic of the designated hospital for definite diagnosis.'}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'positive number diagnosed by national guideline in the evaluated population',\n", + " 'PrimaryOutcomeDescription': 'after the end of this study, investigators calculate and sum up the total evaluated population and positively diagnosed population, then check the ROC of this system, finally to calculate the sensitivity and accuracy of this self-test and self-alert system',\n", + " 'PrimaryOutcomeTimeFrame': '5 months'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'distribution map of evaluated people',\n", + " 'SecondaryOutcomeDescription': 'after the end of this study, investigators calculate the proportion and distribution of evaluated people with normal and abnormal scores',\n", + " 'SecondaryOutcomeTimeFrame': '5 month'},\n", + " {'SecondaryOutcomeMeasure': 'Effect of medical guidance by designated feedback questionnaire',\n", + " 'SecondaryOutcomeDescription': 'after the end of this study, investigators sent the feedback inform to every evaluated people and collect and analysis the response to find out whether this applet can help them in the following surveillance or medical treatment. And how it works.',\n", + " 'SecondaryOutcomeTimeFrame': '5 month'},\n", + " {'SecondaryOutcomeMeasure': 'mental scale of relief the mental anxiety and avoid unnecessary outpatient',\n", + " 'SecondaryOutcomeDescription': 'after the end of this study, investigators sent the designated mental scale including anxiety, and collect the response and draw the conclusion.',\n", + " 'SecondaryOutcomeTimeFrame': '5 month'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\npeople who lived in or out of China at present and threatened by the infection and spread of COVID-19\\n\\nwithout gender and age restriction\\npeople who have concerns of his health\\nvoluntary completion of the self-test and evaluation.\\n\\nExclusion Criteria:\\n\\npeople who are not internet accessible or can not use this Mobile Applet.\\npeople who can not recognize the questionnaire.',\n", + " 'Gender': 'All',\n", + " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'Most people including healthy or susceptible patients or diagnosed patients will be enrolled. People whoever worry about his heath status relating with infection of COVID-19 at present can register and answer the question and get a score for risk evaluation. If a high risk achieved, the applet will guide the interviewer for further medical diagnosis and treatment.',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Xiaobin Feng, M.D',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+86 13228683243',\n", + " 'CentralContactEMail': 'fengxiaobin200708@aliyun.com'},\n", + " {'CentralContactName': 'Bin Yang, Ph.D',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+86 13501102704',\n", + " 'CentralContactEMail': 'fxb19@mails.tsinghua.edu.cn'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Jiahong Dong, M.D',\n", + " 'OverallOfficialAffiliation': 'Beijing Tsinghua Changgung Hospital',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Beijing Tsinghua Changgung Hospital',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Beijing',\n", + " 'LocationState': 'Beijing',\n", + " 'LocationZip': '102218',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Xiaobin Feng, M.D',\n", + " 'LocationContactRole': 'Contact'},\n", + " {'LocationContactName': 'xiaobin feng, M.D',\n", + " 'LocationContactRole': 'Principal Investigator'},\n", + " {'LocationContactName': 'bin yang, Ph.D',\n", + " 'LocationContactRole': 'Principal Investigator'},\n", + " {'LocationContactName': 'jiahong dong, M.D',\n", + " 'LocationContactRole': 'Principal Investigator'},\n", + " {'LocationContactName': 'xiaojuan wang, Ph.D',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'chenquan li, D.E',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", + " 'ConditionMeshTerm': 'Infection'},\n", + " {'ConditionMeshId': 'D000003141',\n", + " 'ConditionMeshTerm': 'Communicable Diseases'},\n", + " {'ConditionMeshId': 'D000009164',\n", + " 'ConditionMeshTerm': 'Mycobacterium Infections'},\n", + " {'ConditionMeshId': 'D000004198',\n", + " 'ConditionMeshTerm': 'Disease Susceptibility'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000020969',\n", + " 'ConditionAncestorTerm': 'Disease Attributes'},\n", + " {'ConditionAncestorId': 'D000010335',\n", + " 'ConditionAncestorTerm': 'Pathologic Processes'},\n", + " {'ConditionAncestorId': 'D000000193',\n", + " 'ConditionAncestorTerm': 'Actinomycetales Infections'},\n", + " {'ConditionAncestorId': 'D000016908',\n", + " 'ConditionAncestorTerm': 'Gram-Positive Bacterial Infections'},\n", + " {'ConditionAncestorId': 'D000001424',\n", + " 'ConditionAncestorTerm': 'Bacterial Infections'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafAsFound': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafAsFound': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M5963',\n", + " 'ConditionBrowseLeafName': 'Disease Susceptibility',\n", + " 'ConditionBrowseLeafAsFound': 'Susceptibility',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M10702',\n", + " 'ConditionBrowseLeafName': 'Mycobacterium Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Mycobacterial Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M21284',\n", + " 'ConditionBrowseLeafName': 'Disease Attributes',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M3303',\n", + " 'ConditionBrowseLeafName': 'Bacterial Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M17835',\n", + " 'ConditionBrowseLeafName': 'Gram-Positive Bacterial Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'}]}}}}},\n", + " {'Rank': 52,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04333407',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '20HH5868'},\n", + " 'Organization': {'OrgFullName': 'Imperial College London',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial.',\n", + " 'OfficialTitle': 'Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial.',\n", + " 'Acronym': 'C-19-ACS'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 31, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 30, 2021',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'March 30, 2021',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'April 1, 2020',\n", + " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 3, 2020',\n", + " 'StudyFirstPostDateType': 'Estimate'},\n", + " 'LastUpdateSubmitDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", + " 'LastUpdatePostDateType': 'Estimate'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Imperial College London',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'The outbreak of a novel coronavirus (SARS-CoV-2) and associated COVID-19 disease in late December 2019 has led to a global pandemic. At the time of writing, there have been 150 000 confirmed cases and 3500 deaths. Apart from the morbidity and mortality directly related to COVID-19 cases, society has had to also cope with complex political and economic repercussions of this disease.\\n\\nAt present, and despite pressing need for therapeutic intervention, management of patients with COVID-19 is entirely supportive. Despite the majority of patients experiencing a mild respiratory illness a subgroup, and in particular those with pre-existing cardiovascular disease, will experience severe illness that requires invasive cardiorespiratory support in the intensive care unit.\\n\\nFurthermore, the severity of COVID-19 disease (as well as the likelihood of progressing to severe disease) appears to be in part driven by direct injury to the cardiovascular system. Analysis of data from two recent studies confirms a significantly higher likelihood of acute cardiac injury in patients who have to be admitted to intensive care for the management of COVID-19 disease.\\n\\nThe exact type of acute of cardiac injury that COVID-19 patients suffer remains unclear. There is however mounting evidence that heart attack like events are responsible. Tests ordinarily performed to definitely assess for heart attacks will not be possible in very sick COVID-19 patients. Randomising patients to cardioprotective medicines will help us understand the role of the cardiovascular system in COVID-19 disease. It will also help us determine if there is more we can do to treat these patients.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", + " 'KeywordList': {'Keyword': ['Coronavirus, SARS-CoV-2, COVID-19, Cardiovascular']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Not Applicable']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignInterventionModelDescription': 'Prospective Multicentre Randomised Controlled Trial',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '3170',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Active Arm',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Aspirin 75mg',\n", + " 'Drug: Clopidogrel 75mg',\n", + " 'Drug: Rivaroxaban 2.5 MG',\n", + " 'Drug: Atorvastatin 40mg',\n", + " 'Drug: Omeprazole 20mg']}},\n", + " {'ArmGroupLabel': 'Control Arm', 'ArmGroupType': 'No Intervention'}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Aspirin 75mg',\n", + " 'InterventionDescription': '• If patient not on aspirin, add aspirin 75mg once daily unless contraindicated.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Active Arm']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Clopidogrel 75mg',\n", + " 'InterventionDescription': '• If patient not on clopidogrel or equivalent, add clopidogrel 75mg once daily unless contraindicated',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Active Arm']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Rivaroxaban 2.5 MG',\n", + " 'InterventionDescription': 'If patient not on an anticoagulation, add rivaroxaban 2.5mg bd unless contraindicated\\nIf patient on DOAC then change to rivaroxaban 2.5mg unless contraindicated',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Active Arm']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Atorvastatin 40mg',\n", + " 'InterventionDescription': '• If patient not on a statin, add atorvastatin 40mg once daily unless contraindicated',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Active Arm']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Omeprazole 20mg',\n", + " 'InterventionDescription': '• If patient not on a proton pump inhibitor, add omeprazole 20mg once daily.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Active Arm']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Primary Efficacy Outcome',\n", + " 'PrimaryOutcomeDescription': 'All-cause mortality',\n", + " 'PrimaryOutcomeTimeFrame': 'at 30 days after admission'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Secondary Efficacy Outcome 1',\n", + " 'SecondaryOutcomeDescription': 'Absolute change in serum troponin from admission (or from suspicion/diagnosis of Covid-19 if already an inpatient) measurement to peak value (measured using high sensitivity troponin assay). (Phase I interim analysis)',\n", + " 'SecondaryOutcomeTimeFrame': 'within 7 days and within 30 days of admission'},\n", + " {'SecondaryOutcomeMeasure': 'Secondary Efficacy Outcome 2',\n", + " 'SecondaryOutcomeDescription': 'Discharge Rate: Proportion of patients discharged (or documented as medically fit for discharge)',\n", + " 'SecondaryOutcomeTimeFrame': 'at 7 days and 30 days after admission'},\n", + " {'SecondaryOutcomeMeasure': 'Secondary Efficacy Outcome 3',\n", + " 'SecondaryOutcomeDescription': 'Intubation Rate: Proportion of patients who have been intubated for mechanical ventilation',\n", + " 'SecondaryOutcomeTimeFrame': 'at 7 days and at 30 days after admission'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nConfirmed COVID-19 infection\\nAge =/>40 or diabetes or known coronary disease or hypertension\\nRequires hospital admission for further clinical management.\\n\\nExclusion Criteria:\\n\\nClear evidence of cardiac pathology needing ACS treatment.\\nMyocarditis with serum Troponin > 5000\\nBleeding risk suspected e.g. recent surgery, history of GI bleed, other abnormal blood results (Hb<10g/dl, Plts <100, any evidence of DIC)\\nStudy treatment may negatively impact standard best care (physician discretion).\\nUnrelated co-morbidity with life expectancy <3 months.\\nPregnancy.\\nAge <18 years and >85 years.',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '85 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Alena Marynina, BSc, MSc',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '07404750659',\n", + " 'CentralContactEMail': 'alena.marynina@nhs.net'},\n", + " {'CentralContactName': 'Clare Coyle, BMBCh, BA, MRCP',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '07985 352148',\n", + " 'CentralContactEMail': 'c.coyle@imperial.ac.uk'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Prapa Kanagaratnam, FRCP, PhD',\n", + " 'OverallOfficialAffiliation': 'Imperial College Healthcare NHS Trust',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No',\n", + " 'IPDSharingDescription': 'No individual participant data will be shared with other researchers or organisations. Anonymised data might be shared with other research organisations'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000001241',\n", + " 'InterventionMeshTerm': 'Aspirin'},\n", + " {'InterventionMeshId': 'D000009853',\n", + " 'InterventionMeshTerm': 'Omeprazole'},\n", + " {'InterventionMeshId': 'D000069552',\n", + " 'InterventionMeshTerm': 'Rivaroxaban'},\n", + " {'InterventionMeshId': 'D000077144',\n", + " 'InterventionMeshTerm': 'Clopidogrel'},\n", + " {'InterventionMeshId': 'D000069059',\n", + " 'InterventionMeshTerm': 'Atorvastatin'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000894',\n", + " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents, Non-Steroidal'},\n", + " {'InterventionAncestorId': 'D000018712',\n", + " 'InterventionAncestorTerm': 'Analgesics, Non-Narcotic'},\n", + " {'InterventionAncestorId': 'D000000700',\n", + " 'InterventionAncestorTerm': 'Analgesics'},\n", + " {'InterventionAncestorId': 'D000018689',\n", + " 'InterventionAncestorTerm': 'Sensory System Agents'},\n", + " {'InterventionAncestorId': 'D000018373',\n", + " 'InterventionAncestorTerm': 'Peripheral Nervous System Agents'},\n", + " {'InterventionAncestorId': 'D000045505',\n", + " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", + " {'InterventionAncestorId': 'D000000893',\n", + " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents'},\n", + " {'InterventionAncestorId': 'D000018501',\n", + " 'InterventionAncestorTerm': 'Antirheumatic Agents'},\n", + " {'InterventionAncestorId': 'D000005343',\n", + " 'InterventionAncestorTerm': 'Fibrinolytic Agents'},\n", + " {'InterventionAncestorId': 'D000050299',\n", + " 'InterventionAncestorTerm': 'Fibrin Modulating Agents'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000010975',\n", + " 'InterventionAncestorTerm': 'Platelet Aggregation Inhibitors'},\n", + " {'InterventionAncestorId': 'D000016861',\n", + " 'InterventionAncestorTerm': 'Cyclooxygenase Inhibitors'},\n", + " {'InterventionAncestorId': 'D000004791',\n", + " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", + " {'InterventionAncestorId': 'D000058633',\n", + " 'InterventionAncestorTerm': 'Antipyretics'},\n", + " {'InterventionAncestorId': 'D000000924',\n", + " 'InterventionAncestorTerm': 'Anticholesteremic Agents'},\n", + " {'InterventionAncestorId': 'D000000960',\n", + " 'InterventionAncestorTerm': 'Hypolipidemic Agents'},\n", + " {'InterventionAncestorId': 'D000000963',\n", + " 'InterventionAncestorTerm': 'Antimetabolites'},\n", + " {'InterventionAncestorId': 'D000057847',\n", + " 'InterventionAncestorTerm': 'Lipid Regulating Agents'},\n", + " {'InterventionAncestorId': 'D000019161',\n", + " 'InterventionAncestorTerm': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'},\n", + " {'InterventionAncestorId': 'D000058921',\n", + " 'InterventionAncestorTerm': 'Purinergic P2Y Receptor Antagonists'},\n", + " {'InterventionAncestorId': 'D000058919',\n", + " 'InterventionAncestorTerm': 'Purinergic P2 Receptor Antagonists'},\n", + " {'InterventionAncestorId': 'D000058914',\n", + " 'InterventionAncestorTerm': 'Purinergic Antagonists'},\n", + " {'InterventionAncestorId': 'D000058905',\n", + " 'InterventionAncestorTerm': 'Purinergic Agents'},\n", + " {'InterventionAncestorId': 'D000018377',\n", + " 'InterventionAncestorTerm': 'Neurotransmitter Agents'},\n", + " {'InterventionAncestorId': 'D000065427',\n", + " 'InterventionAncestorTerm': 'Factor Xa Inhibitors'},\n", + " {'InterventionAncestorId': 'D000000991',\n", + " 'InterventionAncestorTerm': 'Antithrombins'},\n", + " {'InterventionAncestorId': 'D000015842',\n", + " 'InterventionAncestorTerm': 'Serine Proteinase Inhibitors'},\n", + " {'InterventionAncestorId': 'D000011480',\n", + " 'InterventionAncestorTerm': 'Protease Inhibitors'},\n", + " {'InterventionAncestorId': 'D000000925',\n", + " 'InterventionAncestorTerm': 'Anticoagulants'},\n", + " {'InterventionAncestorId': 'D000000897',\n", + " 'InterventionAncestorTerm': 'Anti-Ulcer Agents'},\n", + " {'InterventionAncestorId': 'D000005765',\n", + " 'InterventionAncestorTerm': 'Gastrointestinal Agents'},\n", + " {'InterventionAncestorId': 'D000054328',\n", + " 'InterventionAncestorTerm': 'Proton Pump Inhibitors'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M3129',\n", + " 'InterventionBrowseLeafName': 'Aspirin',\n", + " 'InterventionBrowseLeafAsFound': 'Aspirin',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M11368',\n", + " 'InterventionBrowseLeafName': 'Omeprazole',\n", + " 'InterventionBrowseLeafAsFound': 'Omeprazole',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M463',\n", + " 'InterventionBrowseLeafName': 'Rivaroxaban',\n", + " 'InterventionBrowseLeafAsFound': 'Rivaroxaban',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M1669',\n", + " 'InterventionBrowseLeafName': 'Clopidogrel',\n", + " 'InterventionBrowseLeafAsFound': 'Clopidogrel',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M351',\n", + " 'InterventionBrowseLeafName': 'Atorvastatin',\n", + " 'InterventionBrowseLeafAsFound': 'Atorvastatin',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M19739',\n", + " 'InterventionBrowseLeafName': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M26217',\n", + " 'InterventionBrowseLeafName': 'Proton Pump Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2798',\n", + " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2799',\n", + " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents, Non-Steroidal',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2613',\n", + " 'InterventionBrowseLeafName': 'Analgesics',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19370',\n", + " 'InterventionBrowseLeafName': 'Analgesics, Non-Narcotic',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19188',\n", + " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M7056',\n", + " 'InterventionBrowseLeafName': 'Fibrinolytic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M12448',\n", + " 'InterventionBrowseLeafName': 'Platelet Aggregation Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M17792',\n", + " 'InterventionBrowseLeafName': 'Cyclooxygenase Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M27763',\n", + " 'InterventionBrowseLeafName': 'Antipyretics',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2824',\n", + " 'InterventionBrowseLeafName': 'Anticholesteremic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2859',\n", + " 'InterventionBrowseLeafName': 'Hypolipidemic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2862',\n", + " 'InterventionBrowseLeafName': 'Antimetabolites',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M27470',\n", + " 'InterventionBrowseLeafName': 'Lipid Regulating Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M27881',\n", + " 'InterventionBrowseLeafName': 'Purinergic P2Y Receptor Antagonists',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19088',\n", + " 'InterventionBrowseLeafName': 'Neurotransmitter Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M29100',\n", + " 'InterventionBrowseLeafName': 'Factor Xa Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2888',\n", + " 'InterventionBrowseLeafName': 'Antithrombins',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2887',\n", + " 'InterventionBrowseLeafName': 'Antithrombin III',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M12926',\n", + " 'InterventionBrowseLeafName': 'Protease Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M16974',\n", + " 'InterventionBrowseLeafName': 'Serine Proteinase Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M18192',\n", + " 'InterventionBrowseLeafName': 'HIV Protease Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2825',\n", + " 'InterventionBrowseLeafName': 'Anticoagulants',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2769',\n", + " 'InterventionBrowseLeafName': 'Antacids',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2800',\n", + " 'InterventionBrowseLeafName': 'Anti-Ulcer Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M7464',\n", + " 'InterventionBrowseLeafName': 'Gastrointestinal Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'T18',\n", + " 'InterventionBrowseLeafName': 'Serine',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Antipy',\n", + " 'InterventionBrowseBranchName': 'Antipyretics'},\n", + " {'InterventionBrowseBranchAbbrev': 'Infl',\n", + " 'InterventionBrowseBranchName': 'Anti-Inflammatory Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'FiAg',\n", + " 'InterventionBrowseBranchName': 'Fibrinolytic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'Analg',\n", + " 'InterventionBrowseBranchName': 'Analgesics'},\n", + " {'InterventionBrowseBranchAbbrev': 'PlAggInh',\n", + " 'InterventionBrowseBranchName': 'Platelet Aggregation Inhibitors'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", + " {'InterventionBrowseBranchAbbrev': 'Gast',\n", + " 'InterventionBrowseBranchName': 'Gastrointestinal Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'AnCoag',\n", + " 'InterventionBrowseBranchName': 'Anticoagulants'},\n", + " {'InterventionBrowseBranchAbbrev': 'Lipd',\n", + " 'InterventionBrowseBranchName': 'Lipid Regulating Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'AA',\n", + " 'InterventionBrowseBranchName': 'Amino Acids'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000054058',\n", + " 'ConditionMeshTerm': 'Acute Coronary Syndrome'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000017202',\n", + " 'ConditionAncestorTerm': 'Myocardial Ischemia'},\n", + " {'ConditionAncestorId': 'D000006331',\n", + " 'ConditionAncestorTerm': 'Heart Diseases'},\n", + " {'ConditionAncestorId': 'D000002318',\n", + " 'ConditionAncestorTerm': 'Cardiovascular Diseases'},\n", + " {'ConditionAncestorId': 'D000014652',\n", + " 'ConditionAncestorTerm': 'Vascular Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M14938',\n", + " 'ConditionBrowseLeafName': 'Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M26132',\n", + " 'ConditionBrowseLeafName': 'Acute Coronary Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Acute Coronary Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M5129',\n", + " 'ConditionBrowseLeafName': 'Coronary Artery Disease',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M18089',\n", + " 'ConditionBrowseLeafName': 'Myocardial Ischemia',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M9126',\n", + " 'ConditionBrowseLeafName': 'Ischemia',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M8002',\n", + " 'ConditionBrowseLeafName': 'Heart Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M15983',\n", + " 'ConditionBrowseLeafName': 'Vascular Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC14',\n", + " 'ConditionBrowseBranchName': 'Heart and Blood Diseases'}]}}}}},\n", + " {'Rank': 53,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04328454',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'HBCBH-IEC-2020-101'},\n", + " 'Organization': {'OrgFullName': \"Shanghai 10th People's Hospital\",\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Clinical Characteristics and Prognostic Factors of Patients With COVID-19',\n", + " 'OfficialTitle': 'Clinical Characteristics and Prognostic Factors of Patients With COVID-19 in Chibi Hospital of Hubei Province'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'January 30, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 2, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'April 15, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 27, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 30, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 31, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 30, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 31, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Ming Li',\n", + " 'ResponsiblePartyInvestigatorTitle': \"Shanghai 10th People's Hospital\",\n", + " 'ResponsiblePartyInvestigatorAffiliation': \"Shanghai 10th People's Hospital\"},\n", + " 'LeadSponsor': {'LeadSponsorName': \"Shanghai 10th People's Hospital\",\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': \"Chibi People's Hospital, Hubei Province\",\n", + " 'CollaboratorClass': 'UNKNOWN'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.',\n", + " 'DetailedDescription': 'As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Retrospective']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '120',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'COVID-19 patients',\n", + " 'ArmGroupDescription': 'Hospitalized patients with COVID-19',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: retrospective analysis']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", + " 'InterventionName': 'retrospective analysis',\n", + " 'InterventionDescription': 'The investigators retrospectively analyzed the hospitalized patients with COVID-19',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['COVID-19 patients']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Time to negative conversion of severe acute respiratory syndrome coronavirus 2',\n", + " 'PrimaryOutcomeDescription': 'The primary outcome is the time to negative conversion of coronavirus',\n", + " 'PrimaryOutcomeTimeFrame': '1 month'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Length of stay in hospital',\n", + " 'SecondaryOutcomeDescription': 'The time of hospitalization',\n", + " 'SecondaryOutcomeTimeFrame': '1 month'},\n", + " {'SecondaryOutcomeMeasure': 'Survival',\n", + " 'SecondaryOutcomeDescription': 'The rate of survival within hospitalization of these patients will be tracked. The rate of survival within hospitalization of these patients will be tracked. The rate of survival within hospitalization of these patients will be tracked. The rate of survival within hospitalization of these patients will be tracked.',\n", + " 'SecondaryOutcomeTimeFrame': '1 month'},\n", + " {'SecondaryOutcomeMeasure': 'Intubation',\n", + " 'SecondaryOutcomeDescription': 'The rate of intubation within hospitalization of these patients will be tracked',\n", + " 'SecondaryOutcomeTimeFrame': '1 month'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAdult aged >=18years old; Diagnosed with CONVID19. Diagnostic criteria including: Laboratory (RT-PCR) confirmed SARS-Cov-2 infection; CT of the lung conformed to the manifestation of viral pneumonia.\\n\\nExclusion Criteria:\\n\\nNear-death state (expected survival time less than 24 hours); Malignant tumor; Pregnancy or puerperium women; Patients who refused to participant.',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'Patients with COVID-19',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'LocationList': {'Location': [{'LocationFacility': \"Shanghai 10th People's Hospital\",\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Shanghai',\n", + " 'LocationState': 'Shanghai',\n", + " 'LocationZip': '+86200072',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Ming Li, M.D.',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+8613524348108',\n", + " 'LocationContactEMail': 'mlid163@163.com'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 54,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04333550',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '1398.1224'},\n", + " 'Organization': {'OrgFullName': 'Kermanshah University of Medical Sciences',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Application of Desferal to Treat COVID-19',\n", + " 'OfficialTitle': 'Application of Iron Chelator (Desferal) to Reduce the Severity of COVID-19 Manifestations'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'September 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'March 2021',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'April 1, 2020',\n", + " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 3, 2020',\n", + " 'StudyFirstPostDateType': 'Estimate'},\n", + " 'LastUpdateSubmitDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", + " 'LastUpdatePostDateType': 'Estimate'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Dr. Yadollah Shakiba',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Dr. Yadollah Shakiba, MD, PhD',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Kermanshah University of Medical Sciences'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Kermanshah University of Medical Sciences',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'In this study, defined cases of COVID-19 with mild, moderate or severe pneumonia will be treated with standard treatment regimens in combination with IV injection of Deferoxamine. Improvement in clinical, laboratory and radiological manifestations will be evaluated in treated patient compared to control group.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", + " 'KeywordList': {'Keyword': ['COVID-19, Deferoxamine']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 1', 'Phase 2']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Double',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", + " 'Investigator']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '50',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Experimental: Desferal addition to standard treatment',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Deferoxamine']}},\n", + " {'ArmGroupLabel': 'Experimental: standard treatment',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Deferoxamine']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Deferoxamine',\n", + " 'InterventionDescription': 'Daily intravenous (IV) dose of Deferoxamine for 3 to 5 days',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Experimental: Desferal addition to standard treatment',\n", + " 'Experimental: standard treatment']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Mortality rate',\n", + " 'PrimaryOutcomeDescription': 'All cause of death',\n", + " 'PrimaryOutcomeTimeFrame': 'up to 20 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'change in patients clinical manifestation',\n", + " 'SecondaryOutcomeDescription': 'Mild, Moderate or Severe',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 20 days'},\n", + " {'SecondaryOutcomeMeasure': 'change in patients PaO2',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 20 days'},\n", + " {'SecondaryOutcomeMeasure': 'Length of hospitalization',\n", + " 'SecondaryOutcomeDescription': 'days',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 20 days'},\n", + " {'SecondaryOutcomeMeasure': 'C-reactive protein',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 20 days'},\n", + " {'SecondaryOutcomeMeasure': 'lymphocyte count',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 20 days'},\n", + " {'SecondaryOutcomeMeasure': 'length of intensive care unit stay',\n", + " 'SecondaryOutcomeTimeFrame': '1 to 20 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nMale or Female Age between 3 and 99 years, Patients with mild, moderate or severe COVID-19 pneumonia based on clinical evaluation\\n\\n,\\n\\nExclusion Criteria:\\n\\nPatients with previous history of allergy to Deferoxamin Pregnant patient Patients with kidney dysfunction (blood creatinine>2) co-existence of bacterial pneumonia consent denied',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '3 Years',\n", + " 'MaximumAge': '99 Years',\n", + " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Alireza Ghaffarieh, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+1-608-698-7334',\n", + " 'CentralContactEMail': 'alireza_ghaffarieh@meei.harvard.edu'},\n", + " {'CentralContactName': 'Yadollah Shakiba, MD, PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactEMail': 'yshakiba@gmail.com'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Alireza Ghaffarieh, MD',\n", + " 'OverallOfficialAffiliation': 'Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran',\n", + " 'OverallOfficialRole': 'Study Director'},\n", + " {'OverallOfficialName': 'Yadollah Shakiba, MD, PhD',\n", + " 'OverallOfficialAffiliation': 'Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran',\n", + " 'OverallOfficialRole': 'Study Chair'},\n", + " {'OverallOfficialName': 'Amir Kiani, PhD',\n", + " 'OverallOfficialAffiliation': 'Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Kermanshah',\n", + " 'LocationZip': '083',\n", + " 'LocationCountry': 'Iran, Islamic Republic of',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Yadollah Shakiba, MD, PhD',\n", + " 'LocationContactRole': 'Contact'}]}}]}},\n", + " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '18552864',\n", + " 'ReferenceType': 'result',\n", + " 'ReferenceCitation': 'Drakesmith H, Prentice A. Viral infection and iron metabolism. Nat Rev Microbiol. 2008 Jul;6(7):541-52. doi: 10.1038/nrmicro1930. Review.'},\n", + " {'ReferencePMID': '25076907',\n", + " 'ReferenceType': 'result',\n", + " 'ReferenceCitation': 'Nairz M, Haschka D, Demetz E, Weiss G. Iron at the interface of immunity and infection. Front Pharmacol. 2014 Jul 16;5:152. doi: 10.3389/fphar.2014.00152. eCollection 2014. Review.'},\n", + " {'ReferencePMID': '10669330',\n", + " 'ReferenceType': 'result',\n", + " 'ReferenceCitation': 'Georgiou NA, van der Bruggen T, Oudshoorn M, Nottet HS, Marx JJ, van Asbeck BS. Inhibition of human immunodeficiency virus type 1 replication in human mononuclear blood cells by the iron chelators deferoxamine, deferiprone, and bleomycin. J Infect Dis. 2000 Feb;181(2):484-90.'},\n", + " {'ReferencePMID': '22187937',\n", + " 'ReferenceType': 'result',\n", + " 'ReferenceCitation': 'Vlahakos D, Arkadopoulos N, Kostopanagiotou G, Siasiakou S, Kaklamanis L, Degiannis D, Demonakou M, Smyrniotis V. Deferoxamine attenuates lipid peroxidation, blocks interleukin-6 production, ameliorates sepsis inflammatory response syndrome, and confers renoprotection after acute hepatic ischemia in pigs. Artif Organs. 2012 Apr;36(4):400-8. doi: 10.1111/j.1525-1594.2011.01385.x. Epub 2011 Dec 21.'},\n", + " {'ReferencePMID': '29619244',\n", + " 'ReferenceType': 'result',\n", + " 'ReferenceCitation': 'Wang H, Li Z, Niu J, Xu Y, Ma L, Lu A, Wang X, Qian Z, Huang Z, Jin X, Leng Q, Wang J, Zhong J, Sun B, Meng G. Antiviral effects of ferric ammonium citrate. Cell Discov. 2018 Mar 27;4:14. doi: 10.1038/s41421-018-0013-6. eCollection 2018.'},\n", + " {'ReferencePMID': '7811060',\n", + " 'ReferenceType': 'result',\n", + " 'ReferenceCitation': 'Cinatl J Jr, Cinatl J, Rabenau H, Gümbel HO, Kornhuber B, Doerr HW. In vitro inhibition of human cytomegalovirus replication by desferrioxamine. Antiviral Res. 1994 Sep;25(1):73-7.'},\n", + " {'ReferencePMID': '11886437',\n", + " 'ReferenceType': 'result',\n", + " 'ReferenceCitation': 'Visseren F, Verkerk MS, van der Bruggen T, Marx JJ, van Asbeck BS, Diepersloot RJ. Iron chelation and hydroxyl radical scavenging reduce the inflammatory response of endothelial cells after infection with Chlamydia pneumoniae or influenza A. Eur J Clin Invest. 2002 Mar;32 Suppl 1:84-90.'},\n", + " {'ReferencePMID': '8554902',\n", + " 'ReferenceType': 'result',\n", + " 'ReferenceCitation': 'Sappey C, Boelaert JR, Legrand-Poels S, Forceille C, Favier A, Piette J. Iron chelation decreases NF-kappa B and HIV type 1 activation due to oxidative stress. AIDS Res Hum Retroviruses. 1995 Sep;11(9):1049-61.'},\n", + " {'ReferencePMID': '25291189',\n", + " 'ReferenceType': 'result',\n", + " 'ReferenceCitation': 'Chang HC, Bayeva M, Taiwo B, Palella FJ Jr, Hope TJ, Ardehali H. Short communication: high cellular iron levels are associated with increased HIV infection and replication. AIDS Res Hum Retroviruses. 2015 Mar;31(3):305-12. doi: 10.1089/aid.2014.0169. Epub 2014 Oct 7.'},\n", + " {'ReferencePMID': '16787239',\n", + " 'ReferenceType': 'result',\n", + " 'ReferenceCitation': 'Meyer D. Iron chelation as therapy for HIV and Mycobacterium tuberculosis co-infection under conditions of iron overload. Curr Pharm Des. 2006;12(16):1943-7. Review.'},\n", + " {'ReferencePMID': '8665150',\n", + " 'ReferenceType': 'result',\n", + " 'ReferenceCitation': 'Cinatl J, Scholz M, Weber B, Cinatl J, Rabenau H, Markus BH, Encke A, Doerr HW. Effects of desferrioxamine on human cytomegalovirus replication and expression of HLA antigens and adhesion molecules in human vascular endothelial cells. Transpl Immunol. 1995 Dec;3(4):313-20.'},\n", + " {'ReferencePMID': '10051178',\n", + " 'ReferenceType': 'result',\n", + " 'ReferenceCitation': 'Mabeza GF, Loyevsky M, Gordeuk VR, Weiss G. Iron chelation therapy for malaria: a review. Pharmacol Ther. 1999 Jan;81(1):53-75. Review.'},\n", + " {'ReferencePMID': '8067783',\n", + " 'ReferenceType': 'result',\n", + " 'ReferenceCitation': 'Weinberg GA. Iron chelators as therapeutic agents against Pneumocystis carinii. Antimicrob Agents Chemother. 1994 May;38(5):997-1003.'},\n", + " {'ReferencePMID': '18369153',\n", + " 'ReferenceType': 'result',\n", + " 'ReferenceCitation': 'Paradkar PN, De Domenico I, Durchfort N, Zohn I, Kaplan J, Ward DM. Iron depletion limits intracellular bacterial growth in macrophages. Blood. 2008 Aug 1;112(3):866-74. doi: 10.1182/blood-2007-12-126854. Epub 2008 Mar 27.'},\n", + " {'ReferencePMID': '29719970',\n", + " 'ReferenceType': 'result',\n", + " 'ReferenceCitation': 'Giannakopoulou E, Pardali V, Zoidis G. Metal-chelating agents against viruses and parasites. Future Med Chem. 2018 Jun 1;10(11):1283-1285. doi: 10.4155/fmc-2018-0100. Epub 2018 May 3. Review.'},\n", + " {'ReferencePMID': '1406879',\n", + " 'ReferenceType': 'result',\n", + " 'ReferenceCitation': 'Gordeuk V, Thuma P, Brittenham G, McLaren C, Parry D, Backenstose A, Biemba G, Msiska R, Holmes L, McKinley E, et al. Effect of iron chelation therapy on recovery from deep coma in children with cerebral malaria. N Engl J Med. 1992 Nov 19;327(21):1473-7.'},\n", + " {'ReferencePMID': '28583206',\n", + " 'ReferenceType': 'result',\n", + " 'ReferenceCitation': 'Duchemin JB, Paradkar PN. Iron availability affects West Nile virus infection in its mosquito vector. Virol J. 2017 Jun 5;14(1):103. doi: 10.1186/s12985-017-0770-0.'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000003676',\n", + " 'InterventionMeshTerm': 'Deferoxamine'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000017262',\n", + " 'InterventionAncestorTerm': 'Siderophores'},\n", + " {'InterventionAncestorId': 'D000007502',\n", + " 'InterventionAncestorTerm': 'Iron Chelating Agents'},\n", + " {'InterventionAncestorId': 'D000002614',\n", + " 'InterventionAncestorTerm': 'Chelating Agents'},\n", + " {'InterventionAncestorId': 'D000064449',\n", + " 'InterventionAncestorTerm': 'Sequestering Agents'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M5461',\n", + " 'InterventionBrowseLeafName': 'Deferoxamine',\n", + " 'InterventionBrowseLeafAsFound': 'Deferoxamine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M9116',\n", + " 'InterventionBrowseLeafName': 'Iron',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M4443',\n", + " 'InterventionBrowseLeafName': 'Chelating Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M18141',\n", + " 'InterventionBrowseLeafName': 'Siderophores',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M9117',\n", + " 'InterventionBrowseLeafName': 'Iron Chelating Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", + " {'InterventionBrowseBranchAbbrev': 'Micro',\n", + " 'InterventionBrowseBranchName': 'Micronutrients'}]}}}}},\n", + " {'Rank': 55,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04318444',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'AAAS9676'},\n", + " 'Organization': {'OrgFullName': 'Columbia University',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Hydroxychloroquine Post Exposure Prophylaxis for Coronavirus Disease (COVID-19)',\n", + " 'OfficialTitle': 'Hydroxychloroquine Post Exposure Prophylaxis (PEP) for Household Contacts of COVID-19 Patients: A NYC Community-Based Randomized Clinical Trial'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 2021',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'March 2022',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 20, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 20, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 24, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 24, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 25, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Elizabeth Oelsner',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Assistant Professor',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Columbia University'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Columbia University',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'Yes',\n", + " 'IsFDARegulatedDevice': 'No',\n", + " 'IsUSExport': 'Yes'},\n", + " 'DescriptionModule': {'BriefSummary': 'The purpose of this study is to test the hypothesis that post-exposure prophylaxis with hydroxychloroquine will reduce the symptomatic secondary attack rate among household contacts of known or suspected COVID-19 patients.',\n", + " 'DetailedDescription': 'COVID-19 is a massive threat to public health worldwide. Current estimates suggest that the novel coronavirus (SARS-CoV-2) is both highly contagious (estimated reproductive rate, 2-3) and five to fifty-fold more lethal than seasonal influenza (estimated mortality rate, 0.5-5%). Interventions to decrease the incidence and severity of COVID-19 are emergently needed.\\n\\nHydroxychloroquine (brand name, Plaquenil), an inexpensive anti-malarial medication with immunomodulatory effects, is a promising therapy for COVID-19. Chloroquine, a related compound with a less favorable toxicity profile, has shown benefit in clinical studies conducted in approximately one-hundred SARS-CoV-2 infected patients. In vitro, hydroxychloroquine has been recently shown to have greater efficacy against SARS-CoV-2 versus chloroquine.\\n\\nCurrently, there is no established post-exposure prophylaxis for persons at high risk of developing COVID-19. Hydroxychloroquine (brand name, Plaquenil), is a medicine that has been found to be effective against the novel coronavirus in some recent experiments. Previously, hydroxychloquine has been safety used to prevent malaria or to treat autoimmune diseases.\\n\\nThis study will test if hydroxychloroquine may be used to prevent the development of COVID-19 symptoms in persons who live with an individual who has been diagnosed with COVID-19. If hydroxychloroquine is shown to reduce the risk of developing symptoms of COVID-19 among people at high risk of infection, this could help to reduce the morbidity and mortality of the COVID-19 epidemic.\\n\\nThis is a trial of hydroxychloroquine PEP among adult household contacts of COVID-19 patients in New York City (NYC). The trial will be initiated at NewYork-Presbyterian (NYP)/Columbia University Irving Medical Center (CUIMC).'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", + " 'Corona Virus Infection']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 2', 'Phase 3']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Prevention',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Quadruple',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", + " 'Care Provider',\n", + " 'Investigator',\n", + " 'Outcomes Assessor']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '1600',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Hydroxychloroquine',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Two tablets (400mg) twice daily on day 1; for days 2-5, they will be instructed to take one tablet (200mg) twice daily.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine']}},\n", + " {'ArmGroupLabel': 'Placebo',\n", + " 'ArmGroupType': 'Placebo Comparator',\n", + " 'ArmGroupDescription': 'Two tablets (400mg) twice daily on day 1; for days 2-5, they will be instructed to take one tablet (200mg) twice daily.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo oral tablet']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Hydroxychloroquine',\n", + " 'InterventionDescription': 'Two tablets (400mg) twice daily on day 1; for days 2-5, they will be instructed to take one tablet (200mg) twice daily.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Hydroxychloroquine']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Plaquenil']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Placebo oral tablet',\n", + " 'InterventionDescription': 'Two tablets (400mg) twice daily on day 1; for days 2-5, they will be instructed to take one tablet (200mg) twice daily.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Placebo']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Number of participants with symptomatic, lab-confirmed COVID-19.',\n", + " 'PrimaryOutcomeDescription': 'This is defined as either 1. COVID-19 infection confirmed within 14 days of enrollment, following self-report of COVID-19 symptoms to the research study; OR, 2. COVID-19 infection confirmed within 14 days of enrollment, with self-report of COVID-19 symptoms to a treating physician.',\n", + " 'PrimaryOutcomeTimeFrame': 'Date of enrollment to 14 days post-enrollment date'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nHousehold contact of index case: currently residing in the same household as an individual evaluated at NYP via outpatient, emergency department (ED), or inpatient services who (1) test positive for COVID-19, or (2) are defined as suspected cases, or persons under investigations (PUI), by the treating physician.\\nWilling to take study drug as directed for 5 days.\\n\\nExclusion Criteria:\\n\\nAge <18 years old\\nSuspected or confirmed current COVID-19, defined as: (1) temperature > 38 Celsius; (2) cough; (3) shortness of breath; (4) sore throat; or, if available (not required), (5) positive confirmatory testing for COVID-19\\nSuspected or confirmed convalescent COVID-19, defined as any of the above symptoms within the prior 4 weeks.\\nInability to take medications orally\\nInability to provide written consent\\nKnown sensitivity/allergy to hydroxychloroquine\\nCurrent use of hydroxychloroquine for another indication\\nPregnancy\\nPrior diagnosis of retinopathy\\nPrior diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency\\nMajor comorbidities increasing risk of study drug including: i. Hematologic malignancy, ii. Advanced (stage 4-5) chronic kidney disease or dialysis therapy, iii. Known history of ventricular arrhythmias, iv. Current use of drugs that prolong the QT interval',\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Elizabeth Oelsner, MD, MPH',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '212-305-9056',\n", + " 'CentralContactEMail': 'eco7@cumc.columbia.edu'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Elizabeth Oelsner, MD, MPH',\n", + " 'OverallOfficialAffiliation': 'Columbia University Irving Medical Center',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Columbia University Irving Medical Center',\n", + " 'LocationCity': 'New York',\n", + " 'LocationState': 'New York',\n", + " 'LocationZip': '10032',\n", + " 'LocationCountry': 'United States'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", + " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", + " 'InterventionAncestorTerm': 'Antimalarials'},\n", + " {'InterventionAncestorId': 'D000000981',\n", + " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", + " {'InterventionAncestorId': 'D000000977',\n", + " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", + " {'InterventionAncestorId': 'D000000890',\n", + " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", + " {'InterventionAncestorId': 'D000004791',\n", + " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000018501',\n", + " 'InterventionAncestorTerm': 'Antirheumatic Agents'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", + " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M2861',\n", + " 'InterventionBrowseLeafName': 'Antimalarials',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2879',\n", + " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2875',\n", + " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2795',\n", + " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19188',\n", + " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", + " {'ConditionMeshId': 'D000045169',\n", + " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'},\n", + " {'ConditionMeshId': 'D000014777',\n", + " 'ConditionMeshTerm': 'Virus Diseases'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Corona Virus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Corona Virus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafAsFound': 'Virus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M14938',\n", + " 'ConditionBrowseLeafName': 'Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Corona Virus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 56,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04326920',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'SARPAC'},\n", + " 'Organization': {'OrgFullName': 'University Hospital, Ghent',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Sargramostim in Patients With Acute Hypoxic Respiratory Failure Due to COVID-19 (SARPAC)',\n", + " 'OfficialTitle': 'A Prospective, Randomized, Open-label, Interventional Study to Investigate the Efficacy of Sargramostim (Leukine®) in Improving Oxygenation and Short- and Long-term Outcome of COVID-19 (Corona Virus Disease) Patients With Acute Hypoxic Respiratory Failure.',\n", + " 'Acronym': 'SARPAC'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 24, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'October 31, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 24, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 27, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 30, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 31, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Bart N. Lambrecht',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Director, VIB-UGent Center for Inflammation Research',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'University Hospital, Ghent'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'University Hospital, Ghent',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Flanders Institute of Biotechnology',\n", + " 'CollaboratorClass': 'UNKNOWN'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'Yes',\n", + " 'IsFDARegulatedDevice': 'No',\n", + " 'IsUSExport': 'Yes'},\n", + " 'DescriptionModule': {'BriefSummary': 'Phase IV study to evaluate the effectiveness of additional inhaled sargramostim (GM-CSF) versus standard of care on blood oxygenation in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure.',\n", + " 'DetailedDescription': \"Leukine® is a yeast-derived recombinant humanized granulocyte-macrophage colony stimulating factor (rhuGM-CSF, sargramostim) and the only FDA approved GM-CSF. GMCSF, a pleiotropic cytokine, is an important leukocyte growth factor known to play a key role in hematopoiesis, effecting the growth and maturation of multiple cell lineages as well as the functional activities of these cells in antigen presentation and cell mediated immunity.\\n\\nLeukine inhalation or intravenous administration, as an adjuvant therapy, may confer benefit to patients with ARDS (Acute Respiratory Distress Syndrome) due to COVID-19 exposure, who are at significant risk of mortality. While there is no active IND (Investigational New Drug) for Leukine in the proposed patient population, Leukine is being studied in Fase II as an adjuvant therapy in the management of life-threatening infections to boost the hosts innate immune response to fight infection, reduce the risk of secondary infection, and in varied conditions as prevention of infection during critical illness. Inhaled Leukine has also been successfully used as primary therapy to improve oxygenation in patients with disordered gas exchange in the lungs. We propose that based on preclinical and clinical data, Leukine inhalation, as an adjuvant therapy, has an acceptable benefit-risk for use in patients with hypoxic respiratory failure and ARDS due to COVID-19 exposure, who are at significant risk of mortality.\\n\\nConfirmed COVID19 patients with hypoxic respiratory failure (saturation below 93% on minimal 2 l/min O2) will be randomized to receive sargramostim 125mcg twice daily for 5 days as a nebulized inhalation on top of standard of care, or to receive standard of care treatment. Upon progression to ARDS and initiation of invasive mechanical ventilator support within the 5 day period, in patients in the active group, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment. In the control group progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, the treating physician will have the option to initiate IV sargramostim 125mcg/m2 body surface area for 5 days. Safety data, including blood leukocyte counts, will be collected in all patients. Efficacy data will also be collected and will include arterial blood gases, oxygenation parameters, need for ventilation, lung compliance, organ function, radiographic changes, ferritin levels, etc. as well as occurrence of secondary bacterial infections.\"},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", + " 'KeywordList': {'Keyword': ['GM-CSF',\n", + " 'Acute Lung Injury',\n", + " 'Hypoxia',\n", + " 'Acute Respiratory Distress Syndrome',\n", + " 'Corona virus',\n", + " 'COVID-19',\n", + " 'SARS (Severe Acute Respiratory Syndrome)',\n", + " 'Alveolar Macrophage',\n", + " 'Acute Hypoxic respiratory failure']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 4']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '80',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Active sargramostim treatment group',\n", + " 'ArmGroupType': 'Active Comparator',\n", + " 'ArmGroupDescription': \"Inhaled sargramostim 125mcg twice daily for 5 days on top of standard of care. Upon progression to ARDS and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment\",\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Sargramostim']}},\n", + " {'ArmGroupLabel': 'Control group',\n", + " 'ArmGroupType': 'Placebo Comparator',\n", + " 'ArmGroupDescription': \"standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, will have the option (clinician's decision) to initiate IV sargramostim 125mcg/m2 body surface area once daily for 5 days\",\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Sargramostim',\n", + " 'Other: Control']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Sargramostim',\n", + " 'InterventionDescription': 'Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Active sargramostim treatment group',\n", + " 'Control group']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['LEUKINE']}},\n", + " {'InterventionType': 'Other',\n", + " 'InterventionName': 'Control',\n", + " 'InterventionDescription': 'Standard of care',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Control group']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Improvement in oxygenation at a dose of 250 mcg daily during 5 days improves oxygenation in COVID-19 patients with acute hypoxic respiratory failure',\n", + " 'PrimaryOutcomeDescription': 'by mean change in PaO2/FiO2 (PaO2=Partial pressure of oxygen; FiO2= Fraction of inspired oxygen)',\n", + " 'PrimaryOutcomeTimeFrame': 'at end of 5 day treatment period'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Incidence of AE (Adverse Event)',\n", + " 'SecondaryOutcomeTimeFrame': 'at end of 5 day treatment period, 10 day period, 10-20 weeks'},\n", + " {'SecondaryOutcomeMeasure': 'Incidence of SAEs (Serious Adverse Event)',\n", + " 'SecondaryOutcomeTimeFrame': 'at end of 5 day treatment period, 10 day period, 10-20 weeks'},\n", + " {'SecondaryOutcomeMeasure': 'Clinical Status using 6-point ordinal scale',\n", + " 'SecondaryOutcomeTimeFrame': 'at end of 5 day treatment period, 10 day period, 10-20 weeks'},\n", + " {'SecondaryOutcomeMeasure': 'Clinical Status using Clincal sign score',\n", + " 'SecondaryOutcomeTimeFrame': 'at end of 5 day treatment period, 10 day period,10-20 weeks'},\n", + " {'SecondaryOutcomeMeasure': 'Clinical Status using SOFA score (Sequential Organ Failure Assessment score),',\n", + " 'SecondaryOutcomeTimeFrame': 'at end of 5 day treatment period, 10 day period, 10-20 weeks'},\n", + " {'SecondaryOutcomeMeasure': 'Clinical Status using NEWS2 score (National Early Warning Score)',\n", + " 'SecondaryOutcomeTimeFrame': 'at end of 5 day treatment period, 10 day period, 10-20 weeks'},\n", + " {'SecondaryOutcomeMeasure': 'incidence of severe or life-threatening bacterial, invasive fungal or opportunistic infection',\n", + " 'SecondaryOutcomeDescription': 'demonstrated by bacterial or fungal culture',\n", + " 'SecondaryOutcomeTimeFrame': 'during hospital admission (up to 28 days)'},\n", + " {'SecondaryOutcomeMeasure': 'number of patients requiring initiation of mechanical ventilation',\n", + " 'SecondaryOutcomeTimeFrame': 'during hospital admission (up to 28 days)'},\n", + " {'SecondaryOutcomeMeasure': 'Number of deaths due to any cause at 4 weeks',\n", + " 'SecondaryOutcomeTimeFrame': '4 weeks post inclusion'},\n", + " {'SecondaryOutcomeMeasure': 'Number of deaths due to any cause at 20 weeks',\n", + " 'SecondaryOutcomeTimeFrame': '20 weeks post inclusion'},\n", + " {'SecondaryOutcomeMeasure': 'number of patients developing features of secondary haemophagocytic lymphohistiocytosis',\n", + " 'SecondaryOutcomeDescription': 'defined by HS (Hemophagocytic Syndrome) score',\n", + " 'SecondaryOutcomeTimeFrame': 'at enrolment, end of 5 day treatment period, 10 day period, 10-20 weeks'},\n", + " {'SecondaryOutcomeMeasure': 'long term Clinical status defined by 6-point ordinal scale',\n", + " 'SecondaryOutcomeTimeFrame': '10-20 week'},\n", + " {'SecondaryOutcomeMeasure': 'long term Clinical status defined by chest X-ray',\n", + " 'SecondaryOutcomeTimeFrame': '10-20 weeks'},\n", + " {'SecondaryOutcomeMeasure': 'long term Clinical status defined lung function',\n", + " 'SecondaryOutcomeTimeFrame': '10-12 weeks'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nRecent (≤2weeks prior to randomization) PCR(Polymerase Chain Reaction) -Confirmed COVID-19 infection\\n\\nPresence of acute hypoxic respiratory failure defined as (either or both)\\n\\nsaturation below 93% on minimal 2 l/min O2\\nPaO2/FiO2 below 300\\nAdmitted to specialized COVID-19 ward\\nAge 18-80\\nMale or Female\\nWilling to provide informed consent\\n\\nExclusion Criteria:\\n\\nPatients with known history of serious allergic reactions, including anaphylaxis, to human granulocyte-macrophage colony stimulating factor such as sargramostim, yeast-derived products, or any component of the product.\\nmechanical ventilation before start of study\\npatients with peripheral white blood cell count above 25.000 per microliter and/or active myeloid malignancy\\npatients on high dose systemic steroids (> 20 mg methylprednisolone or equivalent)\\npatients on lithium carbonate therapy\\nPatients enrolled in another investigational drug study\\nPregnant or breastfeeding females (all female subjects regardless of childbearing potential status must have negative pregnancy test at screening)\\nPatients with serum ferritin >2000 mcg/ml (which will exclude ongoing HLH)',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '80 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Anja Delporte',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+32-9-3320228',\n", + " 'CentralContactEMail': 'anja.delporte@uzgent.be'},\n", + " {'CentralContactName': 'Bart Lambrecht, MD PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+32-9-3329110',\n", + " 'CentralContactEMail': 'bart.lambrecht@ugent.be'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Bart Lambrecht',\n", + " 'OverallOfficialAffiliation': 'University Hospital, Ghent',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'AZ Sint Jan Brugge',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Brugge',\n", + " 'LocationZip': '8000',\n", + " 'LocationCountry': 'Belgium',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Stefaan Vandecasteele, MD Phd',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+32-50 45 23 10',\n", + " 'LocationContactEMail': 'stefaan.vandecasteele@azsintjan.be'}]}},\n", + " {'LocationFacility': 'University Hospital Ghent',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Gent',\n", + " 'LocationZip': '9000',\n", + " 'LocationCountry': 'Belgium',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Anja Delporte',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+32-9-3320228',\n", + " 'LocationContactEMail': 'anja.delporte@uzgent.be'},\n", + " {'LocationContactName': 'Bart Lambrecht, MD PhD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+32-9-3329110',\n", + " 'LocationContactEMail': 'bart.lambrecht@ugent.be'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020',\n", + " 'RemovedCountryList': {'RemovedCountry': ['Italy']}},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'C000081222',\n", + " 'InterventionMeshTerm': 'Sargramostim'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000007155',\n", + " 'InterventionAncestorTerm': 'Immunologic Factors'},\n", + " {'InterventionAncestorId': 'D000045505',\n", + " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M267719',\n", + " 'InterventionBrowseLeafName': 'Sargramostim',\n", + " 'InterventionBrowseLeafAsFound': 'Sargramostim',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M8784',\n", + " 'InterventionBrowseLeafName': 'Immunologic Factors',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000012131',\n", + " 'ConditionMeshTerm': 'Respiratory Insufficiency'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000012120',\n", + " 'ConditionAncestorTerm': 'Respiration Disorders'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M14938',\n", + " 'ConditionBrowseLeafName': 'Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13547',\n", + " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Newborn',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13548',\n", + " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Adult',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M26731',\n", + " 'ConditionBrowseLeafName': 'Acute Lung Injury',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13551',\n", + " 'ConditionBrowseLeafName': 'Respiratory Insufficiency',\n", + " 'ConditionBrowseLeafAsFound': 'Respiratory Failure',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M26730',\n", + " 'ConditionBrowseLeafName': 'Lung Injury',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M2766',\n", + " 'ConditionBrowseLeafName': 'Hypoxia',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13102',\n", + " 'ConditionBrowseLeafName': 'Pulmonary Valve Insufficiency',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13540',\n", + " 'ConditionBrowseLeafName': 'Respiration Disorders',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T4953',\n", + " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Infant',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T191',\n", + " 'ConditionBrowseLeafName': 'Acute Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC16',\n", + " 'ConditionBrowseBranchName': 'Diseases and Abnormalities at or Before Birth'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC26',\n", + " 'ConditionBrowseBranchName': 'Wounds and Injuries'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC14',\n", + " 'ConditionBrowseBranchName': 'Heart and Blood Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 57,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04324866',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'Gisondi 4'},\n", + " 'Organization': {'OrgFullName': 'Universita di Verona',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Prevalence and Incidence of COVID-19 Infection in Patients With Chronic Plaque Psoriasis on Immunosuppressant Therapy',\n", + " 'OfficialTitle': 'Prevalence and Incidence of COVID-19 Infection in Patients With Chronic Plaque Psoriasis on Immunosuppressant Therapy'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'November 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'December 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 24, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 26, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 27, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 26, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 27, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Paolo Gisondi',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Associate Professor',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Universita di Verona'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Universita di Verona',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Azienda Ospedaliera Universitaria Integrata Verona',\n", + " 'CollaboratorClass': 'OTHER'}]}},\n", + " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'This study will assess the prevalence and incidence of COVID-19 infection in patients with chronic plaque psoriasis on immunosuppressant therapy.',\n", + " 'DetailedDescription': 'The ongoing COVID-19 pandemic has hit Northern Italy (including the Veneto region) particularly hard, causing several deaths and putting a huge strain on the Italian National Healthcare System. In the absence of specific treatments, preventing the infection from spreading remains the only effective measure. There is a lot of apprehension both from doctors (including dermatologists, rheumatologists and gastroenterologists) and their patients that immunosuppressive medications (biologics, methotrexate, ciclosporin and corticosteroids) might lead to an increased susceptibility to COVID-19 infection or negatively influence the course of the infection. However, there is currently a lack of scientific evidence to recommend whether immunosuppressive treatments should or should not be continued in patients who have no symptoms of COVID-19 infection. Besides, treatment discontinuation would cause flare-ups of diseases - such as plaque psoriasis, psoriatic arthritis and inflammatory bowel diseases - which are invalidating and have a relatively high prevalence in the Veneto population. In the Unit of Dermatology of the Azienda Ospedaliera Universitaria Intergrata di Verona alone, more than 2000 patients are currently being treated with immunosuppressive agents. As of now, there are no data available on the prevalence and incidence of COVID-19 infection in patients with immune-mediated diseases, nor can data from randomized clinical trials be extrapolated to the susceptibility to COVID-19 infection in patients on biologic drugs. This study aims to assess the prevalence and incidence of COVID-19 infection in patients with chronic plaque psoriasis on immunosuppressive therapy and to identify associated risk factors. Such data would prove invaluable for clinicians dealing with patients on immunosuppressive agents during the coronavirus outbreak.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus Infection']},\n", + " 'KeywordList': {'Keyword': ['psoriasis',\n", + " 'immunosuppressant therapy',\n", + " 'covid 19']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'BioSpec': {'BioSpecRetention': 'Samples Without DNA',\n", + " 'BioSpecDescription': 'Nasopharyngeal swabs'},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '300',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Group 1',\n", + " 'ArmGroupDescription': 'Patients with chronic plaque psoriasis on immunosuppressant therapy',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Diagnostic Test: Nasopharyngeal swab']}},\n", + " {'ArmGroupLabel': 'Group 2',\n", + " 'ArmGroupDescription': \"Psoriatic patients' partners\",\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Diagnostic Test: Nasopharyngeal swab']}},\n", + " {'ArmGroupLabel': 'Group 3',\n", + " 'ArmGroupDescription': 'Patients with atopic dermatitis treated with dupilumab',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Diagnostic Test: Nasopharyngeal swab']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Diagnostic Test',\n", + " 'InterventionName': 'Nasopharyngeal swab',\n", + " 'InterventionDescription': 'Nasopharyngeal swab for the molecular diagnosis of COVID-19 infection',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Group 1',\n", + " 'Group 2',\n", + " 'Group 3']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Point prevalence of COVID-19 infection',\n", + " 'PrimaryOutcomeTimeFrame': 'Baseline up to 6 months'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Incidence of COVID-19 infection',\n", + " 'SecondaryOutcomeTimeFrame': 'Baseline up to 6 months'},\n", + " {'SecondaryOutcomeMeasure': 'Percentage of subjects presenting fever or respiratory symptoms',\n", + " 'SecondaryOutcomeTimeFrame': 'Baseline up to 6 months'},\n", + " {'SecondaryOutcomeMeasure': 'Evaluate the relationship between COVID-19 infection and chronic pharmacological treatments',\n", + " 'SecondaryOutcomeTimeFrame': 'Baseline up to 6 months'},\n", + " {'SecondaryOutcomeMeasure': 'Evaluate the relationship between COVID-19 infection and comorbid medical conditions',\n", + " 'SecondaryOutcomeTimeFrame': 'Baseline up to 6 months'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Group 1\\n\\nInclusion Criteria:\\n\\nAged 18 to 75 years old\\nIndividuals with a clinical diagnosis of moderate-to-severe chronic plaque psoriasis confirmed by the Investigator\\nContinuous immunosuppressive therapy (etanercept, adalimumab, infliximab, ustekinumab, secukinumab, ixekizumab, brodalumab, guselkumab, apremilast, methotrexate, ciclsoporin, acitretin) for the past 3 months\\nIs willing and able to sign informed consent to participate\\n\\nExclusion Criteria:\\n\\nPatients unwilling to undergo noasopharyngeal swab\\nInability to give informed consent\\n\\nGroup 2\\n\\nInclusion Criteria:\\n\\nAged 18 to 75 years old\\nPartner of a patient with psoriasis enrolled in the study\\nIs willing and able to sign informed consent to participate\\n\\nExclusion Criteria:\\n\\nPersonal history of psoriasis\\nOngoing immunosuppressive therapy\\nPatients unwilling to undergo noasopharyngeal swab\\nInability to give informed consent\\n\\nGroup 3\\n\\nAged 18 to 75 years old\\nIndividuals with a clinical diagnosis of moderate-to-severe atopic dermatitis confirmed by the Investigator\\nContinuous therapy with dupilumab for the past 3 months\\nIs willing and able to sign informed consent to participate\\n\\nExclusion Criteria:\\n\\nPatients unwilling to undergo noasopharyngeal swab\\nInability to give informed consent',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '75 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'This study will enroll patients from the Unit of Dermatology of Azienda Ospedaliera Universitaria di Verona and their partners.',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Paolo Gisondi',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+39 0458122547',\n", + " 'CentralContactEMail': 'paolo.gisondi@univr.it'}]}}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000007166',\n", + " 'InterventionMeshTerm': 'Immunosuppressive Agents'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000007155',\n", + " 'InterventionAncestorTerm': 'Immunologic Factors'},\n", + " {'InterventionAncestorId': 'D000045505',\n", + " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8795',\n", + " 'InterventionBrowseLeafName': 'Immunosuppressive Agents',\n", + " 'InterventionBrowseLeafAsFound': 'Immunosuppressant',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M8784',\n", + " 'InterventionBrowseLeafName': 'Immunologic Factors',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", + " 'ConditionMeshTerm': 'Infection'},\n", + " {'ConditionMeshId': 'D000003141',\n", + " 'ConditionMeshTerm': 'Communicable Diseases'},\n", + " {'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", + " {'ConditionMeshId': 'D000045169',\n", + " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'},\n", + " {'ConditionMeshId': 'D000011565', 'ConditionMeshTerm': 'Psoriasis'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000017444',\n", + " 'ConditionAncestorTerm': 'Skin Diseases, Papulosquamous'},\n", + " {'ConditionAncestorId': 'D000012871',\n", + " 'ConditionAncestorTerm': 'Skin Diseases'},\n", + " {'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafAsFound': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafAsFound': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M13005',\n", + " 'ConditionBrowseLeafName': 'Psoriasis',\n", + " 'ConditionBrowseLeafAsFound': 'Psoriasis',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M14938',\n", + " 'ConditionBrowseLeafName': 'Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M14257',\n", + " 'ConditionBrowseLeafName': 'Skin Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M18296',\n", + " 'ConditionBrowseLeafName': 'Skin Diseases, Papulosquamous',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC17',\n", + " 'ConditionBrowseBranchName': 'Skin and Connective Tissue Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 58,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04275947',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'CAALC-008-CMHS'},\n", + " 'Organization': {'OrgFullName': 'Chinese Alliance Against Lung Cancer',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'The COVID-19 Mobile Health Study (CMHS)',\n", + " 'OfficialTitle': 'The COVID-19 Mobile Health Study, a Large-scale Clinical Observational Study Using nCapp',\n", + " 'Acronym': 'CMHS'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'February 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'February 14, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 30, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'May 31, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'February 17, 2020',\n", + " 'StudyFirstSubmitQCDate': 'February 17, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'February 19, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'February 17, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'February 19, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Bai Chunxue',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Chair',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Chinese Alliance Against Lung Cancer'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Chinese Alliance Against Lung Cancer',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Shanghai Respiratory Research Institution',\n", + " 'CollaboratorClass': 'UNKNOWN'}]}},\n", + " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'This study evaluates a brand-new cell phone-based auto-diagnosis system, which is based on the clinical guidelines, clinical experience, and statistic training model. We will achieve secure and 1st hand data from physicians in Wuhan, which including 150 cases in the training cohort and 300 cases in the validation cohort.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '450',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Training',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: nCapp, a cell phone-based auto-diagnosis system']}},\n", + " {'ArmGroupLabel': 'Validation',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: nCapp, a cell phone-based auto-diagnosis system']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", + " 'InterventionName': 'nCapp, a cell phone-based auto-diagnosis system',\n", + " 'InterventionDescription': 'Combined with 15 questions online, and a predicated formula to auto-diagnosis of the risk of COVID-19',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Training',\n", + " 'Validation']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Accuracy of nCapp COVID-19 risk diagnostic model',\n", + " 'PrimaryOutcomeDescription': 'Sensitivity, specificity and area under the ROC curve of nCapp model',\n", + " 'PrimaryOutcomeTimeFrame': '1 day'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nHigh risk of COVID-19\\nRT-PCR test result of SAR2-CoV-19\\n\\nExclusion Criteria:\\n\\nNot available for RT-PCR test result of SAR2-CoV-19',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '90 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': '-High risk of COVID-19',\n", + " 'SamplingMethod': 'Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Chunxue Bai',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+8618621170011\\u202c',\n", + " 'CentralContactEMail': 'bai.chunxue@zs-hospital.sh.cn'},\n", + " {'CentralContactName': 'Dawei Yang',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+8613564703813',\n", + " 'CentralContactEMail': 'yang.dawei@zs-hospital.sh.cn'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Chunxue Bai',\n", + " 'OverallOfficialAffiliation': 'Shanghai Respiratory Research Institution',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Renmin Hospital of Wuhan University',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Wuhan',\n", + " 'LocationState': 'Hubei',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Chunxue Bai',\n", + " 'LocationContactRole': 'Contact'},\n", + " {'LocationContactName': 'Xun Wang',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Jie Liu',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Chunlin Dong',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Yong Zhang',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Maosong Ye',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Chunxue Bai',\n", + " 'LocationContactRole': 'Principal Investigator'}]}}]}},\n", + " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '28940455',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Yang D, Zhang X, Powell CA, Ni J, Wang B, Zhang J, Zhang Y, Wang L, Xu Z, Zhang L, Wu G, Song Y, Tian W, Hu JA, Zhang Y, Hu J, Hong Q, Song Y, Zhou J, Bai C. Probability of cancer in high-risk patients predicted by the protein-based lung cancer biomarker panel in China: LCBP study. Cancer. 2018 Jan 15;124(2):262-270. doi: 10.1002/cncr.31020. Epub 2017 Sep 20.'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided',\n", + " 'IPDSharingDescription': 'The anonymous clinical data for training and validation the model'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'}}}},\n", + " {'Rank': 59,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04330144',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '3-2020-0036'},\n", + " 'Organization': {'OrgFullName': 'Gangnam Severance Hospital',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial)',\n", + " 'OfficialTitle': 'A Study of Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial)'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 30, 2021',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'March 30, 2022',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 30, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 31, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 31, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Young Goo Song',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Professor, Department of Internal Medicine,',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Gangnam Severance Hospital'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Gangnam Severance Hospital',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No',\n", + " 'IsUSExport': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'There is no known definite treatment after exposure to SARS-CoV-2, but the some animal and clinical trials confirmed the efficacy of hydroxychloroquine (HCQ) or chloroquine against SARS-CoV-2. Thus, in this study, we aim to evaluate the efficacy and safety of hydroxychloroquine as post exposure prophylaxis for SARS-CoV-2.\\n\\nPrimary end point: comparison the rate of COVID-19 between PEP with HCQ and control group.\\nSecondary end point: Comparison of the rate of COVID-19 according to the contact level (time, place, degree of wearing personal protective equipment).\\nSafety comparison: Safety verification by identifying major side effects in the HCQ group.\"'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Contact Person From COVID-19 Confirmed Patient']},\n", + " 'KeywordList': {'Keyword': ['Postexposure prophylaxis',\n", + " 'hydroxychloroquine',\n", + " 'SARS-CoV-2',\n", + " 'COVID-19']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 3']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Prevention',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Single',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Outcomes Assessor']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '2486',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'administration of hydroxychloroquine as PEP',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine as post exposure prophylaxis']}},\n", + " {'ArmGroupLabel': 'control with no PEP',\n", + " 'ArmGroupType': 'Active Comparator',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: Others(No intervention)']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Hydroxychloroquine as post exposure prophylaxis',\n", + " 'InterventionDescription': '1day: Hydroxychloroquine 800mg Qd po 2-5dy: Hydroxychloroquine 400mg Qd po',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['administration of hydroxychloroquine as PEP']}},\n", + " {'InterventionType': 'Other',\n", + " 'InterventionName': 'Others(No intervention)',\n", + " 'InterventionDescription': 'No treatment. Close monitoring and quarantine.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['control with no PEP']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'The rate of COVID-19',\n", + " 'PrimaryOutcomeDescription': 'After postexposure prophylaxis, the rate of COVID-19 conversion between two groups',\n", + " 'PrimaryOutcomeTimeFrame': 'PCR test of COVID-19 at 14 days after the contact from confirmed case'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nA contact person from confirmed case of SARS-CoV-2 infection\\nMedical staff exposed from confirmed case of SARS-CoV-2 infection in hospitals\\n\\nPersons exposed to SARS-CoV-2 in COVID-19 outbreak situation with certain workplaces, religious groups, and military, etc.\\n\\nSubjects of study include both symptomatic and asymptomatic contacts.\\n\\nExclusion Criteria:\\n\\nHypersensitivity to Chloroquine or Hydroxychloroquine\\nThose who are contraindicated in Hydroxychloroquine administration according to the permission requirements such as pregnant women, nursing mothers, visual disorders, macular disease, and porphyria, etc.\\nHuman immunodeficiency virus (HIV) infected person\\nPatients with autoimmune disease (Systemic lupus erythematosus, Mixed connective tissue disease)\\nPatients with autoimmune rheumatoid inflammatory disease (AIIRD; Autoimmune inflammatory rheumatic diseases - Ankylosing spondylitis, Rheumatic arthritis, Psoriatic arthritis)\\nArrhythmia, liver cirrhosis of Child Pugh C, chronic renal failure with eGFR≤30mL / min / 1.73m2\\nA person who is positive in the COVID-19 screening PCR test before starting PEP',\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '99 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Yong Goo Song, Professor',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '82-2-2019-3310',\n", + " 'CentralContactPhoneExt': '3310',\n", + " 'CentralContactEMail': 'imfell@yuhs.ac'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Yong Goo Song, Professor',\n", + " 'OverallOfficialAffiliation': 'Gangnam Severance Hospital',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]}}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", + " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", + " 'InterventionAncestorTerm': 'Antimalarials'},\n", + " {'InterventionAncestorId': 'D000000981',\n", + " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", + " {'InterventionAncestorId': 'D000000977',\n", + " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", + " {'InterventionAncestorId': 'D000000890',\n", + " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", + " {'InterventionAncestorId': 'D000004791',\n", + " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000018501',\n", + " 'InterventionAncestorTerm': 'Antirheumatic Agents'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", + " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M2861',\n", + " 'InterventionBrowseLeafName': 'Antimalarials',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2879',\n", + " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2875',\n", + " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2795',\n", + " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19188',\n", + " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}}}}},\n", + " {'Rank': 60,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04327206',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '62586'},\n", + " 'Organization': {'OrgFullName': 'Murdoch Childrens Research Institute',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'BCG Vaccination to Protect Healthcare Workers Against COVID-19',\n", + " 'OfficialTitle': 'BCG Vaccination to Reduce the Impact of COVID-19 in Australian Healthcare Workers Following Coronavirus Exposure (BRACE) Trial',\n", + " 'Acronym': 'BRACE'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 30, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'October 30, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'March 30, 2022',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 25, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 27, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 31, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Murdoch Childrens Research Institute',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': \"Royal Children's Hospital\",\n", + " 'CollaboratorClass': 'OTHER'}]}},\n", + " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Open label, two-group, phase III randomised controlled trial in up to 4170 healthcare workers to determine if BCG vaccination reduces the incidence and severity of COVID-19 during the 2020 pandemic.',\n", + " 'DetailedDescription': 'Healthcare workers are at the frontline of the coronavirus disease (COVID-19) pandemic. Participants will be healthcare workers in Australian hospital sites. They will be randomised to receive a single dose of BCG vaccine, or no BCG vaccine. Participants will be followed-up for 12 months with regular mobile phone text messages (up to weekly) and surveys to identify and detail COVID-19 infection. Additional information on severe disease will be obtained from hospital medical records and government databases. Blood samples will be collected prior to randomisation and at 12 months to determine exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Where required, swab/blood samples will be taken at illness episodes to assess SARS-CoV-2 infection.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus Disease 2019 (COVID-19)',\n", + " 'Febrile Respiratory Illness',\n", + " 'Corona Virus Infection',\n", + " 'COVID-19']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 3']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignInterventionModelDescription': 'Phase III, two group, multicentre, open label randomised controlled trial',\n", + " 'DesignPrimaryPurpose': 'Prevention',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '4170',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'BCG vaccine',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Participants will receive a single dose of BCG vaccine (BCG-Denmark). The adult dose of BCG vaccine is 0.1 mL injected intradermally over the distal insertion of the deltoid muscle onto the humerus (approximately one third down the upper arm).',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: BCG Vaccine']}},\n", + " {'ArmGroupLabel': 'No BCG vaccine',\n", + " 'ArmGroupType': 'No Intervention',\n", + " 'ArmGroupDescription': 'Participants will not receive the BCG vaccine.'}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'BCG Vaccine',\n", + " 'InterventionDescription': 'Freeze-dried powder: Live attenuated strain of Mycobacterium bovis (BCG), Danish strain 1331.\\n\\nEach 0.1 ml vaccine contains between 200000 to 800000 colony forming units. Adult dose is 0.1 ml given by intradermal injection',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['BCG vaccine']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Bacille Calmette-Guerin Vaccine',\n", + " 'Bacillus Calmette-Guerin Vaccine',\n", + " 'Statens Serum Institute BCG vaccine',\n", + " 'Mycobacterium bovis BCG (Bacille Calmette Guérin), Danish Strain 1331',\n", + " 'BCG Denmark']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'COVID-19 disease incidence',\n", + " 'PrimaryOutcomeDescription': 'Number of participants with COVID-19 disease defined as\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus\\npositive SARS-Cov-2 test (PCR or serology)',\n", + " 'PrimaryOutcomeTimeFrame': 'Measured over the 6 months following randomisation'},\n", + " {'PrimaryOutcomeMeasure': 'Severe COVID-19 disease incidence',\n", + " 'PrimaryOutcomeDescription': 'Number of participants who were admitted to hospital or died (using self-reported questionnaire and/or medical/hospital records) in the context of a positive SARS-CoV-2 test',\n", + " 'PrimaryOutcomeTimeFrame': 'Measured over the 6 months following randomisation'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'COVID-19 incidence by 12 months',\n", + " 'SecondaryOutcomeDescription': 'Number of participants with COVID-19 disease defined as\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus\\npositive SARS-Cov-2 test (PCR or serology)',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Severe COVID-19 incidence by 12 months',\n", + " 'SecondaryOutcomeDescription': 'Number of participants with severe COVID-19 disease defined as hospitalisation or death in the context of a positive SARS-Cov-2 test (PCR or serology)',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Time to first symptom of COVID-19',\n", + " 'SecondaryOutcomeDescription': 'Time to first symptom of COVID-19 in a participant who subsequently meets the case definition:\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus\\npositive SARS-Cov-2 test (PCR or serology)',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Episodes of COVID-19',\n", + " 'SecondaryOutcomeDescription': 'Number of episodes of COVID-19 disease defined as\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus\\npositive SARS-Cov-2 test (PCR or serology)',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Asymptomatic SARS-CoV-2 infection',\n", + " 'SecondaryOutcomeDescription': 'Number of participants with asymptomatic SARS-CoV-2 infection defined as\\n\\nEvidence of SARS-CoV-2 infection (by PCR or seroconversion)\\nAbsence of respiratory illness (using self-reported questionnaire)\\nNo evidence of exposure prior to randomisation (inclusion serology negative)',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Work absenteeism due to COVID-19',\n", + " 'SecondaryOutcomeDescription': 'Number of days (using self-reported questionnaire) unable to work (excludes quarantine/workplace restrictions) due to COVID-19 disease defined as\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus\\npositive SARS-Cov-2 test (PCR or serology)',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Bed confinement due to COVID-19',\n", + " 'SecondaryOutcomeDescription': 'Number of days confined to bed (using self-reported questionnaire) due to COVID-19 disease defined as\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus\\npositive SARS-Cov-2 test (PCR or serology)',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Symptom duration of COVID-19',\n", + " 'SecondaryOutcomeDescription': 'Number of days with symptoms in any episode of illness that meets the case definition for COVID-19 disease:\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus\\npositive SARS-Cov-2 test (PCR or serology)',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'SARS-CoV-2 pneumonia',\n", + " 'SecondaryOutcomeDescription': 'Number of pneumonia cases (abnormal chest X-ray) (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Oxygen therapy with SARS-CoV-2',\n", + " 'SecondaryOutcomeDescription': 'Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Critical care admissions with SARS-CoV-2',\n", + " 'SecondaryOutcomeDescription': 'Number of admission to critical care (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Critical care admission duration with SARS-CoV-2',\n", + " 'SecondaryOutcomeDescription': 'Number of days admitted to critical care (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Mechanical ventilation with SARS-CoV-2',\n", + " 'SecondaryOutcomeDescription': 'Number of participants needing mechanical ventilation (using self-reported questionnaire and/or medical/hospital records) and a positive SARS-CoV-2 test',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Mechanical ventilation duration with SARS-CoV-2',\n", + " 'SecondaryOutcomeDescription': 'Number of days that participants needed mechanical ventilation (using self-reported questionnaire and/or medical/hospital records) and a positive SARS-CoV-2 test',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Hospitalisation duration with COVID-19',\n", + " 'SecondaryOutcomeDescription': 'Number of days of hospitalisation due to COVID-19 (using self-reported questionnaire and/or medical/hospital records).',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Mortality with SARS-CoV-2',\n", + " 'SecondaryOutcomeDescription': 'Number of deaths (from death registry) associated with a positive SARS-CoV-2 test',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Febrile respiratory illness',\n", + " 'SecondaryOutcomeDescription': 'Number of participants with febrile respiratory illness defined as\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Episodes of febrile respiratory illness',\n", + " 'SecondaryOutcomeDescription': 'Number of episodes of febrile respiratory illness, defined as\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Work absenteeism due to febrile respiratory illness',\n", + " 'SecondaryOutcomeDescription': 'Number of days (using self-reported questionnaire) unable to work (excludes quarantine/workplace restrictions) due to febrile respiratory illness defined as\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Bed confinement due to febrile respiratory illness',\n", + " 'SecondaryOutcomeDescription': 'Number of days confined to bed (using self-reported questionnaire) due to febrile respiratory illness defined as\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Symptom duration of febrile respiratory illness',\n", + " 'SecondaryOutcomeDescription': 'Number of days with symptoms in any episode of illness that meets the case definition for febrile respiratory illness:\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Pneumonia',\n", + " 'SecondaryOutcomeDescription': 'Number of pneumonia cases (abnormal chest X-ray) (using self-reported questionnaire and/or medical/hospital records)',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Oxygen therapy',\n", + " 'SecondaryOutcomeDescription': 'Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records)',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Critical care admissions',\n", + " 'SecondaryOutcomeDescription': 'Number of admission to critical care (using self-reported questionnaire and/or medical/hospital records)',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Mechanical ventilation',\n", + " 'SecondaryOutcomeDescription': 'Number of participants needing mechanical ventilation (using self-reported questionnaire and/or medical/hospital records)',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Mortality',\n", + " 'SecondaryOutcomeDescription': 'Number of deaths (from death registry)',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Hospitalisation duration with febrile respiratory illness',\n", + " 'SecondaryOutcomeDescription': 'Number of days of hospitalisation due to febrile respiratory illness (using self-reported questionnaire and/or medical/hospital records)',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Unplanned work absenteeism',\n", + " 'SecondaryOutcomeDescription': 'Number of days of unplanned absenteeism for any reason (using self-reported questionnaire)',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Hospitalisation cost to treat COVID-19',\n", + " 'SecondaryOutcomeDescription': 'Cost of hospitalisation due to COVID-19 reported in Australian dollars (using hospital administrative linked costing records held by individual hospitals and state government routine costing data collections to provide an estimate of the cost to hospitals for each episode of COVID-19 care)',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", + " {'SecondaryOutcomeMeasure': 'Local and systemic adverse events to BCG vaccination in healthcare workers',\n", + " 'SecondaryOutcomeDescription': 'Type and severity of local and systemic adverse events will be collected in self-reported questionnaire and graded using toxicity grading scale.',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured over the 3 months following randomisation'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\nOver 18 years of age\\nEmployed by one of the hospitals involved in the study\\nProvide a signed and dated informed consent form\\nPre-randomisation blood collected\\n\\nExclusion Criteria:\\n\\nHas any BCG vaccine contraindication\\nFever or generalised skin infection (where feasible, randomisation can be delayed until cleared)\\nWeakened resistance toward infections due to a disease in/of the immune system\\nReceiving medical treatment that affects the immune response or other immunosuppressive therapy in the last year. These therapies include systemic corticosteroids (more than or equal to 20 mg for more than or equal to 2 weeks), non-biological immunosuppressant (also known as 'DMARDS'), biological agents (such as monoclonal antibodies against tumour necrosis factor (TNF)-alpha).\\nHas a congenital cellular immunodeficiency, including specific deficiencies of the interferon-gamma pathway\\nHas a malignancy involving bone marrow or lymphoid systems\\nHas any serious underlying illness (such as malignancy). Please note: People with cardiovascular disease, hypertension, diabetes, and/or chronic respiratory disease are eligible if not immunocompromised\\nKnown or suspected HIV infection, even if asymptomatic or has normal immune function. This is because of the risk of disseminated BCG infection\\nHas active skin disease such as eczema, dermatitis or psoriasis at or near the site of vaccination. A different site (other than left arm) can be chosen if necessary\\nPregnant or breastfeeding Although there is no evidence that BCG vaccination is harmful during pregnancy or breastfeeding, it is a contra-indication to BCG vaccination. Therefore, we will exclude women who think they could be pregnant.\\nAnother live vaccine administered in the month prior to randomisation\\nRequire another live vaccine to be administered within the month following BCG randomisation If the other live vaccine can be given on the same day, this exclusion criteria does not apply\\nKnown anaphylactic reaction to any of the ingredient present in the BCG vaccine\\nBCG vaccine given within the last year\\nHas previously had a SARS-CoV-2 positive test result\\nAlready part of this trial, recruited at a different hospital\",\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Prof Nigel Curtis, MBBS PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '93456366',\n", + " 'CentralContactEMail': 'nigel.curtis@rch.org.au'},\n", + " {'CentralContactName': 'Kaya Gardiner',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '99366461',\n", + " 'CentralContactEMail': 'kaya.gardiner@mcri.edu.au'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Prof Nigel Curtis',\n", + " 'OverallOfficialAffiliation': \"Murdoch Children's Research Institute\",\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': \"Royal Children's Hospital\",\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Melbourne',\n", + " 'LocationState': 'Victoria',\n", + " 'LocationZip': '3108',\n", + " 'LocationCountry': 'Australia',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Prof Nigel Curtis, MBBS PhD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '9345 6366',\n", + " 'LocationContactEMail': 'nigel.curtis@mcri.edu.au'},\n", + " {'LocationContactName': 'Kaya Gardiner',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '9936 6042',\n", + " 'LocationContactEMail': 'kaya.gardiner@mcri.edu.au'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", + " 'IPDSharingDescription': \"Beginning 6 months following analysis and article publications, the following may be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions, under a collaborator agreement, for accessing:\\n\\nIndividual participant data that underlie the results reported in our articles after de-identification (text, tables, figures and appendices)\\nStudy protocol, Statistical Analysis Plan, Participant Informed Consent Form (PICF)\",\n", + " 'IPDSharingInfoTypeList': {'IPDSharingInfoType': ['Study Protocol',\n", + " 'Statistical Analysis Plan (SAP)',\n", + " 'Informed Consent Form (ICF)']},\n", + " 'IPDSharingTimeFrame': 'Beginning 6 months following analysis and article publications, for long-term use',\n", + " 'IPDSharingAccessCriteria': \"Researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions, under a collaborator agreement\"}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000014612',\n", + " 'InterventionMeshTerm': 'Vaccines'},\n", + " {'InterventionMeshId': 'D000001500',\n", + " 'InterventionMeshTerm': 'BCG Vaccine'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000007155',\n", + " 'InterventionAncestorTerm': 'Immunologic Factors'},\n", + " {'InterventionAncestorId': 'D000045505',\n", + " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", + " {'InterventionAncestorId': 'D000000276',\n", + " 'InterventionAncestorTerm': 'Adjuvants, Immunologic'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M15943',\n", + " 'InterventionBrowseLeafName': 'Vaccines',\n", + " 'InterventionBrowseLeafAsFound': 'Vaccine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M3374',\n", + " 'InterventionBrowseLeafName': 'BCG Vaccine',\n", + " 'InterventionBrowseLeafAsFound': 'BCG vaccine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M8784',\n", + " 'InterventionBrowseLeafName': 'Immunologic Factors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2209',\n", + " 'InterventionBrowseLeafName': 'Adjuvants, Immunologic',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", + " {'ConditionMeshId': 'D000045169',\n", + " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'},\n", + " {'ConditionMeshId': 'D000014777',\n", + " 'ConditionMeshTerm': 'Virus Diseases'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Corona Virus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Corona Virus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafAsFound': 'Virus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M7047',\n", + " 'ConditionBrowseLeafName': 'Fever',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M14938',\n", + " 'ConditionBrowseLeafName': 'Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Corona Virus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 61,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04330690',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '2114'},\n", + " 'Organization': {'OrgFullName': 'Sunnybrook Health Sciences Centre',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Treatments for COVID-19: Canadian Arm of the SOLIDARITY Trial',\n", + " 'OfficialTitle': 'A Multi-centre, Adaptive, Randomized, Open-label, Controlled Clinical Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Patients',\n", + " 'Acronym': 'CATCO'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Active, not recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 18, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 18, 2022',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'May 18, 2022',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 23, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 31, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 31, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Sunnybrook Health Sciences Centre',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'AbbVie',\n", + " 'CollaboratorClass': 'INDUSTRY'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'This study is an adaptive, randomized, open-label, controlled clinical trial.\\n\\nSubjects will be randomized to receive either standard-of-care products or the study medication plus standard of care, while being hospitalized for COVID-19.\\n\\nLopinavir/ritonavir will be administered 400 mg/100 mg orally (or weight based dose adjustment for children) for a 14-day course, or until discharge from hospital, whichever occurs first',\n", + " 'DetailedDescription': 'This study is an adaptive, randomized, open-label, controlled clinical trial.\\n\\nSubjects will be randomized to receive either standard-of-care products (control) or the study medication plus standard of care while being hospitalized for lab confirmed COVID-19. Randomization will be stratified by i) site; and ii) severity of illness (see section 5); iii) age < 55\\n\\nLopinavir/ritonavir will be administered orally for a 14-day course, or until discharge from hospital; subjects who can swallow will be given 2 tablets (200 mg/50mg) twice daily; for those who cannot swallow, 5 mL oral suspension (400 mg.100 mg/5 mL) will be given twice daily. Children will receive 10 mg/kg of lopinavir/ritonavir, via tablet or suspension, twice daily, capped at the maximum adult dose.\\n\\nSubjects will be assessed daily while hospitalized, including Oropharyngeal (OP) swabbing on days 1, 3, 5, 8, 11, 15, and 29. Discharged subjects will be telephoned at Days 15, 29, and 60. Hospitalized subjects will require blood sampling on days 1, 5 and 11'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 2']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignInterventionModelDescription': '2-arms in a 1:1 ratio randomization to either the control arm, consisting of standard of care supportive treatment for COVID-19, or the investigational product, lopinavir/ritonavir plus standard of care. Lopinavir/ritonavir will be the first agent tested. Additional arms will be added as data emerges.\\n\\nThis study is intended to allow for multiple adaptations, including: i) the primary endpoint at the first interim analysis, based on performance characteristics, both in its characteristics and its timepoint, with adapted sample size calculations performed for the new primary endpoints; ii) Intervention arm, with emerging data from both internal and external to the trial, with arms being dropped or added based on pre-specified stopping rules in conjunction with the DSMB.',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)',\n", + " 'DesignMaskingDescription': 'Endpoint assessment'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '440',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Control',\n", + " 'ArmGroupType': 'No Intervention',\n", + " 'ArmGroupDescription': 'This arm will receive standard of care using supportive care guidelines for COVID-19. This is expected the vary regionally and may change throughout the trial based on new and emerging data on best care guidelines for patients.'},\n", + " {'ArmGroupLabel': 'lopinavir/ritonavir plus standard of care',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Lopinavir/ritonavir will be administered 400 mg/100 mg orally (or weight based dose adjustment for children) for a 14-day course, or until discharge from hospital, whichever occurs first plus expected standard of care.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Lopinavir/ritonavir']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Lopinavir/ritonavir',\n", + " 'InterventionDescription': 'Lopinavir/ritonavir will be administered 400 mg/100 mg orally (or weight based dose adjustment for children) for a 14-day course, or until discharge from hospital, whichever occurs first',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['lopinavir/ritonavir plus standard of care']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Efficacy of Intervention',\n", + " 'PrimaryOutcomeDescription': 'The overall objective of the study is to evaluate the clinical efficacy and safety of lopinavir/ritonavir relative to the control arm in participants hospitalized with COVID-19, specifically looking at the subjects clinical status at day 29 as measured on a 10-point ordinal scale through a proportional odds model.\\n\\nThe scale is as below 0: Uninfected, no viral RNA\\n\\nAsymptomatic, viral RNA detected\\nSymptomatic, independent\\nSymptomatic, Assistance Needed\\nHospitalized: no oxygen therapy\\nHospitalized, on oxygen\\nHospitalized, Oxygen by NIV or high-flow\\nMechanical ventilation, p/f>150 or s/f >200\\nMechanical ventilation, p/f<150 or s/f<200 OR vasopressors\\nmechanical ventilation, p/f<150 AND vasopressors, dialysis, or ECMO\\ndeath',\n", + " 'PrimaryOutcomeTimeFrame': '29 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Time to improvement of one catergory from admission',\n", + " 'SecondaryOutcomeDescription': 'Measure with Ordinal Scale the time it takes for subject improvement',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 60 days'},\n", + " {'SecondaryOutcomeMeasure': 'Subject clinical status',\n", + " 'SecondaryOutcomeDescription': 'Subject clinical status at days 3, 5, 8, 11, 15, 29, 60 measured using an ordinal scale',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 60 days'},\n", + " {'SecondaryOutcomeMeasure': 'Change in Subject clinical status',\n", + " 'SecondaryOutcomeDescription': 'Mean change in the ranking from baseline to days 3, 5, 8, 11, 15, 29, 60 using an ordinal scale',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 60 days'},\n", + " {'SecondaryOutcomeMeasure': 'Oxygen free days',\n", + " 'SecondaryOutcomeDescription': 'the number of oxygen free days exprienced',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 29 days'},\n", + " {'SecondaryOutcomeMeasure': 'Incidence of oxygen use',\n", + " 'SecondaryOutcomeDescription': 'if the subject required oxygen during hospitalization',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 29 days'},\n", + " {'SecondaryOutcomeMeasure': 'Duration of oxygen use',\n", + " 'SecondaryOutcomeDescription': 'if the subject required oxygen, for how long was it required',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 29 days'},\n", + " {'SecondaryOutcomeMeasure': 'Incidence of new mechanical ventilation',\n", + " 'SecondaryOutcomeDescription': 'if the subject required mechanical ventilation during hospitalization',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 29 days'},\n", + " {'SecondaryOutcomeMeasure': 'Duration of mechanical ventilation',\n", + " 'SecondaryOutcomeDescription': 'if the subject required mechanical ventilation, for how long was it required',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 29 days'},\n", + " {'SecondaryOutcomeMeasure': 'Duration of hospitalization',\n", + " 'SecondaryOutcomeDescription': 'the length of hospitalization required',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 29 days'},\n", + " {'SecondaryOutcomeMeasure': 'Mortality',\n", + " 'SecondaryOutcomeDescription': 'Mortality rates calculated at day 15, 29, and 60.',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 60 days'},\n", + " {'SecondaryOutcomeMeasure': 'Cumulative Incidence of Grade 3 and 4 Adverse Events (AEs) and Serious Adverse Events (SAEs)',\n", + " 'SecondaryOutcomeDescription': 'The safety of the intervention will be evaluated during the trial period as compared to the control arm as assessed by the cumulative incidence of Grade 3 and 4 AEs and SAEs using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Paediatric Adverse Events, version 2.1 (July 2017).',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 30 days after last dose of drug adminstration'}]},\n", + " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'Time to viral clearance of lopinavir/ritonavir as compared to the control arm',\n", + " 'OtherOutcomeDescription': 'To evaluate the virologic efficacy of lopinavir/ritonavir as compared to the control arm as assessed by the percent of subjects with SARS-CoV-2 detectable in OP sample at days 3, 5, 8, 11, 15, and 29',\n", + " 'OtherOutcomeTimeFrame': '29 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\n> 6 months of age\\nHas laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen prior to randomization.\\nHospitalized at a participating centre\\n\\nExclusion Criteria:\\n\\nAnticipated transfer to another hospital, within 72 hours, which is not a study site\\nKnown allergy to study medication or its components (non-medicinal ingredients)\\n\\nCurrently taking any of the following medications:\\n\\nalfuzosin (e.g., Xatral®)\\namiodarone (eg Cordarone™)\\napalutamide (e.g. Erleada™)\\nastemizole*, terfenadine*\\ncisapride*\\ncolchicine, when used in patients with renal and/or hepatic impairment\\ndronedarone (e.g., Multaq®)\\ndisulfiram (for those who may need to take the oral solution)\\nelbasvir/grazoprevir (e.g., ZepatierTM) - used to treat hepatitis C virus (HCV)\\nergotamine*, dihydroergotamine\\nergonovine, methylergonovine* (used after labour and delivery), such as Cafergot®, Migranal®, D.H.E. 45®*, Methergine®*, and others\\nfusidic acid (e.g., Fucidin®), systemic\\nlurasidone (e.g., Latuda®), pimozide (e.g., Orap®*)\\nmetronidazole (for those who may need to take the oral solution)\\nneratinib (e.g., Nerlynx®) - used for breast cancer\\nsildenafil (e.g., Revatio®)\\ntriazolam, oral midazolam\\nrifampin, also known as Rimactane®*, Rifadin®, Rifater®*, or Rifamate®*.\\nSt. John's Wort\\nVenetoclax\\nlovastatin (e.g., Mevacor®*), lomitapide (e.g., JuxtapidTM) or simvastatin (e.g., Zocor®)\\nPDE5 inhibitors vardenafil (e.g., Levitra® or Revatio).\\nsalmeterol, also known as Advair® and Serevent®.\\nKnown HIV infection\",\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '6 Months',\n", + " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'LocationList': {'Location': [{'LocationFacility': 'Sunnybrook Health Sciences Centre',\n", + " 'LocationCity': 'Toronto',\n", + " 'LocationState': 'Ontario',\n", + " 'LocationZip': 'M4N3M5',\n", + " 'LocationCountry': 'Canada'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", + " 'IPDSharingDescription': 'As per World Health Organization policies on data sharing in a Public Health Emergency, any clinical trial outcome data will be shared at the earliest possible opportunity. In addition, given the nature of this protocol, being performed across regions, the DSMB may access other regions trials, and possibly recommend alterations in study design based on accumulating data, through a centralized data repository being built under the auspices of the World Health Organization.\\n\\nData Sharing for Secondary Research Data from this study may be used for secondary research. All of the individual subject data collected during the trial will be made available after de-identification through expert determination. The SAP and Analytic Code will also be made available. This data will be available immediately following publication, with no end date, as part of data sharing requirements from journals and funding agencies.',\n", + " 'IPDSharingInfoTypeList': {'IPDSharingInfoType': ['Study Protocol',\n", + " 'Statistical Analysis Plan (SAP)',\n", + " 'Clinical Study Report (CSR)']},\n", + " 'IPDSharingTimeFrame': 'Unknown and variable'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000019438',\n", + " 'InterventionMeshTerm': 'Ritonavir'},\n", + " {'InterventionMeshId': 'D000061466',\n", + " 'InterventionMeshTerm': 'Lopinavir'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000017320',\n", + " 'InterventionAncestorTerm': 'HIV Protease Inhibitors'},\n", + " {'InterventionAncestorId': 'D000011480',\n", + " 'InterventionAncestorTerm': 'Protease Inhibitors'},\n", + " {'InterventionAncestorId': 'D000004791',\n", + " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000019380',\n", + " 'InterventionAncestorTerm': 'Anti-HIV Agents'},\n", + " {'InterventionAncestorId': 'D000044966',\n", + " 'InterventionAncestorTerm': 'Anti-Retroviral Agents'},\n", + " {'InterventionAncestorId': 'D000000998',\n", + " 'InterventionAncestorTerm': 'Antiviral Agents'},\n", + " {'InterventionAncestorId': 'D000000890',\n", + " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", + " {'InterventionAncestorId': 'D000065692',\n", + " 'InterventionAncestorTerm': 'Cytochrome P-450 CYP3A Inhibitors'},\n", + " {'InterventionAncestorId': 'D000065607',\n", + " 'InterventionAncestorTerm': 'Cytochrome P-450 Enzyme Inhibitors'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M4846',\n", + " 'InterventionBrowseLeafName': 'Coal Tar',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19978',\n", + " 'InterventionBrowseLeafName': 'Ritonavir',\n", + " 'InterventionBrowseLeafAsFound': 'Ritonavir',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M28424',\n", + " 'InterventionBrowseLeafName': 'Lopinavir',\n", + " 'InterventionBrowseLeafAsFound': 'Lopinavir',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M18192',\n", + " 'InterventionBrowseLeafName': 'HIV Protease Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M12926',\n", + " 'InterventionBrowseLeafName': 'Protease Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19934',\n", + " 'InterventionBrowseLeafName': 'Anti-HIV Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M24015',\n", + " 'InterventionBrowseLeafName': 'Anti-Retroviral Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2895',\n", + " 'InterventionBrowseLeafName': 'Antiviral Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2795',\n", + " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M29151',\n", + " 'InterventionBrowseLeafName': 'Cytochrome P-450 CYP3A Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M29124',\n", + " 'InterventionBrowseLeafName': 'Cytochrome P-450 Enzyme Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Derm',\n", + " 'InterventionBrowseBranchName': 'Dermatologic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", + " {'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'}]}}}}},\n", + " {'Rank': 62,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04329832',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '1051355'},\n", + " 'Organization': {'OrgFullName': 'Intermountain Health Care, Inc.',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19',\n", + " 'OfficialTitle': 'Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19 (HAHPS): A Prospective Pragmatic Trial',\n", + " 'Acronym': 'HAHPS'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'December 31, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2021',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 30, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 30, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 30, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Samuel Brown',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Director, Critical Care Research',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Intermountain Health Care, Inc.'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Intermountain Health Care, Inc.',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'University of Utah',\n", + " 'CollaboratorClass': 'OTHER'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'Yes',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'This study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating hospitalized patients with suspected or confirmed COVID-19.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", + " 'KeywordList': {'Keyword': ['SARS-CoV-2',\n", + " 'Hydroxychloroquine',\n", + " 'Azithromycin']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 2']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '300',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Hydroxychloroquine',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine']}},\n", + " {'ArmGroupLabel': 'Azithromycin',\n", + " 'ArmGroupType': 'Active Comparator',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Azithromycin']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Hydroxychloroquine',\n", + " 'InterventionDescription': 'Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 4 days (dose reductions for weight < 45 kg or GFR (glomerular filtration rate)<50ml/min).',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Hydroxychloroquine']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Azithromycin',\n", + " 'InterventionDescription': 'Patients in the azithromycin arm will receive azithromycin 500 mg on day 1 plus 250 mg daily on days 2-5 (may be administered intravenously per clinician preference). If the patient has already received azithromycin prior to randomization, the prior doses will count toward the 5-day total.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Azithromycin']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'COVID Ordinal Outcomes Scale at 14 days',\n", + " 'PrimaryOutcomeDescription': 'Per https://www.who.int/blueprint/priority-diseases/key-action/COVID-19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf, this scale reflects a range from uninfected to dead, where 0 is \"no clinical or virological evidence of infection\", 1 is \"no limitation of activities\", 2 is \"limitation of activities\", 3 is \"hospitalized, no oxygen therapy\", 4 is \"oxygen by mask or nasal prongs\", 5 is \"non-invasive ventilation or high-flow oxygen\", 6 is \"intubation and mechanical ventilation\", 7 is \"ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)\", and 8 is \"death\".',\n", + " 'PrimaryOutcomeTimeFrame': 'Assessed once on day 14 after enrollment (enrollment is day 0)'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Hospital-free days at 28 days (number of days patient not in hospital)',\n", + " 'SecondaryOutcomeDescription': 'Calculated as a worst-rank ordinal (death is counted as -1 days).',\n", + " 'SecondaryOutcomeTimeFrame': 'Admission (day 1) to 28 days after admission (day 28)'},\n", + " {'SecondaryOutcomeMeasure': 'Ventilator-free days at 28 days (number of days patient not on a ventilator)',\n", + " 'SecondaryOutcomeDescription': 'Calculated as a worst-rank ordinal (death is counted as -1 days).',\n", + " 'SecondaryOutcomeTimeFrame': 'Admission (day 1) to 28 days after admission (day 28)'},\n", + " {'SecondaryOutcomeMeasure': 'ICU-free days at 28 days (number of days patient not in an ICU)',\n", + " 'SecondaryOutcomeDescription': 'Calculated as a worst-rank ordinal (death is counted as -1 days).',\n", + " 'SecondaryOutcomeTimeFrame': 'Admission (day 1) to 28 days after admission (day 28)'},\n", + " {'SecondaryOutcomeMeasure': 'Time to a 1-point decrease in the WHO ordinal recovery score',\n", + " 'SecondaryOutcomeTimeFrame': 'Admission (day 1) to 14 days after admission (day 14)'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAdult (age ≥ 18 years)\\n\\nConfirmed OR suspected COVID-19,\\n\\nConfirmed: Positive assay for COVID-19 within the last 10 days\\nSuspected: Pending assay for COVID-19 WITH high clinical suspicion\\nScheduled for admission or already admitted to an inpatient bed\\nPatients must be enrolled within 48 hours of hospital admission\\n\\nExclusion Criteria:\\n\\nAllergy to hydroxychloroquine or azithromycin\\nHistory of bone marrow transplant\\nKnown G6PD deficiency\\nChronic hemodialysis or Glomerular Filtration Rate < 20ml/min\\nPsoriasis\\nPorphyria\\nConcomitant use of digitalis, flecainide, amiodarone, procainamide, or propafenone\\nKnown history of long QT syndrome\\nCurrent known QTc>500 msec\\nPregnant or nursing\\nPrisoner\\nWeight < 35kg\\nSevere liver disease\\nSeizure disorder',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Valerie T Aston, MBA',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '8015074606',\n", + " 'CentralContactEMail': 'Valerie.Aston@imail.org'},\n", + " {'CentralContactName': 'David P Tomer, MS',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '801-507-4694',\n", + " 'CentralContactEMail': 'David.Tomer@imail.org'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Samuel M Brown, MD MS',\n", + " 'OverallOfficialAffiliation': 'Intermountain Health Care, Inc.',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Intermountain Medical Center',\n", + " 'LocationCity': 'Murray',\n", + " 'LocationState': 'Utah',\n", + " 'LocationZip': '84107',\n", + " 'LocationCountry': 'United States',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Valerie T Aston, MD MS',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '801-507-4606',\n", + " 'LocationContactEMail': 'Valerie.Aston@imail.org'},\n", + " {'LocationContactName': 'Samuel M Brown, MD MS',\n", + " 'LocationContactRole': 'Principal Investigator'}]}},\n", + " {'LocationFacility': 'University of Utah',\n", + " 'LocationCity': 'Salt Lake City',\n", + " 'LocationState': 'Utah',\n", + " 'LocationZip': '84112',\n", + " 'LocationCountry': 'United States',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Estelle Harris, MD',\n", + " 'LocationContactRole': 'Contact'},\n", + " {'LocationContactName': 'Estelle Harris, MD',\n", + " 'LocationContactRole': 'Principal Investigator'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No',\n", + " 'IPDSharingDescription': 'In order to protect patient privacy and comply with relevant regulations, identified data are unavailable. Requests for deidentified data from qualified researchers with appropriate ethics board approvals and relevant data use agreements will be processed by the Intermountain Office of Research, officeofresearch@imail.org.'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", + " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", + " 'InterventionAncestorTerm': 'Antimalarials'},\n", + " {'InterventionAncestorId': 'D000000981',\n", + " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", + " {'InterventionAncestorId': 'D000000977',\n", + " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", + " {'InterventionAncestorId': 'D000000890',\n", + " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", + " {'InterventionAncestorId': 'D000004791',\n", + " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000018501',\n", + " 'InterventionAncestorTerm': 'Antirheumatic Agents'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", + " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M18715',\n", + " 'InterventionBrowseLeafName': 'Azithromycin',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2861',\n", + " 'InterventionBrowseLeafName': 'Antimalarials',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2879',\n", + " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2875',\n", + " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2795',\n", + " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19188',\n", + " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}}}}},\n", + " {'Rank': 63,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04324996',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'ChongqingPublicHMC'},\n", + " 'Organization': {'OrgFullName': 'Chongqing Public Health Medical Center',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'A Phase I/II Study of Universal Off-the-shelf NKG2D-ACE2 CAR-NK Cells for Therapy of COVID-19',\n", + " 'OfficialTitle': 'A Phase I/II Study of Universal Off-the-shelf NKG2D-ACE2 CAR-NK Cells Secreting IL15 Superagonist and GM-CSF-neutralizing scFv for Therapy of COVID-19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 21, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 31, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'September 30, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 25, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 25, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 27, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 25, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 27, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Chongqing Public Health Medical Center',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Chongqing Sidemu Biotechnology Technology Co.,Ltd.',\n", + " 'CollaboratorClass': 'UNKNOWN'}]}},\n", + " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'SARS-CoV-2 infection mainly leads to interstitial pneumonia. The patients with low immunity have more serious conditions. At present, there is no specific drug/therapy available for COVID-19. NK cells are the major cells of the natural immune system, which are essential for innate immunity and adaptive immunity, and are indispensable in the defense of virus infection. NKG2D is an activating receptor of NK cells, which can recognize and thus clear virus infected cells. NK cells modified by CAR play a role in targeted cell therapy, and have benn demonstrated very safe without severe side effects such as cytokine releasing syndromes. The survival time of NK cells will be very short if there is no IL-15-sustained support after adoptive transfer into the body. In comparison with natural IL-15 in vivo, IL-15 superagonist (sIL-15/IL-15Rɑ chimeric protein) has increased the activity by nearly 20 times and as well as improved pharmacokinetic characteristics with longer persistence and enhanced target cytotoxicity. CAR-T cell-mediated cytokine release syndrome (CRS) and neurotoxicity have been shown to be abrogated through GM-CSF neutralization. ACE2 is the receptor of SARS-CoV-2 and binds to S protein of the virus envelope. We have constructed and prepared the universal off-the-shelf IL15 superagonist- and GM-CSF neutralizing scFv-secreting NKG2D-ACE2 CAR-NK derived from cord blood. By targeting the S protein of SARS-CoV-2 and NKG2DL on the surface of infected cells with ACE2 and NKG2D, respectively, and with the strong synergistic effect of IL15 superagonist and CRS prevention through GM-CSF neutralizing scFv, we hope that the SARS-CoV-2 virus particles and their infected cells can be safely and effectively removed, thus providing a safe and effective cell therapy for COVID-19. In addition, ACE2 CAR-NK cells can competitively inhibit SARS-CoV-2 infection of type II alveolar epithelial cells and other important organ or tissue cells through ACE2 so as to make SARS-CoV-2 abortive infection (i.e., no production of infectious virus particles).\\n\\nThis project is an open, randomized, parallel, multicenter phase I/II clinical trial. The NKG2D-ACE2 CAR-NK cells secreting super IL15 superagonist and GM-CSF neutralizing scFv are going to be give by intravenous infusion (108 cells per kilogram of body weight, once a week) for the treatment of 30 patients with each common, severe and critical type COVID-19, respectively.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", + " 'KeywordList': {'Keyword': ['NKG2D-ACE2 CAR-NK',\n", + " 'IL15 superagonist',\n", + " 'GM-CSF-neutralizing scFv',\n", + " 'COVID-19']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 1', 'Phase 2']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Quadruple',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", + " 'Care Provider',\n", + " 'Investigator',\n", + " 'Outcomes Assessor']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '90',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'NK cells',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'The NK cells are going to be give by intravenous infusion (10E8 cells per kilogram of body weight, once a week) .',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: NK cells,IL15-NK cells,NKG2D CAR-NK cells,ACE2 CAR-NK cells,NKG2D-ACE2 CAR-NK cells']}},\n", + " {'ArmGroupLabel': 'IL15-NK cells',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'The NK cells secreting super IL15 superagonist are going to be give by intravenous infusion (10E8 cells per kilogram of body weight, once a week) .',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: NK cells,IL15-NK cells,NKG2D CAR-NK cells,ACE2 CAR-NK cells,NKG2D-ACE2 CAR-NK cells']}},\n", + " {'ArmGroupLabel': 'NKG2D CAR-NK cells',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'The NKG2D CAR-NK cells are going to be give by intravenous infusion (10E8 cells per kilogram of body weight, once a week).',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: NK cells,IL15-NK cells,NKG2D CAR-NK cells,ACE2 CAR-NK cells,NKG2D-ACE2 CAR-NK cells']}},\n", + " {'ArmGroupLabel': 'ACE2 CAR-NK cells',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'The ACE2 CAR-NK cells are going to be give by intravenous infusion (10E8 cells per kilogram of body weight, once a week).',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: NK cells,IL15-NK cells,NKG2D CAR-NK cells,ACE2 CAR-NK cells,NKG2D-ACE2 CAR-NK cells']}},\n", + " {'ArmGroupLabel': 'NKG2D-ACE2 CAR-NK cells',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'The NKG2D-ACE2 CAR-NK cells secreting IL15 superagonist and GM-CSF-neutralizing scFv are going to be give by intravenous infusion (10E8 cells per kilogram of body weight, once a week).',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: NK cells,IL15-NK cells,NKG2D CAR-NK cells,ACE2 CAR-NK cells,NKG2D-ACE2 CAR-NK cells']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Biological',\n", + " 'InterventionName': 'NK cells,IL15-NK cells,NKG2D CAR-NK cells,ACE2 CAR-NK cells,NKG2D-ACE2 CAR-NK cells',\n", + " 'InterventionDescription': 'The CAR-NK cells are universal off the shelf NK cells enriched from umbilical cord blood and engineered genetically.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['ACE2 CAR-NK cells',\n", + " 'IL15-NK cells',\n", + " 'NK cells',\n", + " 'NKG2D CAR-NK cells',\n", + " 'NKG2D-ACE2 CAR-NK cells']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Clinical response',\n", + " 'PrimaryOutcomeDescription': 'the efficacy of NKG2D-ACE2 CAR-NK cells in treating severe and critical 2019 new coronavirus (COVID-19) pneumonia',\n", + " 'PrimaryOutcomeTimeFrame': 'Up to 28 days'},\n", + " {'PrimaryOutcomeMeasure': 'Side effects in the treatment group',\n", + " 'PrimaryOutcomeDescription': 'the safety and tolerability of NKG2D-ACE2 CAR-NK cells in patients with severe and critical 2019 new coronavirus (COVID-19) pneumonia',\n", + " 'PrimaryOutcomeTimeFrame': 'Up to 28 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nSign written informed consent;\\nAge ≥18 years;\\nConforms to the NCP Critical and Critical Diagnostic Standards, namely \"Pneumonitis Diagnosis and Treatment Scheme for New Coronavirus Infection (Trial Version 6)\". Comprehensive judgment based on epidemiological history, clinical manifestations and etiological examination;\\nThe course of disease is within 14 days after the onset of illness;\\nWilling to collect nasopharyngeal or oropharyngeal swabs before administration.\\n\\nExclusion Criteria:\\n\\nPatients participating in clinical trials of other drugs;\\npregnant or lactating women;\\nALT / AST> 5 times ULN, or neutrophils <0.5 * 109 / L, or platelets less than 50 * 109 / L;\\nExpected survival time is less than 1 week;\\nA clear diagnosis of rheumatism-related diseases;\\nLong-term oral anti-rejection drugs or immunomodulatory drugs;\\nPatients hypersensitive to NK cells and their preservation solution.',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Min Liu, A.B',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '13668072999',\n", + " 'CentralContactEMail': 'gwzxliumin@foxmail.com'},\n", + " {'CentralContactName': 'Jimin Gao, PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '0577-86699341',\n", + " 'CentralContactEMail': 'jimingao64@163.com'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Min Liu, A.B',\n", + " 'OverallOfficialAffiliation': 'Chongqing Public Health Center',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Chongqing Public Health Medical Center',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Chongqing',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Min Liu, A.B',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '13668072999',\n", + " 'LocationContactEMail': 'gwzxliumin@foxmail.com'}]}}]}},\n", + " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '32015507',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3.'},\n", + " {'ReferencePMID': '32015508',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Wu F, Zhao S, Yu B, Chen YM, Wang W, Song ZG, Hu Y, Tao ZW, Tian JH, Pei YY, Yuan ML, Zhang YL, Dai FH, Liu Y, Wang QM, Zheng JJ, Xu L, Holmes EC, Zhang YZ. A new coronavirus associated with human respiratory disease in China. Nature. 2020 Mar;579(7798):265-269. doi: 10.1038/s41586-020-2008-3. Epub 2020 Feb 3.'},\n", + " {'ReferencePMID': '16988814',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Kuba K, Imai Y, Rao S, Jiang C, Penninger JM. Lessons from SARS: control of acute lung failure by the SARS receptor ACE2. J Mol Med (Berl). 2006 Oct;84(10):814-20. Epub 2006 Sep 19. Review.'},\n", + " {'ReferencePMID': '31978945',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.'},\n", + " {'ReferencePMID': '32007143',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.'},\n", + " {'ReferencePMID': '31995857',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Li M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JTK, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Jan 29. doi: 10.1056/NEJMoa2001316. [Epub ahead of print]'},\n", + " {'ReferencePMID': '31867006',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Minetto P, Guolo F, Pesce S, Greppi M, Obino V, Ferretti E, Sivori S, Genova C, Lemoli RM, Marcenaro E. Harnessing NK Cells for Cancer Treatment. Front Immunol. 2019 Dec 6;10:2836. doi: 10.3389/fimmu.2019.02836. eCollection 2019. Review.'},\n", + " {'ReferencePMID': '31720075',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Liu H, Wang S, Xin J, Wang J, Yao C, Zhang Z. Role of NKG2D and its ligands in cancer immunotherapy. Am J Cancer Res. 2019 Oct 1;9(10):2064-2078. eCollection 2019. Review.'},\n", + " {'ReferencePMID': '31790761',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Wang W, Jiang J, Wu C. CAR-NK for tumor immunotherapy: Clinical transformation and future prospects. Cancer Lett. 2020 Mar 1;472:175-180. doi: 10.1016/j.canlet.2019.11.033. Epub 2019 Nov 29.'},\n", + " {'ReferencePMID': '28386260',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Sarvaria A, Jawdat D, Madrigal JA, Saudemont A. Umbilical Cord Blood Natural Killer Cells, Their Characteristics, and Potential Clinical Applications. Front Immunol. 2017 Mar 23;8:329. doi: 10.3389/fimmu.2017.00329. eCollection 2017. Review.'},\n", + " {'ReferencePMID': '16284400',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Mortier E, Quéméner A, Vusio P, Lorenzen I, Boublik Y, Grötzinger J, Plet A, Jacques Y. Soluble interleukin-15 receptor alpha (IL-15R alpha)-sushi as a selective and potent agonist of IL-15 action through IL-15R beta/gamma. Hyperagonist IL-15 x IL-15R alpha fusion proteins. J Biol Chem. 2006 Jan 20;281(3):1612-9. Epub 2005 Nov 11.'},\n", + " {'ReferencePMID': '32023374',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Liu E, Marin D, Banerjee P, Macapinlac HA, Thompson P, Basar R, Nassif Kerbauy L, Overman B, Thall P, Kaplan M, Nandivada V, Kaur I, Nunez Cortes A, Cao K, Daher M, Hosing C, Cohen EN, Kebriaei P, Mehta R, Neelapu S, Nieto Y, Wang M, Wierda W, Keating M, Champlin R, Shpall EJ, Rezvani K. Use of CAR-Transduced Natural Killer Cells in CD19-Positive Lymphoid Tumors. N Engl J Med. 2020 Feb 6;382(6):545-553. doi: 10.1056/NEJMoa1910607.'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'C000081222',\n", + " 'InterventionMeshTerm': 'Sargramostim'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000007155',\n", + " 'InterventionAncestorTerm': 'Immunologic Factors'},\n", + " {'InterventionAncestorId': 'D000045505',\n", + " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M267719',\n", + " 'InterventionBrowseLeafName': 'Sargramostim',\n", + " 'InterventionBrowseLeafAsFound': 'GM-CSF',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M8784',\n", + " 'InterventionBrowseLeafName': 'Immunologic Factors',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}}}}},\n", + " {'Rank': 64,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04327570',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'COntAGIouS'},\n", + " 'Organization': {'OrgFullName': 'Universitaire Ziekenhuizen Leuven',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'In-depth Immunological Investigation of COVID-19.',\n", + " 'OfficialTitle': 'In-depth Characterisation of the Dynamic Host Immune Response to Coronavirus SARS-CoV-2',\n", + " 'Acronym': 'COntAGIouS'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 27, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'September 30, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'September 30, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 26, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 26, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 31, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 26, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 31, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Universitaire Ziekenhuizen Leuven',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'The COntAGIouS trial (COvid-19 Advanced Genetic and Immunologic Sampling; an in-depth characterization of the dynamic host immune response to coronavirus SARS-CoV-2) proposes a transdisciplinary approach to identify host factors resulting in hyper-susceptibility to SARS-CoV-2 infection, which is urgently needed for directed medical interventions.',\n", + " 'DetailedDescription': \"The overall aim of this prospective study is to provide an in-depth characterization of clinical and immunological features of patients hospitalized in UZ Leuven because of SARS-CoV-2 infection. For this purpose, clinical data and blood, nasopharyngeal/rectal swab, and if safe, bronchoalveolar lavage (BAL) fluid and lung tissue samples will be collected from PCR- or CT-confirmed COVID-19 patients, with varying degrees of disease severity. Assessed characteristics will be compared between severe and non-severe COVID-19 patients, and between COVID-19 positive and negative ('control') patients.\"},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus Infections']},\n", + " 'KeywordList': {'Keyword': ['COVID-19']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'Yes',\n", + " 'TargetDuration': '6 Months',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Other']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'BioSpec': {'BioSpecRetention': 'Samples With DNA',\n", + " 'BioSpecDescription': 'Blood, plasma, PBMC, BAL, lung tissue'},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '100',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'ICU-hospitalised COVID-19 patients',\n", + " 'ArmGroupDescription': \"COVID-19 positive patients hospitalised in intensive care ('severe disease').\",\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: Patient sampling']}},\n", + " {'ArmGroupLabel': 'ward-hospitalised COVID-19 patients',\n", + " 'ArmGroupDescription': \"COVID-19 positive patients requiring hospitalisation,not on intensive care department ('non-severe').\",\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: Patient sampling']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", + " 'InterventionName': 'Patient sampling',\n", + " 'InterventionDescription': 'Blood draw, NP/rectal swab, bronchoscopy if clinically indicated, lung tissue if applicable',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['ICU-hospitalised COVID-19 patients',\n", + " 'ward-hospitalised COVID-19 patients']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Clinical Features',\n", + " 'PrimaryOutcomeDescription': 'Description of clinical, laboratory and radiological features of illness and complications.',\n", + " 'PrimaryOutcomeTimeFrame': '6 months'},\n", + " {'PrimaryOutcomeMeasure': 'Immune host response at systemic level',\n", + " 'PrimaryOutcomeDescription': 'Evaluation of dynamic host immune response at systemic level (immune signalling molecules in plasma, peripheral blood mononuclear cell isolation for advanced immunophenotyping and transcriptomics). Real-time analysis using CyTOF will be performed as screening, in combination with in-depth immunophenotyping.',\n", + " 'PrimaryOutcomeTimeFrame': '6 months'},\n", + " {'PrimaryOutcomeMeasure': 'Immune host response at local level',\n", + " 'PrimaryOutcomeDescription': 'Evaluation of dynamic host immune response at systemic level (immune signalling molecules in plasma, peripheral blood mononuclear cell isolation for advanced immunophenotyping and transcriptomics).',\n", + " 'PrimaryOutcomeTimeFrame': '6 months'},\n", + " {'PrimaryOutcomeMeasure': 'Host genetic variation',\n", + " 'PrimaryOutcomeDescription': 'Identification of host genetic variants that are associated with severity of disease.',\n", + " 'PrimaryOutcomeTimeFrame': '6 months'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Comparison severe and non-severe COVID-19 hospitalised patients',\n", + " 'SecondaryOutcomeDescription': 'Differences in baseline factors',\n", + " 'SecondaryOutcomeTimeFrame': '6 months'},\n", + " {'SecondaryOutcomeMeasure': 'Comparison severe and non-severe COVID-19 hospitalised patients',\n", + " 'SecondaryOutcomeDescription': 'Differences in immune characteristics',\n", + " 'SecondaryOutcomeTimeFrame': '6 months'},\n", + " {'SecondaryOutcomeMeasure': 'Correlation of findings with outcome',\n", + " 'SecondaryOutcomeDescription': 'Correlation of findings with outcome, aiming to identify early biomarkers of severe disease and putative targets for immunomodulatory therapy',\n", + " 'SecondaryOutcomeTimeFrame': '6 months'},\n", + " {'SecondaryOutcomeMeasure': 'Correlation of immune profiling - microbiome',\n", + " 'SecondaryOutcomeDescription': 'Correlation of immune profiling with microbiome analysis of patients',\n", + " 'SecondaryOutcomeTimeFrame': '6 months'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nPatients >/= 18 years old AND\\nHospitalised with PCR-confirmed and/or CT-confirmed SARS-CoV-2 disease\\n\\nExclusion Criteria:\\n\\nAge < 18 years old\\nNo informed consent\\nPatients on cyclosporine/tacrolimus/sirolimus/everolimus therapy*',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'All non-immunosuppressed* consecutive patients (>18 years old) that are admitted to UZ Leuven from March 2020 until September 2020 with PCR-confirmed and/or CT-confirmed SARS-CoV-2 disease are eligible for inclusion.',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Joost Wauters, MD PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '003216344275',\n", + " 'CentralContactEMail': 'joost.wauters@uzleuven.com'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Joost Wauters, MD PhD',\n", + " 'OverallOfficialAffiliation': 'UZ Leuven',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", + " {'ConditionMeshId': 'D000045169',\n", + " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M14938',\n", + " 'ConditionBrowseLeafName': 'Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 65,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04332016',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'CHUBX 2020/11'},\n", + " 'Organization': {'OrgFullName': 'University Hospital, Bordeaux',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'COVID-19 Biological Samples Collection',\n", + " 'OfficialTitle': 'Biological Samples Collection From Patients and Caregivers Treated at Bordeaux University Hospital for Asymptomatic and Symptomatic Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) Infection (COVID-19).',\n", + " 'Acronym': 'COLCOV19-BX'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 2, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 2023',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'March 2023',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 30, 2020',\n", + " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 2, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'April 2, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", + " 'LastUpdatePostDateType': 'Estimate'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'University Hospital, Bordeaux',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'The coronavirus disease 2019 (COVID-19) outbreak is now considered as a public health emergency of international concern by the World Health Organization.\\n\\nIn the context of the health emergency, research on the pathogen (the SARS-CoV-2 coronavirus), the disease and the therapeutic care is being organized. Research projects require the use of biological samples. This study aims at setting up a collection of biological samples intended for application projects in any discipline.\\n\\nThe main objective of the study is to collect, process and store biological samples from patients and caregivers infected with SARS-CoV-2 (COVID-19) at the biological ressources center of the Bordeaux University Hospital.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Infection Viral']},\n", + " 'KeywordList': {'Keyword': ['COVID-19',\n", + " 'SARS-CoV-2',\n", + " 'coronavirus',\n", + " 'biological samples']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Case-Only']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'BioSpec': {'BioSpecRetention': 'Samples With DNA',\n", + " 'BioSpecDescription': 'Whole Blood Sample Upper respiratory sampling Urine and stool collection Post mortem biopsies'},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '2000',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'COVID-19 infected patients',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: biological samples collection']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", + " 'InterventionName': 'biological samples collection',\n", + " 'InterventionDescription': 'collection of whole blood samples, urine and stool samples, upper respiratory samples, post-mortem biopsies',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['COVID-19 infected patients']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'COVID-19 desease description',\n", + " 'PrimaryOutcomeDescription': 'From blood samples: protein levels, whole genome sequence, transcriptomic analysis data.\\n\\nFrom upper respiratory samples: protein levels, virus transcriptomic analysis data.\\n\\nFrom stool: microbiota analysis data.\\n\\nFrom urine: protein level.',\n", + " 'PrimaryOutcomeTimeFrame': 'Inclusion visit (Day 1)'},\n", + " {'PrimaryOutcomeMeasure': 'COVID-19 desease description',\n", + " 'PrimaryOutcomeDescription': 'From blood samples: protein levels.',\n", + " 'PrimaryOutcomeTimeFrame': 'Day 30 to 90'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nPatients / caregivers treated at Bordeaux University Hospital for asymptomatic or symptomatic infection by SARS -CoV-2\\nmen and women, adults and minors as well as pregnant or breastfeeding women\\npatients who died following infection with SARS-CoV-2 (specific criterion for post-mortem biopsies)\\nBe affiliated with or beneficiary of a social security scheme\\nFree and informed consent obtained and signed by the patient\\n\\nExclusion Criteria:\\n\\nUnder guardianship or curatorship',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MaximumAge': '100 Years',\n", + " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'Patients / caregivers treated at Bordeaux University Hospital for asymptomatic or symptomatic infection by SARS -CoV-2.',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Isabelle PELLEGRIN',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '05 57 82 11 50',\n", + " 'CentralContactEMail': 'isabelle.pellegrin@chu-bordeaux.fr'},\n", + " {'CentralContactName': 'Aurélie POUZET',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '05 57 82 17 31',\n", + " 'CentralContactEMail': 'aurelie.pouzet@chu-bordeaux.fr'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Centre Hospitalier Universitaire de Bordeaux',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Bordeaux',\n", + " 'LocationZip': '33076',\n", + " 'LocationCountry': 'France',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Isabelle PELLEGRIN',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '05 57 82 11 50',\n", + " 'LocationContactEMail': 'isabelle.pellegrin@chu-bordeaux.fr'},\n", + " {'LocationContactName': 'Aurélie POUZET',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '05 57 82 17 31',\n", + " 'LocationContactEMail': 'aurelie.pouzet@chu-bordeaux.fr'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", + " 'ConditionMeshTerm': 'Infection'},\n", + " {'ConditionMeshId': 'D000014777',\n", + " 'ConditionMeshTerm': 'Virus Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafAsFound': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M14938',\n", + " 'ConditionBrowseLeafName': 'Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafAsFound': 'Infection Viral',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 66,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04321421',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'IRCCSSanMatteoH'},\n", + " 'Organization': {'OrgFullName': 'Foundation IRCCS San Matteo Hospital',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Hyperimmune Plasma for Critical Patients With COVID-19',\n", + " 'OfficialTitle': 'Plasma From Donors Recovered From New Coronavirus 2019 As Therapy For Critical Patients With Covid-19',\n", + " 'Acronym': 'COV19-PLASMA'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Active, not recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 17, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 31, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'May 31, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 23, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 23, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 25, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 23, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 25, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Cesare Perotti',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Medical Doctor',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Foundation IRCCS San Matteo Hospital'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Foundation IRCCS San Matteo Hospital',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'OSPEDALE CARLO POMA ASST MANTOVA',\n", + " 'CollaboratorClass': 'UNKNOWN'},\n", + " {'CollaboratorName': 'OSPEDALE MAGGIORE LODI',\n", + " 'CollaboratorClass': 'UNKNOWN'},\n", + " {'CollaboratorName': 'OSPEDALE ASST CREMONA',\n", + " 'CollaboratorClass': 'UNKNOWN'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has become pandemic. To date, no specific treatment has been proven to be effective. Promising results were obtained in China using Hyperimmune plasma from patients recovered from the disease.We plan to treat critical Covid-19 patients with hyperimmune plasma.',\n", + " 'DetailedDescription': 'Apheresis from recovered donors will be performed with a cell separator device , with 500-600 mL of plasma obtained from each donor. Donors are males, age 18 yrs or more, evaluated for transmissible diseases according to the italian law. Adjunctive tests will be for hepatitis A virus, hepatatis E virusand Parvovirus B-19. All donors will be tested for the Covid-19 neutralizing title. Each plasma bag obtained from plasmapheresis will be immediately divided in two units and frozen according to the national standards and stored separately.\\n\\nBased on experience published in literature 250-300 mL of convalescent plasma will be used to treat each of the recruited patients at most 3 times over 5 days.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", + " 'KeywordList': {'Keyword': ['hyperimmune plasma', 'COVID-19']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Not Applicable']},\n", + " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", + " 'DesignInterventionModelDescription': 'Longitudinal assessment of COVID-19 patients treated with hyperimmune plasma',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '49',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'treated',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'treated with hyperimmune plasma',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: hyperimmune plasma']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", + " 'InterventionName': 'hyperimmune plasma',\n", + " 'InterventionDescription': 'administration of hyperimmune plasma at day 1 and based on clinical response on day 3 and 5',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['treated']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'death',\n", + " 'PrimaryOutcomeDescription': 'death from any cause',\n", + " 'PrimaryOutcomeTimeFrame': 'within 7 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'time to extubation',\n", + " 'SecondaryOutcomeDescription': 'days since intubation',\n", + " 'SecondaryOutcomeTimeFrame': 'within 7 days'},\n", + " {'SecondaryOutcomeMeasure': 'length of intensive care unit stay',\n", + " 'SecondaryOutcomeDescription': 'days from entry to exit from ICU',\n", + " 'SecondaryOutcomeTimeFrame': 'within 7 days'},\n", + " {'SecondaryOutcomeMeasure': 'time to CPAP weaning',\n", + " 'SecondaryOutcomeDescription': 'days since CPAP initiation',\n", + " 'SecondaryOutcomeTimeFrame': 'within 7 days'},\n", + " {'SecondaryOutcomeMeasure': 'viral load',\n", + " 'SecondaryOutcomeDescription': 'naso-pharyngeal swab, sputum and BAL',\n", + " 'SecondaryOutcomeTimeFrame': 'at days 1, 3 and 7'},\n", + " {'SecondaryOutcomeMeasure': 'immune response',\n", + " 'SecondaryOutcomeDescription': 'neutralizing title',\n", + " 'SecondaryOutcomeTimeFrame': 'at days 1, 3 and 7'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nage >=18 yrs\\npositive for reverse transcription polymerase chain reaction (RT-PCR) severe acute respiratory syndrome (SARS)-CoV-2\\nAcute respiratory distress syndrome (ARDS) moderate to severe, according to Berlin definition, lasting less than10 days\\nPolymerase chain reaction (PCR) increased by 3.5 with respect to baseline or >18 mg/dl\\nneed for mechanical ventilation or continuous positive airway pressure (CPAP)\\nsigned informed consent unless unfeasible for the critical condition\\n\\nExclusion Criteria:\\n\\nModerate to severe ARDS lasting more than 10 days\\nproven hypersensitivity or allergic reaction to hemoderivatives or immunoglobulins\\nconsent denied',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Cesare Perotti, MD',\n", + " 'OverallOfficialAffiliation': 'Foundation IRCCS San Matteo Hospital',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Catherine Klersy',\n", + " 'LocationCity': 'Pavia',\n", + " 'LocationState': 'PV',\n", + " 'LocationZip': '27100',\n", + " 'LocationCountry': 'Italy'}]}},\n", + " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '32113510',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Chen L, Xiong J, Bao L, Shi Y. Convalescent plasma as a potential therapy for COVID-19. Lancet Infect Dis. 2020 Feb 27. pii: S1473-3099(20)30141-9. doi: 10.1016/S1473-3099(20)30141-9. [Epub ahead of print]'},\n", + " {'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'WHO. Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected. 2020. https://www.who. int/docs/default-source/coronaviruse/clinical-management-of-novel-cov. pdf (accessed Feb 20, 2020).'},\n", + " {'ReferencePMID': '16172857',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Lai ST. Treatment of severe acute respiratory syndrome. Eur J Clin Microbiol Infect Dis. 2005 Sep;24(9):583-91. Review.'},\n", + " {'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'WHO. Use of convalescent whole blood or plasma collected from patients recovered from Ebola virus disease for transfusion, as an empirical treatment during outbreaks. 2014. http://apps.who.int/iris/rest/ bitstreams/604045/retrieve (accessed Feb 20, 2020).'},\n", + " {'ReferencePMID': '26618098',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Arabi Y, Balkhy H, Hajeer AH, Bouchama A, Hayden FG, Al-Omari A, Al-Hameed FM, Taha Y, Shindo N, Whitehead J, Merson L, AlJohani S, Al-Khairy K, Carson G, Luke TC, Hensley L, Al-Dawood A, Al-Qahtani S, Modjarrad K, Sadat M, Rohde G, Leport C, Fowler R. Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol. Springerplus. 2015 Nov 19;4:709. doi: 10.1186/s40064-015-1490-9. eCollection 2015.'},\n", + " {'ReferencePMID': '21248066',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19.'},\n", + " {'ReferencePMID': '32004427',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H, Spitters C, Ericson K, Wilkerson S, Tural A, Diaz G, Cohn A, Fox L, Patel A, Gerber SI, Kim L, Tong S, Lu X, Lindstrom S, Pallansch MA, Weldon WC, Biggs HM, Uyeki TM, Pillai SK; Washington State 2019-nCoV Case Investigation Team. First Case of 2019 Novel Coronavirus in the United States. N Engl J Med. 2020 Mar 5;382(10):929-936. doi: 10.1056/NEJMoa2001191. Epub 2020 Jan 31.'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided',\n", + " 'IPDSharingDescription': 'will be decided'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", + " {'Rank': 67,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04305574',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '2020-CERC-001'},\n", + " 'Organization': {'OrgFullName': 'Yale-NUS College',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Social Media Use During COVID-19',\n", + " 'OfficialTitle': 'Getting it Right: Towards Responsible Social Media Use During a Pandemic'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 8, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 31, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'May 31, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 8, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 11, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 12, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 16, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 17, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor-Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Jean Liu',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Assistant Professor',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Yale-NUS College'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Jean Liu',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'The investigators plan to conduct a cross-sectional survey to examine how social media use during COVID-19 relates to: (1) information management, (2) assessment of the situation, and (3) affect.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus',\n", + " 'Depression',\n", + " 'Anxiety',\n", + " 'Stress']},\n", + " 'KeywordList': {'Keyword': ['COVID-19',\n", + " 'Social media',\n", + " 'Communication']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Cross-Sectional']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '5000',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Community sample',\n", + " 'ArmGroupDescription': 'We plan to recruit a representative sample of the Singapore population.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Behavioral: Use of social media during COVID-19']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Behavioral',\n", + " 'InterventionName': 'Use of social media during COVID-19',\n", + " 'InterventionDescription': \"Participants' self-reported use of social media to receive and share news about COVID-19\",\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Community sample']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Assessment of COVID-19 situation',\n", + " 'PrimaryOutcomeDescription': '3 items on fear of the situation, confidence the government can manage the situation, and assessed chance of being infected (each rated using 4-point scales: min = 1, max = 4; higher scores indicate increased confidence / likelihood / fear)',\n", + " 'PrimaryOutcomeTimeFrame': 'Single measurement (upon study enrolment)'},\n", + " {'PrimaryOutcomeMeasure': 'Depression, Anxiety and Stress Scale',\n", + " 'PrimaryOutcomeDescription': '21-item validated scale assessing symptoms of depression, anxiety, and stress (DASS-21): Min score = 0, Max score = 21; higher score indicates a worse outcome',\n", + " 'PrimaryOutcomeTimeFrame': 'Single measurement (upon study enrolment)'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Familiarity and trust in COVID-related rumours',\n", + " 'SecondaryOutcomeDescription': \"Participants' self-report of their familiarity (yes/no) and belief of specific (yes/no), and whether they shared these on social media (yes/no)\",\n", + " 'SecondaryOutcomeTimeFrame': 'Single measurement (upon study enrolment)'},\n", + " {'SecondaryOutcomeMeasure': 'Availability heuristic',\n", + " 'SecondaryOutcomeDescription': \"Participants' assessment of how many cases there have been in COVID-19 and SARS\",\n", + " 'SecondaryOutcomeTimeFrame': 'Single measurement (upon study enrolment)'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAt least 21 years\\nHas stayed in Singapore for at least 2 years\\n\\nExclusion Criteria:\\n\\nBelow 21 years\\nHas stayed in Singapore for less than 2 years',\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '21 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'Representative sample of the Singapore population',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Jean Liu, PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '66013694',\n", + " 'CentralContactEMail': 'jeanliu@yale-nus.edu.sg'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Jean Liu, PhD',\n", + " 'OverallOfficialAffiliation': 'Yale-NUS College',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Yale-NUS College',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Singapore',\n", + " 'LocationZip': '138527',\n", + " 'LocationCountry': 'Singapore',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Jean Liu, PhD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactEMail': 'jeanliu@yale-nus.edu.sg'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No',\n", + " 'IPDSharingDescription': 'Due to stipulations by the Institutional Review Board, data cannot be shared.'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", + " {'ConditionMeshId': 'D000003863',\n", + " 'ConditionMeshTerm': 'Depression'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000001526',\n", + " 'ConditionAncestorTerm': 'Behavioral Symptoms'},\n", + " {'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M5641',\n", + " 'ConditionBrowseLeafName': 'Depression',\n", + " 'ConditionBrowseLeafAsFound': 'Depression',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M5644',\n", + " 'ConditionBrowseLeafName': 'Depressive Disorder',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M2905',\n", + " 'ConditionBrowseLeafName': 'Anxiety Disorders',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M3399',\n", + " 'ConditionBrowseLeafName': 'Behavioral Symptoms',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BXM',\n", + " 'ConditionBrowseBranchName': 'Behaviors and Mental Disorders'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 68,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04331795',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'IRB20-0515'},\n", + " 'Organization': {'OrgFullName': 'University of Chicago',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Tocilizumab to Prevent Clinical Decompensation in Hospitalized, Non-critically Ill Patients With COVID-19 Pneumonitis',\n", + " 'OfficialTitle': 'Early Institution of Tocilizumab Titration in Non-Critical Hospitalized COVID-19 Pneumonitis',\n", + " 'Acronym': 'COVIDOSE'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 3, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'July 1, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'December 1, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'April 1, 2020',\n", + " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 2, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'University of Chicago',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'IsFDARegulatedDrug': 'Yes',\n", + " 'IsFDARegulatedDevice': 'No',\n", + " 'IsUSExport': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Coronavirus disease-2019 (COVID-19) has a quoted inpatient mortality as high as 25%. This high mortality may be driven by hyperinflammation resembling cytokine release syndrome (CRS), offering the hope that therapies targeting the interleukin-6 (IL-6) axis therapies commonly used to treat CRS can be used to reduce COVID-19 mortality. Retrospective analysis of severe to critical COVID-19 patients receiving tocilizumab demonstrated that the majority of patients had rapid resolution (i.e., within 24-72 hours following administration) of both clinical and biochemical signs (fever and CRP, respectively) of hyperinflammation with only a single tocilizumab dose.\\n\\nHypotheses:\\n\\nTocilizumab is effective in decreasing signs, symptoms, and laboratory evidence of COVID-19 pneumonitis in hospitalized, non-critically ill patients with clinical risk factors for clinical decompensation, intensive care utilization, and death.\\nLow-dose tocilizumab is effective in decreasing signs, symptoms, and laboratory evidence of COVID-19 pneumonitis in hospitalized, non-critically ill patients with and without clinical risk factors for clinical decompensation, intensive care utilization, and death.\\n\\nObjectives:\\n\\nTo establish proof of concept that tocilizumab is effective in decreasing signs, symptoms, and laboratory evidence of COVID-19 pneumonitis in hospitalized, non-critically ill patients with clinical risk factors for clinical decompensation, intensive care utilization, and death, as determined by the clinical outcome of resolution of fever and the biochemical outcome measures of time to CRP normalization for the individual patient and the rate of patients whose CRP normalize.\\nTo establish proof of concept that low-dose tocilizumab is effective in decreasing signs, symptoms, and laboratory evidence of COVID-19 pneumonitis in hospitalized, non-critically ill patients without clinical risk factors for clinical decompensation, intensive care utilization, and death, as determined by the clinical outcome of resolution of fever and the biochemical outcome measures of time to CRP normalization for the individual patient and the rate of patients whose CRP normalize.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 2']},\n", + " 'DesignInfo': {'DesignAllocation': 'Non-Randomized',\n", + " 'DesignInterventionModel': 'Single Group Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '50',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Group A',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Hospitalized, non-critically ill patients with COVID-19 pneumonitis with risk factors for decompensation',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Tocilizumab']}},\n", + " {'ArmGroupLabel': 'Group B',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Hospitalized, non-critically ill patients with COVID-19 pneumonitis without risk factors for decompensation',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Tocilizumab']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Tocilizumab',\n", + " 'InterventionDescription': 'Group A: Tocilizumab (beginning dose 200mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.\\n\\nSecond dose is provisioned if evidence of clinical worsening or lack of C-reactive protein response.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Group A']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Tocilizumab',\n", + " 'InterventionDescription': 'Group B: Low-dose tocilizumab (beginning dose 80mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.\\n\\nSecond dose is provisioned if evidence of clinical worsening or lack of C-reactive protein response.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Group B']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Clinical response',\n", + " 'PrimaryOutcomeDescription': 'Tmax Response: Resolution of fever (from Tmax > 38C in 24H period to Tmax < 38C in following 24H period, with Tmax measured by commonly accepted clinical methods [forehead, tympanic, oral, axillary, rectal]). Maximum temperature within 24-hour period of time (0:00-23:59) on the day prior to, day of, and every 24 hours after tocilizumab administration. The primary endpoint is absence of Tmax greater than or equal to 38ºC in the 24-hour period following tocilizumab administration.',\n", + " 'PrimaryOutcomeTimeFrame': 'Assessed for the 24 hour period after tocilizumab administration'},\n", + " {'PrimaryOutcomeMeasure': 'Biochemical response',\n", + " 'PrimaryOutcomeDescription': 'CRP normalization rate: Calculated as the ratio of the number of patients who achieve normal CRP value following tocilizumab administration and total number of patients who receive tocilizumab.\\n\\nTime to CRP normalization: Calculated as the number of hours between tocilizumab administration and first normal CRP value.',\n", + " 'PrimaryOutcomeTimeFrame': \"Assessed every 24 hours during patient's hospitalization, up to 4 weeks after tocilizumab administration\"}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Overall survival',\n", + " 'SecondaryOutcomeDescription': '28-Day Overall Survival is defined as the status of the patient at the end of 28 days, beginning from the time of the first dose of tocilizumab.',\n", + " 'SecondaryOutcomeTimeFrame': '28 days'},\n", + " {'SecondaryOutcomeMeasure': 'Survival to hospital discharge',\n", + " 'SecondaryOutcomeDescription': 'This will be defined as the percentage of patients who are discharged in stable condition compared to the percentage of patients who die in the hospital. Patients who are discharged to hospice will be excluded from this calculation.',\n", + " 'SecondaryOutcomeTimeFrame': 'Hospitalization, up to 4 weeks after tocilizumab administration'},\n", + " {'SecondaryOutcomeMeasure': 'Progression of COVID-19 pneumonitis',\n", + " 'SecondaryOutcomeDescription': \"This will be a binary outcome defined by worsening COVID-19 pneumonitis resulting in transition from clinical Group A or Group B COVID-19 pneumonitis to critical COVID-19 pneumonitis during the course of the patient's COVID-19 infection. This diagnosis will be determined by treating physicians on the basis of worsening pulmonary infiltrates on chest imaging as well as clinical deterioration marked by persistent fever, rising supplemental oxygen requirement, declining PaO2/FiO2 ratio, and the need for intensive care such as mechanical ventilation or vasopressor/inotrope medication(s).\",\n", + " 'SecondaryOutcomeTimeFrame': 'Hospitalization, up to 4 weeks after tocilizumab administration'},\n", + " {'SecondaryOutcomeMeasure': 'Rate of non-elective mechanical ventilation',\n", + " 'SecondaryOutcomeDescription': \"This will be a binary outcome defined as worsening COVID-19 disease resulting in the use of non-invasive (BiPap, heated high-flow nasal cannula) or invasive positive pressure ventilation during the course of the patient's COVID-19 infection. For patients admitted to the hospital using non-invasive mechanical ventilation, the utilization of mechanical ventilation will count toward this metric, as well. Calculated as the ratio of the number of patients who require non-invasive or invasive positive pressure ventilation during hospitalization and total number of patients who receive tocilizumab.\",\n", + " 'SecondaryOutcomeTimeFrame': 'Hospitalization, up to 4 weeks after tocilizumab administration'},\n", + " {'SecondaryOutcomeMeasure': 'Duration of mechanical ventilation',\n", + " 'SecondaryOutcomeDescription': 'This will be a continuous outcome defined by the amount of time between initiation and cessation of mechanical ventilation (invasive and non-invasive).',\n", + " 'SecondaryOutcomeTimeFrame': 'Hospitalization, up to 4 weeks after tocilizumab administration'},\n", + " {'SecondaryOutcomeMeasure': 'Time to mechanical ventilation',\n", + " 'SecondaryOutcomeDescription': 'This will be a continuous outcome defined by the amount of time between tocilizumab dose administration and the initiation of mechanical ventilation. This will be treated as a time-to-event with possible censoring.',\n", + " 'SecondaryOutcomeTimeFrame': 'Assessed over hospitalization, up to 4 weeks after tocilizumab administration'},\n", + " {'SecondaryOutcomeMeasure': 'Rate of vasopressor/inotrope utilization',\n", + " 'SecondaryOutcomeDescription': \"This will be a binary outcome defined as utilization of any vasopressor or inotropic medication during the course of the patient's COVID-19 infection. Calculated as the ratio of the number of patients who require vasopressor or inotrope medication during hospitalization and total number of patients who receive tocilizumab.\",\n", + " 'SecondaryOutcomeTimeFrame': 'Hospitalization, up to 4 weeks after tocilizumab administration'},\n", + " {'SecondaryOutcomeMeasure': 'Duration of vasopressor/inotrope utilization',\n", + " 'SecondaryOutcomeDescription': 'This will be a continuous outcome defined by the amount of time between initiation of first and cessation of last vasopressor or inotrope medication(s).',\n", + " 'SecondaryOutcomeTimeFrame': 'Hospitalization, up to 4 weeks after tocilizumab administration'},\n", + " {'SecondaryOutcomeMeasure': 'Time to vasopressor or inotropic utilization',\n", + " 'SecondaryOutcomeDescription': 'This will be a continuous outcome defined by the amount of time between first tocilizumab dose administration and the initiation of vasopressor or inotropic medication(s). This will be treated as a time-to-event with possible censoring.',\n", + " 'SecondaryOutcomeTimeFrame': 'Assessed over hospitalization, up to 4 weeks after tocilizumab administration'},\n", + " {'SecondaryOutcomeMeasure': 'Number of ICU days',\n", + " 'SecondaryOutcomeDescription': 'Number of ICU days is defined as the time period when a patient is admitted to the ICU (defined as the timestamp on the first vital signs collected in an ICU) until they are transferred from the ICU to a non-ICU setting such as a general acute care bed (defined as the timestamp on the first vital signs collected outside an ICU, excepting any \"off the floor\" vital signs charted from operating rooms or procedure or imaging suites). Death in the ICU will be a competing risk.',\n", + " 'SecondaryOutcomeTimeFrame': 'Hospitalization, up to 4 weeks after tocilizumab administration'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\nAdults ≥ 18 years of age\\nApproval from the patient's primary service\\nAdmitted as an inpatient to University of Chicago Medicine\\nFever, documented in electronic medical record and defined as: T ≥ 38*C by any conventional clinical method (forehead, tympanic, oral, axillary, rectal)\\nPositive test for active SARS-CoV-2 infection\\nRadiographic evidence of infiltrates on chest radiograph (CXR) or computed tomography (CT)\\n\\nExclusion Criteria:\\n\\nConcurrent use of invasive mechanical ventilation (patients receiving non-invasive mechanical ventilation [CPAP, BiPap, HHFNC] are eligible)\\nConcurrent use of vasopressor or inotropic medications\\nPrevious receipt of tocilizumab or another anti-IL6R or IL-6 inhibitor.\\nKnown history of hypersensitivity to tocilizumab.\\nPatients who are actively being considered for a study of an antiviral agent that would potentially exclude concurrent enrollment on this study.\\nPatients actively receiving an investigational antiviral agent in the context of a clinical research study.\\nDiagnosis of end-stage liver disease or listed for liver transplant.\\nElevation of AST or ALT in excess of 5 times the upper limit of normal.\\nNeutropenia (Absolute neutrophil count < 500/uL).\\nThrombocytopenia (Platelets < 50,000/uL).\\nOn active therapy with a biologic immunosuppressive agent.\\nHistory of bone marrow transplantation or solid organ transplant.\\nKnown history of Hepatitis B or Hepatitis C.\\nKnown history of mycobacterium tuberculosis infection at risk for reactivation.\\nKnown history of gastrointestinal perforation or active diverticulitis.\\nMulti-organ failure as determined by primary treating team\\nAny other documented serious, active infection besides COVID-19.\\nPregnant patients\\nPatients who are unable to discontinue scheduled antipyretic medications, either as monotherapy (e.g., acetaminophen or ibuprofen [aspirin is acceptable]) or as part of combination therapy (e.g., hydrocodone/acetaminophen, aspirin/acetaminophen/caffeine [Excedrin®])\\nCRP < 40 mg/L (or ug/mL)\\n\\nPatients will be assigned to Group A if:\\n\\n● C-reactive protein (CRP) ≥ 75 ug/mL\\n\\nAND\\n\\nAny one of the following criteria are met:\\n\\nPrevious ICU admission\\nPrevious non-elective intubation\\nAdmission for heart failure exacerbation within the past 12 months\\nHistory of percutaneous coronary intervention (PCI)\\nHistory of coronary artery bypass graft (CABG) surgery\\nDiagnosis of pulmonary hypertension\\nBaseline requirement for supplemental O2\\nDiagnosis of interstitial lung disease (ILD)\\nAdmission for chronic obstructive pulmonary disease (COPD) exacerbation within the past 12 months\\nAsthma with use of daily inhaled corticosteroid\\nHistory of pneumonectomy or lobectomy\\nHistory of radiation therapy to the lung\\nHistory of HIV\\nCancer of any stage and receiving active treatment (excluding hormonal therapy)\\nAny history of diagnosed immunodeficiency\\nEnd-stage renal disease (ESRD) requiring peritoneal or hemodialysis\\n\\nAll other eligible patients assigned to Group B\",\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Pankti Reid, MD, MPH',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '7737021220',\n", + " 'CentralContactEMail': 'pankti.reid@uchospitals.edu'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Pankti Reid, MD, MPH',\n", + " 'OverallOfficialAffiliation': 'University of Chicago, Department of Medicine, Section of Rheumatology',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'University of Chicago Medicine',\n", + " 'LocationCity': 'Chicago',\n", + " 'LocationState': 'Illinois',\n", + " 'LocationZip': '60637',\n", + " 'LocationCountry': 'United States',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Pankti Reid, MD, MPH',\n", + " 'LocationContactRole': 'Contact'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000011014',\n", + " 'ConditionMeshTerm': 'Pneumonia'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000008171',\n", + " 'ConditionAncestorTerm': 'Lung Diseases'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M12487',\n", + " 'ConditionBrowseLeafName': 'Pneumonia',\n", + " 'ConditionBrowseLeafAsFound': 'Pneumonitis',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M9751',\n", + " 'ConditionBrowseLeafName': 'Lung Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'}]}}}}},\n", + " {'Rank': 69,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04316884',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'EPN 2017/043 Covid19'},\n", + " 'Organization': {'OrgFullName': 'Uppsala University',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Mechanisms for Organ Dysfunction in Covid-19',\n", + " 'OfficialTitle': 'Uppsala Intensive Care Study of Mechanisms for Organ Dysfunction in Covid-19',\n", + " 'Acronym': 'UMODCOVID19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 12, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'December 31, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2021',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 13, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 18, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 20, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 18, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 20, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Uppsala University',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'The study aims to investigate organ dysfunction and biomarkers in patients with suspected or verified COVID-19 during intensive care at Uppsala University Hospital.',\n", + " 'DetailedDescription': 'Consenting patients with suspected or verified SARS-COV-2 infection, COVID-19, will undergo daily blood, urine and sputum sampling during their stay in intensive care. Data on organ dysfunction will be collected through the electronic patient journal and electronic patient data management system. The collected samples will be analysed for a panel of potential biomarkers that will be correlated to organ dysfunction and clinical outcome.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", + " 'Organ Dysfunction Syndrome Sepsis',\n", + " 'Organ Dysfunction Syndrome, Multiple',\n", + " 'Septic Shock',\n", + " 'Acute Kidney Injury',\n", + " 'Acute Respiratory Distress Syndrome']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'BioSpec': {'BioSpecRetention': 'Samples With DNA',\n", + " 'BioSpecDescription': 'Plasma, Urine and Sputum'},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '100',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'COVID-19',\n", + " 'ArmGroupDescription': 'Patients with suspected or verified COVID-19 admitted to intensive care at Uppsala University Hospital'}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Acute Kidney Injury',\n", + " 'PrimaryOutcomeDescription': 'KDIGO AKI score',\n", + " 'PrimaryOutcomeTimeFrame': 'During Intensive Care, an estimated average of 10 days.'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'ARDS',\n", + " 'SecondaryOutcomeDescription': 'Acute Respiratory Distress Syndrome yes/no',\n", + " 'SecondaryOutcomeTimeFrame': 'During intensive care, an estimated average of 10 days.'},\n", + " {'SecondaryOutcomeMeasure': '30 day mortality',\n", + " 'SecondaryOutcomeDescription': 'Death within 30 days of ICU admission',\n", + " 'SecondaryOutcomeTimeFrame': '30 days'},\n", + " {'SecondaryOutcomeMeasure': '1 year mortality',\n", + " 'SecondaryOutcomeDescription': 'Death within 1 year of ICU admission',\n", + " 'SecondaryOutcomeTimeFrame': '1 year'},\n", + " {'SecondaryOutcomeMeasure': 'Chronic Kidney Disease',\n", + " 'SecondaryOutcomeDescription': 'Development of Chronic Kidney Disease',\n", + " 'SecondaryOutcomeTimeFrame': '60 days and 1 year after ICU admission'},\n", + " {'SecondaryOutcomeMeasure': 'SOFA-score',\n", + " 'SecondaryOutcomeDescription': 'Sequential Organ Failure Score as a continuous variable',\n", + " 'SecondaryOutcomeTimeFrame': 'During Intensive Care, an estimated average of 10 days.'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAdmitted to intensive care\\nsuspected or verified COVID-19\\n\\nExclusion Criteria:\\n\\nPregnancy or breastfeeding\\nPreexisting end-stage kidney failure or dialysis\\nUnder-age',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'All patients requiring intensive care with suspected or verified COVID19',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Robert Frithiof, MD. PhD.',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '0736563473',\n", + " 'CentralContactEMail': 'robert.frithiof@surgsci.uu.se'},\n", + " {'CentralContactName': 'Sara Bülow Anderberg, MD.',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '0730247414',\n", + " 'CentralContactEMail': 'sarabulow@gmail.com'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Robert Frithiof, MD. PhD',\n", + " 'OverallOfficialAffiliation': 'Uppsala University Hospital',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Uppsala University Hospital',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Uppsala',\n", + " 'LocationZip': '75185',\n", + " 'LocationCountry': 'Sweden',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Robert Frithiof, MD. PhD.',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '073-6563473',\n", + " 'LocationContactEMail': 'robert.frithiof@surgsci.uu.se'},\n", + " {'LocationContactName': 'Sara Bülow Anderberg, MD.',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '073-0247414',\n", + " 'LocationContactEMail': 'sarabulow@gmail.com'},\n", + " {'LocationContactName': 'Robert Frithiof, MD. PhD.',\n", + " 'LocationContactRole': 'Principal Investigator'},\n", + " {'LocationContactName': 'Sara Bülow Anderberg, MD.',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Michael Hultström, MD. PhD.',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Miklos Lipcsey, MD. PhD.',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided',\n", + " 'IPDSharingDescription': 'IPD may be made available upon reasonable request.'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000012127',\n", + " 'ConditionMeshTerm': 'Respiratory Distress Syndrome, Newborn'},\n", + " {'ConditionMeshId': 'D000012128',\n", + " 'ConditionMeshTerm': 'Respiratory Distress Syndrome, Adult'},\n", + " {'ConditionMeshId': 'D000055371',\n", + " 'ConditionMeshTerm': 'Acute Lung Injury'},\n", + " {'ConditionMeshId': 'D000058186',\n", + " 'ConditionMeshTerm': 'Acute Kidney Injury'},\n", + " {'ConditionMeshId': 'D000013577', 'ConditionMeshTerm': 'Syndrome'},\n", + " {'ConditionMeshId': 'D000018746',\n", + " 'ConditionMeshTerm': 'Systemic Inflammatory Response Syndrome'},\n", + " {'ConditionMeshId': 'D000009102',\n", + " 'ConditionMeshTerm': 'Multiple Organ Failure'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000004194',\n", + " 'ConditionAncestorTerm': 'Disease'},\n", + " {'ConditionAncestorId': 'D000010335',\n", + " 'ConditionAncestorTerm': 'Pathologic Processes'},\n", + " {'ConditionAncestorId': 'D000051437',\n", + " 'ConditionAncestorTerm': 'Renal Insufficiency'},\n", + " {'ConditionAncestorId': 'D000007674',\n", + " 'ConditionAncestorTerm': 'Kidney Diseases'},\n", + " {'ConditionAncestorId': 'D000014570',\n", + " 'ConditionAncestorTerm': 'Urologic Diseases'},\n", + " {'ConditionAncestorId': 'D000007249',\n", + " 'ConditionAncestorTerm': 'Inflammation'},\n", + " {'ConditionAncestorId': 'D000012769',\n", + " 'ConditionAncestorTerm': 'Shock'},\n", + " {'ConditionAncestorId': 'D000008171',\n", + " 'ConditionAncestorTerm': 'Lung Diseases'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", + " {'ConditionAncestorId': 'D000012120',\n", + " 'ConditionAncestorTerm': 'Respiration Disorders'},\n", + " {'ConditionAncestorId': 'D000007235',\n", + " 'ConditionAncestorTerm': 'Infant, Premature, Diseases'},\n", + " {'ConditionAncestorId': 'D000007232',\n", + " 'ConditionAncestorTerm': 'Infant, Newborn, Diseases'},\n", + " {'ConditionAncestorId': 'D000055370',\n", + " 'ConditionAncestorTerm': 'Lung Injury'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M14938',\n", + " 'ConditionBrowseLeafName': 'Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M13547',\n", + " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Newborn',\n", + " 'ConditionBrowseLeafAsFound': 'Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M13548',\n", + " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Adult',\n", + " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M26731',\n", + " 'ConditionBrowseLeafName': 'Acute Lung Injury',\n", + " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M14160',\n", + " 'ConditionBrowseLeafName': 'Shock',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M19448',\n", + " 'ConditionBrowseLeafName': 'Sepsis',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M15452',\n", + " 'ConditionBrowseLeafName': 'Toxemia',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M27585',\n", + " 'ConditionBrowseLeafName': 'Acute Kidney Injury',\n", + " 'ConditionBrowseLeafAsFound': 'Acute Kidney Injury',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M14163',\n", + " 'ConditionBrowseLeafName': 'Shock, Septic',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M19402',\n", + " 'ConditionBrowseLeafName': 'Systemic Inflammatory Response Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Organ Dysfunction Syndrome Sepsis',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M26730',\n", + " 'ConditionBrowseLeafName': 'Lung Injury',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M10642',\n", + " 'ConditionBrowseLeafName': 'Multiple Organ Failure',\n", + " 'ConditionBrowseLeafAsFound': 'Organ Dysfunction Syndrome, Multiple',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M25305',\n", + " 'ConditionBrowseLeafName': 'Renal Insufficiency',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M9281',\n", + " 'ConditionBrowseLeafName': 'Kidney Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M15902',\n", + " 'ConditionBrowseLeafName': 'Urologic Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M8876',\n", + " 'ConditionBrowseLeafName': 'Inflammation',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M9751',\n", + " 'ConditionBrowseLeafName': 'Lung Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13540',\n", + " 'ConditionBrowseLeafName': 'Respiration Disorders',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M24456',\n", + " 'ConditionBrowseLeafName': 'Premature Birth',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M8862',\n", + " 'ConditionBrowseLeafName': 'Infant, Premature, Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M8859',\n", + " 'ConditionBrowseLeafName': 'Infant, Newborn, Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T4953',\n", + " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Infant',\n", + " 'ConditionBrowseLeafAsFound': 'Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'T191',\n", + " 'ConditionBrowseLeafName': 'Acute Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC16',\n", + " 'ConditionBrowseBranchName': 'Diseases and Abnormalities at or Before Birth'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BXS',\n", + " 'ConditionBrowseBranchName': 'Urinary Tract, Sexual Organs, and Pregnancy Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC26',\n", + " 'ConditionBrowseBranchName': 'Wounds and Injuries'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 70,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04333693',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'RIV-2020-1'},\n", + " 'Organization': {'OrgFullName': 'Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery',\n", + " 'OrgClass': 'NETWORK'},\n", + " 'BriefTitle': 'Outcomes of Vascular Surgery in COVID-19 Infection: National Cohort Study',\n", + " 'OfficialTitle': 'Outcomes of Vascular Surgery in COVID-19 Infection: National Cohort Study (Covid-VAS)',\n", + " 'Acronym': 'Covid-VAS'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'October 1, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'November 1, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 31, 2020',\n", + " 'StudyFirstSubmitQCDate': 'April 2, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 3, 2020',\n", + " 'StudyFirstPostDateType': 'Estimate'},\n", + " 'LastUpdateSubmitDate': 'April 2, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", + " 'LastUpdatePostDateType': 'Estimate'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery',\n", + " 'LeadSponsorClass': 'NETWORK'}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'There is an urgent need to understand the outcomes of COVID-19 infected patients who undergo surgery, specially vascular surgery. Capturing real-world data and sharing Spanish national experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, improving their clinical care.\\n\\nThe global community has recognised that rapid dissemination and completion of studies in COVID-19 infected patients is a high priority, so we encourage all stakeholders (local investigators, ethics committees, IRBs) to work as quickly as possible to approve this project.\\n\\nThis investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk. This study does not collect any patient identifiable information (including no dates) and data will not be analysed at hospital-level.',\n", + " 'DetailedDescription': 'To determine 30-day mortality in patients with COVID-19 infection who undergo vascular surgery.\\n\\nThis will inform future risk stratification, decision making, and patient consent.\\n\\nInclusion criteria\\n\\nThe inclusion criteria are:\\n\\n• Adults (age ≥18 years) undergoing ANY type of vascular surgery in an operating theatre, this includes open surgery, endovascular surgery or hybrid procedures.\\n\\nAND\\n\\n• Either before or after surgery: (i) lab test confirmed COVID-19 infection or (ii) clinical diagnosis of COVID-19 infection (no test performed).\\n\\nTherefore this study should capture:\\n\\nemergency surgery patients with clinical diagnosis or lab confirmation of COVID-19 infection before surgery.\\nemergency surgery patients with clinical diagnosis or lab confirmation of COVID-19 infection after surgery.\\nelective surgery patients with clinical diagnosis or lab confirmation of COVID-19 infection after surgery. Patients who meet the inclusion criteria should be included regardless of surgical indication (aneurysm, limb or visceral ischemia, carotid stenosis, vascular trauma), anaesthetic type (local, regional, general), procedure type, or surgical approach (open surgery, endovascular surgery, hybrid procedure).\\n\\nAt most sites it is anticipated that the number of eligible patients is likely to be low. If possible all consecutive patients fulfilling inclusion criteria should be entered.\\n\\nStudy period Overall we plan to close data entry in September 2020 when the global pandemic is likely to be over, however individual centres may select their own study windows, depending on the timing of COVID-19 epidemic in their community.\\n\\nPatient enrolment Ideally patients should be identified prospectively. However, given the rapid progression of the global pandemic, there may be no further new cases of COVID-19 infection in some hospitals that treated large numbers of COVID-19 earlier in the pandemic. It is important to capture the experience of these centres, therefore retrospective patient identification and data entry is permitted.\\n\\nPrimary outcome\\n\\n30-day mortality Secondary outcome\\n7-day mortality\\n30-day reoperation\\nPostoperative ICU admission\\nPostoperative respiratory failure\\nPostoperative acute respiratory distress syndrome (ARDS)\\nPostoperative sepsis\\n\\nData collection Data will be collected and stored online through a secure server running the Spanish Society for Angiology and Vascular Surgery (SEACV) web application. This secure server allows collaborators to enter and store data in a secure system. A designated collaborator at each participating site will be provided with a project server login details, allowing them to securely submit data on to the system. Only anonymised data will be uploaded to the database. No patient identifiable data will be collected. Data collected will be on comorbidities, physiological state, treatment/operation, and outcome. No dates (e.g. date of surgery) will be collected. qSOFA and CURB-65 will be calculated based on the individual data points entered.\\n\\nLocal approvals The principal investigator at each participating site is responsible for obtaining necessary local approvals (e.g. research ethics committee or institutional review board approvals).The first approval will be on the Valladolid East Ethics Committee for Clinical Investigation.\\n\\nCollaborators will be required to confirm that a local approval is in place at the time of uploading each patient record to the study database.\\n\\nWhere an audit approval is needed, this can be either registered as service evaluation, or to benchmark against an auditable standard (e.g. overall mortality after emergency surgery should be <15%).\\n\\nPrior to formal local study approval, collaborators may prospectively collect data, but this should not be uploaded to the database until approval is confirmed.\\n\\nAnalysis A detailed statistical analysis plan will be written. Analyses will be overseen by the independent data monitoring committee (DMC). Reports will include description of the primary and secondary outcomes in the cohort. Multivariable modelling will be undertaken to CovidVAS protocol identify risk factors for 30-days mortality. Analyses will be stratified according to whether or not diagnosis of COVID-19 was confirmed by a lab test. Interim analyses will be performed as guided by the independent DMC. The first analysis will be performed once 50 patients have been entered on to the database, and the frequency of subsequent analyses will be agreed with the DMC. The decision to submit data for publication will be agreed by the steering committee with the DMC. Hospital-level data will not be released or published.\\n\\nAuthorship Collaborators from each site who contribute patients will be recognised on any resulting publications as PubMed-citable co-authors.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Vascular Surgical Procedures',\n", + " 'COVID-19',\n", + " 'Postoperative Complications']},\n", + " 'KeywordList': {'Keyword': ['Vascular surgical procedures',\n", + " 'Endovascular procedures',\n", + " 'COVID-19',\n", + " 'Postoperative complications',\n", + " 'Prognosis']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'Yes',\n", + " 'TargetDuration': '6 Months',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '50',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Cases',\n", + " 'ArmGroupDescription': 'Adults (age>18years) undergoing any type of vascular surgery (open surgery, endovascular surgery or hybrid procedure) in an operating theatre and either before or after surgery: lab test confirmed COVID-19 or clinical diagnosis of COVI-19 infection (no test performed)',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Procedure: Vascular surgery']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Procedure',\n", + " 'InterventionName': 'Vascular surgery',\n", + " 'InterventionDescription': 'Open vascular, endovascular or hybrid procedures',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Cases']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': '30-days mortality',\n", + " 'PrimaryOutcomeDescription': '30-days mortality after vascular surgery in patients with COVID-19 infection',\n", + " 'PrimaryOutcomeTimeFrame': '30-days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': '7-days mortality',\n", + " 'SecondaryOutcomeDescription': '7-days mortality after vascular surgery in patients with COVID-19 infection',\n", + " 'SecondaryOutcomeTimeFrame': '7-days'},\n", + " {'SecondaryOutcomeMeasure': '30-days reoperation',\n", + " 'SecondaryOutcomeDescription': '30-days reoperation after vascular surgery in patients with COVID-19 infection',\n", + " 'SecondaryOutcomeTimeFrame': '30-days'},\n", + " {'SecondaryOutcomeMeasure': 'Postoperative ICU admission',\n", + " 'SecondaryOutcomeDescription': 'Postoperative ICU admission after vascular surgery in patients with COVID-19 infection',\n", + " 'SecondaryOutcomeTimeFrame': '30-days'},\n", + " {'SecondaryOutcomeMeasure': 'Postoperative respiratory failure',\n", + " 'SecondaryOutcomeDescription': 'Postoperative respiratory failure after vascular surgery in patients with COVID-19 infection',\n", + " 'SecondaryOutcomeTimeFrame': '30-days'},\n", + " {'SecondaryOutcomeMeasure': 'Postoperative acute respiratory distress syndrome (ARDS)',\n", + " 'SecondaryOutcomeDescription': 'Postoperative acute respiratory distress syndrome (ARDS) after vascular surgery in patients with COVID-19 infection',\n", + " 'SecondaryOutcomeTimeFrame': '30-days'},\n", + " {'SecondaryOutcomeMeasure': 'Postoperative sepsis',\n", + " 'SecondaryOutcomeDescription': 'Postoperative sepsis after vascular surgery in patients with COVID-19 infection',\n", + " 'SecondaryOutcomeTimeFrame': '30-days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAdults (age ≥18 years) undergoing ANY type of vascular surgery in an operating theatre, this includes obstetrics. AND\\nEither before or after surgery: (i) lab test confirmed COVID-19 infection or (ii) clinical diagnosis of COVID-19 infection (no test performed).\\n\\nTherefore this study should capture:\\n\\nemergency surgery patients with clinical diagnosis or lab confirmation of COVID-19 infection before surgery.\\nemergency surgery patients with clinical diagnosis or lab confirmation of COVID-19 infection after surgery.\\nelective surgery patients with clinical diagnosis or lab confirmation of COVID-19 infection after surgery.\\n\\nExclusion Criteria:\\n\\nNot informed consent signed.',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'Patients with COVID-19 infection who undergo vascular surgery.',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Enrique M San Norberto, MD, PhD, MsC',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '0034686754618',\n", + " 'CentralContactEMail': 'esannorberto@hotmail.com'},\n", + " {'CentralContactName': 'Investigator Council',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '0034910569145',\n", + " 'CentralContactEMail': 'secretaria@seacv.es'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Spanish Society for Angiology and Vascular Surgery',\n", + " 'LocationCity': 'Madrid',\n", + " 'LocationZip': '28006',\n", + " 'LocationCountry': 'Spain',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Enrique M San Norberto, MD, PhD, MsC',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '0034686754618',\n", + " 'LocationContactEMail': 'esannorberto@hotmail.com'},\n", + " {'LocationContactName': 'Investigator Council',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '0034910569145',\n", + " 'LocationContactEMail': 'secretaria@seacv.es'},\n", + " {'LocationContactName': 'Enrique M San Norberto, MD, PhD, MsC',\n", + " 'LocationContactRole': 'Principal Investigator'},\n", + " {'LocationContactName': 'Joaquin de Haro, MD, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Carlos Vaquero, MD, PhD, Prof',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Luis Riera, MD, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Alvaro Torres, MD, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Raul Lara, MD, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Jorge Cuenca, MD, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Jorge Fernández-Noya, MD, PdD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Sergi Bellmunt, MD, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}}]}},\n", + " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '32222820',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Zoia C, Bongetta D, Veiceschi P, Cenzato M, Di Meco F, Locatelli D, Boeris D, Fontanella MM. Neurosurgery during the COVID-19 pandemic: update from Lombardy, northern Italy. Acta Neurochir (Wien). 2020 Mar 28. doi: 10.1007/s00701-020-04305-w. [Epub ahead of print]'},\n", + " {'ReferencePMID': '32221117',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Aminian A, Safari S, Razeghian-Jahromi A, Ghorbani M, Delaney CP. COVID-19 Outbreak and Surgical Practice: Unexpected Fatality in Perioperative Period. Ann Surg. 2020 Mar 26. doi: 10.1097/SLA.0000000000003925. [Epub ahead of print]'},\n", + " {'ReferencePMID': '32202401',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Ficarra V, Novara G, Abrate A, Bartoletti R, Crestani A, De Nunzio C, Giannarini G, Gregori A, Liguori G, Mirone V, Pavan N, Scarpa RM, Simonato A, Trombetta C, Tubaro A, Porpiglia F; Members of the Research Urology Network (RUN). Urology practice during COVID-19 pandemic. Minerva Urol Nefrol. 2020 Mar 23. doi: 10.23736/S0393-2249.20.03846-1. [Epub ahead of print]'},\n", + " {'ReferencePMID': '32188602',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Iacobucci G. Covid-19: all non-urgent elective surgery is suspended for at least three months in England. BMJ. 2020 Mar 18;368:m1106. doi: 10.1136/bmj.m1106.'},\n", + " {'ReferencePMID': '32109013',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMoa2002032. [Epub ahead of print]'}]},\n", + " 'SeeAlsoLinkList': {'SeeAlsoLink': [{'SeeAlsoLinkLabel': 'Spanish Society for Angiology and Vascular Surgery',\n", + " 'SeeAlsoLinkURL': 'http://www.seacv.es'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided',\n", + " 'IPDSharingDescription': 'No sharing plan available nowadays.'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000011183',\n", + " 'ConditionMeshTerm': 'Postoperative Complications'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000010335',\n", + " 'ConditionAncestorTerm': 'Pathologic Processes'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M12648',\n", + " 'ConditionBrowseLeafName': 'Postoperative Complications',\n", + " 'ConditionBrowseLeafAsFound': 'Postoperative Complications',\n", + " 'ConditionBrowseLeafRelevance': 'high'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'}]}}}}},\n", + " {'Rank': 71,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04324606',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'COV001'},\n", + " 'Organization': {'OrgFullName': 'University of Oxford',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'A Study of a Candidate COVID-19 Vaccine (COV001)',\n", + " 'OfficialTitle': 'A Phase I/II Study to Determine Efficacy, Safety and Immunogenicity of the Candidate Coronavirus Disease (COVID-19) Vaccine ChAdOx1 nCoV-19 in UK Healthy Adult Volunteers'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 2021',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'May 2021',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 20, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 26, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 27, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 26, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 27, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'University of Oxford',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'A phase I/II single-blinded, randomised, placebo controlled, multi-centre study to determine efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in UK healthy adult volunteers aged 18-55 years. The vaccine will be administered intramuscularly (IM).',\n", + " 'DetailedDescription': 'There will be 5 study groups and it is anticipated that a total of 510 volunteers will be enrolled. Volunteers will participate in the study for approximately 6 months, with the option to come for an additional follow up visit at Day 364.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus']},\n", + " 'KeywordList': {'Keyword': ['COVID-19, Vaccine']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 1', 'Phase 2']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Sequential Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Single',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '510',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Group 1a',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19. Volunteers will be blinded and will not know if they have received the IMP or the placebo.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: ChAdOx1 nCoV-19']}},\n", + " {'ArmGroupLabel': 'Group 1b',\n", + " 'ArmGroupType': 'Placebo Comparator',\n", + " 'ArmGroupDescription': 'Volunteers will receive a single injection of saline intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: Saline Placebo']}},\n", + " {'ArmGroupLabel': 'Group 2a',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19. Volunteers will be blinded and will not know if they have received the IMP or the placebo.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: ChAdOx1 nCoV-19']}},\n", + " {'ArmGroupLabel': 'Group 2b',\n", + " 'ArmGroupType': 'Placebo Comparator',\n", + " 'ArmGroupDescription': 'Volunteers will receive a single injection of saline intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: Saline Placebo']}},\n", + " {'ArmGroupLabel': 'Group 3',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Volunteers will receive two doses of 5x10^10vp ChAdOx1 nCoV-19 at week 0 and week 4.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: ChAdOx1 nCoV-19']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Biological',\n", + " 'InterventionName': 'ChAdOx1 nCoV-19',\n", + " 'InterventionDescription': '5x10^10vp of ChAdOx1 nCoV-19',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Group 1a',\n", + " 'Group 2a',\n", + " 'Group 3']}},\n", + " {'InterventionType': 'Other',\n", + " 'InterventionName': 'Saline Placebo',\n", + " 'InterventionDescription': 'Saline injection delivered intramuscularly',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Group 1b',\n", + " 'Group 2b']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19: Number of virologically confirmed (PCR positive) symptomatic cases',\n", + " 'PrimaryOutcomeDescription': 'Number of virologically confirmed (PCR positive) symptomatic cases of COVID-19',\n", + " 'PrimaryOutcomeTimeFrame': '6 months'},\n", + " {'PrimaryOutcomeMeasure': 'Assess the safety of the candidate vaccine ChAdOx1 nCoV: Occurrence of serious adverse events (SAEs)',\n", + " 'PrimaryOutcomeDescription': 'Occurrence of serious adverse events (SAEs) throughout the study duration',\n", + " 'PrimaryOutcomeTimeFrame': '6 months'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited local reactogenicity signs and symptoms',\n", + " 'SecondaryOutcomeDescription': 'Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination',\n", + " 'SecondaryOutcomeTimeFrame': '7 days following vaccination'},\n", + " {'SecondaryOutcomeMeasure': 'Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited systemic reactogenicity signs and symptoms',\n", + " 'SecondaryOutcomeDescription': 'Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination',\n", + " 'SecondaryOutcomeTimeFrame': '7 days following vaccination'},\n", + " {'SecondaryOutcomeMeasure': 'Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of unsolicited adverse events (AEs)',\n", + " 'SecondaryOutcomeDescription': 'Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination',\n", + " 'SecondaryOutcomeTimeFrame': '28 days following vaccination'},\n", + " {'SecondaryOutcomeMeasure': 'Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV through standard blood tests',\n", + " 'SecondaryOutcomeDescription': 'Change from baseline for safety laboratory measures (haematology and biochemistry blood results)',\n", + " 'SecondaryOutcomeTimeFrame': '6 months'},\n", + " {'SecondaryOutcomeMeasure': 'Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV by measuring the number of disease enhancement episodes',\n", + " 'SecondaryOutcomeDescription': 'Occurrence of disease enhancement episodes',\n", + " 'SecondaryOutcomeTimeFrame': '6 months'},\n", + " {'SecondaryOutcomeMeasure': 'Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19',\n", + " 'SecondaryOutcomeDescription': 'Number of deaths associated with COVID-19',\n", + " 'SecondaryOutcomeTimeFrame': '6 months'},\n", + " {'SecondaryOutcomeMeasure': 'Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19',\n", + " 'SecondaryOutcomeDescription': 'Number of hospital admissions associated with COVID-19',\n", + " 'SecondaryOutcomeTimeFrame': '6 months'},\n", + " {'SecondaryOutcomeMeasure': 'Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19',\n", + " 'SecondaryOutcomeDescription': 'Number of intensive care unit admissions associated with COVID-19',\n", + " 'SecondaryOutcomeTimeFrame': '6 months'},\n", + " {'SecondaryOutcomeMeasure': 'Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates',\n", + " 'SecondaryOutcomeDescription': 'Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study',\n", + " 'SecondaryOutcomeTimeFrame': '6 months'},\n", + " {'SecondaryOutcomeMeasure': 'Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays',\n", + " 'SecondaryOutcomeDescription': 'Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein',\n", + " 'SecondaryOutcomeTimeFrame': '6 months'},\n", + " {'SecondaryOutcomeMeasure': 'Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19',\n", + " 'SecondaryOutcomeDescription': 'Enzyme-linked immunosorbent assay (ELISA) to quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)',\n", + " 'SecondaryOutcomeTimeFrame': '6 months'}]},\n", + " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through Virus neutralising antibody assays',\n", + " 'OtherOutcomeDescription': 'Virus neutralising antibody (NAb) assays against live and/or pseudotype SARS-CoV-2 virus',\n", + " 'OtherOutcomeTimeFrame': '6 months'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\nHealthy adults aged 18-55 years.\\nAble and willing (in the Investigator's opinion) to comply with all study requirements.\\nWilling to allow the investigators to discuss the volunteer's medical history with their General Practitioner and access all medical records when relevant to study procedures.\\nFor females only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination.\\nAgreement to refrain from blood donation during the course of the study.\\nProvide written informed consent.\\n\\nExclusion Criteria:\\n\\nPrior receipt of any vaccines (licensed or investigational) ≤30 days before enrolment\\nPlanned receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination .\\nPrior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines).\\nAdministration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.\\nAny confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and chronic use (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed).\\nHistory of allergic disease or reactions likely to be exacerbated by any component of the vaccine.\\nAny history of hereditary angioedema or idiopathic angioedema.\\nAny history of anaphylaxis in relation to vaccination.\\nPregnancy, lactation or willingness/intention to become pregnant during the study.\\nHistory of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).\\nHistory of serious psychiatric condition likely to affect participation in the study.\\nBleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.\\nAny other serious chronic illness requiring hospital specialist supervision.\\nSuspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week.\\nSuspected or known injecting drug abuse in the 5 years preceding enrolment.\\nAny clinically significant abnormal finding on screening biochemistry, haematology blood tests or urinalysis.\\nAny other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.\\nHistory of laboratory confirmed COVID-19.\\nNew onset of fever and a cough or shortness of breath in the 30 days preceding screening and/or enrolment\\n\\nRe-Vaccination Exclusion Criteria\\n\\nAnaphylactic reaction following administration of vaccine\\nPregnancy\",\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '55 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Volunteer Recruitment Co-ordinator',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '01865 611424',\n", + " 'CentralContactEMail': 'vaccinetrials@ndm.ox.ac.uk'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Andrew Pollard, Prof',\n", + " 'OverallOfficialAffiliation': 'University of Oxford',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'NIHR WTCRF, University Hospital Southampton NHS Foundation Trust',\n", + " 'LocationCity': 'Southampton',\n", + " 'LocationState': 'Hampshire',\n", + " 'LocationZip': 'SO16 6YD',\n", + " 'LocationCountry': 'United Kingdom'},\n", + " {'LocationFacility': 'Imperial College Healthcare NHS Trust',\n", + " 'LocationCity': 'London',\n", + " 'LocationZip': 'W2 1NY',\n", + " 'LocationCountry': 'United Kingdom'},\n", + " {'LocationFacility': 'CCVTM, University of Oxford, Churchill Hospital',\n", + " 'LocationCity': 'Oxford',\n", + " 'LocationZip': 'OX3 7LE',\n", + " 'LocationCountry': 'United Kingdom'},\n", + " {'LocationFacility': 'John Radcliffe Hospital',\n", + " 'LocationCity': 'Oxford',\n", + " 'LocationZip': 'OX3 9DU',\n", + " 'LocationCountry': 'United Kingdom'}]}}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000014612',\n", + " 'InterventionMeshTerm': 'Vaccines'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000007155',\n", + " 'InterventionAncestorTerm': 'Immunologic Factors'},\n", + " {'InterventionAncestorId': 'D000045505',\n", + " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M15943',\n", + " 'InterventionBrowseLeafName': 'Vaccines',\n", + " 'InterventionBrowseLeafAsFound': 'Vaccine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M8784',\n", + " 'InterventionBrowseLeafName': 'Immunologic Factors',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 72,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04313946',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '0110'},\n", + " 'Organization': {'OrgFullName': 'Grigore T. Popa University of Medicine and Pharmacy',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Artificial Intelligence Algorithms for Discriminating Between COVID-19 and Influenza Pneumonitis Using Chest X-Rays',\n", + " 'OfficialTitle': 'The Benefits of Artificial Intelligence Algorithms (CNNs) for Discriminating Between COVID-19 and Influenza Pneumonitis in an Emergency Department Using Chest X-Ray Examinations',\n", + " 'Acronym': 'AI-COVID-Xr'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 18, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'August 16, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'August 18, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 17, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 17, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 18, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor-Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Professor Adrian Covic',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Clinical Professor',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Grigore T. Popa University of Medicine and Pharmacy'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Professor Adrian Covic',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Falcon Trading Iasi',\n", + " 'CollaboratorClass': 'UNKNOWN'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'This project aims to use artificial intelligence (image discrimination) algorithms, specifically convolutional neural networks (CNNs) for scanning chest radiographs in the emergency department (triage) in patients with suspected respiratory symptoms (fever, cough, myalgia) of coronavirus infection COVID 19. The objective is to create and validate a software solution that discriminates on the basis of the chest x-ray between Covid-19 pneumonitis and influenza',\n", + " 'DetailedDescription': 'This project aims to use artificial intelligence (image discrimination) algorithms;\\n\\nspecifically convolutional neural networks (CNNs) for scanning chest radiographs in the emergency department (triage) in patients with suspected respiratory symptoms (fever, cough, myalgia) of coronavirus infection COVID 19;\\nthe objective is to create and validate a software solution that discriminates on the basis of the chest x-ray between Covid-19 pneumonitis and influenza;\\nthis software will be trained by introducing X-Rays from patients with/without COVID-19 pneumonitis and/or flu pneumonitis;\\nthe same AI algorithm will run on future X-Ray scans for predicting possible COVID-19 pneumonitis'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", + " 'Pneumonia, Viral',\n", + " 'Influenza With Pneumonia',\n", + " 'Flu Symptom',\n", + " 'Flu Like Illness',\n", + " 'Pneumonia, Interstitial',\n", + " 'Pneumonia, Ventilator-Associated',\n", + " 'Pneumonia Atypical']},\n", + " 'KeywordList': {'Keyword': ['Artificial Intelligence',\n", + " 'CNNs',\n", + " 'COVID-19',\n", + " 'chest X-Ray',\n", + " 'Emergency Department',\n", + " 'Triage',\n", + " 'Flu']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Ecologic or Community']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '200',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Symptomatic Patients',\n", + " 'ArmGroupDescription': 'Our goal is to identify an artificial intelligence algorithm that can be run on lung radiographs in patients with influenza / respiratory viral symptoms who come to the emergency department / triage. This algorithm aims to identify the radiographs of patients with COVID-19 and those with influenza pneumonitis, with accuracy verified by COVID-19 tests.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Diagnostic Test: Scanning Chest X-rays and performing AI algorithms on images']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Diagnostic Test',\n", + " 'InterventionName': 'Scanning Chest X-rays and performing AI algorithms on images',\n", + " 'InterventionDescription': 'Chest X-Rays; AI CNNs; Results',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Symptomatic Patients']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'COVID-19 positive X-Rays',\n", + " 'PrimaryOutcomeDescription': 'Number of participants with pneumonitis on Chest X-Ray and COVID 19 positive',\n", + " 'PrimaryOutcomeTimeFrame': '6 months'},\n", + " {'PrimaryOutcomeMeasure': 'COVID-19 negative X-Rays',\n", + " 'PrimaryOutcomeDescription': 'Number of participants with pneumonitis on Chest X-Ray and COVID 19 negative',\n", + " 'PrimaryOutcomeTimeFrame': '6 months'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nflu-like symptoms: myalgia, cough, fever, sputum\\nChest X-Rays\\nCOVID-19 biological tests\\n\\nExclusion Criteria:\\n\\npatient refusal\\nuncertain radiographs\\nuncertain tests results',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'All patients with influenza symptoms that arrive at emergency department with cough, fever, myalgia - which are suspected of COVID-19 infection',\n", + " 'SamplingMethod': 'Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Alexandru Burlacu, MD, PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '0040744488580',\n", + " 'CentralContactEMail': 'alexandru.burlacu@umfiasi.ro'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Alexandru Burlacu, Lecturer',\n", + " 'OverallOfficialAffiliation': 'University of Medicine and Pharmacy Gr T Popa - Iasi',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Radu Dabija, Lecturer',\n", + " 'OverallOfficialAffiliation': 'University of Medicine and Pharmacy Gr T Popa - Iasi',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'U.O. Multidisciplinare di Patologia Mammaria e Ricerca Traslazionale; Dipartimento Universitario Clinico di Scienze Mediche, Chirurgiche e della Salute Università degli Studi di Trieste',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Cremona',\n", + " 'LocationZip': '26100',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Daniele Generali, MD, PhD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+390372408042',\n", + " 'LocationContactEMail': 'dgenerali@units.it'},\n", + " {'LocationContactName': 'Daniele Generali, MD, PhD',\n", + " 'LocationContactRole': 'Principal Investigator'}]}},\n", + " {'LocationFacility': 'University of Medicine and Pharmacy Gr T Popa',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Iaşi',\n", + " 'LocationZip': '700503',\n", + " 'LocationCountry': 'Romania',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Alexandru Burlacu, MD, PhD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '0040744488580',\n", + " 'LocationContactEMail': 'alexandru.burlacu@umfiasi.ro'},\n", + " {'LocationContactName': 'Alexandru Burlacu, MD, PhD',\n", + " 'LocationContactRole': 'Principal Investigator'}]}},\n", + " {'LocationFacility': 'Department of Cardiology at Chelsea and Westminster NHS hospital',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'London',\n", + " 'LocationCountry': 'United Kingdom',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Emmanuel Ako, MD, PhD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+447932970131',\n", + " 'LocationContactEMail': 'e.ako@ucl.ac.uk'},\n", + " {'LocationContactName': 'Emmanuel Ako, MD, PhD',\n", + " 'LocationContactRole': 'Principal Investigator'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", + " 'IPDSharingDescription': 'Yes, we would be happy to share the algorithm code and the results with any scientist interested (without any financial interests)',\n", + " 'IPDSharingInfoTypeList': {'IPDSharingInfoType': ['Study Protocol',\n", + " 'Informed Consent Form (ICF)',\n", + " 'Analytic Code']}}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000053717',\n", + " 'ConditionMeshTerm': 'Pneumonia, Ventilator-Associated'},\n", + " {'ConditionMeshId': 'D000007251',\n", + " 'ConditionMeshTerm': 'Influenza, Human'},\n", + " {'ConditionMeshId': 'D000011024',\n", + " 'ConditionMeshTerm': 'Pneumonia, Viral'},\n", + " {'ConditionMeshId': 'D000011014', 'ConditionMeshTerm': 'Pneumonia'},\n", + " {'ConditionMeshId': 'D000017563',\n", + " 'ConditionMeshTerm': 'Lung Diseases, Interstitial'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000009976',\n", + " 'ConditionAncestorTerm': 'Orthomyxoviridae Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", + " {'ConditionAncestorId': 'D000008171',\n", + " 'ConditionAncestorTerm': 'Lung Diseases'},\n", + " {'ConditionAncestorId': 'D000003428',\n", + " 'ConditionAncestorTerm': 'Cross Infection'},\n", + " {'ConditionAncestorId': 'D000007239',\n", + " 'ConditionAncestorTerm': 'Infection'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M12487',\n", + " 'ConditionBrowseLeafName': 'Pneumonia',\n", + " 'ConditionBrowseLeafAsFound': 'Pneumonia',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M6379',\n", + " 'ConditionBrowseLeafName': 'Emergencies',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M12497',\n", + " 'ConditionBrowseLeafName': 'Pneumonia, Viral',\n", + " 'ConditionBrowseLeafAsFound': 'Pneumonia, Viral',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M8878',\n", + " 'ConditionBrowseLeafName': 'Influenza, Human',\n", + " 'ConditionBrowseLeafAsFound': 'Influenza',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M26032',\n", + " 'ConditionBrowseLeafName': 'Pneumonia, Ventilator-Associated',\n", + " 'ConditionBrowseLeafAsFound': 'Pneumonia, Ventilator-Associated',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M9751',\n", + " 'ConditionBrowseLeafName': 'Lung Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M18396',\n", + " 'ConditionBrowseLeafName': 'Lung Diseases, Interstitial',\n", + " 'ConditionBrowseLeafAsFound': 'Pneumonia, Interstitial',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M11485',\n", + " 'ConditionBrowseLeafName': 'Orthomyxoviridae Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M5225',\n", + " 'ConditionBrowseLeafName': 'Cross Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'}]}}}}},\n", + " {'Rank': 73,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04306497',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'JSZYJ202001'},\n", + " 'Organization': {'OrgFullName': 'Jiangsu Famous Medical Technology Co., Ltd.',\n", + " 'OrgClass': 'INDUSTRY'},\n", + " 'BriefTitle': 'Clinical Trial on Regularity of TCM Syndrome and Differentiation Treatment of COVID-19.',\n", + " 'OfficialTitle': 'Clinical Trial on Regularity of TCM Syndrome and Differentiation Treatment of COVID-19 in Jiangsu Province',\n", + " 'Acronym': 'CTOROTSADTOC'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'January 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 2, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'May 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 1, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 10, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 13, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 14, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 17, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Jiangsu Famous Medical Technology Co., Ltd.',\n", + " 'LeadSponsorClass': 'INDUSTRY'}},\n", + " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Evaluation of the efficacy and safety of TCM differential treatment of COVID-19 in Jiangsu Province based on a prospective multicenter cohort study.',\n", + " 'DetailedDescription': \"In order to further observe the efficacy and safety of this project under natural intervention. A prospective multicenter cohort study was designed, focusing on the common type with the largest number of confirmed cases, to evaluate the intervention effect of this project in relieving the disease and preventing disease progression, in order to provide more sufficient clinical evidence for the further improvement and application of this project.\\n\\nAccording to the actual situation of receiving treatment, according to whether or not exposed to this study to observe the treatment of TCM, COVID-19 (common type) will be divided into two cohorts: control group (western medicine cohort) and exposure group (integrated traditional Chinese and western medicine cohort). The choice of treatment for patients is entirely determined by clinicians according to the patient's condition, and patients are free to choose after fully understanding different schemes). western medicine cohort:Routine treatment + one or both of the following antiviral drugs.Cohort of integrated TCM and western medicine: routine treatment + one or two of the following antiviral drugs + the following TCM regimens.The sample size is tentatively set at 340.\"},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", + " 'KeywordList': {'Keyword': ['COVID-19',\n", + " 'Syndrome investigation',\n", + " 'differentiation treatment',\n", + " 'multicenter cohort study']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '340',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Cohort of western medicine',\n", + " 'ArmGroupDescription': \"Routine treatment：\\n\\n① support treatment:maintain water and electrolyte balance .\\n\\n②oxygen therapy: give nasal catheters to inhale oxygen.\\n\\n③ basic treatment of traditional Chinese and western medicine: antiviral drugs and proprietary Chinese medicines with similar composition or function to the observed scheme of differentiation and treatment of traditional Chinese medicine are not included in the scope of such drugs.\\n\\nAntiviral drugs ：Clinicians can judge according to the patient's condition according to the latest version of the diagnosis and treatment plan for COvID-19 issued by the General Office of the National Health Commission / the Office of the State Administration of traditional Chinese Medicine (currently the latest version is the sixth trial edition). Select any of the recommended antiviral drugs(for example:IFN-α、lopinavir-ritonavir、Ribavirin、Chloroquine Phosphate、Arbidol)or a combination of two antiviral drugs.\",\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: TCM prescriptions']}},\n", + " {'ArmGroupLabel': 'Cohort of integrated TCM and western medicine',\n", + " 'ArmGroupDescription': 'routine treatment + Antiviral drugs + the following TCM regimens. 1.TCM regimens:① Early stage: Dampness trapped in exterior and interior. Recommended prescription: Huoxiang 15g, Suye15g, Cangzhu15g, Houpo10g, Qianhu15g, Chaihu15g, Huangqin10g, Qinghao20g, Xingren10g, JInyinhua15g, Lianqiao15g.\\n\\nTake decocted or granule, one dose a day.\\n\\n② Middle stage: Dampness-toxicity blocking lung Recommended prescription: Zhimahuang9g, Xingren10g, Sangbaipi30g, Tinglizi20g, Dongguazi20g, Fabanxia10g, Houpo10g, Suzi15g, Baijiezi10g, Gualoupi15g, Xuanfuhua9g, Xiangfu10g, Yujin10g, Taoren10g, Huangqi20g.\\n\\nTake decocted or granule, one dose a day.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: TCM prescriptions']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'TCM prescriptions',\n", + " 'InterventionDescription': 'TCM prescriptions1:Take decocted or granule, one dose a day; TCM prescriptions2:Take decocted or granule, one dose a day.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Cohort of integrated TCM and western medicine',\n", + " 'Cohort of western medicine']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'The relief / disappearance rate of main symptoms',\n", + " 'PrimaryOutcomeDescription': 'disappearance of fever, cough and shortness of breath/ the rate of complete relief /.',\n", + " 'PrimaryOutcomeTimeFrame': '9day'},\n", + " {'PrimaryOutcomeMeasure': 'Chest CT absorption',\n", + " 'PrimaryOutcomeDescription': 'with reference to the \"pneumonia chest X-ray absorption Evaluation scale\" developed by Renyi Yin et al, the final absorption judgment will be used to evaluate the chest CT absorption of patients with pneumonia, which is divided into four levels according to the degree of absorption: complete absorption, majority absorption, partial absorption and no absorption.',\n", + " 'PrimaryOutcomeTimeFrame': '9day'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Virus antigen negative conversion rate',\n", + " 'SecondaryOutcomeDescription': 'detection negative rat of nasopharyngeal swab, conjunctival sac secretion virus nucleic acid e',\n", + " 'SecondaryOutcomeTimeFrame': '9day'},\n", + " {'SecondaryOutcomeMeasure': 'Clinical effective time: the average effective time',\n", + " 'SecondaryOutcomeDescription': 'the average time it takes for the clinical curative effect to reach the effective standard. Median response time: the average time it takes for 50% of patients to reach the effective standard.',\n", + " 'SecondaryOutcomeTimeFrame': '9day'},\n", + " {'SecondaryOutcomeMeasure': 'The number of severe and critical conversion cases',\n", + " 'SecondaryOutcomeDescription': 'the number of severe and critical cases occurred after the start of intervention.',\n", + " 'SecondaryOutcomeTimeFrame': '9day'},\n", + " {'SecondaryOutcomeMeasure': 'Incidence of complications',\n", + " 'SecondaryOutcomeDescription': 'defined as complications during isolation and hospitalization due to pneumonia infected by novel coronavirus, including bacterial infection, aggravation of underlying diseases, etc',\n", + " 'SecondaryOutcomeTimeFrame': '9day'},\n", + " {'SecondaryOutcomeMeasure': 'Traditional Chinese Medicine Syndrome Score',\n", + " 'SecondaryOutcomeDescription': 'According to the Traditional Chinese Medicine symptom score scale, the change of symptom score before and after treatment was observed.The highest score was 92 points, and the lowest was 23 points. The higher the score, the more severe the symptoms.',\n", + " 'SecondaryOutcomeTimeFrame': '9day'}]},\n", + " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'CRP changes',\n", + " 'OtherOutcomeDescription': 'Changes in c-reactive protein.',\n", + " 'OtherOutcomeTimeFrame': '9day'},\n", + " {'OtherOutcomeMeasure': 'ESR changes',\n", + " 'OtherOutcomeDescription': 'Changes in erythrocyte sedimentation rate.',\n", + " 'OtherOutcomeTimeFrame': '9day'},\n", + " {'OtherOutcomeMeasure': 'PCTchanges',\n", + " 'OtherOutcomeDescription': 'Changes in procalcitonin.',\n", + " 'OtherOutcomeTimeFrame': '9day'},\n", + " {'OtherOutcomeMeasure': 'The index of T cell subsets changed',\n", + " 'OtherOutcomeDescription': 'Changes of CD4+ and CD8+',\n", + " 'OtherOutcomeTimeFrame': '9day'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nIt conforms to the diagnostic criteria of confirmed cases of COVID-19;\\nAge from 18-75, regardless gender.\\nThe patient informed consent and sign the informed consent form (if the subject has no capacity, limited capacity and limited expression of personal will, he or she should obtain the consent of his guardian and sign the informed consent at the same time).\\n\\nExclusion Criteria:\\n\\nWomen during pregnancy or lactation;\\nAllergic constitution, such as those who have a history of allergy to two or more drugs or food, or who are known to be allergic to drug ingredients observed in this study.\\nSevere complications such as multiple organ failure and shock occurred.\\nComplicated with severe primary diseases such as heart, brain, liver, kidney and so on.\\nPatients have mental illness.\\nPatients who participated in or is currently participating in other clinical trials within the first month of this study.',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '75 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'It conforms to the diagnostic criteria of confirmed cases of COVID-19.',\n", + " 'SamplingMethod': 'Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Haibo Cheng, phD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '13815857118',\n", + " 'CentralContactEMail': '363994906@qq.com'},\n", + " {'CentralContactName': 'Zhe Feng, phD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '13584046875',\n", + " 'CentralContactEMail': '794200027@qq.com'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': \"Huai'an fourth people's Hospital\",\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Huaian',\n", + " 'LocationState': 'Jiangsu',\n", + " 'LocationZip': '210029',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Lei Cui, phD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '13951266803',\n", + " 'LocationContactEMail': 'houy@famousmed.net'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided',\n", + " 'IPDSharingDescription': 'All researchers in this study'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M4562',\n", + " 'InterventionBrowseLeafName': 'Chloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M151035',\n", + " 'InterventionBrowseLeafName': 'Chloroquine diphosphate',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19978',\n", + " 'InterventionBrowseLeafName': 'Ritonavir',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M28424',\n", + " 'InterventionBrowseLeafName': 'Lopinavir',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2895',\n", + " 'InterventionBrowseLeafName': 'Antiviral Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M17826',\n", + " 'InterventionBrowseLeafName': 'Interferon-alpha',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M3435',\n", + " 'InterventionBrowseLeafName': 'Benzocaine',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M13666',\n", + " 'InterventionBrowseLeafName': 'Ribavirin',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'T433',\n", + " 'InterventionBrowseLeafName': 'Tannic Acid',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'T309',\n", + " 'InterventionBrowseLeafName': 'Sweet Wormwood',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", + " {'InterventionBrowseBranchAbbrev': 'Infl',\n", + " 'InterventionBrowseBranchName': 'Anti-Inflammatory Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'Analg',\n", + " 'InterventionBrowseBranchName': 'Analgesics'},\n", + " {'InterventionBrowseBranchAbbrev': 'CNSDep',\n", + " 'InterventionBrowseBranchName': 'Central Nervous System Depressants'},\n", + " {'InterventionBrowseBranchAbbrev': 'Ot',\n", + " 'InterventionBrowseBranchName': 'Other Dietary Supplements'},\n", + " {'InterventionBrowseBranchAbbrev': 'HB',\n", + " 'InterventionBrowseBranchName': 'Herbal and Botanical'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000013577',\n", + " 'ConditionMeshTerm': 'Syndrome'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000004194',\n", + " 'ConditionAncestorTerm': 'Disease'},\n", + " {'ConditionAncestorId': 'D000010335',\n", + " 'ConditionAncestorTerm': 'Pathologic Processes'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M14938',\n", + " 'ConditionBrowseLeafName': 'Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", + " {'Rank': 74,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04329923',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '842838'},\n", + " 'Organization': {'OrgFullName': 'University of Pennsylvania',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'The PATCH Trial (Prevention And Treatment of COVID-19 With Hydroxychloroquine)',\n", + " 'OfficialTitle': 'The PATCH Trial (Prevention And Treatment of COVID-19 With Hydroxychloroquine)',\n", + " 'Acronym': 'PATCH'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 6, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 1, 2021',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'December 1, 2021',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 30, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 30, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 30, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor-Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Ravi Amaravadi, MD',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Associate Professor',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'University of Pennsylvania'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Ravi Amaravadi, MD',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'Yes',\n", + " 'IsFDARegulatedDevice': 'No',\n", + " 'IsUSExport': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'The PATCH trial (Prevention And Treatment of COVID-19 with Hydroxychloroquine) is funded investigator-initiated trial that includes 3 cohorts. Cohort 1: a double-blind placebo controlled trial of high dose HCQ as a treatment for home bound COVID-19 positive patients; Cohort 2: a randomized study testing different doses of HCQ in hospitalized patients; Cohort 3: a double blind placebo controlled trial of low dose HCQ as a preventative medicine in health care workers.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 2']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignInterventionModelDescription': 'There are 3 cohorts. All partcipants in of each the cohorts are randomized to one of two arms',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Triple',\n", + " 'DesignMaskingDescription': 'Cohorts 1 and 3 are double-blind placebo control cohorts. Cohort 2 is an open label randomized study',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", + " 'Care Provider',\n", + " 'Investigator']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '400',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Cohort 1 HCQ',\n", + " 'ArmGroupType': 'Active Comparator',\n", + " 'ArmGroupDescription': 'COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with hydroxychloroquine 400 mg twice a day for up to 14 days',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine Sulfate 400 mg twice a day']}},\n", + " {'ArmGroupLabel': 'Cohort 1 Placebo',\n", + " 'ArmGroupType': 'Placebo Comparator',\n", + " 'ArmGroupDescription': 'COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with placebo twice a day for up to 14 days',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo oral tablet']}},\n", + " {'ArmGroupLabel': 'Cohort 2 HCQ high dose',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Hospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg twice a day for up to 14 days',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine Sulfate 600 mg twice a day']}},\n", + " {'ArmGroupLabel': 'Cohort 2 HCQ low dose',\n", + " 'ArmGroupType': 'Active Comparator',\n", + " 'ArmGroupDescription': 'Hospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg once a day for up to 7 days',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine Sulfate 600 mg once a day']}},\n", + " {'ArmGroupLabel': 'Cohort 3 HCQ',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Health care workers at high risk of contracting COVID-19 randomized to this arm will be treated with hydroxychloroquine 600 mg once a day for 2 months',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine Sulfate 600 mg once a day']}},\n", + " {'ArmGroupLabel': 'Cohort 3 Placebo',\n", + " 'ArmGroupType': 'Placebo Comparator',\n", + " 'ArmGroupDescription': 'Health care workers at high risk of contracting COVID-19 randomized to this arm will be treated with placebo for 2 months',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo oral tablet']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Hydroxychloroquine Sulfate 400 mg twice a day',\n", + " 'InterventionDescription': 'Antimalarial compound',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Cohort 1 HCQ']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Plaquenil']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Hydroxychloroquine Sulfate 600 mg twice a day',\n", + " 'InterventionDescription': 'Antimalarial compound',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Cohort 2 HCQ high dose']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Plaquenil']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Hydroxychloroquine Sulfate 600 mg once a day',\n", + " 'InterventionDescription': 'Antimalarial compound',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Cohort 2 HCQ low dose',\n", + " 'Cohort 3 HCQ']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Plaqeunil']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Placebo oral tablet',\n", + " 'InterventionDescription': 'Placebo',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Cohort 1 Placebo',\n", + " 'Cohort 3 Placebo']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Placebo']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Median release from quarantine time',\n", + " 'PrimaryOutcomeDescription': 'Cohort 1 (home quarantined COVID-19 patients): Median time to release from quarantine by meeting the following criteria: 1) No fever for 72 hours 2) improvement in other symptoms and 3) 7 days have elapsed since the beginning of symptom onset.',\n", + " 'PrimaryOutcomeTimeFrame': '14 days or less'},\n", + " {'PrimaryOutcomeMeasure': 'Rate of hospital discharge',\n", + " 'PrimaryOutcomeDescription': 'Cohort 2 (hospitalized COVID-19 patients): Rate of participants discharged at or before 14 days',\n", + " 'PrimaryOutcomeTimeFrame': '14 days'},\n", + " {'PrimaryOutcomeMeasure': 'Rate of infection',\n", + " 'PrimaryOutcomeDescription': 'Cohort 3 Physicians and nurse prophylaxis: Rate of COVID-19 infection at 2 months',\n", + " 'PrimaryOutcomeTimeFrame': '2 months'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Rate of housemate infection',\n", + " 'SecondaryOutcomeDescription': 'Cohort 1 rate of participant-reported secondary infection of housemates',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Rate of hospitalization',\n", + " 'SecondaryOutcomeDescription': 'Cohort 1 rate of hospitalization',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Cohort 1 adverse event rate',\n", + " 'SecondaryOutcomeDescription': 'Cohort 1 rate of treatment related adverse events',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Time to condition appropriate for discharge',\n", + " 'SecondaryOutcomeDescription': 'Cohort 2 Time to condition appropriate for discharge. The primary care team indicates the patients has improved to the point of being discharged.',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Rate of ICU admission',\n", + " 'SecondaryOutcomeDescription': 'Cohort 2 rate of ICU admission from a floor bed in the hospital',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Time to PCR negativity',\n", + " 'SecondaryOutcomeDescription': 'Cohort 2 the number of days between hospital admission and a negative PCR test for SARS-CoV-2.',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Cohort 2 adverse events',\n", + " 'SecondaryOutcomeDescription': 'Cohort 2 rate of treatment related adverse events',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Scheduled shifts missed',\n", + " 'SecondaryOutcomeDescription': 'Cohort 3 number of scheduled shifts at the hospital that are missed.',\n", + " 'SecondaryOutcomeTimeFrame': '2 months'},\n", + " {'SecondaryOutcomeMeasure': 'Cohort 3 adverse events',\n", + " 'SecondaryOutcomeDescription': 'Cohort 3 rate of treatment related adverse events',\n", + " 'SecondaryOutcomeTimeFrame': '2 months'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAge ≥ 18 years old (Sub-studies 2 and 3)\\nCompetent and capable to provide informed consent\\nHave access to a smart device such as a cell phone, tablet, laptop computer with necessary data/internet accessibility\\nSubjects meeting the following criteria by Sub-Study\\n\\nCohort 1:\\n\\nAge ≥40 years since the risk of prolonged disease that progresses to severe COVID-19 disease increases with age.\\nPCR-positive for the SARS-CoV2 virus\\nAt least one symptom of COVID-19 (T> 100.5º F, cough, headache, fatigue, shortness of breath, diarrhea, smell disturbance)\\n≤4 days since the first symptoms of COVID-19 and date of testing\\nNot requiring hospitalization and is sent home for quarantine.\\nMust live within 30 miles of HUP or Penn Presbytarian Medical Center to facilitate drop-off of medication\\nMust own a working computer, or smartphone and have internet access\\nMust be willing to fill out a daily symptom diary\\nMust be available for a daily phone call,\\nMust take their own temperature twice a day\\nMust be willing to report the observed symptoms and development of COVID-19 in the co-inhabitants of the residence at which the quarantine will be served.\\n\\nCohort 2 Hospitalized non-ICU patients.\\n\\nPCR-positive for SARS-CoV-2\\nPatients admitted to a floorbed at Hospital of the University of Pennsylvania or Penn Presbytarian.\\nOne or more of the following risk factors for progression to severe disease including: immunocompromising conditions, structural lung disease, hypertension, coronary artery disease, diabetes, age > 60, ferritin > 850, CRP > 6, D-dimer > 1000\\n\\nCohort 3 Health Care Worker Prevention\\n\\nEmergency Medicine or Infectious Disease Team physician or nurse at HUP or PPMC\\n≥20 hours per week of clinical work scheduled in the coming 2 months during the COVID-19 pandemic\\nWilling to report compliance with HCQ in the form of a diary\\nPatients must be able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.\\n\\nExclusion Criteria:\\n\\n<18 years of age\\nPrisoners or other detained persons\\nAllergy to hydroxychloroquine\\nPregnant or lactating or positive pregnancy test during pre-medication examination\\nReceiving any treatment drug for 2019-ncov within 14 days prior to screening evaluation (off label, compassionate use or trial related).\\nKnown history of retinal disease including but not limited to age related macular degeneration.\\nHistory of interstitial lung disease or chronic pneumonitis unrelated COVID-19.\\nDue to risk of disease exacerbation patients with porphyria or psoriasis are ineligible unless the disease is well controlled and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations.\\nPatients with serious intercurrent illness that requires active infusional therapy, intense monitoring, or frequent dose adjustments for medication including but not limited to infectious disease, cancer, autoimmune disease, cardiovascular disease.\\nPatients who have undergone major abdominal, thoracic, spine or CNS surgery in the last 2 months, or plan to undergo surgery during study participation.\\nPatients receiving cytochrome P450 enzyme-inducing anticonvulsant drugs (i.e. phenytoin, carbamazepine, Phenobarbital, primidone or oxcarbazepine) within 4 weeks of the start of the study treatment\\nHistory or evidence of increased cardiovascular risk including any of the following:\\nLeft ventricular ejection fraction (LVEF) < institutional lower limit of normal. Baseline echocardiogram is not required.\\nA QT interval corrected for heart rate using the Frederica formula > 500 msec (Sub-study 2)\\nCurrent clinically significant uncontrolled arrhythmias. Exception: Subjects with controlled atrial fibrillation\\nHistory of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to enrollment\\nCurrent ≥ Class II congestive heart failure as defined by New York Heart Association',\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Ravi Amaravadi, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '2157965159',\n", + " 'CentralContactEMail': 'ravi.amaravadi@pennmedicine.upenn.edu'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Ravi Amaravadi',\n", + " 'OverallOfficialAffiliation': 'University of Pennsylvania',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'University of Pennsylvania',\n", + " 'LocationCity': 'Philadelphia',\n", + " 'LocationState': 'Pennsylvania',\n", + " 'LocationZip': '19104',\n", + " 'LocationCountry': 'United States',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Ravi Amaravadi, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '215-796-5159',\n", + " 'LocationContactEMail': 'ravi.amaravadi@pennmedicine.upenn.edu'},\n", + " {'LocationContactName': 'Ravi Amaravadi, MD',\n", + " 'LocationContactRole': 'Principal Investigator'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", + " 'IPDSharingDescription': 'We will publish our results in a peer-reviewed journal and make available de-identified data for additional analysis',\n", + " 'IPDSharingInfoTypeList': {'IPDSharingInfoType': ['Study Protocol',\n", + " 'Statistical Analysis Plan (SAP)',\n", + " 'Informed Consent Form (ICF)',\n", + " 'Clinical Study Report (CSR)',\n", + " 'Analytic Code']},\n", + " 'IPDSharingTimeFrame': 'One year after study completion',\n", + " 'IPDSharingAccessCriteria': 'Open access'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", + " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", + " 'InterventionAncestorTerm': 'Antimalarials'},\n", + " {'InterventionAncestorId': 'D000000981',\n", + " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", + " {'InterventionAncestorId': 'D000000977',\n", + " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", + " {'InterventionAncestorId': 'D000000890',\n", + " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", + " {'InterventionAncestorId': 'D000004791',\n", + " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000018501',\n", + " 'InterventionAncestorTerm': 'Antirheumatic Agents'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", + " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M2861',\n", + " 'InterventionBrowseLeafName': 'Antimalarials',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2879',\n", + " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2875',\n", + " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2795',\n", + " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19188',\n", + " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}}}}},\n", + " {'Rank': 75,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04285801',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '2020.059'},\n", + " 'Organization': {'OrgFullName': 'Chinese University of Hong Kong',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Critically Ill Patients With COVID-19 in Hong Kong: a Multicentre Observational Cohort Study',\n", + " 'OfficialTitle': 'Critically Ill Patients With COVID-19 in Hong Kong: a Multicentre Observational Cohort Study'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Completed',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'February 14, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'February 25, 2020',\n", + " 'PrimaryCompletionDateType': 'Actual'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'February 25, 2020',\n", + " 'CompletionDateType': 'Actual'},\n", + " 'StudyFirstSubmitDate': 'February 24, 2020',\n", + " 'StudyFirstSubmitQCDate': 'February 24, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'February 26, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 8, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 10, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Lowell Ling',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Clinical Lecturer',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Chinese University of Hong Kong'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Chinese University of Hong Kong',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'The purpose of this case series is to describe the characteristics, organ dysfunction and support and 2 week outcomes of critically ill patients with nCov infection.',\n", + " 'DetailedDescription': 'The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China 1. It has manifest into a global health crisis with escalating confirmed cases and spread across 15 countries. Whilst it is currently an epidemic in China, The World Health Organization (WHO) Global Level risk assessment is set at high 2.\\n\\nSequencing showed that 2019-nCov is similar to bat severe acute syndrome (SARS)-related coronaviruses found in Chinese horseshoe bats 3. This is compatible with the initial epidemiological link with a local wet market which sells bats. Furthermore, data sharing and sequencing data has facilitated development of accurate diagnostic tests.\\n\\nIn contrast, our current understanding of the epidemiological and clinical features of 2019-nCov is limited. In a case series of 41 hospitalized patients with confirmed infection, at least 30% of these patients required critical care admission. These patients developed severe respiratory failure and 10% required mechanical ventilation and 5% needed extracorporeal membrane oxygenation support. More worryingly 2019-nCov infection was associated with 15% mortality. Although these figures are likely overestimates due to unreported mild cases, there is currently no effective treatment. The optimal supportive care for patients with severe 2019-nCov infection is a research priority.\\n\\nThe spread of the 2019-nCov epidemic to Hong Kong has started. Patients have been admitted to the Intensive Care Unit for multiorgan dysfunction. Currently there are no published data focused specifically on critically ill patients with nCov infection. The purpose of this case series is to describe the characteristics, organ dysfunction and support and 2 week outcomes of critically ill patients with nCov infection.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Case-Only']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Retrospective']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '8', 'EnrollmentType': 'Actual'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'COVID-19 infection',\n", + " 'ArmGroupDescription': 'critically ill patients with COVID-19 infection'}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': '28 day mortality',\n", + " 'PrimaryOutcomeDescription': 'survival or death at 28 days',\n", + " 'PrimaryOutcomeTimeFrame': '28 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'vasopressor days',\n", + " 'SecondaryOutcomeDescription': 'days on vasopressor',\n", + " 'SecondaryOutcomeTimeFrame': '28 days'},\n", + " {'SecondaryOutcomeMeasure': 'days on mechanical ventilation',\n", + " 'SecondaryOutcomeDescription': 'days on mechanical ventilation during ICU stay',\n", + " 'SecondaryOutcomeTimeFrame': '28 days'},\n", + " {'SecondaryOutcomeMeasure': 'sequential organ function assessment score',\n", + " 'SecondaryOutcomeDescription': 'daily sequential organ function assessment score (0 minimum to 24 maximum), higher scores worse organ function',\n", + " 'SecondaryOutcomeTimeFrame': 'daily for first 5 days'},\n", + " {'SecondaryOutcomeMeasure': 'ECMO use',\n", + " 'SecondaryOutcomeDescription': 'Percentage of patients requiring ECMO during ICU stay.',\n", + " 'SecondaryOutcomeTimeFrame': '28 days'},\n", + " {'SecondaryOutcomeMeasure': 'percentage nitric oxide use',\n", + " 'SecondaryOutcomeDescription': 'percentage of patients requiring nitric oxide during ICU stay.',\n", + " 'SecondaryOutcomeTimeFrame': '28 days'},\n", + " {'SecondaryOutcomeMeasure': 'percentage free from oxygen supplement',\n", + " 'SecondaryOutcomeDescription': 'percentage not requiring oxygen therapy',\n", + " 'SecondaryOutcomeTimeFrame': '28 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nadmission to ICU\\nadult (≥18 years old)\\nconfirmed case of 2019-nCov infection by 2019-nCov RNA by reverse transcription polymerase chain reaction , isolation in cell culture of 2019-nCov from a clinical specimen or serum antibody to 2019-nCov\\n\\nExclusion Criteria:\\n\\n- none',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'All critically ill patients with confirmed COVID-19 infection in Hong Kong',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'LocationList': {'Location': [{'LocationFacility': 'Pamela Youde Nethersole Eastern Hospital',\n", + " 'LocationCity': 'Hong Kong',\n", + " 'LocationCountry': 'Hong Kong'},\n", + " {'LocationFacility': 'Prince of Wales Hospital',\n", + " 'LocationCity': 'Hong Kong',\n", + " 'LocationCountry': 'Hong Kong'},\n", + " {'LocationFacility': 'Princess Margaret Hospital',\n", + " 'LocationCity': 'Hong Kong',\n", + " 'LocationCountry': 'Hong Kong'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000016638',\n", + " 'ConditionMeshTerm': 'Critical Illness'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000020969',\n", + " 'ConditionAncestorTerm': 'Disease Attributes'},\n", + " {'ConditionAncestorId': 'D000010335',\n", + " 'ConditionAncestorTerm': 'Pathologic Processes'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M17593',\n", + " 'ConditionBrowseLeafName': 'Critical Illness',\n", + " 'ConditionBrowseLeafAsFound': 'Critically Ill',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M21284',\n", + " 'ConditionBrowseLeafName': 'Disease Attributes',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", + " {'Rank': 76,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04291053',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'TJ-IRB20200205'},\n", + " 'Organization': {'OrgFullName': 'Tongji Hospital', 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'The Efficacy and Safety of Huai er in the Adjuvant Treatment of COVID-19',\n", + " 'OfficialTitle': 'The Efficacy and Safety of Huai er in the Adjuvant Treatment of COVID-19: a Prospective, Multicenter, Randomized, Parallel Controlled Clinical Study'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'August 1, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'September 1, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'February 27, 2020',\n", + " 'StudyFirstSubmitQCDate': 'February 27, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 2, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 14, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 17, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Chen Xiaoping',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Tongji Hospital'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Tongji Hospital',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'In December 2019,a new type of pneumonia caused by the coronavirus (COVID-2019) broke out in Wuhan ,China, and spreads quickly to other Chinese cities and 28 countries. More than 70000 people were infected and over 2000 people died all over the world.There is no specific drug treatment for this disease. This study is planned to observe the efficacy and safety of Huaier granule in the adjuvant treatment COVID-19.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", + " 'KeywordList': {'Keyword': ['COVID-19', 'Huaier granule']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 2', 'Phase 3']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '550',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'experimental group',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Standard therapy+Huaier granule Huaier granule 20g, po, tid for 2 weeks( or until discharge)',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Huaier Granule']}},\n", + " {'ArmGroupLabel': 'control group',\n", + " 'ArmGroupType': 'No Intervention',\n", + " 'ArmGroupDescription': 'standard therapy'}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Huaier Granule',\n", + " 'InterventionDescription': 'standard treatment + Huaier Granule 20g po tid for 2weeks',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['experimental group']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Mortality rate',\n", + " 'PrimaryOutcomeDescription': 'All cause mortality',\n", + " 'PrimaryOutcomeTimeFrame': 'up to 28 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Clinical status assessed according to the official guideline',\n", + " 'SecondaryOutcomeDescription': '1.mild type：no No symptoms, Imaging examination showed no signs of pneumonia; 2,moderate type: with fever or respiratory symptoms,Imaging examination showed signs of pneumonia, SpO2＞93% without oxygen inhalation ; severe type:Match any of the following：a. R≥30bpm；b.Pulse Oxygen Saturation(SpO2)≤93% without oxygen inhalation，c. PaO2/FiO2(fraction of inspired oxygen )≤300mmHg ；4. Critically type：match any of the follow: a. need mechanical ventilation; b. shock; c. (multiple organ dysfunction syndrome) MODS',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", + " {'SecondaryOutcomeMeasure': 'The differences in oxygen intake methods',\n", + " 'SecondaryOutcomeDescription': 'Pulse Oxygen Saturation(SpO2)＞93%，1. No need for supplemental oxygenation; 2. nasal catheter oxygen inhalation（oxygen concentration%,The oxygen flow rate：L/min）；3. Mask oxygen inhalation（oxygen concentration%,The oxygen flow rate：L/min）；4. Noninvasive ventilator oxygen supply（Ventilation mode,oxygen concentration%,The oxygen flow rate：L/min,）；5. Invasive ventilator oxygen supply（Ventilation mode,oxygen concentration%,The oxygen flow rate：L/min,）.',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", + " {'SecondaryOutcomeMeasure': 'Duration (days) of supplemental oxygenation',\n", + " 'SecondaryOutcomeDescription': 'days',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", + " {'SecondaryOutcomeMeasure': 'Duration (days) of mechanical ventilation',\n", + " 'SecondaryOutcomeDescription': 'days',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", + " {'SecondaryOutcomeMeasure': 'The mean PaO2/FiO2',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", + " {'SecondaryOutcomeMeasure': 'Length of hospital stay (days)',\n", + " 'SecondaryOutcomeDescription': 'days',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", + " {'SecondaryOutcomeMeasure': 'Length of ICU stay (days)',\n", + " 'SecondaryOutcomeDescription': 'days',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", + " {'SecondaryOutcomeMeasure': 'Pulmonary function',\n", + " 'SecondaryOutcomeDescription': 'forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 3 months after discharge'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAged between 18 and 75 years, extremes included, male or female\\nPatients diagnosed with mild or common type COVID-19, according to the official guideline \"Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)\"\\npatients can generally tolerable for treatment recommended by the official guideline \"Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)\"\\nPatients have not been accompanied by serious physical diseases of heart, lung, brain, etc.,Eastern Cooperative Oncology Group score standard:0-1\\nAbility to understand and the willingness to sign a written informed consent document.\\n\\nExclusion Criteria:\\n\\nFemale subjects who are pregnant or breastfeeding.\\npatients who are allergic to this medicine\\npatients meet the contraindications of Huaier granule\\nPatients with diabetes\\nPatients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.\\npatients can\\'t take drugs orally',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '75 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Lin Chen',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+8613517260864',\n", + " 'CentralContactEMail': 'chenlin_tj@126.com'}]}}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'}}}},\n", + " {'Rank': 77,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04312997',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'PUL-042-502'},\n", + " 'Organization': {'OrgFullName': 'Pulmotect, Inc.',\n", + " 'OrgClass': 'INDUSTRY'},\n", + " 'BriefTitle': 'The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection',\n", + " 'OfficialTitle': 'A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'September 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'October 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 16, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 16, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 18, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 22, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 24, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Pulmotect, Inc.',\n", + " 'LeadSponsorClass': 'INDUSTRY'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'Yes',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Adults who have tested positive for SARS-CoV-2 infection and are under observation or admitted to a controlled facility (such as a hospital) will receive PUL-042 Inhalation Solution or placebo up to 3 times over a one week period in addition to their normal care. Subjects will be be followed and assessed for their clinical status over a 14 day period with follow up at 28 days to see if PUL-042 Inhalation Solution improves the clinical outcome'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 2']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Quadruple',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", + " 'Care Provider',\n", + " 'Investigator',\n", + " 'Outcomes Assessor']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '100',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'PUL-042 Inhalation Solution',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'PUL-042 Inhalation Solution given by nebulization on study days 1, 3 and 6',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: PUL-042 Inhalation Solution']}},\n", + " {'ArmGroupLabel': 'Sterile normal saline for inhalation',\n", + " 'ArmGroupType': 'Placebo Comparator',\n", + " 'ArmGroupDescription': 'Sterile normal saline for Inhalation given by nebulization on study days 1, 3 and 6',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'PUL-042 Inhalation Solution',\n", + " 'InterventionDescription': '20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042) given by nebulization on study days 1, 3 and 6',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['PUL-042 Inhalation Solution']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Placebo',\n", + " 'InterventionDescription': 'Sterile normal saline for inhalation',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Sterile normal saline for inhalation']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Severity of COVID-19',\n", + " 'PrimaryOutcomeDescription': 'Ordinal Scale for Clinical Improvement (score 1-8)',\n", + " 'PrimaryOutcomeTimeFrame': '14 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'All cause mortality',\n", + " 'SecondaryOutcomeDescription': 'Death',\n", + " 'SecondaryOutcomeTimeFrame': '28 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\n1. Subjects must have a documented positive test for the COVID-19 virus within 72 hours of the administration of study drug\\n2. Subjects who have no requirement for oxygen (Ordinal Scale for Clinical Improvement score of 3 or less)\\n3. Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient)\\n4. Subjects must be receiving standard of care (SOC) for COVID-19\\n5. Subject's spirometry (forced expiratory volume in one second [FEV1] and forced vital capacity [FVC]) must be ≥70% of predicted value\\n6. If female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception must be: practicing two effective methods of birth control (acceptable methods include intrauterine device, spermicide, barrier, male partner surgical sterilization, and hormonal contraception) during the study and through 30 days after completion of the study. Abstinence is not classified as an effective method of birth control.\\n7. If female, must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study. A pregnancy test must be negative at the Screening Visit, prior to dosing on Day 1.\\n8. If male, must be surgically sterile or willing to practice two effective methods of birth control (acceptable methods include barrier, spermicide, or female partner surgical sterilization) during the study and through 30 days after completion of the study. Abstinence is not classified as an effective method of birth control.\\n9. Must have the ability to understand and give informed consent.\\n\\nExclusion Criteria:\\n\\n1. No documented infection with SARS-CoV-2\\n2. Patients who are symptomatic and require oxygen (Ordinal Scale for Clinical Improvement score >3) at the time of screening\\n3. Known history of chronic pulmonary disease (e.g., asthma [including atopic asthma, exercise-induced asthma, or asthma triggered by respiratory infection], chronic pulmonary disease, pulmonary fibrosis, COPD), pulmonary hypertension, or heart failure.\\n4. Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints.\\n5. Previous exposure to PUL-042 Inhalation Solution\",\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Colin Broom, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '713-579-9226',\n", + " 'CentralContactEMail': 'clinicaltrials@pulmotect.com'},\n", + " {'CentralContactName': 'Brenton Scott, Ph D',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '713-579-9226',\n", + " 'CentralContactEMail': 'clinicaltrials@pulmotect.com'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Colin Broom, MD',\n", + " 'OverallOfficialAffiliation': 'Pulmotect, Inc.',\n", + " 'OverallOfficialRole': 'Study Director'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Houston Methodist Hospital',\n", + " 'LocationCity': 'Houston',\n", + " 'LocationState': 'Texas',\n", + " 'LocationZip': '77030',\n", + " 'LocationCountry': 'United States'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'C000627946',\n", + " 'InterventionMeshTerm': 'PUL-042'},\n", + " {'InterventionMeshId': 'D000019999',\n", + " 'InterventionMeshTerm': 'Pharmaceutical Solutions'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000019141',\n", + " 'InterventionAncestorTerm': 'Respiratory System Agents'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M20444',\n", + " 'InterventionBrowseLeafName': 'Pharmaceutical Solutions',\n", + " 'InterventionBrowseLeafAsFound': 'Solution',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M266568',\n", + " 'InterventionBrowseLeafName': 'PUL-042',\n", + " 'InterventionBrowseLeafAsFound': 'PUL-042',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M19721',\n", + " 'InterventionBrowseLeafName': 'Respiratory System Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", + " {'InterventionBrowseBranchAbbrev': 'Resp',\n", + " 'InterventionBrowseBranchName': 'Respiratory System Agents'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", + " 'ConditionMeshTerm': 'Infection'},\n", + " {'ConditionMeshId': 'D000053120',\n", + " 'ConditionMeshTerm': 'Respiratory Aspiration'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000012120',\n", + " 'ConditionAncestorTerm': 'Respiration Disorders'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", + " {'ConditionAncestorId': 'D000010335',\n", + " 'ConditionAncestorTerm': 'Pathologic Processes'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafAsFound': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M25724',\n", + " 'ConditionBrowseLeafName': 'Respiratory Aspiration',\n", + " 'ConditionBrowseLeafAsFound': 'Inhalation',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M13540',\n", + " 'ConditionBrowseLeafName': 'Respiration Disorders',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'}]}}}}},\n", + " {'Rank': 78,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04273581',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '20200214-COVID-19-S-T'},\n", + " 'Organization': {'OrgFullName': 'First Affiliated Hospital of Wenzhou Medical University',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'The Efficacy and Safety of Thalidomide Combined With Low-dose Hormones in the Treatment of Severe COVID-19',\n", + " 'OfficialTitle': 'The Efficacy and Safety of Thalidomide Combined With Low-dose Hormones in the Treatment of Severe New Coronavirus (COVID-19) Pneumonia: a Prospective, Multicenter, Randomized, Double-blind, Placebo, Parallel Controlled Clinical Study'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'February 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'February 18, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 30, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'May 30, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'February 14, 2020',\n", + " 'StudyFirstSubmitQCDate': 'February 14, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'February 18, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'February 19, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'February 21, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'First Affiliated Hospital of Wenzhou Medical University',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Second Affiliated Hospital of Wenzhou Medical University',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'Wenzhou Central Hospital',\n", + " 'CollaboratorClass': 'OTHER'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Patients with severe COVID-19 have rapid disease progression and high mortality. There is currently no effective treatment method, which may be related to the excessive immune response caused by cytokine storm. This study will evaluate thalidomide combined with low-dose hormone adjuvant therapy for severe COVID-19 Patient effectiveness and safety.',\n", + " 'DetailedDescription': 'Thalidomide has been clinically reported, and combined with antiviral drugs and other conventional treatments have achieved good results in the treatment of severe H1N1, especially after the death of a young severe patient. After the addition of thalidomide, the reported 35 patients did not Deaths. Subsequent basic research at Fudan University confirmed that thalidomide can treat H1N1 lung injury. And think that the combination with antiviral drugs may be a better alternative strategy for H1N1 before the vaccine is successfully developed.\\n\\nIn view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Patients with severe COVID-19 have rapid disease progression and high mortality. There is currently no effective treatment method, which may be related to the excessive immune response caused by cytokine storm.It has been reported that the combined use of thalidomide and dexamethasone can effectively inhibit NK / T-cell lymphoma combined with ECSIT V140A mutation of hematophilic syndrome. The AIDS immune reconstitution syndrome (IRIS) is also an abnormal inflammatory response in nature. It has been reported that thalidomide as an immunomodulatory agent for the treatment of IRIS is effective. This study will evaluate thalidomide combined with low-dose hormone adjuvant therapy for severe COVID-19 Patient effectiveness and safety.\\n\\nAlthough the death rate of COVID-19 infected persons is not high, their rapid infectiousness and the lack of effective antiviral treatment currently have become the focus of the national and international epidemic. Thalidomide has been available for more than sixty years, and has been widely used in clinical applications. It has been proved to be safe and effective in IPF, severe H1N1 influenza lung injury and paraquat poisoning lung injury, and the mechanism of anti-inflammatory and anti-fibrosis is relatively clear. As the current research on COVID-19 at home and abroad mainly focuses on the exploration of antiviral efficacy, this study intends to find another way to start with host treatment in the case that antiviral is difficult to overcome in the short term, in order to control or relieve lung inflammation caused by the virus To improve lung function.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19 Thalidomide']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 2']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Quadruple',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", + " 'Care Provider',\n", + " 'Investigator',\n", + " 'Outcomes Assessor']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '40',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Control group',\n", + " 'ArmGroupType': 'Placebo Comparator',\n", + " 'ArmGroupDescription': 'α-interferon： nebulized inhalation, 5 million U or equivalent dose added 2ml of sterile water for injection, 2 times a day, for 7 days； Abidol, 200mg / time, 3 times a day, for 7 days; Methylprednisolone： 40mg, q12h， for 5 days. placebo：100mg/d，qn，for 14 days.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: placebo']}},\n", + " {'ArmGroupLabel': 'Thalidomide group',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'α-interferon： nebulized inhalation, 5 million U or equivalent dose added 2ml of sterile water for injection, 2 times a day, for 7 days； Abidol, 200mg / time, 3 times a day, for 7 days; Methylprednisolone： 40mg, q12h， for 5 days. thalidomide：100mg/d，qn，for 14 days.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Thalidomide']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'placebo',\n", + " 'InterventionDescription': '100mg/d，qn，for 14 days.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Control group']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Thalidomide',\n", + " 'InterventionDescription': '100mg/d，qn，for 14 days.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Thalidomide group']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['fanyingting']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Time to Clinical Improvement (TTCI)',\n", + " 'PrimaryOutcomeDescription': 'TTCI is defined as the time (in days) from initiation of study treatment (active or placebo) until a decline of two categories from admission status on a six-category ordinal scale of clinical status which ranges from 1 (discharged) to 6 (death). Six-category ordinal scale: 6. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy; 3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC); 2. Hospitalization, not requiring supplemental oxygen; 1. Hospital discharge. Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula.',\n", + " 'PrimaryOutcomeTimeFrame': 'up to 28 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Clinical status',\n", + " 'SecondaryOutcomeDescription': 'Clinical status, assessed by the ordinal scale at fixed time points',\n", + " 'SecondaryOutcomeTimeFrame': 'days 7, 14, 21, and 28'},\n", + " {'SecondaryOutcomeMeasure': 'Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", + " {'SecondaryOutcomeMeasure': 'All cause mortality',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", + " {'SecondaryOutcomeMeasure': 'Duration (days) of mechanical ventilation',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", + " {'SecondaryOutcomeMeasure': 'Duration (days) of extracorporeal membrane oxygenation',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", + " {'SecondaryOutcomeMeasure': 'Duration (days) of supplemental oxygenation',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", + " {'SecondaryOutcomeMeasure': 'Length of hospital stay (days)',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", + " {'SecondaryOutcomeMeasure': 'Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", + " {'SecondaryOutcomeMeasure': 'Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve.',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", + " {'SecondaryOutcomeMeasure': 'Frequency of serious adverse drug events',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", + " {'SecondaryOutcomeMeasure': 'Serum TNF-α, IL-1β, IL-2, IL-6, IL-7, IL-10, GSCF, IP10#MCP1, MIP1α and other cytokine expression levels before and after treatment',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 28 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAge ≥18 years;\\nThe laboratory (RT-PCR) confirmed the diagnosis of severe patients infected with CoVID-19 (refer to the fifth edition of the Chinese diagnosis and treatment guideline for trial); the diagnosis of new coronavirus pneumonia was confirmed, and any of the following: 1) Respiratory distress, breathing ≥30 beats / min; 2) In the resting state, the oxygen saturation is ≤93%; 3) Arterial blood oxygen partial pressure / oxygen concentration ≤300mmHg\\nThe diagnosis is less than or equal to 12 days;\\n\\nExclusion Criteria:\\n\\nSevere liver disease (such as Child Pugh score ≥ C, AST> 5 times the upper limit); severe renal dysfunction (the glomerulus is 30ml / min / 1.73m2 or less)\\nPregnancy or breastfeeding or positive pregnancy test;\\nIn the 30 days before the screening assessment, have taken any experimental treatment drugs for CoVID-19 (including off-label, informed consent use or trial-related);\\nThose with a history of thromboembolism, except for those caused by PICC.',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Jinglin Xia, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '0577-55578166',\n", + " 'CentralContactEMail': 'xiajinglin@fudan.edu.cn'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Jinglin Xia, MD',\n", + " 'OverallOfficialAffiliation': 'First Affiliated Hospital of Wenzhou Medical University',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]}},\n", + " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '32029004',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Jin YH, Cai L, Cheng ZS, Cheng H, Deng T, Fan YP, Fang C, Huang D, Huang LQ, Huang Q, Han Y, Hu B, Hu F, Li BH, Li YR, Liang K, Lin LK, Luo LS, Ma J, Ma LL, Peng ZY, Pan YB, Pan ZY, Ren XQ, Sun HM, Wang Y, Wang YY, Weng H, Wei CJ, Wu DF, Xia J, Xiong Y, Xu HB, Yao XM, Yuan YF, Ye TS, Zhang XC, Zhang YW, Zhang YG, Zhang HM, Zhao Y, Zhao MJ, Zi H, Zeng XT, Wang YY, Wang XH; , for the Zhongnan Hospital of Wuhan University Novel Coronavirus Management and Research Team, Evidence-Based Medicine Chapter of China International Exchange and Promotive Association for Medical and Health Care (CPAM). A rapid advice guideline for the diagnosis and treatment of 2019 novel coronavirus (2019-nCoV) infected pneumonia (standard version). Mil Med Res. 2020 Feb 6;7(1):4. doi: 10.1186/s40779-020-0233-6.'},\n", + " {'ReferencePMID': '32043983',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Russell CD, Millar JE, Baillie JK. Clinical evidence does not support corticosteroid treatment for 2019-nCoV lung injury. Lancet. 2020 Feb 15;395(10223):473-475. doi: 10.1016/S0140-6736(20)30317-2. Epub 2020 Feb 7.'},\n", + " {'ReferencePMID': '15057291',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Bartlett JB, Dredge K, Dalgleish AG. The evolution of thalidomide and its IMiD derivatives as anticancer agents. Nat Rev Cancer. 2004 Apr;4(4):314-22. doi: 10.1038/nrc1323. Review.'},\n", + " {'ReferencePMID': '19604271',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Zhao L, Xiao K, Wang H, Wang Z, Sun L, Zhang F, Zhang X, Tang F, He W. Thalidomide has a therapeutic effect on interstitial lung fibrosis: evidence from in vitro and in vivo studies. Clin Exp Immunol. 2009 Aug;157(2):310-5. doi: 10.1111/j.1365-2249.2009.03962.x.'},\n", + " {'ReferencePMID': '32031570',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Feb 7. doi: 10.1001/jama.2020.1585. [Epub ahead of print]'},\n", + " {'ReferencePMID': '29291352',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Wen H, Ma H, Cai Q, Lin S, Lei X, He B, Wu S, Wang Z, Gao Y, Liu W, Liu W, Tao Q, Long Z, Yan M, Li D, Kelley KW, Yang Y, Huang H, Liu Q. Recurrent ECSIT mutation encoding V140A triggers hyperinflammation and promotes hemophagocytic syndrome in extranodal NK/T cell lymphoma. Nat Med. 2018 Feb;24(2):154-164. doi: 10.1038/nm.4456. Epub 2018 Jan 1.'},\n", + " {'ReferencePMID': '24912813',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Zhu H, Shi X, Ju D, Huang H, Wei W, Dong X. Anti-inflammatory effect of thalidomide on H1N1 influenza virus-induced pulmonary injury in mice. Inflammation. 2014 Dec;37(6):2091-8. doi: 10.1007/s10753-014-9943-9.'},\n", + " {'ReferencePMID': '31533530',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Kwon HY, Han YJ, Im JH, Baek JH, Lee JS. Two cases of immune reconstitution inflammatory syndrome in HIV patients treated with thalidomide. Int J STD AIDS. 2019 Oct;30(11):1131-1135. doi: 10.1177/0956462419847297. Epub 2019 Sep 19.'}]},\n", + " 'SeeAlsoLinkList': {'SeeAlsoLink': [{'SeeAlsoLinkLabel': 'Clinical characteristics of 2019 novel coronavirus infection in China by Nan-Shan Zhong',\n", + " 'SeeAlsoLinkURL': 'http://doi.org/10.1101/2020.02.06.20020974'}]}}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000013792',\n", + " 'InterventionMeshTerm': 'Thalidomide'},\n", + " {'InterventionMeshId': 'D000006728',\n", + " 'InterventionMeshTerm': 'Hormones'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000006730',\n", + " 'InterventionAncestorTerm': 'Hormones, Hormone Substitutes, and Hormone Antagonists'},\n", + " {'InterventionAncestorId': 'D000045505',\n", + " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", + " {'InterventionAncestorId': 'D000007166',\n", + " 'InterventionAncestorTerm': 'Immunosuppressive Agents'},\n", + " {'InterventionAncestorId': 'D000007155',\n", + " 'InterventionAncestorTerm': 'Immunologic Factors'},\n", + " {'InterventionAncestorId': 'D000007917',\n", + " 'InterventionAncestorTerm': 'Leprostatic Agents'},\n", + " {'InterventionAncestorId': 'D000000900',\n", + " 'InterventionAncestorTerm': 'Anti-Bacterial Agents'},\n", + " {'InterventionAncestorId': 'D000000890',\n", + " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", + " {'InterventionAncestorId': 'D000020533',\n", + " 'InterventionAncestorTerm': 'Angiogenesis Inhibitors'},\n", + " {'InterventionAncestorId': 'D000043924',\n", + " 'InterventionAncestorTerm': 'Angiogenesis Modulating Agents'},\n", + " {'InterventionAncestorId': 'D000006133',\n", + " 'InterventionAncestorTerm': 'Growth Substances'},\n", + " {'InterventionAncestorId': 'D000006131',\n", + " 'InterventionAncestorTerm': 'Growth Inhibitors'},\n", + " {'InterventionAncestorId': 'D000000970',\n", + " 'InterventionAncestorTerm': 'Antineoplastic Agents'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8372',\n", + " 'InterventionBrowseLeafName': 'Hormones',\n", + " 'InterventionBrowseLeafAsFound': 'Hormone',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M10332',\n", + " 'InterventionBrowseLeafName': 'Methylprednisolone',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M1833',\n", + " 'InterventionBrowseLeafName': 'Methylprednisolone Acetate',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M10333',\n", + " 'InterventionBrowseLeafName': 'Methylprednisolone Hemisuccinate',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M12703',\n", + " 'InterventionBrowseLeafName': 'Prednisolone',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M237203',\n", + " 'InterventionBrowseLeafName': 'Prednisolone acetate',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M218859',\n", + " 'InterventionBrowseLeafName': 'Prednisolone hemisuccinate',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M243004',\n", + " 'InterventionBrowseLeafName': 'Prednisolone phosphate',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M8990',\n", + " 'InterventionBrowseLeafName': 'Interferons',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M15142',\n", + " 'InterventionBrowseLeafName': 'Thalidomide',\n", + " 'InterventionBrowseLeafAsFound': 'Thalidomide',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M8371',\n", + " 'InterventionBrowseLeafName': 'Hormone Antagonists',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M8795',\n", + " 'InterventionBrowseLeafName': 'Immunosuppressive Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M8784',\n", + " 'InterventionBrowseLeafName': 'Immunologic Factors',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2803',\n", + " 'InterventionBrowseLeafName': 'Anti-Bacterial Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2795',\n", + " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M20902',\n", + " 'InterventionBrowseLeafName': 'Angiogenesis Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", + " {'InterventionBrowseBranchAbbrev': 'Infl',\n", + " 'InterventionBrowseBranchName': 'Anti-Inflammatory Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'AnEm',\n", + " 'InterventionBrowseBranchName': 'Antiemetics'},\n", + " {'InterventionBrowseBranchAbbrev': 'NeuroAg',\n", + " 'InterventionBrowseBranchName': 'Neuroprotective Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'Gast',\n", + " 'InterventionBrowseBranchName': 'Gastrointestinal Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ANeo',\n", + " 'InterventionBrowseBranchName': 'Antineoplastic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'}]}},\n", + " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M12487',\n", + " 'ConditionBrowseLeafName': 'Pneumonia',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'}]}}}}},\n", + " {'Rank': 79,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04317092',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'TOCIVID-19'},\n", + " 'SecondaryIdInfoList': {'SecondaryIdInfo': [{'SecondaryId': '2020-001110-38',\n", + " 'SecondaryIdType': 'EudraCT Number'}]},\n", + " 'Organization': {'OrgFullName': 'National Cancer Institute, Naples',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Tocilizumab in COVID-19 Pneumonia (TOCIVID-19)',\n", + " 'OfficialTitle': 'Multicenter Study on the Efficacy and Tolerability of Tocilizumab in the Treatment of Patients With COVID-19 Pneumonia',\n", + " 'Acronym': 'TOCIVID-19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 19, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'December 19, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'December 19, 2022',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 19, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 19, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 20, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 19, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 20, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'National Cancer Institute, Naples',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'This study project includes a single-arm phase 2 study and a parallel observational cohort study, enrolling patients with COVID-19 pneumonia.',\n", + " 'DetailedDescription': 'Phase 2 study: this is a multicenter, single-arm, open-label, phase 2 study. All the patients enrolled are treated with tocilizumab. One-month mortality rate is the primary endpoint.\\n\\nObservational cohort study: patients who are not eligible for the phase 2 study because: (a) emergency conditions or infrastructural or operational limits prevented registration before the administration of the experimental drug or (b) they had been intubated more than 48 hours before registration. The same information planned for the phase 2 cohort is in principle required also for the observational cohort study. The sample size of the observational study is not defined a priori and the cohort will close at the end of the overall project.\\n\\nIn both study groups (phase 2 and observational study), participants will receive two doses of Tocilizumab 8 mg/kg (up to a maximum of 800mg per dose), with an interval of 12 hours.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19 Pneumonia']},\n", + " 'KeywordList': {'Keyword': ['COVID-19', 'pneumonia', 'tocilizumab']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 2']},\n", + " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", + " 'DesignInterventionModelDescription': 'This is a multicenter, single-arm, open-label, phase 2 study. All the patients enrolled are treated with tocilizumab',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '330',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'tocilizumab treatment',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'All the patients enrolled are treated with tocilizumab.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Tocilizumab Injection']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Tocilizumab Injection',\n", + " 'InterventionDescription': 'Tocilizumab 8 mg/kg (up to a maximum of 800mg per dose), with an interval of 12 hours.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['tocilizumab treatment']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'One-month mortality rate',\n", + " 'PrimaryOutcomeDescription': '1-month mortality is defined as the ratio of patients who will alive after 1month from study start out of those registered at baseline',\n", + " 'PrimaryOutcomeTimeFrame': 'up to 1 month'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Interleukin-6 level',\n", + " 'SecondaryOutcomeDescription': 'IL-6 levels will be assessed using commercial ELISA method.',\n", + " 'SecondaryOutcomeTimeFrame': 'baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month'},\n", + " {'SecondaryOutcomeMeasure': 'Lymphocyte count',\n", + " 'SecondaryOutcomeDescription': 'Lymphocyte count assessed by routinely used determination of blood count',\n", + " 'SecondaryOutcomeTimeFrame': 'baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month'},\n", + " {'SecondaryOutcomeMeasure': 'CRP (C-reactive protein) level',\n", + " 'SecondaryOutcomeDescription': 'CRP is assessed by routinely used determination of CRP',\n", + " 'SecondaryOutcomeTimeFrame': 'baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month'},\n", + " {'SecondaryOutcomeMeasure': 'PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio)',\n", + " 'SecondaryOutcomeDescription': 'calculated from arterial blood gas analyses (values from 300 to 100)',\n", + " 'SecondaryOutcomeTimeFrame': 'baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month'},\n", + " {'SecondaryOutcomeMeasure': 'Change of the SOFA (Sequential Organ Failure Assessment)',\n", + " 'SecondaryOutcomeDescription': 'It evaluates 6 variables, each representing an organ system (one for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems), and scored from 0 (normal) to 4 (high degree of dysfunction/failure). Thus, the maximum score may range from 0 to 24.',\n", + " 'SecondaryOutcomeTimeFrame': 'baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month'},\n", + " {'SecondaryOutcomeMeasure': 'Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) version 5.0',\n", + " 'SecondaryOutcomeDescription': 'graded according to CTCAE citeria (v5.0)',\n", + " 'SecondaryOutcomeTimeFrame': 'during treatment and up to 30 days after the last treatment dose'},\n", + " {'SecondaryOutcomeMeasure': 'Radiological response',\n", + " 'SecondaryOutcomeDescription': 'Thoracic CT scan or Chest XR',\n", + " 'SecondaryOutcomeTimeFrame': 'at baseline (optional), after seven days and if clinically indicated (up to 1 month)'},\n", + " {'SecondaryOutcomeMeasure': 'Duration of hospitalization',\n", + " 'SecondaryOutcomeDescription': 'Days of hospitalization',\n", + " 'SecondaryOutcomeTimeFrame': \"from baseline up to patient's discharge (up to 1 month)\"},\n", + " {'SecondaryOutcomeMeasure': 'Remission of respiratory symptoms',\n", + " 'SecondaryOutcomeDescription': 'time to invasive mechanical ventilation (if not previously initiated) calculated from baseline to intubation',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 1 month'},\n", + " {'SecondaryOutcomeMeasure': 'Remission of respiratory symptoms',\n", + " 'SecondaryOutcomeDescription': 'time to definitive extubation calculated from intubation (any time occurred) to extubation in days',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 1 month'},\n", + " {'SecondaryOutcomeMeasure': 'Remission of respiratory symptoms',\n", + " 'SecondaryOutcomeDescription': 'time to independence from non-invasive mechanical ventilation calculated in days',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 1 month'},\n", + " {'SecondaryOutcomeMeasure': 'Remission of respiratory symptoms',\n", + " 'SecondaryOutcomeDescription': 'time to independence from oxygen therapy in days',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 1 month'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAny gender\\nNo age limit\\nInformed consent for participation in the study\\nVirological diagnosis of Sars-CoV2 infection (PCR)\\nHospitalized due to clinical/instrumental diagnosis of pneumonia\\nOxygen saturation at rest in ambient air ≤93% (valid for not intubated patients and for both phase 2 and observational cohort)\\nIntubated less than 24 hours before registration (eligible for phase 2 only - criterium #6 does not apply in this case)\\nIntubated more than 24 hours before registration (eligible for observational cohort only - criterium #6 does not apply in this case)\\nPatients already treated with tocilizumab before registration are eligible for observational cohort only if one criterium among #6, #7, #8 is valid\\n\\nExclusion Criteria:\\n\\nKnown hypersensitivity to tocilizumab or its excipients\\nPatient being treated with immunomodulators or anti-rejection drugs\\nKnown active infections or other clinical condition that controindicate tocilizumab and cannot be treated or solved according to the judgement of the clinician\\nALT / AST> 5 times the upper limit of the normality\\nNeutrophils <500 / mmc\\nPlatelets <50.000 / mmc\\nBowel diverticulitis or perforation',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Francesco Perrone, MD, PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+390815903571',\n", + " 'CentralContactEMail': 'f.perrone@istitutotumori.na.it'},\n", + " {'CentralContactName': 'Maria Carmela Piccirillo, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+390815903615',\n", + " 'CentralContactEMail': 'm.piccirillo@istitutotumori.na.it'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Francesco Perrone, MD, PhD',\n", + " 'OverallOfficialAffiliation': 'Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Azienda Ospedaliera \"SS. Antonio e Biagio e C. Arrigo\" (Dipartimento Internistico SSD Reumatologia)',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Alessandria',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Stobbione Paolo, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '0131/206860',\n", + " 'LocationContactEMail': 'pstobbione@ospedale.al.it'},\n", + " {'LocationContactName': 'Stobbione Paolo, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'Ospedale di Busto Arsizio ASST Valle Olona (U.O.C. Malattie Infettive)',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Busto Arsizio',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Fabio Franzetti, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '0331/699270',\n", + " 'LocationContactEMail': 'fabio.franzetti@asst-valleolona.it'},\n", + " {'LocationContactName': 'Fabio Franzetti, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': \"A.O.U. Policlinico V. Emanuele (U.O. di Malattie infettive, U.O. di Anestesia e Rianimazione, U.O. di Medicina d'Urgenza)\",\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Catania',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Arturo Montineri, MD',\n", + " 'LocationContactRole': 'Contact'},\n", + " {'LocationContactName': 'Arturo Montineri, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Salvo Nicosia, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Giuseppe Carpinteri, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'AOE Cannizzaro di Catania (U.O. di Malattie Infettive, U.O. di Anestesia e Rianimazione, U.O.',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Catania',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Carmelo Iacobello, MD',\n", + " 'LocationContactRole': 'Contact'},\n", + " {'LocationContactName': 'Carmelo Iacobello, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Maria Concetta Monea, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'Ospedale Annunziata Azienda Ospedaliera di Cosenza (U.O.C. Malattie Infettive)',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Cosenza',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Antonio Mastroianni, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '0984-681833',\n", + " 'LocationContactEMail': 'antoniomastroianni@yahoo.it'},\n", + " {'LocationContactName': 'Antonio Mastroianni, MD',\n", + " 'LocationContactRole': 'Contact'}]}},\n", + " {'LocationFacility': 'ASST OVEST MILANESE presidi Legnano - Magenta',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Magenta',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Paola Faggioli, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '0331449175-919',\n", + " 'LocationContactEMail': 'paola.faggioli@sst-ovestmi.it'},\n", + " {'LocationContactName': 'Paola Faggioli, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'Azienda Ospedaliero-Universitaria di Modena',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Modena',\n", + " 'LocationZip': '42100',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Carlo Salvarani, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+39 0522 296684',\n", + " 'LocationContactEMail': 'salvarani.carlo@ausl.re.it'},\n", + " {'LocationContactName': 'Carlo Salvarani, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'A.O.U. di Modena (Dipartimento Chirurgie Generali e Specialità Chirurgiche - Struttura Complessa di Anestesia e Rianimazione I)',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Modena',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Massimo Girardis, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '0594225868',\n", + " 'LocationContactEMail': 'ricercainnovazione@aou.mo.it'},\n", + " {'LocationContactName': 'Massimo Girardis, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'A.O.U. di Modena (Dipartimento Chirurgie Generali e Specialità Chirurgiche - Struttura Complessa di Anestesia e Rianimazione II)',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Modena',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Elisabetta Bertelli, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '0594225868',\n", + " 'LocationContactEMail': 'ricercainnovazione@aou.mo.it'},\n", + " {'LocationContactName': 'Elisabetta Bertelli, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'A.O.U. di Modena (Dipartimento Medicine Specialistiche - Struttura Complessa Malattie Infettive)',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Modena',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Cristina Mussini, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '0594223673',\n", + " 'LocationContactEMail': 'nb.protocolli@unimore.it'},\n", + " {'LocationContactName': 'Cristina Mussini, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': \"Dipartimento Medicine Specialistiche - Struttura Complessa Malattie dell'Apparato Respiratorio\",\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Modena',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Enrico Clini, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '0594225868',\n", + " 'LocationContactEMail': 'ricercainnovazione@aou.mo.it'},\n", + " {'LocationContactName': 'Enrico Clini, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'A.O.R.N. Ospedale dei Colli Monaldi-Cotugno-CTO (U.O.C. Oncologia)',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Naples',\n", + " 'LocationZip': '80131',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Vincenzo Montesarchio, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+39 0817065268',\n", + " 'LocationContactEMail': 'vincenzo.montesarchio@ospedaledeicolli.it'},\n", + " {'LocationContactName': 'Vincenzo Montesarchio, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'National Cancer Institute',\n", + " 'LocationStatus': 'Not yet recruiting',\n", + " 'LocationCity': 'Naples',\n", + " 'LocationZip': '80131',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Paolo Ascierto, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+39 0815903431',\n", + " 'LocationContactEMail': 'p.ascierto@istitutotumori.na.it'},\n", + " {'LocationContactName': 'Paolo Ascierto, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'A.O.R.N. Ospedale dei Colli Monaldi-Cotugno-CTO (U.O.C. Anestesia Rianimazione e terapia intensiva)',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Naples',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Fiorentino Fragranza, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+39 08170672571',\n", + " 'LocationContactEMail': 'fiorentino.fragranza@ospedaledeicolli.it'},\n", + " {'LocationContactName': 'Fiorentino Fragranza, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'A.O.R.N. Ospedale dei Colli Monaldi-Cotugno-CTO (U.O.C. Malattie Infettive ad indirizzo respiratorio)',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Naples',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Roberto Parrella, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+39 0817067584',\n", + " 'LocationContactEMail': 'roberto.parrella@ospedaledeicolli.it'},\n", + " {'LocationContactName': 'Roberto Parrella, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': \"A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore di Pesaro (UOC Pronto Soccorso e Medicina d'Urgenza)\",\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Pesaro',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Giancarlo Titolo, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '328 4157022',\n", + " 'LocationContactEMail': 'giancarlo.titolo@ospedalimarchenord.it'},\n", + " {'LocationContactName': 'Giancarlo Titolo, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': \"Denominazione: UOC di Medicina e Chirurgia d'Accettazione e d'Urgenza dell'Ospedale Santa Maria delle Grazie di Pozzuoli\",\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Pozzuoli',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Fabio Giuliano Numis, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactEMail': 'fabiogiuliano.numis@aslnapoli2nord.it'},\n", + " {'LocationContactName': 'Fabio Giuliano Numis, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'Ospedale Santa Maria delle Croci, AUSL della Romagna (U.O. Anestesia e Rianimazione)',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Ravenna',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Maurizio Fusari, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '0544285918',\n", + " 'LocationContactEMail': 'maurizio.fusari@auslromagna.it'},\n", + " {'LocationContactName': 'Maurizio Fusari, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'Grande Ospedale Metropolitano, Reggio Calabria',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Reggio Calabria',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Demetrio Labate, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '340 0940460',\n", + " 'LocationContactEMail': 'labatedemtrio84@gmail.com'},\n", + " {'LocationContactName': 'Demetrio Labate',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'Ospedale Infermi, AUSL della Romagna (U.O. Malattie Infettive)',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Rimini',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Francesco Cristini, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '0541705506 - 0541705315',\n", + " 'LocationContactEMail': 'francesco.cristini@auslromagna.it'},\n", + " {'LocationContactName': 'Francesco Cristini, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'Policlinico Gemelli (U.O.C. Dipartimento Scienze di Laboratorio e Infettivologiche)',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Rome',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Roberto Cauda, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '06 3015 4945',\n", + " 'LocationContactEMail': 'roberto.cauda@policlinicogemelli.it'},\n", + " {'LocationContactName': 'Roberto Cauda, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'ASST Sette Laghi (Dipartimento di Medicina Interna)',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Varese',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Francesco Dentali, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '0332/393056',\n", + " 'LocationContactEMail': 'francesco.dentali@asst-settelaghi.it'},\n", + " {'LocationContactName': 'Francesco Dentali, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'ASST Sette Laghi (Dipartimento Emergenze ed Urgenze)',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Varese',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Walter Ageno, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '0332/393056',\n", + " 'LocationContactEMail': 'walter.ageno@asst-settelaghi.it'},\n", + " {'LocationContactName': 'Walter Ageno, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'ASST Sette Laghi (U.O.C. Anestesia e Rianimazione Neurochirurgica e Generale)',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Varese',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Luca Cabrini, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '0332/393056',\n", + " 'LocationContactEMail': 'l.cabrini@asst-settelaghi.it'}]}},\n", + " {'LocationFacility': 'ASST Sette Laghi (U.O.C. Malattie Infettive e Tropicali)',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Varese',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Paolo Grossi, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '0332/393056',\n", + " 'LocationContactEMail': 'paolo.grossi@asst-settelaghi.it'},\n", + " {'LocationContactName': 'Paolo Grossi, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'A.O.U. Integrata di Verona (Dip. Malattie Infettive)',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Verona',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Evelina Tacconelli, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '045 8128243 - 8128244',\n", + " 'LocationContactEMail': 'evelina.tacconelli@univr.it'},\n", + " {'LocationContactName': 'Evelina Tacconelli, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'Ospedale Magalini (U.O. Malattie Infettive)',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Villafranca Di Verona',\n", + " 'LocationCountry': 'Italy',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Maria Danzi, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '331/6237628',\n", + " 'LocationContactEMail': 'maria.danzi@aulss9.veneto.it'},\n", + " {'LocationContactName': 'Maria Danzi, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}}]}},\n", + " 'ReferencesModule': {'SeeAlsoLinkList': {'SeeAlsoLink': [{'SeeAlsoLinkLabel': 'sponsor web-site for study conduction',\n", + " 'SeeAlsoLinkURL': 'http://usc-intnapoli.net'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000011014',\n", + " 'ConditionMeshTerm': 'Pneumonia'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000008171',\n", + " 'ConditionAncestorTerm': 'Lung Diseases'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M12487',\n", + " 'ConditionBrowseLeafName': 'Pneumonia',\n", + " 'ConditionBrowseLeafAsFound': 'Pneumonia',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M9751',\n", + " 'ConditionBrowseLeafName': 'Lung Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'}]}}}}},\n", + " {'Rank': 80,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04323644',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'CS-20200324'},\n", + " 'Organization': {'OrgFullName': 'University of Birmingham',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Outcomes of Surgery in COVID-19 Infection: International Cohort Study (CovidSurg)',\n", + " 'OfficialTitle': 'Outcomes of Surgery in COVID-19 Infection: International Cohort Study (CovidSurg)',\n", + " 'Acronym': 'CovidSurg'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 31, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'September 30, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'September 30, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 25, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 25, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 26, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 25, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 26, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'University of Birmingham',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'CovidSurg will capture real-world international data, to determine 30-day mortality in patients with COVID-19 infection who undergo surgery. This shared international experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, ultimately improving their clinical care.',\n", + " 'DetailedDescription': 'There is an urgent need to understand the outcomes of COVID-19 infected patients who undergo surgery. Capturing real-world data and sharing international experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, improving their clinical care.\\n\\nThe primary aim of the study is to determine 30-day mortality in patients with COVID-19 infection who undergo surgery. In doing so, this will inform future risk stratification, decision making, and patient consent.\\n\\nCovidSurg is an investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk. This study does not collect any patient identifiable information (including no dates) and data will not be analysed at hospital-level.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", + " 'Coronavirus',\n", + " 'Surgery']},\n", + " 'KeywordList': {'Keyword': ['COVID-19', 'Coronavirus', 'Surgery']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Other']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '1000',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Cohort 1',\n", + " 'ArmGroupDescription': 'Patients with COVID-19 infection undergoing surgery',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Procedure: Surgery']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Procedure',\n", + " 'InterventionName': 'Surgery',\n", + " 'InterventionDescription': 'Emergency or elective surgery',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Cohort 1']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': '30-day mortality',\n", + " 'PrimaryOutcomeDescription': 'Death up to 30-days post surgery',\n", + " 'PrimaryOutcomeTimeFrame': '30 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': '7-day mortality',\n", + " 'SecondaryOutcomeDescription': 'Death up to 7-days post surgery',\n", + " 'SecondaryOutcomeTimeFrame': '7 days post surgery'},\n", + " {'SecondaryOutcomeMeasure': '30-day reoperation',\n", + " 'SecondaryOutcomeDescription': 'Reoperation up to 30-days post surgery',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 30-days post surgery'},\n", + " {'SecondaryOutcomeMeasure': 'Postoperative ICU admission',\n", + " 'SecondaryOutcomeDescription': 'Admission to ICU post surgery',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 30 days post surgery'},\n", + " {'SecondaryOutcomeMeasure': 'Postoperative respiratory failure',\n", + " 'SecondaryOutcomeDescription': 'Respiratory failure post surgery',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 30 days post surgery'},\n", + " {'SecondaryOutcomeMeasure': 'Postoperative acute respiratory distress syndrome (ARDS)',\n", + " 'SecondaryOutcomeDescription': 'Acute respiratory distress syndrome post surgery',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 30 days post surgery'},\n", + " {'SecondaryOutcomeMeasure': 'Postoperative sepsis',\n", + " 'SecondaryOutcomeDescription': 'Sepsis post surgery',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 30 days post surgery'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nPatients undergoing ANY type of surgery in an operating theatre, this includes obstetrics\\n\\nAND\\n\\n- The patient had COVID-19 infection either at the time of surgery or within 30 days of surgery, based on\\n\\n(i) positive COVID-19 lab test or computed tomography (CT) chest scan\\n\\nOR\\n\\n(ii) clinical diagnosis (no COVID-19 lab test or CT chest performed)\\n\\nExclusion Criteria:\\n\\nIf COVID-19 infection is diagnosed >30 days after discharge, the patient should not be included.',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'Patients with COVID-19 infection who undergo surgery',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Aneel Bhangu',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+44 1216272949',\n", + " 'CentralContactEMail': 'A.A.Bhangu@bham.ac.uk'},\n", + " {'CentralContactName': 'Dmitri Nepogodiev',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+44 1216272949',\n", + " 'CentralContactEMail': 'D.Nepogodiev@bham.ac.uk'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No',\n", + " 'IPDSharingDescription': 'No individual participant data will be available to other researchers'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 81,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04331886',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'TARGET-COVID-19'},\n", + " 'Organization': {'OrgFullName': 'Target PharmaSolutions, Inc.',\n", + " 'OrgClass': 'INDUSTRY'},\n", + " 'BriefTitle': 'An Observational Study of Patients With Coronavirus Disease 2019',\n", + " 'OfficialTitle': 'An Observational Study of Patients With Coronavirus Disease 2019',\n", + " 'Acronym': 'COVID-19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 2021',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'March 2021',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 31, 2020',\n", + " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 2, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Target PharmaSolutions, Inc.',\n", + " 'LeadSponsorClass': 'INDUSTRY'}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'This is an observational study of patients with COVID-19 designed to specifically address important clinical questions that remain incompletely answered for coronavirus disease 2019.',\n", + " 'DetailedDescription': \"Data from up to 5,000 adult patients in the US will be captured from eligible patients enrolled following admission to the hospital. Participants will have de-identified medical records collected from hospital admission to discharge, including but not limited to critical care monitoring, details on mechanical ventilation, laboratory data, imaging reports, medications, and all procedures. Diagnosis and patient management will follow each hospital's standard of care and no specific treatments, procedures or laboratory tests will be dictated by enrollment in TARGET-COVID-19.\"},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", + " 'Coronavirus']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Other']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '5000',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Natural history of COVID-19: Characteristics of COVID-19',\n", + " 'PrimaryOutcomeTimeFrame': '12 months'},\n", + " {'PrimaryOutcomeMeasure': 'Natural history of COVID-19: Participant demographics',\n", + " 'PrimaryOutcomeTimeFrame': '12 months'},\n", + " {'PrimaryOutcomeMeasure': 'Natural history of COVID-19: Treatment use',\n", + " 'PrimaryOutcomeTimeFrame': '12 months'},\n", + " {'PrimaryOutcomeMeasure': 'Time point of clinical response',\n", + " 'PrimaryOutcomeTimeFrame': '12 months'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAdults (age ≥18 years) who are or have been hospitalized and diagnosed with Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection.\\nSARS-CoV-2 confirmed diagnosis (e.g. polymerase chain reaction [PCR] or other clinically utilized test).\\n\\nExclusion Criteria:\\n\\nN/A',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'Adults and children who are or have been hospitalized for diagnosed or suspected Coronavirus (SARS-CoV-2) infection',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Chuck Moser',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '984-234-0268',\n", + " 'CentralContactEMail': 'cmoser@targetpharmasolutions.com'}]}}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 82,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04287686',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'GIRH-APN01'},\n", + " 'Organization': {'OrgFullName': 'The First Affiliated Hospital of Guangzhou Medical University',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19',\n", + " 'OfficialTitle': 'A Randomized, Open Label, Controlled Clinical Study to Evaluate the Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) in Adult Patients With COVID-19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Withdrawn',\n", + " 'WhyStopped': 'Without CDE Approval',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'February 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'April 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'February 21, 2020',\n", + " 'StudyFirstSubmitQCDate': 'February 25, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'February 27, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 15, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 17, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Yimin LI',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Director Physician',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'The First Affiliated Hospital of Guangzhou Medical University'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'The First Affiliated Hospital of Guangzhou Medical University',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'This is an open label, randomized, controlled, pilot clinical study in patients with COVID-19, to obtain preliminary biologic, physiologic, and clinical data in patients with COVID-19 treated with rhACE2 or control patients, to help determine whether a subsequent Phase 2B trial is warranted.',\n", + " 'DetailedDescription': 'This is a small pilot study investigating whether there is any efficacy signal that warrants a larger Phase 2B trial, or any harm that suggests that such a trial should not be done. It is not expected to produce statistically significant results in the major endpoints. The investigators will examine all of the biologic, physiological, and clinical data to determine whether a Phase 2B trial is warranted.\\n\\nPrimary efficacy analysis will be carried only on patients receiving at least 4 doses of active drug. Safety analysis will be carried out on all patients receiving at least one dose of active drug.\\n\\nIt is planned to enroll more than or equal to 24 subjects with COVID-19. It is expected to have at least 12 evaluable patients in each group.\\n\\nExperimental group: 0.4 mg/kg rhACE2 IV BID and standard of care Control group: standard of care\\n\\nIntervention duration: up to 7 days of therapy\\n\\nNo planned interim analysis.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", + " 'KeywordList': {'Keyword': ['SARS-CoV-2',\n", + " 'Renin-angiotensin-system (RAS)']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Not Applicable']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignInterventionModelDescription': '2-arm pilot study',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '0', 'EnrollmentType': 'Actual'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'rhACE2 group',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': '0.4 mg/kg IV BID for 7 days (unblinded) + standard of care',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Recombinant human angiotensin-converting enzyme 2 (rhACE2)']}},\n", + " {'ArmGroupLabel': 'Control group',\n", + " 'ArmGroupType': 'No Intervention',\n", + " 'ArmGroupDescription': 'Standard of care; no placebo'}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Recombinant human angiotensin-converting enzyme 2 (rhACE2)',\n", + " 'InterventionDescription': 'In this study, the experimental group will receive 0.4 mg/kg rhACE2 IV BID for 7 days.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['rhACE2 group']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Time course of body temperature (fever)',\n", + " 'PrimaryOutcomeDescription': 'Compare the time course of body temperature (fever) between two groups over time.',\n", + " 'PrimaryOutcomeTimeFrame': '14 days'},\n", + " {'PrimaryOutcomeMeasure': 'Viral load over time',\n", + " 'PrimaryOutcomeDescription': 'Compare viral load between two groups over time.',\n", + " 'PrimaryOutcomeTimeFrame': '14 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'P/F ratio over time',\n", + " 'SecondaryOutcomeDescription': 'PaO2/FiO2 ratio',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Sequential organ failure assessment score(SOFA score) over time',\n", + " 'SecondaryOutcomeDescription': 'SOFA, including assessment of respiratory, blood, liver, circulatory, nerve, kidney, from 0 to 4 scores in each systems, the higher scores mean a worse outcome.',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Pulmonary Severity Index (PSI)',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Image examination of chest over time',\n", + " 'SecondaryOutcomeDescription': \"Based on radiologist's assessment of inflammatory exudative disease, category as follows: significant improvement, partial improvement, no improvement, increase of partial exudation, significant increase in exudation, unable to judge.\",\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Proportion of subjects who progressed to critical illness or death',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Time from first dose to conversion to normal or mild pneumonia',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'T-lymphocyte counts over time',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'C-reactive protein levels over time',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Angiotensin II (Ang II) changes over time',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Angiotensin 1-7 (Ang 1-7) changes over time',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Angiotensin 1-5 (Ang 1-5) changes over time',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Renin changes over time',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Aldosterone changes over time',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Angiotensin-converting enzyme (ACE) changes over time',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Angiotensin-converting enzyme 2 (ACE2) changes over time',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Interleukin 6 (IL-6) changes over time',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Interleukin 8 (IL-8) changes over time',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Plasminogen activator inhibitor type-1 (PAI-1) changes over time',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Von willebrand factor (vWF) changes over time',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Tumor necrosis factor-α (TNF-α) changes over time',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Soluble receptor for advanced glycation end products (sRAGE) changes over time',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Surfactant protein-D (SP-D) changes over time',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Angiopoietin-2 changes over time',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Frequency of adverse events and severe adverse events',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nLaboratory diagnosis:\\n\\nRespiratory specimen is positive for SARS-CoV-2 nucleic acid by RT-PCR; OR,\\nThe viral gene sequencing of the respiratory specimen is highly homologous to known novel coronavirus.\\n\\nFever:\\n\\nAxillary temperature >37.3℃\\n\\nRespiratory variables (meets one of the following criteria):\\n\\nRespiratory rate: RR ≥25 breaths/min\\nOxygen saturation ≤93% at rest on room air\\nPaO2/FiO2 ≤300 mmHg（1 mmHg=0.133 KPa）\\nPulmonary imaging showed that the lesions progressed more than 50% within 24-48 hours, and the patients were managed as severe\\nHBsAg negative, or HBV DNA ≤10^4 copy/ml if HBsAg positive; anti-HCV negative; HIV negative two weeks prior to signed Informed Consent Form (ICF)\\nAppropriate ethics approval and\\nICF\\n\\nExclusion Criteria:\\n\\nAge <18 years; Age >80 years\\nPregnant or breast feeding woman or with positive pregnancy test result\\nP/F <100 mmHg\\nMoribund condition (death likely in days) or not expected to survive for >7 days\\nRefusal by attending MD\\nNot hemodynamically stable in the preceding 4 hours (MAP ≤65 mmHg, or SAP <90 mmHg, DAP <60 mmHg, vasoactive agents are required)\\nPatient on invasive mechanical ventilation or ECMO\\nPatient in other therapeutic clinical trial within 30 days before ICF\\nReceive any other ACE inhibitors (ACEI), angiotensin-receptor blockers (ARB) treatment within 7 days before ICF\\nChronic immunosuppression: current autoimmune diseases or patients who received immunotherapy within 30 days before ICF\\nHematologic malignancy (lymphoma, leukemia, multiple myeloma)\\nOther patient characteristics (not thought to be related to underlying COVID-19) that portend a very poor prognosis (e.g, severe liver failure, and ect)\\nKnown allergy to study drug or its ingredients related to renin-angiotensin system (RAS), or frequent and/or severe allergic reactions with multiple medications\\nOther uncontrolled diseases, as judged by investigators\\nBody weight ≥85 kg',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '80 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Yimin Li, PhD, MD',\n", + " 'OverallOfficialAffiliation': 'The First Affiliated Hospital of Guangzhou Medical University',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'GCP Office of The First Affiliated Hospital of Guangzhou Medical University',\n", + " 'LocationCity': 'Guangzhou',\n", + " 'LocationState': 'Guangdong',\n", + " 'LocationZip': '510120',\n", + " 'LocationCountry': 'China'}]}}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'}}}},\n", + " {'Rank': 83,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04329650',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'SILCOR-COVID-19'},\n", + " 'Organization': {'OrgFullName': 'Fundacion Clinic per a la Recerca Biomédica',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Efficacy and Safety of Siltuximab vs. Corticosteroids in Hospitalized Patients With COVID19 Pneumonia',\n", + " 'OfficialTitle': 'Phase 2, Randomized, Open-label Study to Compare Efficacy and Safety of Siltuximab vs. Corticosteroids in Hospitalized Patients With COVID19 Pneumonia'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 20, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'May 20, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 31, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 31, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 31, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor-Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Judit Pich Martínez',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Clinical Research Manager',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Fundacion Clinic per a la Recerca Biomédica'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Judit Pich Martínez',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'In our center up to 25% of the hospitalized patients with COVID-19 progress and need an intensive care unit. It is urgent to find measures that can avoid this progression to severe stages of the disease. We hypothesize that the use of anti-inflammatory drugs used at the time they start hyperinflammation episodes could improve symptoms and prognosis of patients and prevent their progression sufficiently to avoid their need for be admitted to an Intensive Care Unit.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 2']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '100',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Siltuximab 11mg/Kg',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Siltuximab']}},\n", + " {'ArmGroupLabel': 'Methylprednisolone 250mg/24h',\n", + " 'ArmGroupType': 'Active Comparator',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Methylprednisolone']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Siltuximab',\n", + " 'InterventionDescription': 'A single-dose of 11mg/Kg of siltuximab will be administered by intravenous infusion.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Siltuximab 11mg/Kg']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Methylprednisolone',\n", + " 'InterventionDescription': 'A dose of 250mg/24 hours of methylprednisolone during 3 days followed by 30mg/24 hours during 3 days will be administered by intravenous infusion.\\n\\nIf the patient is taken lopinavir/ritonavir, the dose will be 125 mg/ 24 hours during 3 days followed by 15mg/24 hours during 3 days.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Methylprednisolone 250mg/24h']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Proportion of patients requiring ICU admission at any time within the study period.',\n", + " 'PrimaryOutcomeTimeFrame': '29 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Days of stay in the ICU during the study period.',\n", + " 'SecondaryOutcomeTimeFrame': '29 days'},\n", + " {'SecondaryOutcomeMeasure': 'Days until resolution of fever defined as body temperature (axillary ≤ 36.6 ° C, oral ≤ 37.2 ° C, or rectal or tympanic ≤ 37.8 ° C) for at least 48 hours, without administration of antipyretics or until hospital discharge.',\n", + " 'SecondaryOutcomeTimeFrame': '29 days'},\n", + " {'SecondaryOutcomeMeasure': 'Proportion of patients with a worsening requirement of supplemental oxygen at 29 days. days.',\n", + " 'SecondaryOutcomeTimeFrame': '29 days'},\n", + " {'SecondaryOutcomeMeasure': 'Days with hypoxemia (SpO2 <93% in ambient air or requiring oxygen supplemental or mechanical ventilation support) at 29 days.',\n", + " 'SecondaryOutcomeTimeFrame': '29 days'},\n", + " {'SecondaryOutcomeMeasure': 'Proportion of patients using mechanical ventilation at 29 days.',\n", + " 'SecondaryOutcomeTimeFrame': '29 days'},\n", + " {'SecondaryOutcomeMeasure': 'Days with use of mechanical ventilation at 29 days.',\n", + " 'SecondaryOutcomeTimeFrame': '29 days'},\n", + " {'SecondaryOutcomeMeasure': 'Days until the start of use of mechanical ventilation, non-invasive ventilation or use of high flow nasal cannula (if the patient have not previously required these interventions at the inclusion of the study) at 29 days.',\n", + " 'SecondaryOutcomeTimeFrame': '29 days'},\n", + " {'SecondaryOutcomeMeasure': 'Days of hospitalization among survivors at 29 days.',\n", + " 'SecondaryOutcomeTimeFrame': '29 days'},\n", + " {'SecondaryOutcomeMeasure': 'Mortality rate from any cause at 29 days.',\n", + " 'SecondaryOutcomeTimeFrame': '29 days'},\n", + " {'SecondaryOutcomeMeasure': 'Proportion of patients with serious adverse events at 29 days.',\n", + " 'SecondaryOutcomeTimeFrame': '29 days'},\n", + " {'SecondaryOutcomeMeasure': 'Proportion of patients with invasive bacterial or fungal infections clinically significant or opportunistic with grade 4 neutropenia (count neutrophil absolute <500 / mm3) at 29 days.',\n", + " 'SecondaryOutcomeTimeFrame': '29 days'},\n", + " {'SecondaryOutcomeMeasure': 'Proportion of patients with invasive bacterial or fungal infections clinically significant or opportunistic at 29 days.',\n", + " 'SecondaryOutcomeTimeFrame': '29 days'},\n", + " {'SecondaryOutcomeMeasure': 'Proportion of patients with grade 2 or higher adverse reactions related to the infusion of the sudy treatments at 29 days.',\n", + " 'SecondaryOutcomeTimeFrame': '29 days'},\n", + " {'SecondaryOutcomeMeasure': 'Proportion of patients with hypersensitivity reactions of grade 2 or higher related to the administration of the study treatments at 29 days.',\n", + " 'SecondaryOutcomeTimeFrame': '29 days'},\n", + " {'SecondaryOutcomeMeasure': 'Proportion of patients with gastrointestinal perforation at 29 days.',\n", + " 'SecondaryOutcomeTimeFrame': '29 days'},\n", + " {'SecondaryOutcomeMeasure': 'Proportion of patients with secondary severe infections confirmed by laboratory or worsening of existing infections at 29 days.',\n", + " 'SecondaryOutcomeTimeFrame': '29 days'},\n", + " {'SecondaryOutcomeMeasure': 'Changes from baseline in plasma leukocyte levels at days 1, 3, 5, 7 and 9.',\n", + " 'SecondaryOutcomeTimeFrame': 'Days 1, 3, 5, 7 and 9'},\n", + " {'SecondaryOutcomeMeasure': 'Changes from baseline in plasma hemoglobin levels at days 1, 3, 5, 7 and 9.',\n", + " 'SecondaryOutcomeTimeFrame': 'Days 1, 3, 5, 7 and 9'},\n", + " {'SecondaryOutcomeMeasure': 'Changes from baseline in plasma platelet at days 1, 3, 5, 7 and 9.',\n", + " 'SecondaryOutcomeTimeFrame': 'Days 1, 3, 5, 7 and 9'},\n", + " {'SecondaryOutcomeMeasure': 'Changes from baseline in plasma creatinine levels at days 1, 3, 5, 7 and 9.',\n", + " 'SecondaryOutcomeTimeFrame': 'Days 1, 3, 5, 7 and 9'},\n", + " {'SecondaryOutcomeMeasure': 'Changes from baseline in plasma total bilirubin levels at days 1, 3, 5, 7 and 9.',\n", + " 'SecondaryOutcomeTimeFrame': 'Days 1, 3, 5, 7 and 9'},\n", + " {'SecondaryOutcomeMeasure': 'Proportion of patients with ALT≥ 3 times ULN (for patients with initial values normal) or> 3 times ULN AND at least 2 times more than the initial value (for patients with abnormal initial values) at days 1, 3, 5, 7 and 9.',\n", + " 'SecondaryOutcomeTimeFrame': 'Days 1, 3, 5, 7 and 9'},\n", + " {'SecondaryOutcomeMeasure': 'Changes from baseline in plasma biomarkers (PCR, lymphocytes, ferritin, d-dimer and LDH) at days 1, 3, 5, 7 and 9.',\n", + " 'SecondaryOutcomeTimeFrame': 'Days 1, 3, 5, 7 and 9'},\n", + " {'SecondaryOutcomeMeasure': 'Changes from baseline in chest Rx at days 1, 3 and 5.',\n", + " 'SecondaryOutcomeTimeFrame': 'Days 1, 3 and 5'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\nAge ≥ 18 years old.\\n\\nHospitalized patient (or documentation of a hospitalization plan if the patient is in an emergency department) with illness of more than 5 days of duration with evidence of pneumonia by chest radiography / tomography computed chest and meets at least one of the following requirements:\\n\\nNon-critical patient with pneumonia in radiological progression and / or\\nPatient with progressive respiratory failure at the last 24-48 hours.\\nLaboratory confirmed SARS-CoV-2 infection (by PCR) or other commercialized analysis or public health in any sample collected 4 days before the randomization or COVID-19 criteria following the defined diagnostic criteria at that time in the center.\\nPatient with a maximum O2 support of 35%\\nBe willing and able to comply with the study related procedures / evaluations.\\nWomen of childbearing potential * should have a negative serum pregnancy test before enrollment in the study and must commit to using methods highly effective contraceptives (intrauterine device, bilateral tubal occlusion, vasectomized couple and sexual abstinence).\\nWritten informed consent. In case of inability of the patient to sign the informed consent, a verbal informed consent from the legal representative or family witness (or failing this, an impartial witness outside the investigator team) will be obtained by phone.\\n\\nWhen circumstances so allow, participants should sign the consent form. The confirmation of the verbal informed consent will be documented in a document as evidence that verbal consent has been obtained.\\n\\nExclusion Criteria:\\n\\nPatient who, in the investigator's opinion, is unlikely to survive> 48 hours after the inclusion in the study.\\n\\nPresence of any of the following abnormal analytical values at the time of the inclusion in the study:\\n\\nabsolute neutrophil count less than 2000 / mm3;\\nAST or ALT> 5 times the upper limit of normality;\\nplatelets <50,000 per mm3.\\nIn active treatment with immunosuppressants or previous prolonged treatment (more 3 months) of oral corticosteroids for a disease not related to COVID-19 at a dose greater than 10 mg of prednisone or equivalent per day.\\nKnown active tuberculosis or known history of tuberculosis uncompleted treatment.\\nPatients with active systemic bacterial and / or fungal infections.\\nParticipants who, at the investigator's discretion, are not eligible to participate, regardless of the reason, including medical or clinical conditions, or participants potentially at risk of not following study procedures.\\nPatients who do not have entry criteria in the Intensive Care Unit.\\nPregnancy or lactation.\\nKnown hypersensitivity to siltuximab or to any of its excipients (histidine, histidine hydrochloride, polysorbate 80 and sucrose).\",\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Felipe García, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+34932275400',\n", + " 'CentralContactPhoneExt': '2884',\n", + " 'CentralContactEMail': 'fgarcia@clinic.cat'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Felipe García, MD',\n", + " 'OverallOfficialAffiliation': 'Hospital Clínic de Barcelona',\n", + " 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{'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'}]}}}}},\n", + " {'Rank': 84,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04330495',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'EnCOVID-HidroxiCLOROQUINA'},\n", + " 'Organization': {'OrgFullName': 'Instituto de Investigación Marqués de Valdecilla',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Randomized, Controlled, Double-blind Clinical Trial Comparing the Efficacy and Safety of Chemoprophylaxis With Hydroxychloroquine in Patients Under Biological Treatment and / or JAK Inhibitors in the Prevention of SARS-CoV-2 Infection',\n", + " 'OfficialTitle': 'Randomized, Controlled, Double-blind Clinical Trial Comparing the Efficacy and Safety of Chemoprophylaxis With Hydroxychloroquine in Patients Under Biological Treatment and / or JAK Inhibitors in the Prevention of SARS-CoV-2 Infection'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 6, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'November 6, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'November 6, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 31, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 31, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 31, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Instituto de Investigación Marqués de Valdecilla',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'The investigators plan to evaluate a strategy of chemoprophylaxis with hydroxyloquine (HCQ) against COVID-19 infection in patients diagnosed with an immunomediated inflammatory disease who are following a treatment with biological agents and / or Jak inhibitors. The strategy will be carried out through a randomised double blind, placebo-controlled clinical trial and will assess comparative rates of infection (prevalence, incidence), severity including mortality, impact on clínical course of the primary diseases and toxicity. Such evaluation will require prospective surveillance to assess the different end-points.\\n\\nDrug interventions in this protocol will follow the Spanish law about off-label use of medicines.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID 19',\n", + " 'Immunomediated Inflammatory Disease in Treatment With Biological Agents and / or Jak Inhibitors']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 4']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignInterventionModelDescription': 'Randomized, controlled, double-blind clinical trial',\n", + " 'DesignPrimaryPurpose': 'Prevention',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Double',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", + " 'Investigator']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '800',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Testing and prophylaxis of SARS-CoV-2',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Chemoprophylaxis with hydroxychloroquine at a dose of 200 mg twice a day for 6 months.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Experimental group']}},\n", + " {'ArmGroupLabel': 'placebo',\n", + " 'ArmGroupType': 'Active Comparator',\n", + " 'ArmGroupDescription': 'Testing of SARS-CoV-2 and prescription of placebo (Hydroxychloroquine placebo) twice daily for 6 months',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Control group']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Experimental group',\n", + " 'InterventionDescription': 'Chemoprophylaxis with hydroxychloroquine at a dose of 200 mg twice a day for 6 months.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Testing and prophylaxis of SARS-CoV-2']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Control group',\n", + " 'InterventionDescription': 'Testing of SARS-CoV-2 and prescription of placebo (Hydroxychloroquine placebo) twice daily for 6 months',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['placebo']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Incidence rate of new COVID-19 cases in both arms',\n", + " 'PrimaryOutcomeDescription': 'number of new cases divided by number of persons-time at risk',\n", + " 'PrimaryOutcomeTimeFrame': 'From day 14 after start of treatment up to the end of follow-up: week 27'},\n", + " {'PrimaryOutcomeMeasure': 'Prevalence of COVID-19 cases in both arms',\n", + " 'PrimaryOutcomeDescription': 'percentage of cases of COVID 19',\n", + " 'PrimaryOutcomeTimeFrame': '27 weeks after the beginning of the study'},\n", + " {'PrimaryOutcomeMeasure': 'Mortality rate secondary to COVID-19 cases in both groups',\n", + " 'PrimaryOutcomeDescription': 'Case fatality rate (CFR): the proportion of diagnosed cases of COVID 19 that lead to death',\n", + " 'PrimaryOutcomeTimeFrame': '27 weeks after the beginning of the study'},\n", + " {'PrimaryOutcomeMeasure': 'Intensive Care Unit (CU) admission rate secondary to COVID-19 cases in both groups',\n", + " 'PrimaryOutcomeDescription': 'percentage of patients who need admission in an ICU due to COVID 19 infection',\n", + " 'PrimaryOutcomeTimeFrame': '27 weeks after the beginning of the study'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Adverse events',\n", + " 'SecondaryOutcomeDescription': 'Presence and type of adverse events at this point.',\n", + " 'SecondaryOutcomeTimeFrame': '12 weeks after the start of treatment'},\n", + " {'SecondaryOutcomeMeasure': 'Adverse events',\n", + " 'SecondaryOutcomeDescription': 'Proportion of participants that drop out of study',\n", + " 'SecondaryOutcomeTimeFrame': '27 weeks after the beginning of the study'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nPatients who meet the requirements of the New Coronavirus Infection Diagnosis (Acute respiratory infection symptoms or acute cough alone and positive PCR)\\nAged ≥18 and < 75 years male or female;\\nIn women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study.\\nWilling to take study medication\\nWilling to comply with all study procedures,\\nDiagnosis of IBD disease, rheumatoid arthritis, seronegative spondyloarthritis or psoriasis for more than 6 months.\\nBe on stable treatment with biological agents, for a minimum period of 6 months, including treatment with Infliximab, etanercept, adalimumab, certolizumab, golimumab, rituximab, abatacept, tocilizumab, sarilumab, secukinumab, vedolizumab, natalizumab, ustekinumab, tofacit\\nAble to provide oral and written informed consent\\n\\nExclusion Criteria\\n\\nPrevious infection with SARS-CoV-2.\\nCurrent treatment with hydroxychloroquine / chloroquine.\\nPrevious or current treatment with tamoxifen or raloxifene.\\nPrevious eye disease, especially maculopathy.\\nKnown heart failure grade III-IV of the classification of the New York Heart Association).\\nAny type of cancer (except basal cell) in the last 5 years.\\nPregnancy.\\nRefusal to give informed consent.\\nEvidence of any other unstable or clinically significant unstable, clinically significant, immunological, endocrine, hematologic, gastrointestinal, neurological, neoplastic, or psychiatric illness.\\nInstability or mental incompetence, so that the validity of the informed consent or the ability to complete the study is uncertain.\\nPositive antibodies to the human immunodeficiency virus.\\nData on decompensated liver disease:\\n\\nto. Aspartate aminotransferase (AST) and / or ALT> 10 x upper limit of normal (LSN).\\n\\nb. Total bilirubin> 25 μmol / l (1.5 mg / dl). c. International normalized index> 1.4. d. Platelet count <100,000 / mm3. 17. Serum creatinine levels> 135 μmol / l (> 1.53 mg / dl) in men and> 110 μmol / l (> 24 mg / dl) in women.\\n\\n18.Significant kidney disease, including nephrotic syndrome, chronic kidney disease (patients with markers of liver injury or estimated glomerular filtration rate [eGFR] of less than 60 ml / min / 1.73 m2). If an abnormal value is obtained at the first screening visit, the measurement of eGFR may be repeated before randomization within the following time frame: minimum 4 weeks after the initial test and maximum 2 weeks before the planned randomization. Repeated abnormal eGFR (less than 60 ml / min / 1.73 m2) leads to exclusion from the study.Pregnant or lactating women; 19. Inability to consent and/or comply with study protocol; 20. Individuals with known hypersensitivity to the study drugs. 21. Any contraindications as per the Data Sheet of or Hydroxychloroquine.',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '75 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Javier Crespo, MDPhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '942202520',\n", + " 'CentralContactEMail': 'javiercrespo1991@gmail.com'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", + " 'InterventionMeshTerm': 'Hydroxychloroquine'},\n", + " {'InterventionMeshId': 'D000075242',\n", + " 'InterventionMeshTerm': 'Janus Kinase Inhibitors'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", + " 'InterventionAncestorTerm': 'Antimalarials'},\n", + " {'InterventionAncestorId': 'D000000981',\n", + " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", + " {'InterventionAncestorId': 'D000000977',\n", + " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", + " {'InterventionAncestorId': 'D000000890',\n", + " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", + " {'InterventionAncestorId': 'D000004791',\n", + " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000018501',\n", + " 'InterventionAncestorTerm': 'Antirheumatic Agents'},\n", + " {'InterventionAncestorId': 'D000047428',\n", + " 'InterventionAncestorTerm': 'Protein Kinase Inhibitors'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", + " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M1474',\n", + " 'InterventionBrowseLeafName': 'Janus Kinase Inhibitors',\n", + " 'InterventionBrowseLeafAsFound': 'JAK inhibitor',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M2861',\n", + " 'InterventionBrowseLeafName': 'Antimalarials',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2879',\n", + " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2875',\n", + " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2795',\n", + " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19188',\n", + " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M24407',\n", + " 'InterventionBrowseLeafName': 'Protein Kinase Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", + " 'ConditionMeshTerm': 'Infection'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafAsFound': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", + " {'Rank': 85,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04280913',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'GZHZ-COVID19'},\n", + " 'Organization': {'OrgFullName': 'Guangzhou Institute of Respiratory Disease',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Clinical Outcomes of Patients With COVID19',\n", + " 'OfficialTitle': 'Clinical Outcomes of Hospitalized Patients With Coronavirus Disease 2019'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Withdrawn',\n", + " 'WhyStopped': 'The research project was changed.',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'February 22, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 31, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'March 31, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'February 20, 2020',\n", + " 'StudyFirstSubmitQCDate': 'February 20, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'February 21, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 17, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 19, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'LuQian Zhou',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Guangzhou Institute of Respiratory Disease'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Guangzhou Institute of Respiratory Disease',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Huizhou Municipal Central Hospital',\n", + " 'CollaboratorClass': 'OTHER'}]}},\n", + " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus Disease 2019']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Retrospective']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '0', 'EnrollmentType': 'Actual'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'COVID-19 patients',\n", + " 'ArmGroupDescription': 'Hospitalized patients with COVID-19',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: retrospective analysis']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", + " 'InterventionName': 'retrospective analysis',\n", + " 'InterventionDescription': 'The investigators retrospectively analyzed the hospitalized patients with COVID-19.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['COVID-19 patients']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Time to negative conversion of severe acute respiratory syndrome coronavirus 2',\n", + " 'PrimaryOutcomeDescription': 'The primary outcome is the time to negative conversion of coronavirus',\n", + " 'PrimaryOutcomeTimeFrame': '1 month'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Length of stay in hospital',\n", + " 'SecondaryOutcomeDescription': 'The time of hospitalization.',\n", + " 'SecondaryOutcomeTimeFrame': '1 month'},\n", + " {'SecondaryOutcomeMeasure': 'Survival',\n", + " 'SecondaryOutcomeDescription': 'The rate of survival within hospitalization of these patients will be tracked.',\n", + " 'SecondaryOutcomeTimeFrame': '1 month'},\n", + " {'SecondaryOutcomeMeasure': 'Intubation',\n", + " 'SecondaryOutcomeDescription': 'The rate of intubation within hospitalization of these patients will be tracked.',\n", + " 'SecondaryOutcomeTimeFrame': '1 month'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nHospitalized patients with COVID19\\n\\nExclusion Criteria:\\n\\nSuspected patients with COVID19, not confirmed by the laboratory\\nPatients who are refused to receive medical treatments',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'This is a retrospective study of hospitalized patients with COVID19.',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Luqian Zhou, MD',\n", + " 'OverallOfficialAffiliation': 'The First Affiliated Hospital of Guangzhou Medical University',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'HuiZhou Municipal Central Hospital',\n", + " 'LocationCity': 'Huizhou',\n", + " 'LocationState': 'Guangdong',\n", + " 'LocationZip': '516001',\n", + " 'LocationCountry': 'China'}]}}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 86,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04273529',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '20200214-COVID-19-M-T'},\n", + " 'Organization': {'OrgFullName': 'First Affiliated Hospital of Wenzhou Medical University',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'The Efficacy and Safety of Thalidomide in the Adjuvant Treatment of Moderate New Coronavirus (COVID-19) Pneumonia',\n", + " 'OfficialTitle': 'The Efficacy and Safety of Thalidomide in the Adjuvant Treatment of Moderate New Coronavirus (COVID-19) Pneumonia: a Prospective, Multicenter, Randomized, Double-blind, Placebo, Parallel Controlled Clinical Study'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'February 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'February 20, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 30, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'June 30, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'February 14, 2020',\n", + " 'StudyFirstSubmitQCDate': 'February 14, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'February 18, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'February 19, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'February 21, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'First Affiliated Hospital of Wenzhou Medical University',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Second Affiliated Hospital of Wenzhou Medical University',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'Wenzhou Central Hospital',\n", + " 'CollaboratorClass': 'OTHER'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No',\n", + " 'IsUSExport': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a real-time reverse transcription PCR (real time RT-PCR) diagnostic assay.\\n\\nIn view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Thalidomide has anti-inflammatory, anti-fibrotic, anti-angiogenesis, and immune regulation effects. This study is the first Prospective, Multicenter, Randomized, Double-blind, Placebo, Parallel Controlled Clinical Study at home and abroad to use immunomodulators to treat patients with COVID-19 infection.',\n", + " 'DetailedDescription': 'The new coronavirus (COVID-19) [1] belongs to the new beta coronavirus. Current research shows that it has 85% homology with bat SARS-like coronavirus (bat-SL-CoVZC45), but its genetic characteristics are similar to SARSr-CoV. There is a clear difference from MERSr-COV. Since December 2019, Wuhan City, Hubei Province has successively found multiple cases of patients with pneumonia infected by a new type of coronavirus. With the spread of the epidemic, as of 12:00 on February 12, 2020, a total of 44726 confirmed cases nationwide (Hubei Province) 33,366 cases, accounting for 74.6%), with 1,114 deaths (1068 cases in Hubei Province), and a mortality rate of 2.49% (3.20% in Hubei Province).\\n\\nIn view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Thalidomide has anti-inflammatory, anti-fibrotic, anti-angiogenesis, and immune regulation effects. In the early clinical practice of treating severe A H1N1, it was clinically concerned, and combined with hormones and conventional treatment, and achieved good results.\\n\\nAlthough the death rate of COVID-19 infected persons is not high, their rapid infectiousness and the lack of effective antiviral treatment currently have become the focus of the national and international epidemic. Thalidomide has been available for more than sixty years, and has been widely used in clinical applications. It has been proved to be safe and effective in IPF, severe H1N1 influenza lung injury and paraquat poisoning lung injury, and the mechanism of anti-inflammatory and anti-fibrosis is relatively clear. As the current research on COVID-19 at home and abroad mainly focuses on the exploration of antiviral efficacy, this study intends to find another way to start with host treatment in the case that antiviral is difficult to overcome in the short term, in order to control or relieve lung inflammation caused by the virus To improve lung function. This study is the first study at home and abroad to use immunomodulators to treat patients with COVID-19 infection. It is hoped that the patients can get out of the bitter sea as soon as possible and provide effective solutions for the country and society.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19 Thalidomide']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 2']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Quadruple',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", + " 'Care Provider',\n", + " 'Investigator',\n", + " 'Outcomes Assessor']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '100',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Control group',\n", + " 'ArmGroupType': 'Placebo Comparator',\n", + " 'ArmGroupDescription': 'placebo',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: placebo']}},\n", + " {'ArmGroupLabel': 'Thalidomide group',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'thalidomide',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: thalidomide']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'thalidomide',\n", + " 'InterventionDescription': '100mg，po，qn，for 14 days.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Thalidomide group']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['fanyingting']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'placebo',\n", + " 'InterventionDescription': '100mg，po，qn，for 14 days.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Control group']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Time to Clinical recoveryTime to Clinical Recovery (TTCR)',\n", + " 'PrimaryOutcomeDescription': 'TTCR is defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours. Normalisation and alleviation criteria:\\n\\nFever - ≤36.6°C or -axilla, ≤37.2 °C oral or ≤37.8°C rectal or tympanic, Respiratory rate - ≤24/minute on room air, Oxygen saturation - >94% on room air, Cough - mild or absent on a patient reported scale of severe, moderate, mild, absent.',\n", + " 'PrimaryOutcomeTimeFrame': 'up to 28 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'All cause mortality',\n", + " 'SecondaryOutcomeDescription': 'baseline SpO2 during screening, PaO2/FiO2 ＜300mmHg or a respiratory rate ≥ 24 breaths per min without supplemental oxygen',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", + " {'SecondaryOutcomeMeasure': 'Frequency of respiratory progression',\n", + " 'SecondaryOutcomeDescription': 'Defined as SPO2≤ 94% on room air or PaO2/FiO2 <300mmHg and requirement for supplemental oxygen or more advanced ventilator support.',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", + " {'SecondaryOutcomeMeasure': 'Time to defervescence',\n", + " 'SecondaryOutcomeDescription': 'in those with fever at enrolment',\n", + " 'SecondaryOutcomeTimeFrame': 'up to 28 days'}]},\n", + " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'Time to cough reported as mild or absent',\n", + " 'OtherOutcomeDescription': 'in those with cough at enrolment rated severe or moderate',\n", + " 'OtherOutcomeTimeFrame': 'up to 28 days'},\n", + " {'OtherOutcomeMeasure': 'Respiratory improvement time',\n", + " 'OtherOutcomeDescription': 'patients with moderate / severe dyspnea when enrolled',\n", + " 'OtherOutcomeTimeFrame': 'up to 28 days'},\n", + " {'OtherOutcomeMeasure': 'Frequency of requirement for supplemental oxygen or non-invasive ventilation',\n", + " 'OtherOutcomeTimeFrame': 'up to 28 days'},\n", + " {'OtherOutcomeMeasure': 'Time to 2019-nCoV RT-PCR negative in upper respiratory tract specimen',\n", + " 'OtherOutcomeTimeFrame': 'up to 28 days'},\n", + " {'OtherOutcomeMeasure': 'Change (reduction) in 2019-nCoV viral load in upper respiratory tract specimen as assessed by area under viral load curve',\n", + " 'OtherOutcomeTimeFrame': 'up to 28 days'},\n", + " {'OtherOutcomeMeasure': 'Frequency of requirement for mechanical ventilation',\n", + " 'OtherOutcomeTimeFrame': 'up to 28 days'},\n", + " {'OtherOutcomeMeasure': 'Frequency of serious adverse events',\n", + " 'OtherOutcomeTimeFrame': 'up to 28 days'},\n", + " {'OtherOutcomeMeasure': 'Serum TNF-α, IL-1β, IL-2, IL-6, IL-7, IL-10, GSCF, IP10，MCP1, MIP1α and other cytokine expression levels before and after treatment',\n", + " 'OtherOutcomeTimeFrame': 'up to 28 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAge ≥18 years;\\nLaboratory (RT-PCR) diagnosis of common patients infected with COVID-19 (refer to the fifth edition of the Chinese Guidelines for Diagnosis and Treatment);\\nchest imaging confirmed lung damage;\\nThe diagnosis is less than or equal to 8 days;\\n\\nExclusion Criteria:\\n\\nSevere liver disease (such as Child Pugh score ≥ C, AST> 5 times the upper limit); severe renal dysfunction (the glomerulus is 30ml / min / 1.73m2 or less)\\nPositive pregnancy or breastfeeding or pregnancy test;\\nIn the 30 days before the screening assessment, have taken any experimental treatment drugs for COVID-19 (including off-label, informed consent use or trial-related);\\nThose with a history of thromboembolism, except for those caused by PICC.',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Jinglin Xia, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '0577-55578166',\n", + " 'CentralContactEMail': 'xiajinglin@fudan.edu.cn'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Jinglin Xia, MD',\n", + " 'OverallOfficialAffiliation': 'First Affiliated Hospital of Wenzhou Medical University',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]}},\n", + " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '19604271',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Zhao L, Xiao K, Wang H, Wang Z, Sun L, Zhang F, Zhang X, Tang F, He W. Thalidomide has a therapeutic effect on interstitial lung fibrosis: evidence from in vitro and in vivo studies. Clin Exp Immunol. 2009 Aug;157(2):310-5. doi: 10.1111/j.1365-2249.2009.03962.x.'},\n", + " {'ReferencePMID': '32043983',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Russell CD, Millar JE, Baillie JK. Clinical evidence does not support corticosteroid treatment for 2019-nCoV lung injury. Lancet. 2020 Feb 15;395(10223):473-475. doi: 10.1016/S0140-6736(20)30317-2. Epub 2020 Feb 7.'},\n", + " {'ReferencePMID': '32029004',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Jin YH, Cai L, Cheng ZS, Cheng H, Deng T, Fan YP, Fang C, Huang D, Huang LQ, Huang Q, Han Y, Hu B, Hu F, Li BH, Li YR, Liang K, Lin LK, Luo LS, Ma J, Ma LL, Peng ZY, Pan YB, Pan ZY, Ren XQ, Sun HM, Wang Y, Wang YY, Weng H, Wei CJ, Wu DF, Xia J, Xiong Y, Xu HB, Yao XM, Yuan YF, Ye TS, Zhang XC, Zhang YW, Zhang YG, Zhang HM, Zhao Y, Zhao MJ, Zi H, Zeng XT, Wang YY, Wang XH; , for the Zhongnan Hospital of Wuhan University Novel Coronavirus Management and Research Team, Evidence-Based Medicine Chapter of China International Exchange and Promotive Association for Medical and Health Care (CPAM). A rapid advice guideline for the diagnosis and treatment of 2019 novel coronavirus (2019-nCoV) infected pneumonia (standard version). Mil Med Res. 2020 Feb 6;7(1):4. doi: 10.1186/s40779-020-0233-6.'},\n", + " {'ReferencePMID': '32031570',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Feb 7. doi: 10.1001/jama.2020.1585. [Epub ahead of print]'},\n", + " {'ReferencePMID': '29291352',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Wen H, Ma H, Cai Q, Lin S, Lei X, He B, Wu S, Wang Z, Gao Y, Liu W, Liu W, Tao Q, Long Z, Yan M, Li D, Kelley KW, Yang Y, Huang H, Liu Q. Recurrent ECSIT mutation encoding V140A triggers hyperinflammation and promotes hemophagocytic syndrome in extranodal NK/T cell lymphoma. Nat Med. 2018 Feb;24(2):154-164. doi: 10.1038/nm.4456. Epub 2018 Jan 1.'},\n", + " {'ReferencePMID': '31533530',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Kwon HY, Han YJ, Im JH, Baek JH, Lee JS. Two cases of immune reconstitution inflammatory syndrome in HIV patients treated with thalidomide. Int J STD AIDS. 2019 Oct;30(11):1131-1135. doi: 10.1177/0956462419847297. Epub 2019 Sep 19.'},\n", + " {'ReferencePMID': '24912813',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Zhu H, Shi X, Ju D, Huang H, Wei W, Dong X. Anti-inflammatory effect of thalidomide on H1N1 influenza virus-induced pulmonary injury in mice. Inflammation. 2014 Dec;37(6):2091-8. doi: 10.1007/s10753-014-9943-9.'},\n", + " {'ReferencePMID': '15057291',\n", + " 'ReferenceType': 'result',\n", + " 'ReferenceCitation': 'Bartlett JB, Dredge K, Dalgleish AG. The evolution of thalidomide and its IMiD derivatives as anticancer agents. Nat Rev Cancer. 2004 Apr;4(4):314-22. doi: 10.1038/nrc1323. 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Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'}]}}}}},\n", + " {'Rank': 87,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04315896',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'HidroxycloroquinaCOVID19'},\n", + " 'Organization': {'OrgFullName': 'National Institute of Respiratory Diseases, Mexico',\n", + " 'OrgClass': 'OTHER_GOV'},\n", + " 'BriefTitle': 'Hydroxychloroquine Treatment for Severe COVID-19 Pulmonary Infection (HYDRA Trial)',\n", + " 'OfficialTitle': 'Hydroxychloroquine Treatment for Severe COVID-19 Respiratory Disease: Randomised Clinical Trial (HYDRA Trial)',\n", + " 'Acronym': 'HYDRA'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 23, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'October 31, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'March 22, 2021',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 18, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 18, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 20, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 18, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 20, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'National Institute of Respiratory Diseases, Mexico',\n", + " 'LeadSponsorClass': 'OTHER_GOV'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Sanofi',\n", + " 'CollaboratorClass': 'INDUSTRY'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No',\n", + " 'IsUSExport': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Double blinded randomized clinical trial designed to evaluate the security and efficacy of hydroxychloroquine as treatment for COVID-19 severe respiratory disease. The investigators hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause hospital mortality in patients with severe respiratory COVID-19 disease.',\n", + " 'DetailedDescription': \"Since hydroxychloroquine is a low cost and safe anti-malaria drug that has proven effects against COVID-19 in vitro. The investigators aim to study the security and efficacy of this drug in trough a double blinded randomized clinical trial. Recruited patients with severe respiratory disease from COVID-19 will be randomized to an intervention group (400mg per day dose of hydroxychloroquine) and placebo. The investigators' main outcome will be all cause hospital mortality. The investigators hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause hospital mortality in patients with severe respiratory COVID-19 disease. Results will be compared in an intention to treat analysis. All clinical, analysis and data team members will be blinded to treatment assignment.\"},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", + " 'Severe Acute Respiratory Syndrome']},\n", + " 'KeywordList': {'Keyword': ['COVID-19',\n", + " 'Severe acute respiratory syndrome']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 3']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignInterventionModelDescription': 'Double blinded, randomized controlled trial',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Quadruple',\n", + " 'DesignMaskingDescription': 'Clinical practitioners and data analysts will remain blinded all through the study. Blinding will end in case the attending physician considers the patient should abandon the study or some of the exclusion/elimination criteria apply.',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", + " 'Care Provider',\n", + " 'Investigator',\n", + " 'Outcomes Assessor']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '500',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'treatment',\n", + " 'ArmGroupType': 'Active Comparator',\n", + " 'ArmGroupDescription': 'Hydroxychloroquine tablet 200mg every 12 hours for 10 days.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine']}},\n", + " {'ArmGroupLabel': 'placebo',\n", + " 'ArmGroupType': 'Placebo Comparator',\n", + " 'ArmGroupDescription': 'identical placebo, one tablet every 12 hours for 10 days',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo oral tablet']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Hydroxychloroquine',\n", + " 'InterventionDescription': 'hydroxychloroquine 400mg day for 10 days',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['treatment']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Placebo oral tablet',\n", + " 'InterventionDescription': 'Placebo oral tablet',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['placebo']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'All-cause hospital mortality',\n", + " 'PrimaryOutcomeDescription': 'incidence of all-cause mortality',\n", + " 'PrimaryOutcomeTimeFrame': 'From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Length of hospital stay',\n", + " 'SecondaryOutcomeDescription': 'Days from ER admission to hospital discharge',\n", + " 'SecondaryOutcomeTimeFrame': 'From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days'},\n", + " {'SecondaryOutcomeMeasure': 'Need of mechanical ventilation',\n", + " 'SecondaryOutcomeDescription': 'need of invasive or non invasive mechanical ventilation',\n", + " 'SecondaryOutcomeTimeFrame': 'From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days'},\n", + " {'SecondaryOutcomeMeasure': 'Ventilator free days',\n", + " 'SecondaryOutcomeDescription': '28 minus days without invasive ventilation support in patients with invasive mechanical ventilation at randomization',\n", + " 'SecondaryOutcomeTimeFrame': 'From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days'},\n", + " {'SecondaryOutcomeMeasure': 'Grade 3-4 adverse reaction',\n", + " 'SecondaryOutcomeDescription': 'Adverse Reactions',\n", + " 'SecondaryOutcomeTimeFrame': 'From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nSigned informed consent\\nnegative pregnancy test in women\\nCOVID-19 confirmed by rtPCR in any respiratory sample.\\n\\nSevere COVID-19 disease defined as any from the following:\\n\\nPulse oximetry less than 91% or a 3% drop from base pulse oximetry or need to increase supplementary oxygen in chronic hypoxia\\nNeed for mechanical ventilation (invasive or non invasive )\\nSepsis/septic shock.\\n\\nExclusion Criteria:\\n\\nhistory of anaphylactic shock to hydroxychloroquine.\\nHistory of previous administration of chloroquine or hydroxychloroquine (within 1 month)\\ndecision of attending physician by any reason.\\nHistory of chronic hepatic disease (Child-Pugh B or C)\\nHistory of Chronic renal disease (GFR less than 30)',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'MaximumAge': '80 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Carmen Hernandez-Cárdenas, MD. MSc',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '54871700',\n", + " 'CentralContactPhoneExt': '5213',\n", + " 'CentralContactEMail': 'cmhcar@hotmail.com'},\n", + " {'CentralContactName': 'Rogelio Perez-Padilla, MD. PhD.',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '54871700',\n", + " 'CentralContactEMail': 'perezpad@gmail.com'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Carmen Hernandez-Cárdenas, MD. MSc.',\n", + " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Luis-Felipe Jurado-Camacho, MD',\n", + " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", + " 'OverallOfficialRole': 'Study Director'},\n", + " {'OverallOfficialName': 'Ireri Thirion-Romero, MD. MSc',\n", + " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", + " 'OverallOfficialRole': 'Study Chair'},\n", + " {'OverallOfficialName': 'Sebastian Rodriguez-Llamazares, MD.MPH',\n", + " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", + " 'OverallOfficialRole': 'Study Chair'},\n", + " {'OverallOfficialName': 'Rogelio Perez-Padilla, MD. PhD',\n", + " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", + " 'OverallOfficialRole': 'Study Director'},\n", + " {'OverallOfficialName': 'Cristobal Guadarrama, MD MSc',\n", + " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", + " 'OverallOfficialRole': 'Study Chair'},\n", + " {'OverallOfficialName': 'Joel Vasquez-Pérez, MD',\n", + " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", + " 'OverallOfficialRole': 'Study Chair'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided',\n", + " 'IPDSharingDescription': 'As requested by other investigators.'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", + " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", + " 'InterventionAncestorList': 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{'ConditionBrowseLeafId': 'M14938',\n", + " 'ConditionBrowseLeafName': 'Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13540',\n", + " 'ConditionBrowseLeafName': 'Respiration Disorders',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 88,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04324190',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'IPUB_2020_01'},\n", + " 'Organization': {'OrgFullName': 'International Psychoanalytic University Berlin',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'DIgital Online SuPport for COVID-19 StrEss',\n", + " 'OfficialTitle': 'Online Support for Psychosocial Stress in the Context of the COVID-19 Pandemic',\n", + " 'Acronym': 'DISPOSE'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'June 2021',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'December 2021',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 26, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 26, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 27, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 26, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 27, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor-Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Gunther Meinlschmidt',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Prof. Dr.',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'International Psychoanalytic University Berlin'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Gunther Meinlschmidt',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Selfapy GmbH',\n", + " 'CollaboratorClass': 'UNKNOWN'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'The COVID-19 pandemic leads to a greatly increased risk of substantial psychological stress worldwide. We intend to evaluate an online support program aiming at reducing stress in the context of the COVID-19 pandemic. The program consists of twelve modules that participants undergo, covering a broad range of topics related to stress in the context of the COVID-19 pandemic. It has been developed together with and is provided by Selfapy GmbH, Berlin. The aim of this randomised clinical trial with observational components is to estimate the effects of the intervention as a whole, as well as individual modules and selected chapters. Further, follow-up assessments as well as information on risks and the long-term course of COVID pandemic-related stress may help to elucidate COVID-19 pandemic stress across time and what we can do to prevent long-term negative consequences.',\n", + " 'DetailedDescription': 'The overall aim of this randomised trial with observational component is to estimate the effects of a guided digital online support program to increase mental health and reduce psychosocial stress in the context of the COVID-19 pandemic. More specifically, the main hypothesis is to estimate whether the improvement in mental health is stronger during the first two weeks of applying the online support program as compared to a two weeks waiting condition (with provision of WHO information on \\'coping with stress during the 2019-nCoV\\' outbreak only). Furthermore, our aim is to estimate changes in the outcomes along taking part in the program.\\n\\nAdditional research questions are:\\n\\nto compare the intervention effects across modules and chapters of the online support program, including between module comparison with an unspecific, control (comparator) module: \"general information on the corona virus\" and its unspecific chapters;\\nto estimate the effects of selected modules on additional outcomes (e.g. physical activity, and schooling related factors);\\nto describe the magnitude and course of psychosocial stress, mental health and related factors in the context of the COVID-19 pandemic;\\nto estimate and predict which subjects profit most from specific parts of the program.\\n\\nFollow-up assessment shall allow estimating whether the program prevents the development of detrimental mental health conditions, e.g. depression, anxiety, etc.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", + " 'Psychosocial Stress',\n", + " 'Mental Health']},\n", + " 'KeywordList': {'Keyword': ['COVID-19',\n", + " 'SARS-CoV-2',\n", + " 'psychosocial stress',\n", + " 'online support',\n", + " 'guided',\n", + " 'mental health',\n", + " 'anxiety',\n", + " 'depression',\n", + " 'somatic symptom disorder']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Not Applicable']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Sequential Assignment',\n", + " 'DesignInterventionModelDescription': 'Randomized controlled trial with a waiting comparator condition (provision of WHO recommendations, comparable to treatment as usual, TAU), consisting of a two weeks waiting period during which general WHO recommendations how to handle stress in the context of the COVID-19 pandemic will be provided. All subjects in the waiting condition will undergo the intervention following the waiting period. Main assessments will be conducted before the waiting period, before beginning of the intervention, two weeks after beginning of the intervention (+2 weeks), +4 weeks, +12 weeks, and follow ups at +6 months and +12 months.',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Single',\n", + " 'DesignMaskingDescription': 'Care providers (providing guidance) are not informed about wether participants have been assigned to the online support program condition or the comparator condition, consisting of a waiting period followed by the online support program.',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Care Provider']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '600',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Online support program',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Guided Online support program, consisting of 12 modules (structured in chapters) aiming at reduce stress related to the COVID-19 pandemic.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Behavioral: Guided online support program']}},\n", + " {'ArmGroupLabel': 'waiting period (WHO recommendation)',\n", + " 'ArmGroupType': 'Active Comparator',\n", + " 'ArmGroupDescription': 'Waiting period (2 weeks duration) during which subjects are provided with the WHO recommendations \"Coping with stress during the 2019 nCoV outbreak\". Following the 2 weeks waiting period, subjects are provided with the guided online support program outlined in the arm \\'online support program\\'',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Behavioral: Guided online support program',\n", + " 'Behavioral: WHO recommendations (waiting condition)']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Behavioral',\n", + " 'InterventionName': 'Guided online support program',\n", + " 'InterventionDescription': 'Guided online support program consisting of several modules; Module \"General information ...\" is an unspecific control module (providing general information on hygiene etc. with no expected effect on outcomes)',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Online support program',\n", + " 'waiting period (WHO recommendation)']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['online intervention',\n", + " 'guided online support']}},\n", + " {'InterventionType': 'Behavioral',\n", + " 'InterventionName': 'WHO recommendations (waiting condition)',\n", + " 'InterventionDescription': 'During the waiting period, a german translation of the WHO recommendations \"Coping with stress during the 2019-nCoV outbreak\" is provided',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['waiting period (WHO recommendation)']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Change in Short-Form-36 (SF-36) Health Survey - Mental Health Component Summary score',\n", + " 'PrimaryOutcomeDescription': 'The SF-36 is a widely used patient-reported outcome assessment tool to measure health-related quality of life and has high acceptability. The SF-36 is a standardised questionnaire with good psychometric properties.',\n", + " 'PrimaryOutcomeTimeFrame': 'Change from T1 (baseline before online support - day 1) to T2 (T1 + 2 weeks) in arm 1, versus change from T0 (baseline before waiting) to T1 (baseline before online support) in arm 2'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Chronic stress items (9 items)',\n", + " 'SecondaryOutcomeDescription': 'Assessing chronic stress (Petrowski et al., 2019)',\n", + " 'SecondaryOutcomeTimeFrame': 'baseline before waiting (T0, arm 2 only); baseline before online support (day 1, T1), T1+2 weeks, T1+4weeks, T1+12weeks, follow ups: T1+ 6 months; T1+12 months'},\n", + " {'SecondaryOutcomeMeasure': 'Generalized Anxiety Disorder Scale (GAD-7)',\n", + " 'SecondaryOutcomeDescription': 'Assessing anxiety symptoms (Löwe et al., 2008)',\n", + " 'SecondaryOutcomeTimeFrame': 'baseline before waiting (T0, arm 2 only); baseline before online support (day 1, T1), T1+2 weeks, T1+4weeks, T1+12weeks, follow ups: T1+ 6 months; T1+12 months'},\n", + " {'SecondaryOutcomeMeasure': 'Patient Health Questionnaire (PHQ8)',\n", + " 'SecondaryOutcomeDescription': 'Assessing depressive symptoms (Kroenke et al., 2001)',\n", + " 'SecondaryOutcomeTimeFrame': 'baseline before waiting (T0, arm 2 only); baseline before online support (day 1, T1), T1+2 weeks, T1+4weeks, T1+12weeks, follow ups: T1+ 6 months; T1+12 months'},\n", + " {'SecondaryOutcomeMeasure': 'Somatic Symptom Disorder (SSD-12)',\n", + " 'SecondaryOutcomeDescription': 'Assessing depressive symptoms (Toussaint et al., 2019)',\n", + " 'SecondaryOutcomeTimeFrame': 'baseline before waiting (T0, arm 2 only); baseline before online support (day 1, T1), T1+2 weeks, T1+4weeks, T1+12weeks, follow ups: T1+ 6 months; T1+12 months'},\n", + " {'SecondaryOutcomeMeasure': 'Somatic Symptom Scale (SSS-8)',\n", + " 'SecondaryOutcomeDescription': 'Assessing somatic symptoms (Gierk et al., 2015)',\n", + " 'SecondaryOutcomeTimeFrame': 'baseline before waiting (T0, arm 2 only); baseline before online support (day 1, T1), T1+2 weeks, T1+4weeks, T1+12weeks, follow ups: T1+ 6 months; T1+12 months'},\n", + " {'SecondaryOutcomeMeasure': 'Screening Tool for Psychological Distress (STOP-D) - selected items',\n", + " 'SecondaryOutcomeDescription': 'stress, anxiety, depression, social support - single item assessments to be applied repeatedly along the online support intervention (Young, Ignaszewski, Fofonoff, Kaan; 2007)',\n", + " 'SecondaryOutcomeTimeFrame': 'baseline before waiting (T0, arm 2 only); baseline before online support (day 1, T1), T1+2 weeks, T1+4weeks, T1+12weeks, follow ups: T1+ 6 months; T1+12 months'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion criteria:\\n\\nSufficient German language skills to participate in the assessments.\\nProviding informed consent for participation',\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Gunther Meinlschmidt, Prof. Dr.',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+49 30 300117',\n", + " 'CentralContactPhoneExt': '710',\n", + " 'CentralContactEMail': 'gunther.meinlschmidt@ipu-berlin.de'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Selfapy GmbH',\n", + " 'LocationCity': 'Berlin',\n", + " 'LocationZip': '10435',\n", + " 'LocationCountry': 'Germany',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Kati Bermbach',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+49 (0) 30 - 3982031',\n", + " 'LocationContactPhoneExt': '20',\n", + " 'LocationContactEMail': 'contact@selfapy.com'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M5641',\n", + " 'ConditionBrowseLeafName': 'Depression',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M5644',\n", + " 'ConditionBrowseLeafName': 'Depressive Disorder',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M2905',\n", + " 'ConditionBrowseLeafName': 'Anxiety Disorders',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M885',\n", + " 'ConditionBrowseLeafName': 'Medically Unexplained Symptoms',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BXM',\n", + " 'ConditionBrowseBranchName': 'Behaviors and Mental Disorders'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'}]}}}}},\n", + " {'Rank': 89,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04317040',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'CD24Fc-007'},\n", + " 'Organization': {'OrgFullName': 'OncoImmune, Inc.',\n", + " 'OrgClass': 'INDUSTRY'},\n", + " 'BriefTitle': 'CD24Fc as a Non-antiviral Immunomodulator in COVID-19 Treatment',\n", + " 'OfficialTitle': 'A Randomized, Double-blind, Placebo-controlled, Multi-site, Phase III Study to Evaluate the Safety and Efficacy of CD24Fc in COVID-19 Treatment',\n", + " 'Acronym': 'SAC-COVID'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'May 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 2021',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'May 2022',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 19, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 19, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 20, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 19, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 23, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'OncoImmune, Inc.',\n", + " 'LeadSponsorClass': 'INDUSTRY'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'Yes',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'The study is designed as a randomized, placebo-controlled, double blind, multicenter, Phase III trial to compare two COVID-19 treatment regimens in hospitalized adult subjects who are diagnosed with severe COVID 19 and absolute lymphocyte counts ≤ 800/mm^3 in peripheral blood.\\n\\nArm A: CD24Fc/Best Available Treatment; Arm B: placebo/ Best Available Treatment. CD24Fc will be administered as single dose of 480 mg via IV infusion on Day 1. Total of 230 subjects will be enrolled and randomized in 1:1 ratio to receive CD24Fc or placebo. Serum cytokine IL-6 level will be used as stratification factor in randomization. All subjects will be treated with the best available treatment. The follow up period is 15 days.',\n", + " 'DetailedDescription': 'As the newest global medical emergency, the COVID-19 (diagnosed SARS-CoV2 infection with lung involvement) exhibits features that are unlikely ameliorated by antivirals-based approaches alone. First, although the new coronavirus (SARS-CoV-2) infect lung and intestine, many patients suddenly take a turn for the worse even when the viral replication appears to be under control. Second, patients with serious or critical clinical symptoms show remarked T cell lymphopenia that are more severe and more acute than human immunodeficiency virus (HIV) infection. Functional exhaustion of T cells is suggested by high expression of T-cell exhaustion markers, which again appears more acute than in HIV patients. Third, multiple cytokines are elevated among patients with severe clinical symptoms, which potentially explains the multiple organ failure associated with COVID-19. For these reasons, treatment of COVID-19 likely requires a combination of both antivirals and non-antivirals-based approaches.\\n\\nCD24Fc is a biological immunomodulator in Phase II/III clinical trial stage. CD24Fc comprises the nonpolymorphic regions of CD24 attached to the Fc region of human IgG1. We have shown that CD24 is an innate checkpoint against the inflammatory response to tissue injuries or danger-associated molecular patterns (DAMPs). Preclinical and clinical studies have demonstrated that CD24Fc effectively address the major challenges associated with COVID-19. First, a Phase I clinical trial on healthy volunteers not only demonstrated safety of CD24Fc, but also demonstrated its biological activity in suppressing expression of multiple inflammatory cytokines. Second, in Phase II clinical trial in leukemia patients undergoing hematopoietic stem cell transplantation (HCT), three doses of CD24Fc effectively eliminated severe (Grade 3-4) acute graft vs host diseases (GVHD), which is caused by over reacting immune system and transplanted T cells attacking recipient target tissues. Third, in preclinical models of HIV/SIV infections, we have shown that CD24Fc ameliorated production of multiple inflammatory cytokines, reversed the loss of T lymphocytes as well as functional T cell exhaustion and reduced the leukocyte infiltration of multiple organs. It is particularly noteworthy that CD24Fc reduced the rate of pneumonia in SIV-infected Chinese rhesus monkey from 83% to 33%. Therefore, CD24Fc maybe a prime candidate for non-antiviral biological modifier for COVID-19 therapy. The phase III trial will involve 230 patients randomized into blinded placebo and CD24Fc arms, with time to clinical improvement from severe to mild symptom as the primary endpoint.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Severe Coronavirus Disease (COVID-19)']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 3']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Quadruple',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", + " 'Care Provider',\n", + " 'Investigator',\n", + " 'Outcomes Assessor']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '230',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'CD24Fc Treatment',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Single dose at Day 1, CD24Fc, 480mg, diluted to 100ml with normal saline, IV infusion in 60 minutes.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: CD24Fc']}},\n", + " {'ArmGroupLabel': 'Placebo',\n", + " 'ArmGroupType': 'Placebo Comparator',\n", + " 'ArmGroupDescription': 'Single dose at Day 1, normal saline solution 100ml, IV infusion in 60 minutes.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'CD24Fc',\n", + " 'InterventionDescription': 'CD24Fc is given on Day 1.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['CD24Fc Treatment']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Human CD24 and human IgG Fc Fusion Protein']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Placebo',\n", + " 'InterventionDescription': 'Placebo is given on Day 1.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Placebo']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Saline']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Improvement of COVID-19 disease status',\n", + " 'PrimaryOutcomeDescription': 'Time to improve in clinical status: the time (days) required from the start of treatment to the improvement of clinical status \"severe\" to \"moderate/mild\"; or improvement from \"scale 3 or 4\" to \"scale 5 or higher\" based on NIAID ordinal scales.',\n", + " 'PrimaryOutcomeTimeFrame': '14 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Conversion rate of clinical status at Day 8',\n", + " 'SecondaryOutcomeDescription': 'Conversion rate of clinical status on days 8 (proportion of subjects who changed from \"severe\" to \"moderate or mild\", or the improvement from \"scale 3 or 4\" to \"scale 5 or higher\" on NIAID ordinal scale)',\n", + " 'SecondaryOutcomeTimeFrame': '7 days'},\n", + " {'SecondaryOutcomeMeasure': 'Conversion rate of clinical status at Day 15',\n", + " 'SecondaryOutcomeDescription': 'Conversion rate of clinical status on days 15 (proportion of subjects who changed from \"severe\" to \"moderate or mild\", or the improvement from \"scale 3 or 4\" to \"scale 5 or higher\" on NIAID ordinal scale)',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Hospital discharge time',\n", + " 'SecondaryOutcomeDescription': 'The discharge time or NEWS2 (National Early Warning Score 2) of ≤2 is maintained for 24 hours',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'All cause of death',\n", + " 'SecondaryOutcomeDescription': 'All cause of death',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Duration of mechanical ventilation',\n", + " 'SecondaryOutcomeDescription': 'Duration of mechanical ventilation (IMV, NIV) (days)',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Duration of pressors',\n", + " 'SecondaryOutcomeDescription': 'Duration of pressors (days)',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Duration of ECMO',\n", + " 'SecondaryOutcomeDescription': 'Duration of extracorporeal membrane oxygenation (days)',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Duration of oxygen therapy',\n", + " 'SecondaryOutcomeDescription': 'Duration of oxygen therapy (oxygen inhalation by nasal cannula or mask) (days)',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Length of hospital stay',\n", + " 'SecondaryOutcomeDescription': 'Length of hospital stay (days)',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Absolute lymphocyte count',\n", + " 'SecondaryOutcomeDescription': 'Changes of absolute lymphocyte count in peripheral blood',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nShould be at least 18 years of age,\\nMale or female,\\nDiagnosed with COVID-19 and confirmed SARS-coV-2 viral infection.\\nAble to sign the consent form.\\nSevere COVID-19 (Appendix A), or NIAID 7-point ordinal score 3 to 4 (requiring non-invasive ventilation or oxygen, a SpO2 /= 24 breaths/min), Appendix B).\\nThe absolute lymphocyte count is ≤ 0.8 × 10^9 / L (8x10^5 / mL, 800 / mm3).\\n\\nExclusion Criteria:\\n\\nPatients with COVID 19 in critical condition or ARDS (Appendix A) or NIAID 7-point ordinal score 2 (Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)).\\nPatients with bacterial / fungal infections.\\nPatients who are pregnant, breastfeeding, or have a positive pregnancy test result before enrollment.\\nSevere liver damage (Child-Pugh score ≥ C, AST> 5 times the upper limit).\\nPatients with known severe renal impairment (creatinine clearance ≤ 30 mL / min) or patients receiving continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.\\nWill be transferred to a non-study site hospital within 72 hours.\\nThe investigator believes that participating in the trial is not in the best interests of the patient, or the investigator considers unsuitable for enrollment (such as unpredictable risks or subject compliance issues).',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Pan Zheng, MD, PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '(202) 7516823',\n", + " 'CentralContactEMail': 'pzheng@oncoimmune.com'},\n", + " {'CentralContactName': 'Martin Devenport, PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '(410) 2070582',\n", + " 'CentralContactEMail': 'mdevenport@oncoimmune.com'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Shyamasundaran Kottilil',\n", + " 'OverallOfficialAffiliation': 'Institute of Human Virology, University of Maryland Baltimore',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Institute of Human Virology, University of Maryland Baltimore',\n", + " 'LocationCity': 'Baltimore',\n", + " 'LocationState': 'Maryland',\n", + " 'LocationZip': '21201',\n", + " 'LocationCountry': 'United States'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M20444',\n", + " 'InterventionBrowseLeafName': 'Pharmaceutical Solutions',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2209',\n", + " 'InterventionBrowseLeafName': 'Adjuvants, Immunologic',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 90,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04327349',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'IR.MAZUMS.REC.1399.7330'},\n", + " 'SecondaryIdInfoList': {'SecondaryIdInfo': [{'SecondaryId': 'IRCT20181104041551N1',\n", + " 'SecondaryIdType': 'Registry Identifier',\n", + " 'SecondaryIdDomain': 'Iranian Registry of Clinical Trials (IRCT)'}]},\n", + " 'Organization': {'OrgFullName': 'Mazandaran University of Medical Sciences',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial',\n", + " 'OfficialTitle': 'Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Enrolling by invitation',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 28, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 20, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'September 30, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 24, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 30, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 31, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 30, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 31, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Amir Shamshirian',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Mazandaran University of Medical Sciences'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Mazandaran University of Medical Sciences',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Coronavirus disease 2019 (COVID-19) was recognized as a pandemic on March 11, 2020 by the World Health Organization. The virus that causes COVID-19 (SARS-CoV-2) is easily transmitted through person to person and there is still no specific approach against the disease and mortality rate in severe cases is also significant. Therefore, finding effective treatment for the mortality of these patients is very important. In this study the investigators aim to determine the effect of Convalescent Plasma on COVID-19 patients Outcome through a Clinical Trial'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus Infections']},\n", + " 'KeywordList': {'Keyword': ['Coronavirus',\n", + " 'COVID-19',\n", + " 'SARS-CoV-2',\n", + " 'Severe acute respiratory syndrome coronavirus 2']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Not Applicable']},\n", + " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '30',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'COVID-19 Patients',\n", + " 'ArmGroupType': 'Other',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: Convalescent Plasma']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Biological',\n", + " 'InterventionName': 'Convalescent Plasma',\n", + " 'InterventionDescription': 'Intervention to evaluate convalescent plasma transfer to COVID-19 patients admitted to ICU',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['COVID-19 Patients']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Mortality changes in day 10',\n", + " 'PrimaryOutcomeDescription': 'Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.',\n", + " 'PrimaryOutcomeTimeFrame': '10 days after plasma transmission'},\n", + " {'PrimaryOutcomeMeasure': 'Mortality changes in day 30',\n", + " 'PrimaryOutcomeDescription': 'Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.',\n", + " 'PrimaryOutcomeTimeFrame': '30 days after plasma transmission'},\n", + " {'PrimaryOutcomeMeasure': 'Changes of C-reactive protein',\n", + " 'PrimaryOutcomeDescription': 'Measurement of CRP',\n", + " 'PrimaryOutcomeTimeFrame': 'Day 1'},\n", + " {'PrimaryOutcomeMeasure': 'Changes of C-reactive protein',\n", + " 'PrimaryOutcomeDescription': 'Measurement of CRP',\n", + " 'PrimaryOutcomeTimeFrame': 'Day 3'},\n", + " {'PrimaryOutcomeMeasure': 'Changes of C-reactive protein',\n", + " 'PrimaryOutcomeDescription': 'Measurement of CRP',\n", + " 'PrimaryOutcomeTimeFrame': 'Day 7'},\n", + " {'PrimaryOutcomeMeasure': 'Changes of Interleukin 6',\n", + " 'PrimaryOutcomeDescription': 'Measurement of IL-6',\n", + " 'PrimaryOutcomeTimeFrame': 'Day 1'},\n", + " {'PrimaryOutcomeMeasure': 'Changes of Interleukin 6',\n", + " 'PrimaryOutcomeDescription': 'Measurement of IL-6',\n", + " 'PrimaryOutcomeTimeFrame': 'Day 3'},\n", + " {'PrimaryOutcomeMeasure': 'Changes of Interleukin 6',\n", + " 'PrimaryOutcomeDescription': 'Measurement of IL-6',\n", + " 'PrimaryOutcomeTimeFrame': 'Day 7'},\n", + " {'PrimaryOutcomeMeasure': 'Changes of tumor necrosis factor-α',\n", + " 'PrimaryOutcomeDescription': 'Measurement of TNF-α',\n", + " 'PrimaryOutcomeTimeFrame': 'Day 1'},\n", + " {'PrimaryOutcomeMeasure': 'Changes of tumor necrosis factor-α',\n", + " 'PrimaryOutcomeDescription': 'Measurement of TNF-α',\n", + " 'PrimaryOutcomeTimeFrame': 'Day 3'},\n", + " {'PrimaryOutcomeMeasure': 'Changes of tumor necrosis factor-α',\n", + " 'PrimaryOutcomeDescription': 'Measurement of TNF-α',\n", + " 'PrimaryOutcomeTimeFrame': 'Day 7'},\n", + " {'PrimaryOutcomeMeasure': 'Changes of PaO2/FiO2 Ratio',\n", + " 'PrimaryOutcomeDescription': 'Partial pressure of arterial oxygen/Percentage of inspired oxygen',\n", + " 'PrimaryOutcomeTimeFrame': 'Day 1'},\n", + " {'PrimaryOutcomeMeasure': 'Changes of PaO2/FiO2 Ratio',\n", + " 'PrimaryOutcomeDescription': 'Partial pressure of arterial oxygen/Percentage of inspired oxygen',\n", + " 'PrimaryOutcomeTimeFrame': 'Day 3'},\n", + " {'PrimaryOutcomeMeasure': 'Changes of PaO2/FiO2 Ratio',\n", + " 'PrimaryOutcomeDescription': 'Partial pressure of arterial oxygen/Percentage of inspired oxygen',\n", + " 'PrimaryOutcomeTimeFrame': 'Day 7'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Changes of CD3',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of CD3',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of CD3',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of CD4',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of CD4',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of CD4',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of CD8',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of CD8',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of CD8',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of CD4/CD8 ratio',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of CD4/CD8 ratio',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of CD4/CD8 ratio',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of lymphocyte count',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of lymphocyte count',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of lymphocyte count',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of leukocyte count',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of leukocyte count',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of leukocyte count',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of alanine transaminase (ALT)',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of alanine transaminase (ALT)',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of alanine transaminase (ALT)',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of aspartate transaminase (AST)',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of aspartate transaminase (AST)',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of aspartate transaminase (AST)',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of alkaline phosphatase (ALP)',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of alkaline phosphatase (ALP)',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of alkaline phosphatase (ALP)',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of lactate dehydrogenase (LDH)',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of lactate dehydrogenase (LDH)',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of lactate dehydrogenase (LDH)',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of creatine phosphokinase (CPK)',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of creatine phosphokinase (CPK)',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of creatine phosphokinase (CPK)',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of Creatine kinase-MB (CK-MB)',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of Creatine kinase-MB (CK-MB)',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of Creatine kinase-MB (CK-MB)',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of Specific IgG',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of Specific IgG',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", + " {'SecondaryOutcomeMeasure': 'Changes of Specific IgG',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", + " {'SecondaryOutcomeMeasure': 'Radiological findings',\n", + " 'SecondaryOutcomeDescription': 'Computed tomography Scan and Chest X-Ray',\n", + " 'SecondaryOutcomeTimeFrame': 'Within 2 hours after admission'},\n", + " {'SecondaryOutcomeMeasure': 'Radiological findings',\n", + " 'SecondaryOutcomeDescription': 'Computed tomography Scan and Chest X-Ray',\n", + " 'SecondaryOutcomeTimeFrame': 'Day 14'},\n", + " {'SecondaryOutcomeMeasure': 'Number of days ventilated',\n", + " 'SecondaryOutcomeTimeFrame': 'Through study completion, an average of 2 weeks'},\n", + " {'SecondaryOutcomeMeasure': 'Length of hospitalization',\n", + " 'SecondaryOutcomeTimeFrame': 'Through study completion, an average of 2 weeks'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\nRecipient:\\n\\nCOVID-19 Patients\\nConsent to attend the study\\nAge 30 to 70 years\\nDon't be intubated\\nPaO2 / FiO2 is above 200 or Spo2 is greater than 85%.\\n\\nDonator:\\n\\nComplete recovery from severe COVID-19 disease and hospital discharge\\nConsent to donate blood to the infected person\\nAge 30 to 60 years\\nHas normal CBC test results\\nNegative COVID-19 RT-PCR test\\n\\nExclusion Criteria:\\n\\nRecipient:\\n\\nA history of hypersensitivity to blood transfusions or its products\\nHistory of IgA deficiency\\nHeart failure or any other factor that prevents the transmission of of 500 ml plasma\\nEntering the intubation stage\\n\\nDonator:\\n\\nPatients infected with blood-borne viral / infectious diseases\\nUnderlying heart disease, low or high blood pressure, diabetes, epilepsy, and anything that may prohibit blood donation.\\nUse of banned drugs for blood donation (eg, ethertinate, acitretin, aliotretinoin, isotretinoin, antiandrogens, NSAIDs, etc.)\\nUse of different drugs\\nOther prohibited donations based on blood transfusion standards\",\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '30 Years',\n", + " 'MaximumAge': '70 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Majid Saeedi, Ph.D.',\n", + " 'OverallOfficialAffiliation': 'Vice-Chancellor for Research, Mazandaran University of Medical Sciences',\n", + " 'OverallOfficialRole': 'Study Chair'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Imam Khomeini Hospital, Mazandaran University of Medical Sciences',\n", + " 'LocationCity': 'Sari',\n", + " 'LocationState': 'Mazandaran',\n", + " 'LocationZip': '4816633131',\n", + " 'LocationCountry': 'Iran, Islamic Republic of'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", + " {'ConditionMeshId': 'D000045169',\n", + " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M14938',\n", + " 'ConditionBrowseLeafName': 'Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 91,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04308668',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'STUDY00009267'},\n", + " 'Organization': {'OrgFullName': 'University of Minnesota',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2',\n", + " 'OfficialTitle': 'Post-exposure Prophylaxis and Preemptive Therapy for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial',\n", + " 'Acronym': 'COVID-19 PEP'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 17, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 21, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'May 12, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 11, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 11, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 16, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'April 1, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", + " 'LastUpdatePostDateType': 'Estimate'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'University of Minnesota',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'University of Manitoba',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'University of Alberta',\n", + " 'CollaboratorClass': 'OTHER'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'Yes',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Study Objective:\\n\\nTo test if post-exposure prophylaxis with hydroxychloroquine can prevent symptomatic COVID-19 disease after known exposure to the SARS-CoV-2 coronavirus.\\nTo test if preemptive therapy with hydroxychloroquine early in the sypmptomatic COVID-19 disease course can prevent progression of persons with known symptomatic COVID19 disease, decrease hospitalization.',\n", + " 'DetailedDescription': 'Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging viral infection causing COVID19. The current strategy uses a public health model of identifying infected cases, isolation, and quarantine to stop transmission. Once exposed, observation is standard-of-care. Therapy is generally not given to persons who are not hospitalized.\\n\\nHydroxychloroquine may have antiviral effects against SARS-COV2 which may prevent COVID-19 disease or early preemptive therapy may decrease disease severity. This trial will use a modification of standard malaria dosing of hydroxychloroquine to provide post-exposure prophylaxis to prevent disease or preemptive therapy for those with early symptoms. People around the the United States and Canada can participate to help answer this critically important question. No in-person visits are needed.\\n\\nThis trial is targeting 5 groups of people NATIONWIDE to participate:\\n\\nIf you are symptomatic with a positive COVID-19 test within the first 4 days of symptoms and are not hospitalized; OR\\nIf you live with someone who has been diagnosed with COVID-19, with your last exposure within the last 4 days, and do not have any symptoms; OR\\nIf you live with someone who has been diagnosed with COVID-19, and your symptoms started within the last 4 days; OR\\nIf you are a healthcare worker or first responder with known exposure to someone with lab-confirmed COVID-19 within the last 4 days and do not have symptoms; OR\\nIf you are a healthcare worker or first responder and have compatible symptoms starting within the last 4 days;\\n\\nYou may participate if you live anywhere in the United States (including territories) or in the Canadian Provinces of Quebec, Manitoba, or Alberta.\\n\\nFor information on how to participate in the research trial, go to covidpep.umn.edu or email covid19@umn.edu for instructions. Please check your spam folder if you email.\\n\\nIn Canada, for trial information, please go to: www.covid-19research.ca'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Corona Virus Infection',\n", + " 'Acute Respiratory Distress Syndrome',\n", + " 'SARS-CoV Infection',\n", + " 'Coronavirus',\n", + " 'Coronavirus Infections']},\n", + " 'KeywordList': {'Keyword': ['COVID-19',\n", + " 'Corona Virus',\n", + " 'SARS-COV-2',\n", + " 'Coronavirus']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 3']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignInterventionModelDescription': 'Asymptomatic participants are randomized and analyzed separate from symptomatic participants.',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Quadruple',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", + " 'Care Provider',\n", + " 'Investigator',\n", + " 'Outcomes Assessor']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '3000',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Treatment',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Participants in this arm will receive the study drug.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine']}},\n", + " {'ArmGroupLabel': 'Placebo',\n", + " 'ArmGroupType': 'Placebo Comparator',\n", + " 'ArmGroupDescription': 'Participants in this arm will receive a placebo treatment.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: Placebo']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Hydroxychloroquine',\n", + " 'InterventionDescription': '200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Treatment']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Plaquenil']}},\n", + " {'InterventionType': 'Other',\n", + " 'InterventionName': 'Placebo',\n", + " 'InterventionDescription': '4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Placebo']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Incidence of COVID19 Disease among those who are asymptomatic at trial entry',\n", + " 'PrimaryOutcomeDescription': 'Number of participants at 14 days post enrollment with active COVID19 disease.',\n", + " 'PrimaryOutcomeTimeFrame': '14 days'},\n", + " {'PrimaryOutcomeMeasure': 'Ordinal Scale of COVID19 Disease Severity at 14 days among those who are symptomatic at trial entry',\n", + " 'PrimaryOutcomeDescription': 'Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the percent of participants who fall into each category per arm.',\n", + " 'PrimaryOutcomeTimeFrame': '14 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Incidence of Hospitalization',\n", + " 'SecondaryOutcomeDescription': 'Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Incidence of Death',\n", + " 'SecondaryOutcomeDescription': 'Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease.',\n", + " 'SecondaryOutcomeTimeFrame': '90 days'},\n", + " {'SecondaryOutcomeMeasure': 'Incidence of Confirmed SARS-CoV-2 Detection',\n", + " 'SecondaryOutcomeDescription': 'Outcome reported as the number of participants in each arm who have confirmed SARS-CoV-2 infection.',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Incidence of Symptoms Compatible with COVID19 (possible disease)',\n", + " 'SecondaryOutcomeDescription': 'Outcome reported as the number of participants in each arm who self-report symptoms compatible with COVID19 infection.',\n", + " 'SecondaryOutcomeTimeFrame': '90 days'},\n", + " {'SecondaryOutcomeMeasure': 'Incidence of All-Cause Study Medicine Discontinuation or Withdrawal',\n", + " 'SecondaryOutcomeDescription': 'Outcome reported as the number of participants in each arm who discontinue or withdraw medication use for any reason.',\n", + " 'SecondaryOutcomeTimeFrame': '14 days'},\n", + " {'SecondaryOutcomeMeasure': 'Overall symptom severity at 5 and 14 day',\n", + " 'SecondaryOutcomeDescription': 'Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)',\n", + " 'SecondaryOutcomeTimeFrame': '5 and 14 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nProvision of informed consent\\nExposure to a COVID19 case within 4 days as either a healthcare worker or household contact, OR\\nSymptomatic COVID19 case with confirmed diagnosis within 4 days of symptom onset OR symptomatic healthcare worker with known COVID19 contact and within 4 days of symptom onset;\\n\\nExclusion Criteria:\\n\\nCurrent hospitalization\\nAllergy to hydroxychloroquine\\nRetinal eye disease\\nKnown glucose-6 phosphate dehydrogenase (G-6-PD) deficiency\\nKnown chronic kidney disease, stage 4 or 5 or receiving dialysis\\nWeight < 40 kg\\nKnown Porphyria\\nCurrent use of: hydroxychloroquine or cardiac medicines of: flecainide, Tambocor; amiodarone, Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or Procan, Procanbid, propafenone, Rythmal)',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'David Boulware (Please email), MD, MPH',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '6126249996',\n", + " 'CentralContactEMail': 'covid19@umn.edu'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'David Boulware, MD, MPH',\n", + " 'OverallOfficialAffiliation': 'University of Minnesota',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Nationwide Enrollment via Internet, please email: covid19@umn.edu',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Minneapolis',\n", + " 'LocationState': 'Minnesota',\n", + " 'LocationZip': '55455',\n", + " 'LocationCountry': 'United States',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'David Boulware',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactEMail': 'covid19@umn.edu'}]}},\n", + " {'LocationFacility': 'University of Minnesota',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Minneapolis',\n", + " 'LocationState': 'Minnesota',\n", + " 'LocationZip': '55455',\n", + " 'LocationCountry': 'United States',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'David R Boulware, MD, MPH',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactEMail': 'covid19@umn.edu'},\n", + " {'LocationContactName': 'Matt Pullen, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Sarah Lofgren, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Caleb Skipper, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Radha Rajasingham, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Mahsa Abassi, DO, MPH',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Ananta Bangdiwala, MS',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Kathy Hullsiek, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Katelyn Pastick',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Elizabeth Okafor',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'Internet',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'New York',\n", + " 'LocationState': 'New York',\n", + " 'LocationZip': '10001',\n", + " 'LocationCountry': 'United States',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'David Boulware, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactEMail': 'covid19@umn.edu'}]}},\n", + " {'LocationFacility': 'University of Alberta',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Edmonton',\n", + " 'LocationState': 'Alberta',\n", + " 'LocationCountry': 'Canada',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Ilan Schwartz, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactEMail': 'alberta@idtrials.com'}]}},\n", + " {'LocationFacility': 'University of Manitoba',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Winnipeg',\n", + " 'LocationState': 'Manitoba',\n", + " 'LocationCountry': 'Canada',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Ryan Zarychanski, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactEMail': 'manitoba@idtrials.com'},\n", + " {'LocationContactName': 'Lauren E Kelly, PhD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactEMail': 'manitoba@idtrials.com'},\n", + " {'LocationContactName': 'Glen Drobot, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Lauren MacKenzie, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Sylvain Lother, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'Research Institute of the McGill University Heath Centre',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Montréal',\n", + " 'LocationState': 'Quebec',\n", + " 'LocationCountry': 'Canada',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Todd C Lee, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '5149341934',\n", + " 'LocationContactPhoneExt': '32965',\n", + " 'LocationContactEMail': 'quebec@idtrials.com'},\n", + " {'LocationContactName': 'Emily G McDonald, MDCM MSc',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Matthew P Chang, MDCM',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Alek Lefebvre',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", + " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", + " 'InterventionAncestorTerm': 'Antimalarials'},\n", + " {'InterventionAncestorId': 'D000000981',\n", + " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", + " {'InterventionAncestorId': 'D000000977',\n", + " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", + " {'InterventionAncestorId': 'D000000890',\n", + " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", + " {'InterventionAncestorId': 'D000004791',\n", + " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000018501',\n", + " 'InterventionAncestorTerm': 'Antirheumatic Agents'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", + " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M2861',\n", + " 'InterventionBrowseLeafName': 'Antimalarials',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2879',\n", + " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2875',\n", + " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2795',\n", + " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19188',\n", + " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", + " 'ConditionMeshTerm': 'Infection'},\n", + " {'ConditionMeshId': 'D000003141',\n", + " 'ConditionMeshTerm': 'Communicable Diseases'},\n", + " {'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", + " {'ConditionMeshId': 'D000045169',\n", + " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'},\n", + " {'ConditionMeshId': 'D000012127',\n", + " 'ConditionMeshTerm': 'Respiratory Distress Syndrome, Newborn'},\n", + " {'ConditionMeshId': 'D000012128',\n", + " 'ConditionMeshTerm': 'Respiratory Distress Syndrome, Adult'},\n", + " {'ConditionMeshId': 'D000055371',\n", + " 'ConditionMeshTerm': 'Acute Lung Injury'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000008171',\n", + " 'ConditionAncestorTerm': 'Lung Diseases'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", + " {'ConditionAncestorId': 'D000012120',\n", + " 'ConditionAncestorTerm': 'Respiration Disorders'},\n", + " {'ConditionAncestorId': 'D000007235',\n", + " 'ConditionAncestorTerm': 'Infant, Premature, Diseases'},\n", + " {'ConditionAncestorId': 'D000007232',\n", + " 'ConditionAncestorTerm': 'Infant, Newborn, Diseases'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'},\n", + " {'ConditionAncestorId': 'D000055370',\n", + " 'ConditionAncestorTerm': 'Lung Injury'},\n", + " {'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafAsFound': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Corona Virus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M14938',\n", + " 'ConditionBrowseLeafName': 'Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafAsFound': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13547',\n", + " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Newborn',\n", + " 'ConditionBrowseLeafAsFound': 'Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M13548',\n", + " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Adult',\n", + " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M26731',\n", + " 'ConditionBrowseLeafName': 'Acute Lung Injury',\n", + " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M26730',\n", + " 'ConditionBrowseLeafName': 'Lung Injury',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M9751',\n", + " 'ConditionBrowseLeafName': 'Lung Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13540',\n", + " 'ConditionBrowseLeafName': 'Respiration Disorders',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M24456',\n", + " 'ConditionBrowseLeafName': 'Premature Birth',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M8862',\n", + " 'ConditionBrowseLeafName': 'Infant, Premature, Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M8859',\n", + " 'ConditionBrowseLeafName': 'Infant, Newborn, Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Corona Virus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'T4953',\n", + " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Infant',\n", + " 'ConditionBrowseLeafAsFound': 'Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'T191',\n", + " 'ConditionBrowseLeafName': 'Acute Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC16',\n", + " 'ConditionBrowseBranchName': 'Diseases and Abnormalities at or Before Birth'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC26',\n", + " 'ConditionBrowseBranchName': 'Wounds and Injuries'},\n", + " {'ConditionBrowseBranchAbbrev': 'BXS',\n", + " 'ConditionBrowseBranchName': 'Urinary Tract, Sexual Organs, and Pregnancy Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", + " {'Rank': 92,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04326725',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '2020-2/1'},\n", + " 'Organization': {'OrgFullName': 'Istinye University',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Proflaxis Using Hydroxychloroquine Plus Vitamins-Zinc During COVID-19 Pandemia',\n", + " 'OfficialTitle': 'Proflaxis for Healthcare Professionals Using Hydroxychloroquine Plus Vitamin Combining Vitamins A, C, D and Zinc During COVID-19 Pandemia: An Observational Study'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 20, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'July 1, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'September 1, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 26, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 27, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 30, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 27, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 30, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Mehmet Mahir Ozmen',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Professor of Surgery, Department of Surgery',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Istinye University'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Istinye University',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'Yes',\n", + " 'IsFDARegulatedDevice': 'No',\n", + " 'IsUSExport': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Healthcare professionals mainly doctors, nurses and their first degree relatives (spouse, father, mother, sister, brother, child) who have been started hydroxychloroquine(plaquenil) 200mg single dose repeated every three weeks plus vitaminC including zinc once a day were included in the study. Study has conducted on 20th of march. Main purpose of the study was to cover participants those who are facing or treating COVID19 infected patients in Ankara.',\n", + " 'DetailedDescription': 'Healthcare professionals mainly doctors, nurses and their first degree relatives (spouse, father, mother, sister, brother, child) who have been started hydroxychloroquine(plaquenil) 200mg single dose repeated every three weeks plus vitaminC including zinc once a day were included in the study. Study has conducted on 20th of march. Main purpose of the study was to cover participants those who are facing or treating COVID19 infected patients.PArticipants, age, sex, BMI, smoking history, comorbid disease were also registered.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['to Evaluate the Efficacy of Hydroxychloroquine Plus vitACD-Zinc as Prevention for COVID19 Infection']},\n", + " 'KeywordList': {'Keyword': ['Hydroxychloroquine',\n", + " 'coronavirus',\n", + " 'prophylaxis',\n", + " 'healthcare professional',\n", + " 'outbreak']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Case-Control']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '80',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Hydroxychloroquine',\n", + " 'ArmGroupDescription': 'Subjects with prophylaxis',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Plaquenil 200Mg Tablet']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Plaquenil 200Mg Tablet',\n", + " 'InterventionDescription': 'health workers under risk who took this medications',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Hydroxychloroquine']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Redoxan']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Protection against COVID-19',\n", + " 'PrimaryOutcomeDescription': 'persons who took this medication should not have an infection',\n", + " 'PrimaryOutcomeTimeFrame': '4 months'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria: 1.person who are working as health professional 2. Their first degree relatives( child, spouse or parents)\\n\\nExclusion Criteria: 1. Already using plaquenil for other reasons(RA etc) 2. person with the diagnosis of COVID infection 3.Person with the condition may cause complications with this medication (severe CVD, av block, already has ophtalmological complications, organ failure of any degree etc)\\n\\n-',\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '20 Years',\n", + " 'MaximumAge': '90 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'Mainly doctors, nurses, health workers in the hospital whereby they have close contacts with possile COVID-19 infected patients were included. Their first degree relatives(spouse, child, parents)',\n", + " 'SamplingMethod': 'Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Mahir M Ozmen, Professor',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+905324246838',\n", + " 'CentralContactEMail': 'ozmenmm@gmail.com'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Istinye University Medical School',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Istanbul',\n", + " 'LocationZip': '34010',\n", + " 'LocationCountry': 'Turkey',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Istinye University M ozmen, Prof',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+905324246838',\n", + " 'LocationContactEMail': 'mahir.ozmen@istinye.edu.tr'}]}}]}},\n", + " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '32145363',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Colson P, Rolain JM, Lagier JC, Brouqui P, Raoult D. Chloroquine and hydroxychloroquine as available weapons to fight COVID-19. Int J Antimicrob Agents. 2020 Mar 4:105932. doi: 10.1016/j.ijantimicag.2020.105932. [Epub ahead of print]'},\n", + " {'ReferencePMID': '32171740',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Devaux CA, Rolain JM, Colson P, Raoult D. New insights on the antiviral effects of chloroquine against coronavirus: what to expect for COVID-19? Int J Antimicrob Agents. 2020 Mar 11:105938. doi: 10.1016/j.ijantimicag.2020.105938. [Epub ahead of print]'},\n", + " {'ReferencePMID': '32173110',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Cortegiani A, Ingoglia G, Ippolito M, Giarratano A, Einav S. A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19. J Crit Care. 2020 Mar 10. pii: S0883-9441(20)30390-7. doi: 10.1016/j.jcrc.2020.03.005. [Epub ahead of print]'},\n", + " {'ReferencePMID': '32074550',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Gao J, Tian Z, Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends. 2020 Mar 16;14(1):72-73. doi: 10.5582/bst.2020.01047. Epub 2020 Feb 19.'},\n", + " {'ReferencePMID': '32147628',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Dong L, Hu S, Gao J. Discovering drugs to treat coronavirus disease 2019 (COVID-19). Drug Discov Ther. 2020;14(1):58-60. doi: 10.5582/ddt.2020.01012.'},\n", + " {'ReferencePMID': '32117569',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Kruse RL. Therapeutic strategies in an outbreak scenario to treat the novel coronavirus originating in Wuhan, China. F1000Res. 2020 Jan 31;9:72. doi: 10.12688/f1000research.22211.2. eCollection 2020. Review.'},\n", + " {'ReferencePMID': '32092748',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Song P, Karako T. COVID-19: Real-time dissemination of scientific information to fight a public health emergency of international concern. Biosci Trends. 2020 Mar 16;14(1):1-2. doi: 10.5582/bst.2020.01056. Epub 2020 Feb 25.'},\n", + " {'ReferencePMID': '32139372',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Lake MA. What we know so far: COVID-19 current clinical knowledge and research. Clin Med (Lond). 2020 Mar;20(2):124-127. doi: 10.7861/clinmed.2019-coron. Epub 2020 Mar 5. Review.'},\n", + " {'ReferencePMID': '32178711',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Cunningham AC, Goh HP, Koh D. Treatment of COVID-19: old tricks for new challenges. Crit Care. 2020 Mar 16;24(1):91. doi: 10.1186/s13054-020-2818-6.'},\n", + " {'ReferencePMID': '29737455',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Plantone D, Koudriavtseva T. Current and Future Use of Chloroquine and Hydroxychloroquine in Infectious, Immune, Neoplastic, and Neurological Diseases: A Mini-Review. Clin Drug Investig. 2018 Aug;38(8):653-671. doi: 10.1007/s40261-018-0656-y. Review.'}]}}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000014815',\n", + " 'InterventionMeshTerm': 'Vitamins'},\n", + " {'InterventionMeshId': 'D000006886',\n", + " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000018977',\n", + " 'InterventionAncestorTerm': 'Micronutrients'},\n", + " {'InterventionAncestorId': 'D000078622',\n", + " 'InterventionAncestorTerm': 'Nutrients'},\n", + " {'InterventionAncestorId': 'D000006133',\n", + " 'InterventionAncestorTerm': 'Growth Substances'},\n", + " {'InterventionAncestorId': 'D000045505',\n", + " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", + " {'InterventionAncestorId': 'D000000962',\n", + " 'InterventionAncestorTerm': 'Antimalarials'},\n", + " {'InterventionAncestorId': 'D000000981',\n", + " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", + " {'InterventionAncestorId': 'D000000977',\n", + " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", + " {'InterventionAncestorId': 'D000000890',\n", + " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", + " {'InterventionAncestorId': 'D000004791',\n", + " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000018501',\n", + " 'InterventionAncestorTerm': 'Antirheumatic Agents'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M16141',\n", + " 'InterventionBrowseLeafName': 'Vitamins',\n", + " 'InterventionBrowseLeafAsFound': 'Vitamin',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M8523',\n", + " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M16351',\n", + " 'InterventionBrowseLeafName': 'Zinc',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M16127',\n", + " 'InterventionBrowseLeafName': 'Vitamin A',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M217588',\n", + " 'InterventionBrowseLeafName': 'Retinol palmitate',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M15468',\n", + " 'InterventionBrowseLeafName': 'Trace Elements',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19593',\n", + " 'InterventionBrowseLeafName': 'Micronutrients',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M1986',\n", + " 'InterventionBrowseLeafName': 'Nutrients',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2861',\n", + " 'InterventionBrowseLeafName': 'Antimalarials',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2879',\n", + " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2875',\n", + " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2795',\n", + " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19188',\n", + " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'T462',\n", + " 'InterventionBrowseLeafName': 'Retinol',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'T468',\n", + " 'InterventionBrowseLeafName': 'Vitamin A',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Micro',\n", + " 'InterventionBrowseBranchName': 'Micronutrients'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", + " {'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ANeo',\n", + " 'InterventionBrowseBranchName': 'Antineoplastic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'Vi',\n", + " 'InterventionBrowseBranchName': 'Vitamins'}]}},\n", + " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'}]}}}}},\n", + " {'Rank': 93,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04325633',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'APHP200387'},\n", + " 'Organization': {'OrgFullName': 'Assistance Publique - Hôpitaux de Paris',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Efficacy of Addition of Naproxen in the Treatment of Critically Ill Patients Hospitalized for COVID-19 Infection',\n", + " 'OfficialTitle': 'Efficacy of Addition of Naproxen in the Treatment of Critically Ill Patients Hospitalized for COVID-19 Infection',\n", + " 'Acronym': 'ENACOVID'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 27, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 27, 2021',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'June 27, 2021',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 26, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 26, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 27, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 26, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 27, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Assistance Publique - Hôpitaux de Paris',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'The symptoms of respiratory distress caused by COVID-19 may be reduced by drugs combining anti-inflammatory and antiviral effects. This dual effect may simultaneously protect severely-ill patients and reduce the viral load, therefore limiting virus dissemination We want to demonstrate the superiority of naproxen (anti-inflamatory drug) treatment addition to standard of care compared to standard of care in term of 30-day mortality.',\n", + " 'DetailedDescription': 'Coronavirus Disease 2019 (COVID-19) is due to SARS-CoV-2 infection. (1,2) The exacerbated inflammatory response in COVID-19 infected critically ill patients calls for appropriate anti inflammatory therapeutics combined with antiviral effects. Thus, drugs combining anti-inflammatory and antiviral effects may reduce the symptoms of respiratory distress caused by COVID-19. This dual effect may simultaneously protect severely ill patients and reduce the viral load, therefore limiting virus dissemination. Naproxen, an approved anti-inflammatory drug, is an inhibitor of both cyclo oxygenase (COX-2) and of Influenza A virus nucleoprotein (NP). The NP of Coronavirus (CoV), positive-sense single-stranded viruses, share with negative-sense single-stranded viruses as Influenza the ability to bind to- and protect genomic RNA by forming self-associated oligomers in a helical structure with RNA. Naproxen was shown to bind the Influenza A virus NP making electrostatic and hydrophobic interactions with conserved residues of the RNA binding groove and C terminal domain. (3) Consequently, naproxen binding competed with NP association with viral RNA and impeded the NP self-association process which strongly reduced viral transcription/replication. This drug may have the potential to present antiviral properties against SARS-CoV-2 suggested by modelling work based on the structures of CoV NP. The high sequence conservation within the coronavirus family, including severe acute respiratory syndrome (SARS-CoV) and the present SARSCoV-2 coronavirus allows to perform this comparison. (4) A recent clinical trial shown that the combination of clarithromycin, naproxen and oseltamivir reduced mortality of patients hospitalized for H3N2 Influenza infection. (5). Inappropriate inflammatory response in CODIV-19 patients was demonstrated in a recent study where Intensive Care Unit (ICU) patients had higher plasma levels of IL2, IL7, IL10, GSCF, IP10, MCP1, MIP1A, and TNF? compared with non-ICU patients.(2) We suggest that naproxen could combine a broad-spectrum antiviral activity with its well-known anti inflammatory action that could help reducing severe respiratory mortality associated with COVID-19.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", + " 'KeywordList': {'Keyword': ['COVID-19',\n", + " 'SARS-COV-2',\n", + " 'Naproxen',\n", + " 'Nonsteroidal anti-inflamatory drug']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 3']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '584',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': '1: Naproxen',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Administration of naproxen 250 mg twice and lansoprazole 30 mg daily for prevention of gastropathy induced by stress or a nonsteroidal anti-inflammatory drug (NSAID) in addition to standard of care (SOC)',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: 1: Naproxen',\n", + " 'Drug: 2: Standard of care']}},\n", + " {'ArmGroupLabel': '2: Standard of care',\n", + " 'ArmGroupType': 'Placebo Comparator',\n", + " 'ArmGroupDescription': 'Standard of care',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: 2: Standard of care']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': '1: Naproxen',\n", + " 'InterventionDescription': 'Description : Administration of naproxen 250 mg twice and lansoprazole 30 mg daily for prevention of gastropathy induced by stress or a nonsteroidal anti-inflammatory drug (NSAID) in addition to standard of care (SOC)',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['1: Naproxen']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': '2: Standard of care',\n", + " 'InterventionDescription': 'Standard of care',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['1: Naproxen',\n", + " '2: Standard of care']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Mortality all causes at day30',\n", + " 'PrimaryOutcomeTimeFrame': 'at day30'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Number of days alive free of mechanical ventilation',\n", + " 'SecondaryOutcomeTimeFrame': 'during 30 days after randomization'},\n", + " {'SecondaryOutcomeMeasure': 'Number of days alive outside',\n", + " 'SecondaryOutcomeTimeFrame': 'during 30 days after randomization'},\n", + " {'SecondaryOutcomeMeasure': 'Number of days alive outside hospital',\n", + " 'SecondaryOutcomeTimeFrame': 'during 30 days after randomization'},\n", + " {'SecondaryOutcomeMeasure': 'Maximal changes in Sofa score',\n", + " 'SecondaryOutcomeTimeFrame': 'in the first 7 days after randomization'},\n", + " {'SecondaryOutcomeMeasure': 'Time to negativation of virus titer in the nasopharyngeal aspirate (NPA)',\n", + " 'SecondaryOutcomeTimeFrame': 'during 90 days after randomization'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nCOVID-19 infected patient\\nAge 18 years or older\\nPresence of pneumonia\\nPaO2/FiO2 < 300 mm Hg or SpO2 < 93% in air ambient or need to supplementary oxygen administration in order to maintain SpO2 range in [94-98%] or lung infiltrates > 50%\\nMedical insurance\\n\\nExclusion Criteria:\\n\\nPresence of do-not-resuscitate order\\nPregnancy\\nPrisoners\\nKnown Naproxen allergy or intolerance\\nSevere renal failure',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Frédéric ADNET, MD, PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+33 1-48-96-44-08',\n", + " 'CentralContactEMail': 'frederic.adnet@aphp.fr'},\n", + " {'CentralContactName': 'Anny SLAMA SCHWOK, MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactEMail': 'anny.slama-schwok@inserm.fr'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Frédéric ADNET, MD, PhD',\n", + " 'OverallOfficialAffiliation': 'Assistance Publique - Hôpitaux de Paris',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]}}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000009288',\n", + " 'InterventionMeshTerm': 'Naproxen'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000894',\n", + " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents, Non-Steroidal'},\n", + " {'InterventionAncestorId': 'D000018712',\n", + " 'InterventionAncestorTerm': 'Analgesics, Non-Narcotic'},\n", + " {'InterventionAncestorId': 'D000000700',\n", + " 'InterventionAncestorTerm': 'Analgesics'},\n", + " {'InterventionAncestorId': 'D000018689',\n", + " 'InterventionAncestorTerm': 'Sensory System Agents'},\n", + " {'InterventionAncestorId': 'D000018373',\n", + " 'InterventionAncestorTerm': 'Peripheral Nervous System Agents'},\n", + " {'InterventionAncestorId': 'D000045505',\n", + " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", + " {'InterventionAncestorId': 'D000000893',\n", + " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents'},\n", + " {'InterventionAncestorId': 'D000018501',\n", + " 'InterventionAncestorTerm': 'Antirheumatic Agents'},\n", + " {'InterventionAncestorId': 'D000006074',\n", + " 'InterventionAncestorTerm': 'Gout Suppressants'},\n", + " {'InterventionAncestorId': 'D000016861',\n", + " 'InterventionAncestorTerm': 'Cyclooxygenase Inhibitors'},\n", + " {'InterventionAncestorId': 'D000004791',\n", + " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M2798',\n", + " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M10822',\n", + " 'InterventionBrowseLeafName': 'Naproxen',\n", + " 'InterventionBrowseLeafAsFound': 'Naproxen',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M28967',\n", + " 'InterventionBrowseLeafName': 'Dexlansoprazole',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M28966',\n", + " 'InterventionBrowseLeafName': 'Lansoprazole',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2799',\n", + " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents, Non-Steroidal',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2613',\n", + " 'InterventionBrowseLeafName': 'Analgesics',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19370',\n", + " 'InterventionBrowseLeafName': 'Analgesics, Non-Narcotic',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19188',\n", + " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M17792',\n", + " 'InterventionBrowseLeafName': 'Cyclooxygenase Inhibitors',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", + " {'InterventionBrowseBranchAbbrev': 'Infl',\n", + " 'InterventionBrowseBranchName': 'Anti-Inflammatory Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'Analg',\n", + " 'InterventionBrowseBranchName': 'Analgesics'},\n", + " {'InterventionBrowseBranchAbbrev': 'Gast',\n", + " 'InterventionBrowseBranchName': 'Gastrointestinal Agents'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000016638',\n", + " 'ConditionMeshTerm': 'Critical Illness'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000020969',\n", + " 'ConditionAncestorTerm': 'Disease Attributes'},\n", + " {'ConditionAncestorId': 'D000010335',\n", + " 'ConditionAncestorTerm': 'Pathologic Processes'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M17593',\n", + " 'ConditionBrowseLeafName': 'Critical Illness',\n", + " 'ConditionBrowseLeafAsFound': 'Critically Ill',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M21284',\n", + " 'ConditionBrowseLeafName': 'Disease Attributes',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'}]}}}}},\n", + " {'Rank': 94,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04333732',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': '202004xxx'},\n", + " 'Organization': {'OrgFullName': 'Washington University School of Medicine',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'CROWN CORONATION: Chloroquine RepurpOsing to healthWorkers for Novel CORONAvirus mitigaTION',\n", + " 'OfficialTitle': 'A Phase 2, International Multi-site, Bayesian Adaptive, Randomised, Double-blinded, Placebo-controlled Trial Assessing the Effectiveness of Varied Doses of Oral Chloroquine in Preventing or Reducing the Severity of COVID-19 Disease in Healthcare Workers',\n", + " 'Acronym': 'CROWN CORONA'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'February 2021',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'February 2021',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 31, 2020',\n", + " 'StudyFirstSubmitQCDate': 'April 2, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 3, 2020',\n", + " 'StudyFirstPostDateType': 'Estimate'},\n", + " 'LastUpdateSubmitDate': 'April 2, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", + " 'LastUpdatePostDateType': 'Estimate'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Michael Avidan',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Professor of Anesthesiology and Surgery',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Washington University School of Medicine'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Washington University School of Medicine',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'Yes',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Healthcare workers are at the frontline of the fight against COVID-19, and as such they are at high risk for infection and possibly for serious infection, linked to the extent of their exposure. The CROWN CORONATION trial prioritizes the protection of healthcare workers as a strategy to prevent collapse of healthcare services.',\n", + " 'DetailedDescription': 'CROWN CORONATION is a large, Bayesian adaptive, pragmatic, participant-level randomized, multi-center, transdisciplinary, international placebo-controlled trial. It has been designed in accordance with CONSORT guidelines. Randomization will be stratified by age (<50 and ≥50) and study site. Participants will be healthcare workers at risk for contracting SARS-CoV-2. Participants will be randomized into one of four arms:\\n\\nLow-dose (300mg chloroquine base weekly);\\nMedium-dose (300mg chloroquine base twice weekly);\\nHigh-dose (150 mg chloroquine base daily);\\nPlacebo.\\n\\nIn all treatment arms, an induction dose of 1200mg chloroquine or hydroxychloroquine base (or equivalent number of placebo tablets in the placebo arm) will be taken in 4 divided daily doses (that is 300mg chloroquine or hydroxychloroquine base per day for four days) before starting the low, medium, or high dose regimen .\\n\\nIn certain countries (especially where malaria is not endemic), hydroxychloroquine is more readily available and will be used instead of chloroquine. Based on in vitro studies and reviews of drug toxicity , we consider 150mg of hydroxychloroquine base to be equivalent to 150mg of chloroquine base in terms of efficacy. New dosage-based arm(s) might be added or removed. The trial will evaluate which of the intervention arms is most effective at decreasing the incidence of severe COVID-19 disease, without unacceptable side effects or safety events.\\n\\nParticipants will complete weekly (smart phone- based) data logs, and follow- up information will be collected until 2 months after enrolment or death. In addition, where possible, we will use telemedicine approaches to collection information on participants. The study flow overview is outlined in Figure 4. We will provide adherence support interventions that have worked and been tested for Human Immunodeficiency Virus Pre-Exposure Prophylaxis (HIV PrEP) (e.g. two-way SMS with check in for those that report symptoms or adverse events). On enrollment, the local trial team will create a new electronic case record from (CRF) on the web-based study database and record basic demographic information. The database will be hosted on UK based servers managed by Net Solving Ltd. Local investigators will have access to the part of the CRF to enable recording of outcome data and/or severity of COVID-19 symptoms. Participants will be given a secure login to enable them to complete an initial participant health questionnaire and the daily data logs.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID 19']},\n", + " 'KeywordList': {'Keyword': ['COVID 19',\n", + " 'Health care workers',\n", + " 'hydroxychloroquine',\n", + " 'chloroquine']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 2']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignInterventionModelDescription': 'A international, multi-site, randomized, double-blinded, placebo-controlled clinical effectiveness',\n", + " 'DesignPrimaryPurpose': 'Prevention',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'Single',\n", + " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant']}}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '55000',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': '● Low-dose (300mg chloroquine base weekly)',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Placebo 1 administered orally once daily, Placebo 2 administered orally once weekly, Chloroquine base 300 mg administered orally as chloroquine or hydroxychloroquine once weekly. The decision of whether to offer chloroquine or hydroxychloroquine will be based on local availability.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Low-dose chloroquine/hydroxychloroquine']}},\n", + " {'ArmGroupLabel': '● Medium-dose (300mg chloroquine base twice weekly)',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Placebo 1 administered orally once daily, Chloroquine base 300 mg administered orally as chloroquine or hydroxychloroquine twice weekly',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Mid dose chloroquine or hydroxychloroquine']}},\n", + " {'ArmGroupLabel': '● High-dose (150 mg chloroquine base daily)',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Chloroquine base 150 mg administered orally once daily either a chloroquine or hydroxychloroquine, Placebo 2 administered orally once weekly, Placebo 3 administered orally once weekly',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: High does chloroquine or hydroxychloroquine']}},\n", + " {'ArmGroupLabel': 'Placebo',\n", + " 'ArmGroupType': 'Placebo Comparator',\n", + " 'ArmGroupDescription': 'Placebo 1 administered orally once daily, Placebo 2 administered orally once weekly, Placebo 3 administered orally once weekly',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Low-dose chloroquine/hydroxychloroquine',\n", + " 'InterventionDescription': 'In all treatment arms, an induction dose of 1200mg chloroquine or hydroxychloroquine base (or equivalent number of placebo tablets) will be taken in 4 divided daily doses (that is 300mg chloroquine or hydroxychloroquine base per day for four days) before starting the low, medium, or high dose regimen.\\n\\nPlacebo 1 administered orally once daily, Placebo 2 administered orally once weekly, Chloroquine base 300 mg administered orally as chloroquine or hydroxychloroquine once weekly. The decision of whether to offer chloroquine or hydroxychloroquine will be based on local availability.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['● Low-dose (300mg chloroquine base weekly)']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Aralen or Plaquenil']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Mid dose chloroquine or hydroxychloroquine',\n", + " 'InterventionDescription': 'In all treatment arms, an induction dose of 1200mg chloroquine or hydroxychloroquine base (or equivalent number of placebo tablets) will be taken in 4 divided daily doses (that is 300mg chloroquine or hydroxychloroquine base per day for four days) before starting the low, medium, or high dose regimen.\\n\\nPlacebo 1 administered orally once daily, Chloroquine base 300 mg administered orally as chloroquine or hydroxychloroquine twice weekly',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['● Medium-dose (300mg chloroquine base twice weekly)']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Aralen or Plaquenil']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'High does chloroquine or hydroxychloroquine',\n", + " 'InterventionDescription': 'In all treatment arms, an induction dose of 1200mg chloroquine or hydroxychloroquine base (or equivalent number of placebo tablets) will be taken in 4 divided daily doses (that is 300mg chloroquine or hydroxychloroquine base per day for four days) before starting the low, medium, or high dose regimen.\\n\\nIn all treatment arms, an induction dose of 1200mg chloroquine or hydroxychloroquine base (or equivalent number of placebo tablets) will be taken in 4 divided daily doses (that is 300mg chloroquine or hydroxychloroquine base per day for four days) before starting the low, medium, or high dose regimen.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['● High-dose (150 mg chloroquine base daily)']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Aralen or Plaquenil']}},\n", + " {'InterventionType': 'Drug',\n", + " 'InterventionName': 'Placebo',\n", + " 'InterventionDescription': 'Placebo 1 administered orally once daily, Placebo 2 administered orally once weekly, Placebo 3 administered orally once weekly.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Placebo']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Symptomatic COVID-19',\n", + " 'PrimaryOutcomeDescription': 'Clinical diagnosis of COVID-19 with limitation of activities (WHO Severity Scale 2-8)',\n", + " 'PrimaryOutcomeTimeFrame': '3 months'},\n", + " {'PrimaryOutcomeMeasure': 'Peak severity of COVID-19 over the study period',\n", + " 'PrimaryOutcomeDescription': 'i) Uninfected - no clinical or virological evidence of infection (Score = 0) ii) Ambulatory - no limitation of activities (score=1) or with limitation (Score=2) iii) Hospitalized - mild no oxygen (Score=3) or with oxygen (Score=4) iv) Hospitalized severe - Scores 5-7* v) Dead\\n\\n* Score 5 is non-invasive ventilation or high flow oxygen; Score 6 is intubation with mechanical ventilation; Score 7 is intubation with additional organ support (e.g. pressors, renal replacement therapy, extra corporeal membrane oxygenation [ECMO]) These outcome definitions are based on WHO R&D Blueprint consensus definitions for COVID-19.',\n", + " 'PrimaryOutcomeTimeFrame': '3 months'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAge ≥18 years.\\nHealthcare worker based in a primary, secondary or tertiary healthcare setting with a high risk of developing COVID-19 due to their potential exposure to patients with SARS-CoV-2 infection.\\n\\nExclusion Criteria:\\n\\n-',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Linda Yun, BS',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '314-273-2240',\n", + " 'CentralContactEMail': 'lindayun@wustl.edu'},\n", + " {'CentralContactName': 'Sherry McKinnon, BS',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '314-286-1768',\n", + " 'CentralContactEMail': 'smckinnon@wustl.edu'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Michael S. Avidan, MBBCh',\n", + " 'OverallOfficialAffiliation': 'Washington Univeristy School of Medicine',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Ramani Moonesinghe, MD',\n", + " 'OverallOfficialAffiliation': 'University College, London',\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Helen Rees, MD',\n", + " 'OverallOfficialAffiliation': 'Wits University',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Washington University School of Medicine',\n", + " 'LocationCity': 'Saint Louis',\n", + " 'LocationState': 'Missouri',\n", + " 'LocationZip': '63110',\n", + " 'LocationCountry': 'United States',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Linda Yun, BS',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '314-273-2240',\n", + " 'LocationContactEMail': 'lindayun@wustl.edu'},\n", + " {'LocationContactName': 'Sherry McKinnon',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '314-286-1768',\n", + " 'LocationContactEMail': 'mckinnos@anest.wustl.edu'},\n", + " {'LocationContactName': 'Michael S. Avidan, MBBCh, FCASA',\n", + " 'LocationContactRole': 'Principal Investigator'},\n", + " {'LocationContactName': 'Mary Politi, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Eric Dubberke, MD',\n", + " 'LocationContactRole': 'Principal Investigator'}]}},\n", + " {'LocationFacility': 'Melbourne Medical School',\n", + " 'LocationCity': 'Melbourne',\n", + " 'LocationState': 'Victoria',\n", + " 'LocationZip': 'VIC 3010',\n", + " 'LocationCountry': 'Australia',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'David Story, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactEMail': 'dastory@unimelb.edu.au'}]}},\n", + " {'LocationFacility': 'Population Health Resarch Institute',\n", + " 'LocationCity': 'Hamilton',\n", + " 'LocationState': 'Ontario',\n", + " 'LocationZip': 'L8L 2X2',\n", + " 'LocationCountry': 'Canada',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Jessica Spence, MD, FRCPC',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactEMail': 'spencej@phri.ca'},\n", + " {'LocationContactName': 'Jessica Spence, MD, FRCPC',\n", + " 'LocationContactRole': 'Principal Investigator'}]}},\n", + " {'LocationFacility': 'University of Toronto',\n", + " 'LocationCity': 'Toronto',\n", + " 'LocationState': 'Ontario',\n", + " 'LocationZip': 'M5G 1E2',\n", + " 'LocationCountry': 'Canada',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'David Mazer, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '(416) 864-5825',\n", + " 'LocationContactEMail': 'David.Mazer@unityhealth.to'},\n", + " {'LocationContactName': 'David Mazer, MD',\n", + " 'LocationContactRole': 'Principal Investigator'}]}},\n", + " {'LocationFacility': \"St James's Hospital\",\n", + " 'LocationCity': 'Dublin',\n", + " 'LocationState': 'Leinster',\n", + " 'LocationZip': 'Dublin 8',\n", + " 'LocationCountry': 'Ireland',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': \"Ellen O'Sullivan, MD, FRCA,FCAI\",\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '353876993178',\n", + " 'LocationContactEMail': 'ellenosullivan2000@gmail.com'}]}},\n", + " {'LocationFacility': 'Wits RHI, University of the Witwatersrand',\n", + " 'LocationCity': 'Johannesburg',\n", + " 'LocationState': 'Gauteng',\n", + " 'LocationZip': '2001',\n", + " 'LocationCountry': 'South Africa',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Sinead Delany-Moretlwe, MBChB, PhD, DTM&H',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+27 82 377 6275',\n", + " 'LocationContactEMail': 'sdelany@wrhi.ac.za'},\n", + " {'LocationContactName': 'Michelle Moorhouse, MBChB',\n", + " 'LocationContactRole': 'Contact'},\n", + " {'LocationContactName': 'Gloria Maimela, MBBCh MBA',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Saiqa Mullick, MBBCh PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Catherine Martin, MBBCh MSc',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}},\n", + " {'LocationFacility': 'University College London',\n", + " 'LocationCity': 'London',\n", + " 'LocationCountry': 'United Kingdom',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Laurence Lovat, MD, PhD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '020 3447 7488',\n", + " 'LocationContactEMail': 'laurence.lovat@nhs.net'},\n", + " {'LocationContactName': 'Laurence Lovat, MD, PhD',\n", + " 'LocationContactRole': 'Principal Investigator'},\n", + " {'LocationContactName': 'Hakim-Moulay Dehbi, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Nick Freemantle, PhD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Dermot McGuckin, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Gemma Jones, MsC',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Ramani Moonesinghe, MD',\n", + " 'LocationContactRole': 'Sub-Investigator'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", + " 'InterventionMeshTerm': 'Hydroxychloroquine'},\n", + " {'InterventionMeshId': 'D000002738',\n", + " 'InterventionMeshTerm': 'Chloroquine'},\n", + " {'InterventionMeshId': 'C000023676',\n", + " 'InterventionMeshTerm': 'Chloroquine diphosphate'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", + " 'InterventionAncestorTerm': 'Antimalarials'},\n", + " {'InterventionAncestorId': 'D000000981',\n", + " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", + " {'InterventionAncestorId': 'D000000977',\n", + " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", + " {'InterventionAncestorId': 'D000000890',\n", + " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", + " {'InterventionAncestorId': 'D000004791',\n", + " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000018501',\n", + " 'InterventionAncestorTerm': 'Antirheumatic Agents'},\n", + " {'InterventionAncestorId': 'D000000563',\n", + " 'InterventionAncestorTerm': 'Amebicides'},\n", + " {'InterventionAncestorId': 'D000000894',\n", + " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents, Non-Steroidal'},\n", + " {'InterventionAncestorId': 'D000018712',\n", + " 'InterventionAncestorTerm': 'Analgesics, Non-Narcotic'},\n", + " {'InterventionAncestorId': 'D000000700',\n", + " 'InterventionAncestorTerm': 'Analgesics'},\n", + " {'InterventionAncestorId': 'D000018689',\n", + " 'InterventionAncestorTerm': 'Sensory System Agents'},\n", + " {'InterventionAncestorId': 'D000018373',\n", + " 'InterventionAncestorTerm': 'Peripheral Nervous System Agents'},\n", + " {'InterventionAncestorId': 'D000045505',\n", + " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", + " {'InterventionAncestorId': 'D000000893',\n", + " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents'},\n", + " {'InterventionAncestorId': 'D000005369',\n", + " 'InterventionAncestorTerm': 'Filaricides'},\n", + " {'InterventionAncestorId': 'D000000969',\n", + " 'InterventionAncestorTerm': 'Antinematodal Agents'},\n", + " {'InterventionAncestorId': 'D000000871',\n", + " 'InterventionAncestorTerm': 'Anthelmintics'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M4562',\n", + " 'InterventionBrowseLeafName': 'Chloroquine',\n", + " 'InterventionBrowseLeafAsFound': 'Chloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M151035',\n", + " 'InterventionBrowseLeafName': 'Chloroquine diphosphate',\n", + " 'InterventionBrowseLeafAsFound': 'Chloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M8523',\n", + " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M2861',\n", + " 'InterventionBrowseLeafName': 'Antimalarials',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2879',\n", + " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2875',\n", + " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2795',\n", + " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19188',\n", + " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2798',\n", + " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2799',\n", + " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents, Non-Steroidal',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2613',\n", + " 'InterventionBrowseLeafName': 'Analgesics',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19370',\n", + " 'InterventionBrowseLeafName': 'Analgesics, Non-Narcotic',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2777',\n", + " 'InterventionBrowseLeafName': 'Anthelmintics',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", + " {'InterventionBrowseBranchAbbrev': 'Infl',\n", + " 'InterventionBrowseBranchName': 'Anti-Inflammatory Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'Analg',\n", + " 'InterventionBrowseBranchName': 'Analgesics'}]}},\n", + " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", + " {'Rank': 95,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04276896',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'GIMI-IRB-20001'},\n", + " 'Organization': {'OrgFullName': 'Shenzhen Geno-Immune Medical Institute',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Immunity and Safety of Covid-19 Synthetic Minigene Vaccine',\n", + " 'OfficialTitle': 'Phase I/II Multicenter Trial of Lentiviral Minigene Vaccine (LV-SMENP) of Covid-19 Coronavirus'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 24, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'July 31, 2023',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2024',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'February 17, 2020',\n", + " 'StudyFirstSubmitQCDate': 'February 17, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'February 19, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 17, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 19, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Shenzhen Geno-Immune Medical Institute',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': \"Shenzhen Third People's Hospital\",\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': \"Shenzhen Second People's Hospital\",\n", + " 'CollaboratorClass': 'OTHER'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'In December 2019, viral pneumonia caused by a novel beta-coronavirus (Covid-19) broke out in Wuhan, China. Some patients rapidly progressed and suffered severe acute respiratory failure and died, making it imperative to develop a safe and effective vaccine to treat and prevent severe Covid-19 pneumonia. Based on detailed analysis of the viral genome and search for potential immunogenic targets, a synthetic minigene has been engineered based on conserved domains of the viral structural proteins and a polyprotein protease. The infection of Covid-19 is mediated through binding of the Spike protein to the ACEII receptor, and the viral replication depends on molecular mechanisms of all of these viral proteins. This trial proposes to develop and test innovative Covid-19 minigenes engineered based on multiple viral genes, using an efficient lentiviral vector system (NHP/TYF) to express viral proteins and immune modulatory genes to modify dendritic cells (DCs) and to activate T cells. In this study, the safety and efficacy of this LV vaccine (LV-SMENP) will be investigated.',\n", + " 'DetailedDescription': 'Background: The 2019 discovered new coronavirus, Covid-19, is an enveloped positive strand single strand RNA virus. The number of Covid-19 infected people has increased rapidly and WHO has warned that the spread of Covid-19 may soon become pandemic and have disastrous outcomes. Covid-19 could pose a serious threat to human health and global economy. There is no vaccine available or clinically approved antiviral therapy as yet. This study aims to evaluate the safety and efficacy of treating Covid-19 infections with a novel lentiviral based DC and T cell vaccines.\\n\\nObjective: Primary study objectives: Injection and infusion of LV-SMENP DC and antigen-specific cytotoxic T cell vaccines to healthy volunteers and Covid-19 infected patients to evaluate the safety.\\n\\nSecondary study objectives: To evaluate the anti- Covid-19 efficacy of the LV-SMENP DC and antigen-specific cytotoxic T cell vaccines.\\n\\nDesign:\\n\\nBased on the genomic sequence of the new coronavirus Covid-19, select conserved and critical structural and protease protein domains to engineer lentiviral SMENP minigenes to express Covid-19 antigens.\\nLV-SMENP-DC vaccine is made by modifying DC with lentivirus vectors expressing Covid-19 minigene SMENP and immune modulatory genes. CTLs will be activated by LV-DC presenting Covid-19 specific antigens.\\nLV-DC vaccine and antigen-specific CTLs are prepared in 7~21 days. Subject will receive total 5x10^6 cells of LV-DC vaccine and 1x10^8 antigen-specific CTLs via sub-cutaneous injection and IV infusion, respectively. Patients are followed weekly for one month after the infusion, monthly for 3 months, and then every 3 months until the trial ends.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Pathogen Infection Covid-19 Infection']},\n", + " 'KeywordList': {'Keyword': ['Lentiviral vector',\n", + " 'LV-DC vaccine',\n", + " 'Covid-19 CTL']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 1', 'Phase 2']},\n", + " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '100',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'pathogen-specific DC and CTLs',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Patients will receive approximately 5x10^6 LV-DC vaccine and 1x10^8 CTLs via sub-cutaneous injections and iv infusions, respectively.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: Injection and infusion of LV-SMENP-DC vaccine and antigen-specific CTLs']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Biological',\n", + " 'InterventionName': 'Injection and infusion of LV-SMENP-DC vaccine and antigen-specific CTLs',\n", + " 'InterventionDescription': 'Patients will receive approximately 5x10^6 LV-DC vaccine and 1x10^8 CTLs via sub-cutaneous injections and iv infusions, respectively.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['pathogen-specific DC and CTLs']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Clinical improvement based on the 7-point scale',\n", + " 'PrimaryOutcomeDescription': 'A decline of 2 points on the 7-point scale from admission means better outcome. The 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).',\n", + " 'PrimaryOutcomeTimeFrame': '28 days after randomization'},\n", + " {'PrimaryOutcomeMeasure': 'Lower Murray lung injury score',\n", + " 'PrimaryOutcomeDescription': 'Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.',\n", + " 'PrimaryOutcomeTimeFrame': '7 days after randomization'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': '28-day mortality',\n", + " 'SecondaryOutcomeDescription': 'Number of deaths during study follow-up',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured from Day 0 through Day 28'},\n", + " {'SecondaryOutcomeMeasure': 'Duration of mechanical ventilation',\n", + " 'SecondaryOutcomeDescription': 'Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured from Day 0 through Day 28'},\n", + " {'SecondaryOutcomeMeasure': 'Duration of hospitalization',\n", + " 'SecondaryOutcomeDescription': 'Days that a participant spent at the hospital. Multiple hospitalizations are summed up.',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured from Day 0 through Day 28'},\n", + " {'SecondaryOutcomeMeasure': 'Proportion of patients with negative RT-PCR results',\n", + " 'SecondaryOutcomeDescription': 'Proportion of patients with negative RT-PCR results of virus in upper and/or lower respiratory tract samples.',\n", + " 'SecondaryOutcomeTimeFrame': '7 and 14 days after randomization'},\n", + " {'SecondaryOutcomeMeasure': 'Proportion of patients in each category of the 7-point scale',\n", + " 'SecondaryOutcomeDescription': 'Proportion of patients in each category of the 7-point scale, the 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).',\n", + " 'SecondaryOutcomeTimeFrame': '7,14 and 28 days after randomization'},\n", + " {'SecondaryOutcomeMeasure': 'Proportion of patients with normalized inflammation factors',\n", + " 'SecondaryOutcomeDescription': 'Proportion of patients with different inflammation factors in normalization range.',\n", + " 'SecondaryOutcomeTimeFrame': '7 and 14 days after randomization'},\n", + " {'SecondaryOutcomeMeasure': 'Frequency of vaccine/CTL Events',\n", + " 'SecondaryOutcomeDescription': 'Frequency of vaccine/CTL Events',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured from Day 0 through Day 28'},\n", + " {'SecondaryOutcomeMeasure': 'Frequency of Serious vaccine/CTL Events',\n", + " 'SecondaryOutcomeDescription': 'Frequency of Serious vaccine/CTL Events',\n", + " 'SecondaryOutcomeTimeFrame': 'Measured from Day 0 through Day 28'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nLaboratory (RT-PCR) confirmed Covid-19 infection in throat swab and/or sputum and/or lower respiratory tract samples;\\nThe interval between the onset of symptoms and randomized is within 7 days. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used;\\nWhite blood cells ≥ 3,500 / μl, lymphocytes ≥ 750 / μl;\\nHuman immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or tuberculosis (TB) test is negative;\\nSign the Informed Consent Form on a voluntary basis;\\n\\nExclusion Criteria:\\n\\nSubject infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), or HTLV (HTLV antibody positive).\\nSubject is albumin-intolerant.\\nSubject with life expectancy less than 4 weeks.\\nSubject participated in other investigational somatic cell therapies within past 30 days.\\nSubject with positive pregnancy test result.\\nResearchers consider unsuitable.',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '6 Months',\n", + " 'MaximumAge': '80 Years',\n", + " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Lung-Ji Chang, PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+86(755)8672 5195',\n", + " 'CentralContactEMail': 'c@szgimi.org'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Lung-Ji Chang, PhD',\n", + " 'OverallOfficialAffiliation': 'Shenzhen Geno-Immune Medical Institute',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Shenzhen Geno-immune Medical Institute',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Shenzhen',\n", + " 'LocationState': 'Guangdong',\n", + " 'LocationZip': '518000',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Lung-Ji Chang, PhD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '86-755-86725195',\n", + " 'LocationContactEMail': 'c@szgimi.org'}]}},\n", + " {'LocationFacility': \"Shenzhen Second People's Hospital\",\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Shenzhen',\n", + " 'LocationState': 'Guangdong',\n", + " 'LocationZip': '518000',\n", + " 'LocationCountry': 'China'},\n", + " {'LocationFacility': \"Shenzhen Third People's Hospital\",\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Shenzhen',\n", + " 'LocationState': 'Guangdong',\n", + " 'LocationZip': '518000',\n", + " 'LocationCountry': 'China'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000014612',\n", + " 'InterventionMeshTerm': 'Vaccines'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000007155',\n", + " 'InterventionAncestorTerm': 'Immunologic Factors'},\n", + " {'InterventionAncestorId': 'D000045505',\n", + " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M15943',\n", + " 'InterventionBrowseLeafName': 'Vaccines',\n", + " 'InterventionBrowseLeafAsFound': 'Vaccine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M8784',\n", + " 'InterventionBrowseLeafName': 'Immunologic Factors',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", + " 'ConditionMeshTerm': 'Infection'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafAsFound': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'}]}}}}},\n", + " {'Rank': 96,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04279899',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'CHFudanU_NNICU14'},\n", + " 'Organization': {'OrgFullName': \"Children's Hospital of Fudan University\",\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'The Investigation of the Neonates With or With Risk of COVID-19',\n", + " 'OfficialTitle': 'A Multicenter Observational Study of the Perinatal-neonatal Population With or With Risk of COVID-19 in China'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'February 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'February 1, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'November 30, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'February 18, 2020',\n", + " 'StudyFirstSubmitQCDate': 'February 19, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'February 21, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'February 19, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'February 21, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': \"Children's Hospital of Fudan University\",\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'Since December 2019, there has been an outbreak of novel coronavirus pneumonia in China. As of February 18, 2020, 72,530 cases confirmed with 2019 coronavirus disease(COVID-19) have been reported and 1,870 deaths were declared. Until now, cases of COVID-19 have been reported in 26 countries. This observational study aims to analysis the clinical features of neonates with COVID-19 and the neonates born to mother with COVID-19.',\n", + " 'DetailedDescription': 'Given that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads rapidly and is contagious to the general population, all the suspected or confirmed newborns will be admitted to the neonatal departments in designated hospitals of China. In this study, the diagnosis of neonatal SARS-CoV-2 infection is based on the criterion provided by National Health Commission and the Chinese perinatal-neonatal SARS-CoV-2 Committee. All samples will be treated as biohazardous material. SARS-CoV-2 will be tested in blood, cord blood, amniotic fluid, placenta, respiratory tract, stool, urine from mothers or neonates. The medical information questionnaires are classified into maternal and neonatal version, which include demographic details, epidemical history, clinical manifestations, tests collected time and results, imaging performed time and results and therapeutic data. Two researchers independently checked and recorded the data to ensure the accuracy of the data.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Neonatal Infection',\n", + " 'Perinatal Problems',\n", + " 'Infectious Disease']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Case-Only']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '100',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'The death of newborns with COVID-19',\n", + " 'PrimaryOutcomeTimeFrame': 'The date of discharge，an average of 4 weeks after the admission'},\n", + " {'PrimaryOutcomeMeasure': 'The SARS-CoV-2 infection of neonates born to mothers with COVID-19',\n", + " 'PrimaryOutcomeDescription': 'Neonates born to mothers with COVID-19 will be tested for SARS-CoV-2 after birth.Confirmed cases will meet the diagnosed criterion provided by National Health and Health Commission and the Chinese perinatal-neonatal SARS-CoV-2 Committee.',\n", + " 'PrimaryOutcomeTimeFrame': 'within 7days after the admission'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'The Chinese standardized Denver Developmental Screening Test (DDST) in neonates with or with risk of COVID-19',\n", + " 'SecondaryOutcomeDescription': 'The standardized DDST consists of 104 items and covers four areas of development: (a) personal/social, (b) fine motor/adaptive, (c) language, and (d) gross motor. In the present study, three trained professionals examined the children. The results of the DDST could be normal (no delays), suspect (2 or more caution items and/or 1 or more delays), abnormal (2 or more delays) or untestable (refusal of one or more items completely to the left of the age line or more than one item intersected by the age line in the 75-90% area). The children with suspect or abnormal results were retested 2 or 3 weeks later.',\n", + " 'SecondaryOutcomeTimeFrame': 'Infants ( ≥35 weeks）are at 6 months after birth;Infants（＜ 35weeks） are at a corrected age of 6 months.'},\n", + " {'SecondaryOutcomeMeasure': 'The small for gestational age newborns in the neonates born to mothers with COVID-19',\n", + " 'SecondaryOutcomeDescription': 'The small for gestational age infant is defined as live-born infants weighting less than the 10th percentile for gestational age (22 weeks+0 day to 36 weeks+6days).',\n", + " 'SecondaryOutcomeTimeFrame': 'at birth'},\n", + " {'SecondaryOutcomeMeasure': 'The preterm delivery of neonates born to mothers with COVID-19',\n", + " 'SecondaryOutcomeDescription': 'The preterm infant is defined as the gestational age less than 37weeks+0day.The gestational age range is 22 weeks+0 day to 36 weeks+6days',\n", + " 'SecondaryOutcomeTimeFrame': 'at birth'},\n", + " {'SecondaryOutcomeMeasure': 'The disease severity of neonates with COVID-19',\n", + " 'SecondaryOutcomeDescription': 'Infants with SARS-CoV-2 infection are classified into asymptomatic, mild infection and severe infection, according to the expert consensus provided by the Chinese',\n", + " 'SecondaryOutcomeTimeFrame': 'through study completion, estimated an average of 2 weeks'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nThe neonates with COVID-19,or neonates born by infected mothers\\n\\nExclusion Criteria:\\n\\nThe neonates with major anomalies',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MaximumAge': '28 Days',\n", + " 'StdAgeList': {'StdAge': ['Child']},\n", + " 'StudyPopulation': 'The study participants will be recruited from all the designated hospitals in in 31 provinces/municipalities of the mainland of China during SARS-CoV-2 epidemic.',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'LocationList': {'Location': [{'LocationFacility': 'Maternal and Child Health Hospital of Hubei Province',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Wuhan',\n", + " 'LocationState': 'Hubei',\n", + " 'LocationZip': '430070',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Shiwen Xia, M.D.',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '18971025669',\n", + " 'LocationContactEMail': 'shiwenxia66@163.com'}]}},\n", + " {'LocationFacility': 'Children Hospital of Fudan University',\n", + " 'LocationStatus': 'Not yet recruiting',\n", + " 'LocationCity': 'Shanghai',\n", + " 'LocationState': 'Shanghai',\n", + " 'LocationZip': '201102',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Wenhao Zhou, Doctor',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '(+86)021-64931003',\n", + " 'LocationContactEMail': 'zwhchfu@126.com'}]}}]}}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000003141',\n", + " 'ConditionMeshTerm': 'Communicable Diseases'},\n", + " {'ConditionMeshId': 'D000007239', 'ConditionMeshTerm': 'Infection'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafAsFound': 'Infectious Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafAsFound': 'Infectious Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'high'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", + " {'Rank': 97,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04327674',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'COVID-FLUS'},\n", + " 'Organization': {'OrgFullName': 'University of Aarhus',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'The Use of Focused Lung Ultrasound in Patients Suspected of COVID-19',\n", + " 'OfficialTitle': 'The Use of Focused Lung Ultrasound in Patients Suspected of COVID-19'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 14, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 15, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'May 15, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 27, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 30, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 31, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 30, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 31, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'University of Aarhus',\n", + " 'LeadSponsorClass': 'OTHER'}},\n", + " 'OversightModule': {'OversightHasDMC': 'No',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'COVID is a major health problem causing massive capacity problems at hospitals. Rapid and accurate diagnostic workflow is of paramount importance. Access to radiological diagnostics tools such as x-ray or computed tomography of the chest are limited even in high-resource settings.\\n\\nFocused lung ultrasound, FLUS, is a point-of-care diagnostic tool that allows rapid and on-site assessment of lung abnormalities. No transportation of the patient is required thus lowering risk of spreading SAR-CoV- inside the hospital.\\n\\nThis study aims to explore the diagnostic value of FLUS in the COVID-19 pandemic and to explore if FLUS findings can predict risk of respiratory failure.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'Yes',\n", + " 'TargetDuration': '1 Month',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '375',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'FLUS findings and respiratory failure',\n", + " 'PrimaryOutcomeDescription': 'Analysis of FLUS related to risk of development of respiratory failure.',\n", + " 'PrimaryOutcomeTimeFrame': 'Up to 3 months.'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'FLUS findings and chest x-ray.',\n", + " 'SecondaryOutcomeDescription': 'Analysis of FLUS related to risk of result of chest x-ray',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 3 months.'},\n", + " {'SecondaryOutcomeMeasure': 'FLUS findings and admission to intensive care.',\n", + " 'SecondaryOutcomeDescription': 'Analysis of FLUS related to risk of intensive care admission',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 3 months.'},\n", + " {'SecondaryOutcomeMeasure': 'FLUS findings and SAR-CoV-2 PCR-test result.',\n", + " 'SecondaryOutcomeDescription': 'Analysis of FLUS related to result from SAR-CoV-2 PCR-test',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 3 months.'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nClinical suspicion of COVID-19 requiring contact to a hospital.\\n\\nExclusion Criteria:\\n\\nAge less than 18 years\\nPrevious enrollment in this study.',\n", + " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", + " 'StudyPopulation': 'All patients who have symptoms on COVID-19 and is seen at a hospital.',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Søren H Skaarup',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '28911869',\n", + " 'CentralContactEMail': 'soeska@rm.dk'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Søren H Skaarup',\n", + " 'OverallOfficialAffiliation': 'Aarhus Universitets Hospital',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Lungemedicinsk Forskningsafdeling. Aarhus University Hospital',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Aarhus',\n", + " 'LocationZip': '8000',\n", + " 'LocationCountry': 'Denmark',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Søren Helbo SH Skaarup, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactPhone': '+45 28911869',\n", + " 'LocationContactEMail': 'soeska@rm.dk'}]}},\n", + " {'LocationFacility': 'Regionshospitalet Horsens.',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Horsens',\n", + " 'LocationCountry': 'Denmark',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Jesper Weile',\n", + " 'LocationContactRole': 'Contact'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'}}}},\n", + " {'Rank': 98,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04270383',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'BCH Lung 012'},\n", + " 'Organization': {'OrgFullName': \"Beijing Children's Hospital\",\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Clinical Characteristics and Long-term Prognosis of 2019-nCoV Infection in Children',\n", + " 'OfficialTitle': 'A Multicenter Observational Study About the Clinical Characteristics and Long-term Prognosis of 2019-nCoV Infection in Children'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'February 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'February 15, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'December 31, 2020',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2020',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'February 11, 2020',\n", + " 'StudyFirstSubmitQCDate': 'February 13, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'February 17, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'February 14, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'February 17, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Kunling Shen',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Director of National Clinical Research Center for Respiratory Diseases, China',\n", + " 'ResponsiblePartyInvestigatorAffiliation': \"Beijing Children's Hospital\"},\n", + " 'LeadSponsor': {'LeadSponsorName': \"Beijing Children's Hospital\",\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Capital Institute of Pediatrics, China',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'The First Affiliated Hospital of Anhui Medical University',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'China-Japan Friendship Hospital',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'The First Affiliated Hospital of Xiamen University',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': \"Guangzhou Women and Children's Medical Center\",\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': \"Shenzhen Children's Hospital\",\n", + " 'CollaboratorClass': 'OTHER_GOV'},\n", + " {'CollaboratorName': 'First Affiliated Hospital of Guangxi Medical University',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'The Affiliated Hospital Of Guizhou Medical University',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': \"Hainan People's Hospital\",\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': \"Children's Hospital of Hebei Province\",\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': \"Wuhan Women and Children's Medical Center\",\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': \"Changchun Children's Hospital\",\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'Children’s Hospital of Nanjing Medical University',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': \"Jiangxi Province Children's Hospital\",\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'Shengjing Hospital',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': \"Shanxi Provincial Maternity and Children's Hospital\",\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': \"Xian Children's Hospital\",\n", + " 'CollaboratorClass': 'OTHER_GOV'},\n", + " {'CollaboratorName': \"Children's Hospital of Chongqing Medical University\",\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': \"Tianjin Children's Hospital\",\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'Tianjin Medical University Second Hospital',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': \"Kunming Children's Hospital\",\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'Second Affiliated Hospital of Wenzhou Medical University',\n", + " 'CollaboratorClass': 'OTHER'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'The study is designed to clarify the clinical characteristics, risk factors and long-term prognosis of children with 2019-nCoV infection in China.',\n", + " 'DetailedDescription': \"As of February 10th, 2020, more than 40,000 human have been confirmed infected with a novel coronavirus (2019-nCoV) in China, with at least 800 reported deaths. Additional cases have been confirmed in multiple countries, and some are reported in children. Patients with confirmed 2019-nCoV infection have reported respiratory illness with fever, cough, et al. Some are asymptomatic carriers. However, there are relatively few diagnosed cases of children, and the long-term prognosis is unknown. Therefore, a multicenter observational study is needed to better understand the clinical characteristics of 2019-nCoV infection in children.\\n\\nThis observational study will last from February to December 2020. The patients enrolled were diagnosed with 2019-nCoV infection or 2019-nCoV pneumonia by Beijing Children's Hospital and other members of Chinese National Clinical Research Center for Respiratory Diseases in 2019-2020. At the same time, children hospitalized with pneumonia other than 2019-nCoV pneumonia during the same period are classified as the control group by 3~5:1 matching for age and sex to the 2019-nCoV group. After guardians signing the informed consent forms, all the participants' clinical data, laboratory examination results, image data and also the follow-up information after six months of their treatment will be collected.\\n\\nThe trial will be completed in 10 months, with subjects recruited from the hospitals that in partnership with clinical research collaboration of National Clinical Research Center for Respiratory Diseases.\"},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['2019-nCoV']},\n", + " 'KeywordList': {'Keyword': ['2019-nCoV infection',\n", + " '2019-nCoV pneumonia',\n", + " 'Children']}},\n", + " 'DesignModule': {'StudyType': 'Observational',\n", + " 'PatientRegistry': 'No',\n", + " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", + " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", + " 'BioSpec': {'BioSpecRetention': 'Samples Without DNA',\n", + " 'BioSpecDescription': 'Serum'},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '500',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': '2019-nCoV infection group',\n", + " 'ArmGroupDescription': 'Children hospitalized with direct laboratory confirmed of novel coronavirus with or without pneumonia are classified as the 2019-nCoV infection group.'},\n", + " {'ArmGroupLabel': 'Control group',\n", + " 'ArmGroupDescription': 'Children hospitalized with pneumonia other than the novel coronavirus pneumonia during the same hospitalization period as 2019-nCoV infection group are classified as the control group.'}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'The cure rate of 2019-nCoV.',\n", + " 'PrimaryOutcomeDescription': 'Percentage',\n", + " 'PrimaryOutcomeTimeFrame': '6 months'},\n", + " {'PrimaryOutcomeMeasure': 'The improvement rate of 2019-nCoV.',\n", + " 'PrimaryOutcomeDescription': 'Percentage',\n", + " 'PrimaryOutcomeTimeFrame': '6 months'},\n", + " {'PrimaryOutcomeMeasure': 'The incidence of long-term adverse outcomes.',\n", + " 'PrimaryOutcomeTimeFrame': '6 months'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Duration of fever',\n", + " 'SecondaryOutcomeDescription': 'Days',\n", + " 'SecondaryOutcomeTimeFrame': '2 weeks'},\n", + " {'SecondaryOutcomeMeasure': 'Duration of respiratory symptoms',\n", + " 'SecondaryOutcomeDescription': 'Days',\n", + " 'SecondaryOutcomeTimeFrame': '2 weeks'},\n", + " {'SecondaryOutcomeMeasure': 'Duration of hospitalization',\n", + " 'SecondaryOutcomeDescription': 'Days',\n", + " 'SecondaryOutcomeTimeFrame': '2 weeks'},\n", + " {'SecondaryOutcomeMeasure': 'Number of participant(s) need intensive care',\n", + " 'SecondaryOutcomeTimeFrame': '2 weeks'},\n", + " {'SecondaryOutcomeMeasure': 'Number of participant(s) with acute respiratory distress syndrome',\n", + " 'SecondaryOutcomeTimeFrame': '2 weeks'},\n", + " {'SecondaryOutcomeMeasure': 'Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al.',\n", + " 'SecondaryOutcomeTimeFrame': '2 weeks'},\n", + " {'SecondaryOutcomeMeasure': 'Number of participant(s) who died during the trial',\n", + " 'SecondaryOutcomeTimeFrame': '10 months'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'For the 2019-nCoV infection group\\n\\nInclusion Criteria:\\n\\nDiagnosed with 2019-nCoV infection (with direct laboratory evidence).\\n\\nRespiratory or blood samples tested positive for novel coronavirus nucleic acid with RT-PCR.\\nGene sequencing of respiratory or blood samples show highly homologous with known novel coronaviruses.\\n\\nExclusion Criteria:\\n\\nSubjects will be excluded if the children or their parents disagree to conduct this study.\\n\\nFor the control group\\n\\nInclusion Criteria:\\n\\nDiagnosed with pneumonia, and excepted of novel coronavirus infection.\\nThe hospitalization time is the same as that of novel coronavirus pneumonia.\\n\\nExclusion Criteria:\\n\\nSubject will be excluded if she or he has one of the following:\\n\\nFirst diagnosis is not pneumonia.\\nAny one of the novel coronavirus laboratory test results show positive.\\nChildren or their parents disagree to conduct this study.',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MaximumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Child', 'Adult']},\n", + " 'StudyPopulation': 'Patients who are aged 1day to 18 years, and diagnosed with 2019-nCoV infection/pneumonia or pneumonia other than novel coronavirus hospitalized in the same period in China.',\n", + " 'SamplingMethod': 'Non-Probability Sample'},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Baoping Xu, MD,PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '861059616308',\n", + " 'CentralContactEMail': 'xubaopingbch@163.com'},\n", + " {'CentralContactName': 'Kunling Shen, MD,PhD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactEMail': 'kunlingshen1717@163.com'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Kunling Shen, MD,PhD',\n", + " 'OverallOfficialAffiliation': \"Beijing Children's Hospital of Capital Medical University, China\",\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Tianyou Wang, MD,PhD',\n", + " 'OverallOfficialAffiliation': \"Beijing Children's Hospital of Capital Medical University, China\",\n", + " 'OverallOfficialRole': 'Principal Investigator'},\n", + " {'OverallOfficialName': 'Baoping Xu, MD,PhD',\n", + " 'OverallOfficialAffiliation': \"Beijing Children's Hospital of Capital Medical University, China\",\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': \"Beijing Children's Hospital,\",\n", + " 'LocationCity': 'Beijing',\n", + " 'LocationCountry': 'China',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Lina Wang',\n", + " 'LocationContactRole': 'Contact'}]}}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", + " 'ConditionMeshTerm': 'Infection'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafAsFound': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M12487',\n", + " 'ConditionBrowseLeafName': 'Pneumonia',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'}]}}}}},\n", + " {'Rank': 99,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04328493',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'COVID'},\n", + " 'Organization': {'OrgFullName': 'Oxford University Clinical Research Unit, Vietnam',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'The Vietnam Chloroquine Treatment on COVID-19',\n", + " 'OfficialTitle': 'A Multi Center Randomized Open Label Trial on the Safety and Efficacy of Chloroquine for the Treatment of Hospitalized Adults With Laboratory Confirmed SARS-CoV-2 Infection in Vietnam',\n", + " 'Acronym': 'VICO'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", + " 'OverallStatus': 'Not yet recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", + " 'StartDateType': 'Anticipated'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 1, 2021',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'April 1, 2022',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 27, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 30, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 31, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'March 30, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 31, 2020',\n", + " 'LastUpdatePostDateType': 'Actual'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Oxford University Clinical Research Unit, Vietnam',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Ministry of Health, Vietnam',\n", + " 'CollaboratorClass': 'OTHER_GOV'},\n", + " {'CollaboratorName': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': 'Cu Chi COVID Hospital, Vietnam',\n", + " 'CollaboratorClass': 'UNKNOWN'},\n", + " {'CollaboratorName': 'Can Gio COVID Hospital, Vietnam',\n", + " 'CollaboratorClass': 'UNKNOWN'},\n", + " {'CollaboratorName': 'Cho Ray Hospital, Vietnam',\n", + " 'CollaboratorClass': 'UNKNOWN'},\n", + " {'CollaboratorName': 'National Hospital for Tropical Diseases, Hanoi, Vietnam',\n", + " 'CollaboratorClass': 'OTHER_GOV'},\n", + " {'CollaboratorName': 'Department of Health, Ho Chi Minh city',\n", + " 'CollaboratorClass': 'UNKNOWN'}]}},\n", + " 'OversightModule': {'OversightHasDMC': 'Yes',\n", + " 'IsFDARegulatedDrug': 'No',\n", + " 'IsFDARegulatedDevice': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent COVID-19 or therapeutic agent to treat COVID-19. This clinical trial is designed to evaluate potential therapeutics for the treatment of hospitalized COVID-19.\\n\\nWe hypothesis that chloroquine slows viral replication in patients with COVID-19, attenuating the infection, and resulting in more rapid declines in viral load in throat swabs. This viral attenuation should be associated with improved patient outcomes. Given the enormous experience of its use in malaria chemoprophylaxis, excellent safety and tolerability profile, and its very low cost, if proved effective then chloroquine would be a readily deployable and affordable treatment for patients with COVID-19.\\n\\nThe study is funded and leaded by The Ministry of Health, Vietnam.',\n", + " 'DetailedDescription': 'The study will start with a 10-patient prospective observational pilot study. All these patients will be subject to the same entry and exclusion criteria for the randomized trial, and undergo the same procedures. They will all receive chloroquine at the doses used in the trial (see sections below); they will not be randomized. The purpose of the pilot is to develop the study procedures for the randomized controlled trial, including the safe monitoring of patients, to refine the CRF, and to acquire some preliminary data on the safety of chloroquine in those with COVID-19.\\n\\nOnce the pilot study has been completed, and the data reviewed by the TSC and DMC, and the MOH ethics committee, we will then proceed to the trial. We will aim for minimum delay between completing the pilot study and starting the randomized trial.\\n\\nThe main study is an open label, randomised, controlled trial that will be conducted in 240 in-patients in Ho Chi Minh City. Viet Nam.\\n\\nPatients will have daily assessment as per standard of care while in-patients by the hospital staff. While in-patients the study will collect the following data: peripheral oxygen saturation (pulse oximeter), respiratory rate, and FiO2 6 hourly. The use of ventilator or other assisted breathing device will be recorded each day.\\n\\nPatients will have more detailed clinical assessment recorded once weekly (i.e. on study days, 7, 14, 21 and 28 (±2 days) and on the day of discharge. This will include symptoms, respiratory, and cardiovascular examination, blood investigations and microbiological investigations as per the study schedule, recording of all medication and review of any adverse events.\\n\\nThe decision to discharge patients will be at the discretion of the attending physician and depend upon the clinical status of the patient. According to current standard of care recovery and hospital discharge is dependent upon the patient having had 2 daily consecutive negative PCR throat swabs. Following discharge patients will be seen on days 14, 28, 42 and 56 post-randomization.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['SARS-CoV-2 Infection',\n", + " 'COVID-19']},\n", + " 'KeywordList': {'Keyword': ['SARS-CoV-2', 'COVID-19', 'chloroquine']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 2']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignInterventionModelDescription': \"The main trial is an open label, randomised, controlled trial that will be conducted in in-patients in Ho Chi Minh City. Viet Nam. Randomization will be 1:1, stratified by study site and severity of illness, to either with or without chloroquine for 10 days. All patients will also receive a supportive care/treatment according to VN MoH's guidline for COVID-19\",\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '250',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Control arm',\n", + " 'ArmGroupType': 'No Intervention',\n", + " 'ArmGroupDescription': \"Patients randomized to the control arm will receive a standard of care therapy (a supportive care/treatment according to VN MoH's guideline).\"},\n", + " {'ArmGroupLabel': 'Intervention arm',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Patients randomized to the intervention arm receive chloroquine with a loading dose of 1200mg CQ phosphate base over the first 24 hours after randomization, followed by 300mg CQ phosphate base orally once daily for 9 days, in addition to standard of care therapy.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Chloroquine phosphate']}}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Chloroquine phosphate',\n", + " 'InterventionDescription': 'Chloroquine will be administered orally, as tablets. For unconscious patients chloroquine can be crushed and administered as a suspension via a nasogastric tube.\\n\\nA loading dose of 1200mg chloroquine phosphate base, administered with food where possible, is given on the first 24 hours after randomization. Following, patients will receive a dose of chloroquine phosphate base of 300mg once daily for 9 days (unless they are <60Kg, when the dose will be reduced following its pharmacokinetic properties).\\n\\nThe total duration of treatment with Chloroquine will be 10 days',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Intervention arm']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Chloroquine']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Viral clearance time',\n", + " 'PrimaryOutcomeDescription': 'Viral presence will be determined using RT-PCR to detect SARS-CoV-19 RNA. Throat swabs for viral RNA will be taken daily while in hospital until there have at least 2 consecutive negative results . Virus will be defined as cleared when the patient has had ≥2 consecutive negative PCR tests. The time to viral clearance will be defined as the time following randomization to the first of the negative throat swabs.',\n", + " 'PrimaryOutcomeTimeFrame': 'Up to 56 days post randomization'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Lengh of hospital stay',\n", + " 'SecondaryOutcomeDescription': 'The time since randomization to discharge between study groups',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 56 days post randomization'},\n", + " {'SecondaryOutcomeMeasure': 'Ventilator free days',\n", + " 'SecondaryOutcomeDescription': 'The number of ventilator free days over the first 28 days of treatment',\n", + " 'SecondaryOutcomeTimeFrame': 'first 28 days'},\n", + " {'SecondaryOutcomeMeasure': 'Oxygene free days',\n", + " 'SecondaryOutcomeDescription': 'The number of oxygene free days over the first 28 days of treatment',\n", + " 'SecondaryOutcomeTimeFrame': 'first 28 days'},\n", + " {'SecondaryOutcomeMeasure': 'Time to death',\n", + " 'SecondaryOutcomeDescription': 'The time to (all-cause) death following over the first 7, 10, 14, 28 and 56 days since randomization',\n", + " 'SecondaryOutcomeTimeFrame': 'first 7, 10, 14, 28 and 56 days since randomization'},\n", + " {'SecondaryOutcomeMeasure': 'Adverse events',\n", + " 'SecondaryOutcomeDescription': 'The rates of serious adverse events, rates of grade 3 or 4 adverse events',\n", + " 'SecondaryOutcomeTimeFrame': 'Over the first 28 days (due to the prolonged half-life of Chloroquine)'},\n", + " {'SecondaryOutcomeMeasure': 'Time to viral PCR negative from rectal swab',\n", + " 'SecondaryOutcomeDescription': 'Time since randomization to the first viral PCR negative from rectal swab',\n", + " 'SecondaryOutcomeTimeFrame': 'During the first 56 days post randomization'},\n", + " {'SecondaryOutcomeMeasure': 'fever clearance time',\n", + " 'SecondaryOutcomeDescription': 'Time since randomization to the first defervescence day',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 56 days post randomization'},\n", + " {'SecondaryOutcomeMeasure': 'Ordinal outcome scale',\n", + " 'SecondaryOutcomeDescription': 'WHO Ordinal outcome scale for COVID-19',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 56 days post randomization'},\n", + " {'SecondaryOutcomeMeasure': 'Development of ARDS',\n", + " 'SecondaryOutcomeDescription': 'Development of ARDS defined by the Kigali criteria',\n", + " 'SecondaryOutcomeTimeFrame': 'Up to 56 days post randomization'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen < 48 hours prior to randomization, and requiring hospital admission in the opinion of the attending physician.\\nProvides written informed consent prior to initiation of any study procedures (or legally authorized representative).\\nUnderstands and agrees to comply with planned study procedures.\\nAgrees to the collection of OP swabs and venous blood per protocol.\\nMale or female adult ≥18 years of age at time of enrollment.',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Jeremy Day, PhD. MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+84 8 39237954',\n", + " 'CentralContactEMail': 'jday@oucru.org'},\n", + " {'CentralContactName': 'Dung Nguyen, PhD. MD',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+84 28 3924 1983',\n", + " 'CentralContactEMail': 'CTU-Admin@oucru.org'}]},\n", + " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Guy Thwaites, PhD. MD',\n", + " 'OverallOfficialAffiliation': 'University of Oxford, UK',\n", + " 'OverallOfficialRole': 'Principal Investigator'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'National Hospital for Tropical Diseases',\n", + " 'LocationCity': 'Hanoi',\n", + " 'LocationCountry': 'Vietnam',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Thach N Pham, PhD. MD',\n", + " 'LocationContactRole': 'Contact'},\n", + " {'LocationContactName': 'Thach N Pham, PhD.MD',\n", + " 'LocationContactRole': 'Principal Investigator'}]}},\n", + " {'LocationFacility': 'Can Gio COVID Hospital',\n", + " 'LocationCity': 'Ho Chi Minh City',\n", + " 'LocationCountry': 'Vietnam',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Manh Hung Le',\n", + " 'LocationContactRole': 'Contact'},\n", + " {'LocationContactName': 'Manh Hung Le',\n", + " 'LocationContactRole': 'Principal Investigator'}]}},\n", + " {'LocationFacility': 'Cho Ray Hospital',\n", + " 'LocationCity': 'Ho Chi Minh City',\n", + " 'LocationCountry': 'Vietnam',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Hung Le Quoc, MD',\n", + " 'LocationContactRole': 'Principal Investigator'}]}},\n", + " {'LocationFacility': 'Cu Chi COVID Hospital',\n", + " 'LocationCity': 'Ho Chi Minh City',\n", + " 'LocationCountry': 'Vietnam',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Thanh Dung Nguyen',\n", + " 'LocationContactRole': 'Contact'},\n", + " {'LocationContactName': 'Thanh Dung Nguyen',\n", + " 'LocationContactRole': 'Principal Investigator'}]}},\n", + " {'LocationFacility': 'Hospital for Tropical Diseases',\n", + " 'LocationCity': 'Ho Chi Minh City',\n", + " 'LocationCountry': 'Vietnam',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Van Vinh Chau Nguyen, PhD, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactEMail': 'nguyenvanvinhchau@gmail.com'},\n", + " {'LocationContactName': 'Thanh Dung Nguyen, Dr',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Thanh Phong Nguyen, Dr',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Thanh Truong Nguyen, Dr',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Nguyen Huy Man Dinh, Dr',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Phuong Thao Huynh, Phar',\n", + " 'LocationContactRole': 'Sub-Investigator'},\n", + " {'LocationContactName': 'Van Vinh Chau Nguyen, Dr',\n", + " 'LocationContactRole': 'Principal Investigator'}]}}]}},\n", + " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '25186370',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Biggerstaff M, Cauchemez S, Reed C, Gambhir M, Finelli L. Estimates of the reproduction number for seasonal, pandemic, and zoonotic influenza: a systematic review of the literature. BMC Infect Dis. 2014 Sep 4;14:480. doi: 10.1186/1471-2334-14-480. Review.'},\n", + " {'ReferencePMID': '31987001',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Chan JF, Kok KH, Zhu Z, Chu H, To KK, Yuan S, Yuen KY. Genomic characterization of the 2019 novel human-pathogenic coronavirus isolated from a patient with atypical pneumonia after visiting Wuhan. Emerg Microbes Infect. 2020 Jan 28;9(1):221-236. doi: 10.1080/22221751.2020.1719902. eCollection 2020. Erratum in: Emerg Microbes Infect. 2020 Dec;9(1):540.'},\n", + " {'ReferencePMID': '32054787',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'de Wit E, Feldmann F, Cronin J, Jordan R, Okumura A, Thomas T, Scott D, Cihlar T, Feldmann H. Prophylactic and therapeutic remdesivir (GS-5734) treatment in the rhesus macaque model of MERS-CoV infection. Proc Natl Acad Sci U S A. 2020 Feb 13. pii: 201922083. doi: 10.1073/pnas.1922083117. [Epub ahead of print]'},\n", + " {'ReferencePMID': '32074550',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Gao J, Tian Z, Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends. 2020 Mar 16;14(1):72-73. doi: 10.5582/bst.2020.01047. Epub 2020 Feb 19.'},\n", + " {'ReferencePMID': '32094225',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Gordon CJ, Tchesnokov EP, Feng JY, Porter DP, Gotte M. The antiviral compound remdesivir potently inhibits RNA-dependent RNA polymerase from Middle East respiratory syndrome coronavirus. J Biol Chem. 2020 Feb 24. pii: jbc.AC120.013056. doi: 10.1074/jbc.AC120.013056. [Epub ahead of print]'},\n", + " {'ReferencePMID': '30401979',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Jorge A, Ung C, Young LH, Melles RB, Choi HK. Hydroxychloroquine retinopathy - implications of research advances for rheumatology care. Nat Rev Rheumatol. 2018 Dec;14(12):693-703. doi: 10.1038/s41584-018-0111-8. Review.'},\n", + " {'ReferencePMID': '31995857',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Li M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JTK, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Jan 29. doi: 10.1056/NEJMoa2001316. [Epub ahead of print]'},\n", + " {'ReferencePMID': '32164090',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Liu M, He P, Liu HG, Wang XJ, Li FJ, Chen S, Lin J, Chen P, Liu JH, Li CH. [Clinical characteristics of 30 medical workers infected with new coronavirus pneumonia]. Zhonghua Jie He He Hu Xi Za Zhi. 2020 Mar 12;43(3):209-214. doi: 10.3760/cma.j.issn.1001-0939.2020.03.014. Chinese.'},\n", + " {'ReferencePMID': '6059665',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'McChesney EW, Banks WF Jr, Fabian RJ. Tissue distribution of chloroquine, hydroxychloroquine, and desethylchloroquine in the rat. Toxicol Appl Pharmacol. 1967 May;10(3):501-13.'},\n", + " {'ReferencePMID': '32164085',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'multicenter collaboration group of Department of Science and Technology of Guangdong Province and Health Commission of Guangdong Province for chloroquine in the treatment of novel coronavirus pneumonia. [Expert consensus on chloroquine phosphate for the treatment of novel coronavirus pneumonia]. Zhonghua Jie He He Hu Xi Za Zhi. 2020 Mar 12;43(3):185-188. doi: 10.3760/cma.j.issn.1001-0939.2020.03.009. Chinese.'},\n", + " {'ReferencePMID': '16297415',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Shaw K. The 2003 SARS outbreak and its impact on infection control practices. Public Health. 2006 Jan;120(1):8-14. Epub 2005 Nov 16.'},\n", + " {'ReferencePMID': '17300627',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Villegas L, McGready R, Htway M, Paw MK, Pimanpanarak M, Arunjerdja R, Viladpai-Nguen SJ, Greenwood B, White NJ, Nosten F. Chloroquine prophylaxis against vivax malaria in pregnancy: a randomized, double-blind, placebo-controlled trial. Trop Med Int Health. 2007 Feb;12(2):209-18.'},\n", + " {'ReferencePMID': '16115318',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Vincent MJ, Bergeron E, Benjannet S, Erickson BR, Rollin PE, Ksiazek TG, Seidah NG, Nichol ST. Chloroquine is a potent inhibitor of SARS coronavirus infection and spread. Virol J. 2005 Aug 22;2:69.'},\n", + " {'ReferencePMID': '32020029',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Wang M, Cao R, Zhang L, Yang X, Liu J, Xu M, Shi Z, Hu Z, Zhong W, Xiao G. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020 Mar;30(3):269-271. doi: 10.1038/s41422-020-0282-0. Epub 2020 Feb 4.'},\n", + " {'ReferencePMID': '3054558',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'White NJ, Miller KD, Churchill FC, Berry C, Brown J, Williams SB, Greenwood BM. Chloroquine treatment of severe malaria in children. Pharmacokinetics, toxicity, and new dosage recommendations. N Engl J Med. 1988 Dec 8;319(23):1493-500.'},\n", + " {'ReferencePMID': '23075143',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Zaki AM, van Boheemen S, Bestebroer TM, Osterhaus AD, Fouchier RA. Isolation of a novel coronavirus from a man with pneumonia in Saudi Arabia. N Engl J Med. 2012 Nov 8;367(19):1814-20. doi: 10.1056/NEJMoa1211721. Epub 2012 Oct 17. Erratum in: N Engl J Med. 2013 Jul 25;369(4):394.'},\n", + " {'ReferencePMID': '32007643',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Zhao S, Lin Q, Ran J, Musa SS, Yang G, Wang W, Lou Y, Gao D, Yang L, He D, Wang MH. Preliminary estimation of the basic reproduction number of novel coronavirus (2019-nCoV) in China, from 2019 to 2020: A data-driven analysis in the early phase of the outbreak. Int J Infect Dis. 2020 Mar;92:214-217. doi: 10.1016/j.ijid.2020.01.050. Epub 2020 Jan 30.'},\n", + " {'ReferencePMID': '31978945',\n", + " 'ReferenceType': 'background',\n", + " 'ReferenceCitation': 'Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.'}]},\n", + " 'SeeAlsoLinkList': {'SeeAlsoLink': [{'SeeAlsoLinkLabel': 'in press',\n", + " 'SeeAlsoLinkURL': 'https://doi.org/10.1016/j.ijantimicag.2020.105949'},\n", + " {'SeeAlsoLinkLabel': 'World Health Organization Model List of Essential Medicines',\n", + " 'SeeAlsoLinkURL': 'https://apps.who.int/iris/bitstream/handle/10665/325771/WHO-MVP-EMP-IAU-2019.06-eng.pdf?ua=1'},\n", + " {'SeeAlsoLinkLabel': 'COVID-19 Coronavirus Pandemic updates',\n", + " 'SeeAlsoLinkURL': 'https://www.worldometers.info/coronavirus/'}]}},\n", + " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000002738',\n", + " 'InterventionMeshTerm': 'Chloroquine'},\n", + " {'InterventionMeshId': 'C000023676',\n", + " 'InterventionMeshTerm': 'Chloroquine diphosphate'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000563',\n", + " 'InterventionAncestorTerm': 'Amebicides'},\n", + " {'InterventionAncestorId': 'D000000981',\n", + " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", + " {'InterventionAncestorId': 'D000000977',\n", + " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", + " {'InterventionAncestorId': 'D000000890',\n", + " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", + " {'InterventionAncestorId': 'D000000962',\n", + " 'InterventionAncestorTerm': 'Antimalarials'},\n", + " {'InterventionAncestorId': 'D000018501',\n", + " 'InterventionAncestorTerm': 'Antirheumatic Agents'},\n", + " {'InterventionAncestorId': 'D000000894',\n", + " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents, Non-Steroidal'},\n", + " {'InterventionAncestorId': 'D000018712',\n", + " 'InterventionAncestorTerm': 'Analgesics, Non-Narcotic'},\n", + " {'InterventionAncestorId': 'D000000700',\n", + " 'InterventionAncestorTerm': 'Analgesics'},\n", + " {'InterventionAncestorId': 'D000018689',\n", + " 'InterventionAncestorTerm': 'Sensory System Agents'},\n", + " {'InterventionAncestorId': 'D000018373',\n", + " 'InterventionAncestorTerm': 'Peripheral Nervous System Agents'},\n", + " {'InterventionAncestorId': 'D000045505',\n", + " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", + " {'InterventionAncestorId': 'D000000893',\n", + " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents'},\n", + " {'InterventionAncestorId': 'D000005369',\n", + " 'InterventionAncestorTerm': 'Filaricides'},\n", + " {'InterventionAncestorId': 'D000000969',\n", + " 'InterventionAncestorTerm': 'Antinematodal Agents'},\n", + " {'InterventionAncestorId': 'D000000871',\n", + " 'InterventionAncestorTerm': 'Anthelmintics'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M4562',\n", + " 'InterventionBrowseLeafName': 'Chloroquine',\n", + " 'InterventionBrowseLeafAsFound': 'Chloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M151035',\n", + " 'InterventionBrowseLeafName': 'Chloroquine diphosphate',\n", + " 'InterventionBrowseLeafAsFound': 'Chloroquine',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M2879',\n", + " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2875',\n", + " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2795',\n", + " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2861',\n", + " 'InterventionBrowseLeafName': 'Antimalarials',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19188',\n", + " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2798',\n", + " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2799',\n", + " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents, Non-Steroidal',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2613',\n", + " 'InterventionBrowseLeafName': 'Analgesics',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19370',\n", + " 'InterventionBrowseLeafName': 'Analgesics, Non-Narcotic',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2777',\n", + " 'InterventionBrowseLeafName': 'Anthelmintics',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", + " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", + " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", + " {'InterventionBrowseBranchAbbrev': 'Infl',\n", + " 'InterventionBrowseBranchName': 'Anti-Inflammatory Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'Analg',\n", + " 'InterventionBrowseBranchName': 'Analgesics'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", + " 'ConditionMeshTerm': 'Infection'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafAsFound': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", + " {'Rank': 100,\n", + " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04305457',\n", + " 'OrgStudyIdInfo': {'OrgStudyId': 'NOgas mildCOVID-19'},\n", + " 'Organization': {'OrgFullName': 'Massachusetts General Hospital',\n", + " 'OrgClass': 'OTHER'},\n", + " 'BriefTitle': 'Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID-19',\n", + " 'OfficialTitle': 'Nitric Oxide Gas Inhalation Therapy in Spontaneous Breathing Patients With Mild/Moderate COVID-19: a Randomized Clinical Trial',\n", + " 'Acronym': 'NoCovid'},\n", + " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", + " 'OverallStatus': 'Recruiting',\n", + " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", + " 'StartDateStruct': {'StartDate': 'March 21, 2020',\n", + " 'StartDateType': 'Actual'},\n", + " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 1, 2021',\n", + " 'PrimaryCompletionDateType': 'Anticipated'},\n", + " 'CompletionDateStruct': {'CompletionDate': 'April 1, 2022',\n", + " 'CompletionDateType': 'Anticipated'},\n", + " 'StudyFirstSubmitDate': 'March 9, 2020',\n", + " 'StudyFirstSubmitQCDate': 'March 11, 2020',\n", + " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 12, 2020',\n", + " 'StudyFirstPostDateType': 'Actual'},\n", + " 'LastUpdateSubmitDate': 'April 2, 2020',\n", + " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", + " 'LastUpdatePostDateType': 'Estimate'}},\n", + " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", + " 'ResponsiblePartyInvestigatorFullName': 'Lorenzo Berra, MD',\n", + " 'ResponsiblePartyInvestigatorTitle': 'Medical Doctor',\n", + " 'ResponsiblePartyInvestigatorAffiliation': 'Massachusetts General Hospital'},\n", + " 'LeadSponsor': {'LeadSponsorName': 'Massachusetts General Hospital',\n", + " 'LeadSponsorClass': 'OTHER'},\n", + " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Xijing Hospital',\n", + " 'CollaboratorClass': 'OTHER'},\n", + " {'CollaboratorName': \"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico\",\n", + " 'CollaboratorClass': 'OTHER'}]}},\n", + " 'OversightModule': {'IsFDARegulatedDrug': 'Yes',\n", + " 'IsFDARegulatedDevice': 'No',\n", + " 'IsUSExport': 'No'},\n", + " 'DescriptionModule': {'BriefSummary': 'The scientific community is in search for novel therapies that can help to face the ongoing epidemics of novel Coronavirus (SARS-Cov-2) originated in China in December 2019. At present, there are no proven interventions to prevent progression of the disease. Some preliminary data on SARS pneumonia suggest that inhaled Nitric Oxide (NO) could have beneficial effects on SARS-CoV-2 due to the genomic similarities between this two coronaviruses. In this study we will test whether inhaled NO therapy prevents progression in patients with mild to moderate COVID-19 disease.',\n", + " 'DetailedDescription': 'To date, no targeted therapeutic treatments for the ongoing COVID-19 outbreak have been identified. Antiviral combined with adjuvant therapies are currently under investigation. The clinical spectrum of the infection is wide, ranging from mild signs of upper respiratory tract infection to severe pneumonia and death.\\n\\nIn the patients who progress, the time period from symptoms onset to development of dyspnea is reported to be between 5 to 10 days, and that one to severe respiratory distress syndrome from 10 to 14 days. Globally, 15 to 18% of patients deteriorates to the need of mechanical ventilation, despite the use of non-invasive ventilatory support in the earliest phases of the disease. Probability of progression to end stage disease is unpredictable, with the majority of these patients dying from multi-organ failure. Preventing progression in spontaneously breathing patients with mild to moderate disease would translate in improved morbidity and mortality and in a lower use of limited healthcare resources.\\n\\nIn 2004, during the SARS-coronavirus (SARS-CoV) outbreak, a pilot study showed that low dose ( max 30 ppm) inhaled NO for 3 days was able to shorten the time of ventilatory support. At the same time, NO donor compound S-nitroso-N-acetylpenicillamine increased survival rate in an in-vitro model of SARS-CoV infected epithelial cells.Based on the genetic similarities between the two viruses, similar effects of NO on SARS-CoV-2 can be hypothesized. While further in-vitro testing is recommended, we proposed a randomized clinical trial to test the effectiveness of inhaled NO in preventing the progression of SARS-CoV-2 related disease, when administered at an early stage.'},\n", + " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus Infections',\n", + " 'Pneumonia, Viral',\n", + " 'Acute Respiratory Distress Syndrome']},\n", + " 'KeywordList': {'Keyword': ['COVID-19',\n", + " 'ARDS',\n", + " 'Mechanical Ventilation',\n", + " 'Nitric Oxide']}},\n", + " 'DesignModule': {'StudyType': 'Interventional',\n", + " 'PhaseList': {'Phase': ['Phase 2']},\n", + " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", + " 'DesignInterventionModel': 'Parallel Assignment',\n", + " 'DesignPrimaryPurpose': 'Treatment',\n", + " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", + " 'EnrollmentInfo': {'EnrollmentCount': '240',\n", + " 'EnrollmentType': 'Anticipated'}},\n", + " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Nitric Oxide inhalation',\n", + " 'ArmGroupType': 'Experimental',\n", + " 'ArmGroupDescription': 'Nitric Oxide will be delivered through a non invasive CPAP system (with minimal pressure support to decrease discomfort due to the facial mask) or through a non-rebreathing mask system.',\n", + " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Nitric Oxide']}},\n", + " {'ArmGroupLabel': 'Control',\n", + " 'ArmGroupType': 'No Intervention',\n", + " 'ArmGroupDescription': 'Patients assigned to the control group will not receive any gas therapy.'}]},\n", + " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", + " 'InterventionName': 'Nitric Oxide',\n", + " 'InterventionDescription': 'Nitric Oxide (NO) will be delivered together with the standard of care for a period of 20-30 minutes 2 times per day for 14 consecutive days from time of enrollment. Targeted No inhaled concentration will be maintained between 140 and 180 ppm. The gas will be delivered through a CPAP circuit ensuring an end-expiratory pressure between 2 and 10 cmH2O or through a non-rebreathing mask without positive end-expiratory pressure, depending on the clinical needs of the patient.',\n", + " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Nitric Oxide inhalation']},\n", + " 'InterventionOtherNameList': {'InterventionOtherName': ['Nitric Oxide inhalation']}}]}},\n", + " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Reduction in the incidence of patients with mild/moderate COVID-19 requiring intubation and mechanical ventilation',\n", + " 'PrimaryOutcomeDescription': 'The primary outcome will be the reduction in the incidence of patients requiring intubation and mechanical ventilation, as a marker of deterioration from a mild to a severe form of COVID-19. Patients with indication to intubation and mechanical ventilation but concomitant DNI (Do Not Intubate) or not intubated for any other reason external to the clinical judgment of the attending physician will be considered as meeting the criteria for the primary endpoint.',\n", + " 'PrimaryOutcomeTimeFrame': '28 days'}]},\n", + " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Mortality',\n", + " 'SecondaryOutcomeDescription': 'Proportion of deaths from all causes',\n", + " 'SecondaryOutcomeTimeFrame': '28 days'},\n", + " {'SecondaryOutcomeMeasure': 'Time to clinical recovery',\n", + " 'SecondaryOutcomeDescription': 'Time from initiation of the study to discharge or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air), alleviation of cough (defined as mild or absent in a patient reported scale of severe >>moderate>>mild>>absent) and resolution of hypoxia (defined as SpO2 ≥ 93% in room air or P/F ≥ 300 mmHg). All these improvements must be sustained for 72 hours.',\n", + " 'SecondaryOutcomeTimeFrame': '28 days'}]},\n", + " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'Negative conversion of COVID-19 RT-PCR from upper respiratory tract',\n", + " 'OtherOutcomeDescription': 'Proportion of patients with a negative conversion of RT-PCR from an oropharyngeal or oropharyngeal swab.',\n", + " 'OtherOutcomeTimeFrame': '7 days'}]}},\n", + " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nLaboratory confirmed COVID19 infection defined with a positive RT-PCR from any specimen and/or detection of SARS-CoV-2 IgM/IgG antibodies.\\n\\nHospital admission with at least one of the following:\\n\\nfever ≥ 36.6 °C from axillary site; or ≥ 37.2°C from oral site; or ≥ 37.6°C from tympanic or rectal site.\\nRespiratory rate ≥ 24 bpm\\ncough\\nSpontaneous breathing with or without hypoxia of any degree. Gas exchange and ventilation maybe assisted by any continuous continuous airway pressure (CPAP), or any system of Non Invasive Ventilation (NIV), with Positive End-Expiratory Pressure (PEEP) ≤ 10 cmH2O.\\n\\nExclusion Criteria:\\n\\nTracheostomy\\nTherapy with high flow nasal cannula\\nAny clinical contraindications, as judged by the attending physician\\nHospitalized and confirmed diagnosis of COVID-19 for more than 72 hours',\n", + " 'HealthyVolunteers': 'No',\n", + " 'Gender': 'All',\n", + " 'MinimumAge': '18 Years',\n", + " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", + " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Lorenzo Berra',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+16176437733',\n", + " 'CentralContactEMail': 'lberra@mgh.harvard.edu'},\n", + " {'CentralContactName': 'Lei Chong',\n", + " 'CentralContactRole': 'Contact',\n", + " 'CentralContactPhone': '+86 8629011362',\n", + " 'CentralContactEMail': 'crystalleichong@126.com'}]},\n", + " 'LocationList': {'Location': [{'LocationFacility': 'Massachusetts General Hospital',\n", + " 'LocationStatus': 'Recruiting',\n", + " 'LocationCity': 'Boston',\n", + " 'LocationState': 'Massachusetts',\n", + " 'LocationZip': '02114-2621',\n", + " 'LocationCountry': 'United States',\n", + " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Lorenzo Berra, MD',\n", + " 'LocationContactRole': 'Contact',\n", + " 'LocationContactEMail': 'lberra@mgh.harvard.edu'}]}}]}}},\n", + " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", + " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000009569',\n", + " 'InterventionMeshTerm': 'Nitric Oxide'}]},\n", + " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000001993',\n", + " 'InterventionAncestorTerm': 'Bronchodilator Agents'},\n", + " {'InterventionAncestorId': 'D000001337',\n", + " 'InterventionAncestorTerm': 'Autonomic Agents'},\n", + " {'InterventionAncestorId': 'D000018373',\n", + " 'InterventionAncestorTerm': 'Peripheral Nervous System Agents'},\n", + " {'InterventionAncestorId': 'D000045505',\n", + " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", + " {'InterventionAncestorId': 'D000018927',\n", + " 'InterventionAncestorTerm': 'Anti-Asthmatic Agents'},\n", + " {'InterventionAncestorId': 'D000019141',\n", + " 'InterventionAncestorTerm': 'Respiratory System Agents'},\n", + " {'InterventionAncestorId': 'D000016166',\n", + " 'InterventionAncestorTerm': 'Free Radical Scavengers'},\n", + " {'InterventionAncestorId': 'D000000975',\n", + " 'InterventionAncestorTerm': 'Antioxidants'},\n", + " {'InterventionAncestorId': 'D000045504',\n", + " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", + " {'InterventionAncestorId': 'D000018377',\n", + " 'InterventionAncestorTerm': 'Neurotransmitter Agents'},\n", + " {'InterventionAncestorId': 'D000045462',\n", + " 'InterventionAncestorTerm': 'Endothelium-Dependent Relaxing Factors'},\n", + " {'InterventionAncestorId': 'D000014665',\n", + " 'InterventionAncestorTerm': 'Vasodilator Agents'},\n", + " {'InterventionAncestorId': 'D000064426',\n", + " 'InterventionAncestorTerm': 'Gasotransmitters'},\n", + " {'InterventionAncestorId': 'D000020011',\n", + " 'InterventionAncestorTerm': 'Protective Agents'}]},\n", + " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M11090',\n", + " 'InterventionBrowseLeafName': 'Nitric Oxide',\n", + " 'InterventionBrowseLeafAsFound': 'Nitric Oxide',\n", + " 'InterventionBrowseLeafRelevance': 'high'},\n", + " {'InterventionBrowseLeafId': 'M3851',\n", + " 'InterventionBrowseLeafName': 'Bronchodilator Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M3219',\n", + " 'InterventionBrowseLeafName': 'Autonomic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19547',\n", + " 'InterventionBrowseLeafName': 'Anti-Asthmatic Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19721',\n", + " 'InterventionBrowseLeafName': 'Respiratory System Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M17210',\n", + " 'InterventionBrowseLeafName': 'Free Radical Scavengers',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M2873',\n", + " 'InterventionBrowseLeafName': 'Antioxidants',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M19088',\n", + " 'InterventionBrowseLeafName': 'Neurotransmitter Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M15995',\n", + " 'InterventionBrowseLeafName': 'Vasodilator Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'},\n", + " {'InterventionBrowseLeafId': 'M20453',\n", + " 'InterventionBrowseLeafName': 'Protective Agents',\n", + " 'InterventionBrowseLeafRelevance': 'low'}]},\n", + " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'VaDiAg',\n", + " 'InterventionBrowseBranchName': 'Vasodilator Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'Resp',\n", + " 'InterventionBrowseBranchName': 'Respiratory System Agents'},\n", + " {'InterventionBrowseBranchAbbrev': 'All',\n", + " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", + " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", + " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", + " {'ConditionMeshId': 'D000045169',\n", + " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'},\n", + " {'ConditionMeshId': 'D000011024',\n", + " 'ConditionMeshTerm': 'Pneumonia, Viral'},\n", + " {'ConditionMeshId': 'D000012127',\n", + " 'ConditionMeshTerm': 'Respiratory Distress Syndrome, Newborn'},\n", + " {'ConditionMeshId': 'D000012128',\n", + " 'ConditionMeshTerm': 'Respiratory Distress Syndrome, Adult'},\n", + " {'ConditionMeshId': 'D000055371',\n", + " 'ConditionMeshTerm': 'Acute Lung Injury'}]},\n", + " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000011014',\n", + " 'ConditionAncestorTerm': 'Pneumonia'},\n", + " {'ConditionAncestorId': 'D000008171',\n", + " 'ConditionAncestorTerm': 'Lung Diseases'},\n", + " {'ConditionAncestorId': 'D000012140',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", + " {'ConditionAncestorId': 'D000012141',\n", + " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", + " {'ConditionAncestorId': 'D000012120',\n", + " 'ConditionAncestorTerm': 'Respiration Disorders'},\n", + " {'ConditionAncestorId': 'D000007235',\n", + " 'ConditionAncestorTerm': 'Infant, Premature, Diseases'},\n", + " {'ConditionAncestorId': 'D000007232',\n", + " 'ConditionAncestorTerm': 'Infant, Newborn, Diseases'},\n", + " {'ConditionAncestorId': 'D000055370',\n", + " 'ConditionAncestorTerm': 'Lung Injury'},\n", + " {'ConditionAncestorId': 'D000003333',\n", + " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", + " {'ConditionAncestorId': 'D000030341',\n", + " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", + " {'ConditionAncestorId': 'D000012327',\n", + " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", + " {'ConditionAncestorId': 'D000014777',\n", + " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", + " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", + " 'ConditionBrowseLeafName': 'Infection',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M19074',\n", + " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M24032',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M14938',\n", + " 'ConditionBrowseLeafName': 'Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M4951',\n", + " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13547',\n", + " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Newborn',\n", + " 'ConditionBrowseLeafAsFound': 'Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M13548',\n", + " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Adult',\n", + " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M12487',\n", + " 'ConditionBrowseLeafName': 'Pneumonia',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M26731',\n", + " 'ConditionBrowseLeafName': 'Acute Lung Injury',\n", + " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M25724',\n", + " 'ConditionBrowseLeafName': 'Respiratory Aspiration',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M12497',\n", + " 'ConditionBrowseLeafName': 'Pneumonia, Viral',\n", + " 'ConditionBrowseLeafAsFound': 'Pneumonia, Viral',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'M26730',\n", + " 'ConditionBrowseLeafName': 'Lung Injury',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M9751',\n", + " 'ConditionBrowseLeafName': 'Lung Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13560',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13561',\n", + " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13540',\n", + " 'ConditionBrowseLeafName': 'Respiration Disorders',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M24456',\n", + " 'ConditionBrowseLeafName': 'Premature Birth',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M8862',\n", + " 'ConditionBrowseLeafName': 'Infant, Premature, Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M8859',\n", + " 'ConditionBrowseLeafName': 'Infant, Newborn, Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M16105',\n", + " 'ConditionBrowseLeafName': 'Virus Diseases',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'M13732',\n", + " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", + " 'ConditionBrowseLeafRelevance': 'low'},\n", + " {'ConditionBrowseLeafId': 'T5213',\n", + " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'T4953',\n", + " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Infant',\n", + " 'ConditionBrowseLeafAsFound': 'Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'},\n", + " {'ConditionBrowseLeafId': 'T191',\n", + " 'ConditionBrowseLeafName': 'Acute Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", + " 'ConditionBrowseLeafRelevance': 'high'}]},\n", + " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", + " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'All',\n", + " 'ConditionBrowseBranchName': 'All Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC02',\n", + " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC08',\n", + " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC23',\n", + " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC16',\n", + " 'ConditionBrowseBranchName': 'Diseases and Abnormalities at or Before Birth'},\n", + " {'ConditionBrowseBranchAbbrev': 'BC26',\n", + " 'ConditionBrowseBranchName': 'Wounds and Injuries'},\n", + " {'ConditionBrowseBranchAbbrev': 'BXS',\n", + " 'ConditionBrowseBranchName': 'Urinary Tract, Sexual Organs, and Pregnancy Conditions'},\n", + " {'ConditionBrowseBranchAbbrev': 'Rare',\n", + " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}}]}}" + ] + }, + "execution_count": 32, + "metadata": {}, + "output_type": "execute_result" } ], "source": [ - "internationalstudies = xlsUrlToDF(url)" + "apiWrapper(\"covid-19\",1)" ] }, { From 51ab12fc1644cb4798600a69446c3b10d9fa0817 Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Mon, 6 Apr 2020 12:46:03 +1000 Subject: [PATCH 23/47] removed consol useage from scraping data --- modules/TempNB/IngestDrugSynonyms.ipynb | 19273 +--------------------- 1 file changed, 370 insertions(+), 18903 deletions(-) diff --git a/modules/TempNB/IngestDrugSynonyms.ipynb b/modules/TempNB/IngestDrugSynonyms.ipynb index 8e886df..9829536 100644 --- a/modules/TempNB/IngestDrugSynonyms.ipynb +++ b/modules/TempNB/IngestDrugSynonyms.ipynb @@ -2,7 +2,7 @@ "cells": [ { "cell_type": "code", - "execution_count": 1, + "execution_count": 2, "metadata": {}, "outputs": [], "source": [ @@ -19,7 +19,7 @@ }, { "cell_type": "code", - "execution_count": 2, + "execution_count": 17, "metadata": {}, "outputs": [ { @@ -33,16 +33,28 @@ }, "metadata": {}, "output_type": "display_data" + }, + { + "name": "stderr", + "output_type": "stream", + "text": [ + "/home/ben/Projects/Graphs4GoodHackathon/ProjectDomino/.Domino/lib/python3.7/site-packages/ipykernel_launcher.py:3: FutureWarning: Passing a negative integer is deprecated in version 1.0 and will not be supported in future version. Instead, use None to not limit the column width.\n", + " This is separate from the ipykernel package so we can avoid doing imports until\n" + ] } ], "source": [ "from IPython.core.display import display, HTML\n", - "display(HTML(\"\"))" + "display(HTML(\"\"))\n", + "pd.set_option('display.max_colwidth', -1)\n", + "pd.set_option('display.max_rows', 500)\n", + "pd.set_option('display.max_columns', 500)\n", + "pd.set_option('display.width', 1000)" ] }, { "cell_type": "code", - "execution_count": 23, + "execution_count": 4, "metadata": {}, "outputs": [], "source": [ @@ -54,12 +66,11 @@ }, { "cell_type": "code", - "execution_count": 15, + "execution_count": 21, "metadata": {}, "outputs": [], "source": [ - "def xlsUrlToDF(url:str) -> pd.DataFrame:\n", - " r = requests.get(url, allow_redirects=True)\n", + "def xlsHandler(r):\n", " df = pd.DataFrame()\n", " with tempfile.NamedTemporaryFile(\"wb\") as xls_file:\n", " xls_file.write(r.content)\n", @@ -84,12 +95,37 @@ }, { "cell_type": "code", - "execution_count": 24, + "execution_count": 39, + "metadata": {}, + "outputs": [], + "source": [ + "def csvZipHandler(r):\n", + " df = pd.DataFrame()\n", + " with tempfile.NamedTemporaryFile(\"wb\",suffix='.csv.zip') as file:\n", + " file.write(r.content)\n", + " df = pd.read_csv(file.name)\n", + " file.close()\n", + " return df" + ] + }, + { + "cell_type": "code", + "execution_count": 22, + "metadata": {}, + "outputs": [], + "source": [ + "def urlToDF(url:str,respHandler) -> pd.DataFrame:\n", + " r = requests.get(url, allow_redirects=True)\n", + " df = pd.DataFrame()\n", + " return respHandler(r)" + ] + }, + { + "cell_type": "code", + "execution_count": 23, "metadata": {}, "outputs": [], "source": [ - "# TODO url to config\n", - "\n", "def api(query,from_study,to_study):\n", " url = os.environ[\"URL_USA\"].format(query,from_study,to_study)\n", " response = requests.request(\"GET\", url)\n", @@ -98,7 +134,7 @@ }, { "cell_type": "code", - "execution_count": 25, + "execution_count": 24, "metadata": {}, "outputs": [], "source": [ @@ -108,7 +144,7 @@ }, { "cell_type": "code", - "execution_count": 26, + "execution_count": 25, "metadata": {}, "outputs": [], "source": [ @@ -129,26 +165,161 @@ }, { "cell_type": "code", - "execution_count": 29, + "execution_count": 27, "metadata": {}, "outputs": [], "source": [ - "#TODO to config\n", "url_int = os.environ[\"URL_INT\"]" ] }, + { + "cell_type": "code", + "execution_count": 31, + "metadata": {}, + "outputs": [], + "source": [ + "internationalstudies = urlToDF(url_int,xlsHandler)" + ] + }, + { + "cell_type": "code", + "execution_count": 29, + "metadata": {}, + "outputs": [ + { + "data": { + "text/plain": [ + "Index(['TrialID', 'Last Refreshed on', 'Public title', 'Scientific title', 'Acronym', 'Primary sponsor', 'Date registration', 'Date registration3', 'Export date', 'Source Register', 'web address', 'Recruitment Status', 'other records', 'Inclusion agemin', 'Inclusion agemax', 'Inclusion gender', 'Date enrollement', 'Target size', 'Study type', 'Study design', 'Phase', 'Countries', 'Contact Firstname', 'Contact Lastname', 'Contact Address', 'Contact Email', 'Contact Tel', 'Contact Affiliation', 'Inclusion Criteria', 'Exclusion Criteria', 'Condition', 'Intervention', 'Primary outcome', 'results date posted', 'results date completed', 'results url link', 'Retrospective flag', 'Bridging flag truefalse', 'Bridged type', 'results yes no'], dtype='object')" + ] + }, + "execution_count": 29, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "internationalstudies.columns" + ] + }, { "cell_type": "code", "execution_count": 30, "metadata": {}, + "outputs": [ + { + "data": { + "text/plain": [ + "0 survival group:none;died:none; \n", + "1 Case series:Treated with conventional treatment combined with Chloroquine Phosphate; \n", + "2 experimental group:standardized comprehensive treatment combined with convalescent plasma treatment;control group:standardized comprehensive treatment; \n", + "3 control group:Western Medicine;experimental group:Integrated Traditional Chinese and Western Medicine; \n", + "4 Diagnostic Test: Recombinase aided amplification (RAA) assay \n", + " ... \n", + "774 Experimental treatment group:Oral chloroquine phosphate tablets (treatment group);control group:Oral placebo group (control group); \n", + "775 Case series:?; \n", + "776 CM group:Xinguan No. 2 / Xinguan No. 3 alone or + regular treatment;WM group:Regular Ttreatment; \n", + "777 Suspected case treatment group:TCM formula 1 or TCM formula 2;Suspected case control group:null;Confirmed case treatment group:Western medicine+(TCM formula 3 or TCM formula 4 or TCM formula 5 or TCM formula 6);Confirmed case control group:Western medici\n", + "778 experimental group:Fitness Qigong Yangfei prescription;control group:general advice and related psychological comfort.; \n", + "Name: Intervention, Length: 779, dtype: object" + ] + }, + "execution_count": 30, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "internationalstudies[\"Intervention\"]" + ] + }, + { + "cell_type": "code", + "execution_count": 15, + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "> 318 studies found by 'covid-19' keyword\n", + "> 318 studies found by 'SARS-CoV-2' keyword\n", + "> 288 studies found by 'coronavirus' keyword\n" + ] + } + ], + "source": [ + "all_studies_by_keyword:dict = {}\n", + "queries:list = [\"covid-19\", \"SARS-CoV-2\", \"coronavirus\"]\n", + "\n", + "for key in queries:\n", + " all_studies_by_keyword[key] = getAllStudiesByQuery(key)" + ] + }, + { + "cell_type": "code", + "execution_count": 16, + "metadata": {}, + "outputs": [ + { + "data": { + "text/plain": [ + "3" + ] + }, + "execution_count": 16, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "len(all_studies_by_keyword)" + ] + }, + { + "cell_type": "code", + "execution_count": 18, + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "--2020-04-06 12:25:17-- https://www.drugbank.ca/releases/5-1-5/downloads/all-drugbank-vocabulary\n", + "Resolving www.drugbank.ca (www.drugbank.ca)... 104.26.5.2, 104.26.4.2, 2606:4700:20::681a:502, ...\n", + "Connecting to www.drugbank.ca (www.drugbank.ca)|104.26.5.2|:443... connected.\n", + "HTTP request sent, awaiting response... 302 Found\n", + "Location: https://drugbank.s3.us-west-2.amazonaws.com/public_downloads/downloads/000/003/618/original/drugbank_all_drugbank_vocabulary.csv.zip?X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=AKIAJTZC3DSCEEG75A6Q%2F20200406%2Fus-west-2%2Fs3%2Faws4_request&X-Amz-Date=20200406T022518Z&X-Amz-Expires=30&X-Amz-SignedHeaders=host&X-Amz-Signature=89010fbf368ddcaf2609a7d92048b5bd201e1e834e1813f7c116de05036b5d8b [following]\n", + "--2020-04-06 12:25:19-- https://drugbank.s3.us-west-2.amazonaws.com/public_downloads/downloads/000/003/618/original/drugbank_all_drugbank_vocabulary.csv.zip?X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=AKIAJTZC3DSCEEG75A6Q%2F20200406%2Fus-west-2%2Fs3%2Faws4_request&X-Amz-Date=20200406T022518Z&X-Amz-Expires=30&X-Amz-SignedHeaders=host&X-Amz-Signature=89010fbf368ddcaf2609a7d92048b5bd201e1e834e1813f7c116de05036b5d8b\n", + "Resolving drugbank.s3.us-west-2.amazonaws.com (drugbank.s3.us-west-2.amazonaws.com)... 52.218.225.129\n", + "Connecting to drugbank.s3.us-west-2.amazonaws.com (drugbank.s3.us-west-2.amazonaws.com)|52.218.225.129|:443... connected.\n", + "HTTP request sent, awaiting response... 200 OK\n", + "Length: 712150 (695K) [application/zip]\n", + "Saving to: 'drug_vocab.csv.zip’\n", + "\n", + "drug_vocab.csv.zip 100%[===================>] 695.46K 366KB/s in 1.9s \n", + "\n", + "2020-04-06 12:25:22 (366 KB/s) - 'drug_vocab.csv.zip’ saved [712150/712150]\n", + "\n" + ] + } + ], + "source": [ + "! wget -O drug_vocab.csv.zip https://www.drugbank.ca/releases/5-1-5/downloads/all-drugbank-vocabulary" + ] + }, + { + "cell_type": "code", + "execution_count": 42, + "metadata": {}, "outputs": [], "source": [ - "internationalstudies = xlsUrlToDF(url_int)" + "drug_url = os.environ[\"URL_DRUGBANK\"]\n", + "vocab = urlToDF(drug_url,csvZipHandler) " ] }, { "cell_type": "code", - "execution_count": 31, + "execution_count": 43, "metadata": {}, "outputs": [ { @@ -172,18955 +343,251 @@ " \n", " \n", " \n", - " TrialID\n", - " Last Refreshed on\n", - " Public title\n", - " Scientific title\n", - " Acronym\n", - " Primary sponsor\n", - " Date registration\n", - " Date registration3\n", - " Export date\n", - " Source Register\n", - " ...\n", - " Condition\n", - " Intervention\n", - " Primary outcome\n", - " results date posted\n", - " results date completed\n", - " results url link\n", - " Retrospective flag\n", - " Bridging flag truefalse\n", - " Bridged type\n", - " results yes no\n", + " DrugBank ID\n", + " Accession Numbers\n", + " Common name\n", + " CAS\n", + " UNII\n", + " Synonyms\n", + " Standard InChI Key\n", " \n", " \n", " \n", " \n", " 0\n", - " ChiCTR2000029953\n", - " 43878.0\n", - " Construction and Analysis of Prognostic Predic...\n", - " Construction and Analysis of Prognostic Predic...\n", - " NaN\n", - " Zhongnan Hospital of Wuhan University\n", - " 43878.0\n", - " 20200217.0\n", - " 43834.660579\n", - " ChiCTR\n", - " ...\n", - " 2019-nCoV Pneumonia\n", - " survival group:none;died:none;\n", - " duration of in hospital;in hospital mortality;...\n", - " NaN\n", - " NaN\n", - " NaN\n", - " No\n", - " 0\n", - " \n", + " DB00001\n", + " BIOD00024 | BTD00024\n", + " Lepirudin\n", + " 138068-37-8\n", + " Y43GF64R34\n", + " Hirudin variant-1 | Lepirudin recombinant\n", " NaN\n", " \n", " \n", " 1\n", - " ChiCTR2000029935\n", - " 43878.0\n", - " A Single-arm Clinical Trial for Chloroquine Ph...\n", - " A Single-arm Clinical Trial for Chloroquine Ph...\n", - " NaN\n", - " HwaMei Hospital, University of Chinese Academy...\n", - " 43877.0\n", - " 20200216.0\n", - " 43834.660579\n", - " ChiCTR\n", - " ...\n", - " Novel Coronavirus Pneumonia (COVID-19)\n", - " Case series:Treated with conventional treatmen...\n", - " Length of hospital stay;\n", - " NaN\n", - " NaN\n", - " NaN\n", - " No\n", - " 0\n", - " \n", + " DB00002\n", + " BIOD00071 | BTD00071\n", + " Cetuximab\n", + " 205923-56-4\n", + " PQX0D8J21J\n", + " Cetuximab | Cétuximab | Cetuximabum | Immunoglobulin G 1 (human-mouse monoclonal C 225 gamma 1 - chain anti-human epidermal growt factor receptor), disulfide wit human-mouse monoclonal C 225 kappa - chain, dimer\n", " NaN\n", " \n", " \n", " 2\n", - " ChiCTR2000029850\n", - " 43878.0\n", - " Study on convalescent plasma treatment for sev...\n", - " Effecacy and safty of convalescent plasma trea...\n", - " NaN\n", - " The First Affiliated Hospital of Zhejiang Univ...\n", - " 43876.0\n", - " 20200215.0\n", - " 43834.660579\n", - " ChiCTR\n", - " ...\n", - " Novel Coronavirus Pneumonia (COVID-19)\n", - " experimental group:standardized comprehensive ...\n", - " Fatality rate;\n", - " NaN\n", - " NaN\n", - " NaN\n", - " Yes\n", - " 0\n", - " \n", + " DB00003\n", + " BIOD00001 | BTD00001\n", + " Dornase alfa\n", + " 143831-71-4\n", + " 953A26OA1Y\n", + " Deoxyribonuclease (human clone 18-1 protein moiety) | Dornasa alfa | Dornase alfa, recombinant | Dornase alpha | Recombinant deoxyribonuclease (DNAse)\n", " NaN\n", " \n", " \n", " 3\n", - " ChiCTR2000029814\n", - " 43878.0\n", - " Clinical Trial for Integrated Chinese and West...\n", - " Clinical Trial for Integrated Chinese and West...\n", - " NaN\n", - " Children's Hospital of Fudan University\n", - " 43875.0\n", - " 20200214.0\n", - " 43834.660579\n", - " ChiCTR\n", - " ...\n", - " Novel Coronavirus Pneumonia (COVID-19)\n", - " control group:Western Medicine;experimental gr...\n", - " Time fo fever reduction;Time of nucleic acid n...\n", - " NaN\n", - " NaN\n", - " NaN\n", - " Yes\n", - " 0\n", - " \n", + " DB00004\n", + " BIOD00084 | BTD00084\n", + " Denileukin diftitox\n", + " 173146-27-5\n", + " 25E79B5CTM\n", + " Denileukin | Interleukin-2/diptheria toxin fusion protein\n", " NaN\n", " \n", " \n", " 4\n", - " NCT04245631\n", - " 43878.0\n", - " Development of a Simple, Fast and Portable Rec...\n", - " Development of a Simple, Fast and Portable Rec...\n", - " NaN\n", - " Beijing Ditan Hospital\n", - " 43856.0\n", - " 20200126.0\n", - " 43834.660579\n", - " ClinicalTrials.gov\n", - " ...\n", - " New Coronavirus\n", - " Diagnostic Test: Recombinase aided amplificati...\n", - " Detection sensitivity is greater than 95%;Dete...\n", - " NaN\n", - " NaN\n", - " NaN\n", - " Yes\n", - " 0\n", - " \n", + " DB00005\n", + " BIOD00052 | BTD00052\n", + " Etanercept\n", + " 185243-69-0\n", + " OP401G7OJC\n", + " Etanercept | etanercept-szzs | etanercept-ykro | Recombinant human TNF | rhu TNFR:Fc | rhu-TNFR:Fc | TNFR-Immunoadhesin\n", " NaN\n", " \n", " \n", - " ...\n", - " ...\n", - " ...\n", - " ...\n", - " ...\n", - " ...\n", - " ...\n", - " ...\n", - " ...\n", - " ...\n", - " ...\n", - " ...\n", - " ...\n", - " ...\n", - " ...\n", - " ...\n", - " ...\n", - " ...\n", - " ...\n", - " ...\n", - " ...\n", - " ...\n", + " 5\n", + " DB00006\n", + " BIOD00076 | BTD00076 | DB02351 | EXPT03302\n", + " Bivalirudin\n", + " 128270-60-0\n", + " TN9BEX005G\n", + " Bivalirudin | Bivalirudina | Bivalirudinum\n", + " OIRCOABEOLEUMC-GEJPAHFPSA-N\n", " \n", " \n", - " 774\n", - " ChiCTR2000031204\n", - " 43920.0\n", - " A multicenter, single-blind, randomized contro...\n", - " A multicenter, single-blind, randomized contro...\n", - " NaN\n", - " Beijing you'an Hospital, Capital Medical Unive...\n", - " 43914.0\n", - " 20200324.0\n", - " 43834.660579\n", - " ChiCTR\n", - " ...\n", - " Novel Coronavirus Pneumonia (COVID-19)\n", - " Experimental treatment group:Oral chloroquine ...\n", - " Clearance time of virus RNA;\n", - " NaN\n", - " NaN\n", - " NaN\n", - " No\n", - " 0\n", - " \n", - " NaN\n", + " 6\n", + " DB00007\n", + " BIOD00009 | BTD00009\n", + " Leuprolide\n", + " 53714-56-0\n", + " EFY6W0M8TG\n", + " Leuprorelin | Leuprorelina | Leuproreline | Leuprorelinum\n", + " GFIJNRVAKGFPGQ-LIJARHBVSA-N\n", " \n", " \n", - " 775\n", - " ChiCTR2000031187\n", - " 43920.0\n", - " A medical records based retrospective study fo...\n", - " A medical records based retrospective study fo...\n", - " NaN\n", - " Wuhan Third Hospital & Tongren Hospital of Wuh...\n", - " 43913.0\n", - " 20200323.0\n", - " 43834.660579\n", - " ChiCTR\n", - " ...\n", - " Novel Coronavirus Pneumonia (COVID-19)\n", - " Case series:?;\n", - " PT-PCR test;\n", - " NaN\n", - " NaN\n", - " NaN\n", - " Yes\n", - " 0\n", - " \n", + " 7\n", + " DB00008\n", + " BIOD00043 | BTD00043\n", + " Peginterferon alfa-2a\n", + " 198153-51-4\n", + " Q46947FE7K\n", + " PEG-IFN alfa-2A | PEG-Interferon alfa-2A | Peginterferon alfa-2a | Pegylated Interfeaon alfa-2A | Pegylated interferon alfa-2a | Pegylated interferon alpha-2a | Pegylated-interferon alfa 2a\n", " NaN\n", " \n", " \n", - " 776\n", - " ChiCTR2000030936\n", - " 43920.0\n", - " A real-world study for the Chinese medicines '...\n", - " Hospital of Chengdu University of Traditional ...\n", - " NaN\n", - " Hospital of Chengdu University of Traditional ...\n", - " 43908.0\n", - " 20200318.0\n", - " 43834.660579\n", - " ChiCTR\n", - " ...\n", - " Novel Coronavirus Pneumonia (COVID-19)\n", - " CM group:Xinguan No. 2 / Xinguan No. 3 alone o...\n", - " Body temperature returns to normal time;After ...\n", + " 8\n", + " DB00009\n", + " BIOD00050 | BTD00050\n", + " Alteplase\n", + " 105857-23-6\n", + " 1RXS4UE564\n", + " Alteplasa | Alteplase (genetical recombination) | Alteplase, recombinant | Alteplase,recombinant | Plasminogen activator (human tissue-type protein moiety) | rt-PA | t-PA | t-plasminogen activator | Tissue plasminogen activator | Tissue plasminogen activator alteplase | Tissue plasminogen activator, recombinant | tPA\n", " NaN\n", + " \n", + " \n", + " 9\n", + " DB00010\n", + " BIOD00033 | BTD00033\n", + " Sermorelin\n", + " 86168-78-7\n", + " 89243S03TE\n", " NaN\n", " NaN\n", - " No\n", - " 0\n", - " \n", + " \n", + " \n", + " 10\n", + " DB00011\n", + " BIOD00096 | BTD00096 | DB00084\n", + " Interferon alfa-n1\n", + " 74899-72-2\n", + " 41697D4Z5C\n", + " Interferon alpha-n1 (INS)\n", " NaN\n", " \n", " \n", - " 777\n", - " ChiCTR2000030923\n", - " 43920.0\n", - " The treatment and diagnosis plan of integrated...\n", - " The treatment and diagnosis plan of integrated...\n", + " 11\n", + " DB00012\n", + " BIOD00032 | BTD00032\n", + " Darbepoetin alfa\n", + " 209810-58-2\n", + " 15UQ94PT4P\n", + " Darbepoetin | Darbepoetin alfa,recombinant | Darbepoetina alfa\n", " NaN\n", - " Affiliated Hospital of Shaanxi University of T...\n", - " 43907.0\n", - " 20200317.0\n", - " 43834.660579\n", - " ChiCTR\n", - " ...\n", - " Novel Coronavirus Pneumonia (COVID-19)\n", - " Suspected case treatment group:TCM formula 1 o...\n", - " Incidence of COVID-19 pneumonia;COVID-19 pneum...\n", + " \n", + " \n", + " 12\n", + " DB00013\n", + " BIOD00030 | BTD00030\n", + " Urokinase\n", + " 9039-53-6\n", + " 83G67E21XI\n", + " Kinase (enzyme-activating), uro-urokinase | TCUK | Tissue culture urokinase | Two-chain urokinase | Urochinasi | Urokinase | Urokinasum | Uroquinasa\n", " NaN\n", + " \n", + " \n", + " 13\n", + " DB00014\n", + " BIOD00113 | BTD00113\n", + " Goserelin\n", + " 65807-02-5\n", + " 0F65R8P09N\n", + " Goserelin | Goserelina\n", + " BLCLNMBMMGCOAS-URPVMXJPSA-N\n", + " \n", + " \n", + " 14\n", + " DB00015\n", + " BIOD00013 | BTD00013\n", + " Reteplase\n", + " 133652-38-7\n", + " DQA630RIE9\n", + " Human t-PA (residues 1-3 and 176-527) | Reteplasa | Reteplase, recombinant | Reteplase,recombinant\n", " NaN\n", + " \n", + " \n", + " 15\n", + " DB00016\n", + " BIOD00103 | BTD00103 | DB08923\n", + " Erythropoietin\n", + " 11096-26-7\n", + " 64FS3BFH5W\n", + " E.P.O. | Epoetin alfa | Epoetin alfa rDNA | Epoetin alfa-epbx | Epoetin alfa, recombinant | Epoetin beta | Epoetin beta rDNA | Epoetin epsilon | Epoetin gamma | Epoetin gamma rDNA | Epoetin kappa | Epoetin omega | Epoetin theta | Epoetin zeta | Epoetina alfa | Epoetina beta | Epoetina dseta | Epoetina zeta | Epoétine zêta | Epoetinum zeta | Erythropoiesis stimulating factor | Erythropoietin (human, recombinant) | Erythropoietin (recombinant human) | ESF | SH-polypeptide-72\n", " NaN\n", - " No\n", - " 0\n", - " \n", + " \n", + " \n", + " 16\n", + " DB00017\n", + " BIOD00025 | BTD00025\n", + " Salmon Calcitonin\n", + " 47931-85-1\n", + " 7SFC6U2VI5\n", + " Calcitonin (Salmon Synthetic) | Calcitonin Salmon | Calcitonin salmon recombinant | Calcitonin-salmon | Calcitonin, salmon | Calcitonina salmón sintética | Recombinant salmon calcitonin | Salmon calcitonin\n", " NaN\n", " \n", " \n", - " 778\n", - " ChiCTR2000029976\n", - " 43920.0\n", - " The effect of Gymnastic Qigong Yangfeifang on ...\n", - " Novel coronavirus pneumonia (COVID-19) emergen...\n", + " 17\n", + " DB00018\n", + " BIOD00023 | BTD00023\n", + " Interferon alfa-n3\n", " NaN\n", - " Shanghai University of Traditional Chinese Med...\n", - " 43879.0\n", - " 20200218.0\n", - " 43834.660579\n", - " ChiCTR\n", - " ...\n", - " Novel Coronavirus Pneumonia (COVID-19)\n", - " experimental group:Fitness Qigong Yangfei pres...\n", - " Oxygen Inhalation Frequency;Oxygen Intake Time...\n", + " 47BPR3V3MP\n", " NaN\n", " NaN\n", + " \n", + " \n", + " 18\n", + " DB00019\n", + " BIOD00094 | BTD00094\n", + " Pegfilgrastim\n", + " 208265-92-3\n", + " 3A58010674\n", + " Granulocyte colony-stimulating factor pegfilgrastim | peg-filgrastim | pegfilgrastim-bmez | pegfilgrastim-cbqv | pegfilgrastim-jmdb\n", " NaN\n", - " Yes\n", - " 0\n", - " \n", + " \n", + " \n", + " 19\n", + " DB00020\n", + " BIOD00035 | BTD00035\n", + " Sargramostim\n", + " 123774-72-1\n", + " 5TAA004E22\n", + " Recombinant human granulocyte-macrophage colony stimulating factor | rGM-CSF | rHu GM-CSF | Sargramostim\n", " NaN\n", " \n", " \n", "\n", - "

779 rows × 40 columns

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NaN \n", - "1 A Single-arm Clinical Trial for Chloroquine Ph... NaN \n", - "2 Effecacy and safty of convalescent plasma trea... NaN \n", - "3 Clinical Trial for Integrated Chinese and West... NaN \n", - "4 Development of a Simple, Fast and Portable Rec... NaN \n", - ".. ... ... \n", - "774 A multicenter, single-blind, randomized contro... NaN \n", - "775 A medical records based retrospective study fo... NaN \n", - "776 Hospital of Chengdu University of Traditional ... NaN \n", - "777 The treatment and diagnosis plan of integrated... NaN \n", - "778 Novel coronavirus pneumonia (COVID-19) emergen... NaN \n", - "\n", - " Primary sponsor Date registration \\\n", - "0 Zhongnan Hospital of Wuhan University 43878.0 \n", - "1 HwaMei Hospital, University of Chinese Academy... 43877.0 \n", - "2 The First Affiliated Hospital of Zhejiang Univ... 43876.0 \n", - "3 Children's Hospital of Fudan University 43875.0 \n", - "4 Beijing Ditan Hospital 43856.0 \n", - ".. ... ... \n", - "774 Beijing you'an Hospital, Capital Medical Unive... 43914.0 \n", - "775 Wuhan Third Hospital & Tongren Hospital of Wuh... 43913.0 \n", - "776 Hospital of Chengdu University of Traditional ... 43908.0 \n", - "777 Affiliated Hospital of Shaanxi University of T... 43907.0 \n", - "778 Shanghai University of Traditional Chinese Med... 43879.0 \n", - "\n", - " Date registration3 Export date Source Register ... \\\n", - "0 20200217.0 43834.660579 ChiCTR ... \n", - "1 20200216.0 43834.660579 ChiCTR ... \n", - "2 20200215.0 43834.660579 ChiCTR ... \n", - "3 20200214.0 43834.660579 ChiCTR ... \n", - "4 20200126.0 43834.660579 ClinicalTrials.gov ... \n", - ".. ... ... ... ... \n", - "774 20200324.0 43834.660579 ChiCTR ... \n", - "775 20200323.0 43834.660579 ChiCTR ... \n", - "776 20200318.0 43834.660579 ChiCTR ... \n", - "777 20200317.0 43834.660579 ChiCTR ... \n", - "778 20200218.0 43834.660579 ChiCTR ... \n", - "\n", - " Condition \\\n", - "0 2019-nCoV Pneumonia \n", - "1 Novel Coronavirus Pneumonia (COVID-19) \n", - "2 Novel Coronavirus Pneumonia (COVID-19) \n", - "3 Novel Coronavirus Pneumonia (COVID-19) \n", - "4 New Coronavirus \n", - ".. ... \n", - "774 Novel Coronavirus Pneumonia (COVID-19) \n", - "775 Novel Coronavirus Pneumonia (COVID-19) \n", - "776 Novel Coronavirus Pneumonia (COVID-19) \n", - "777 Novel Coronavirus Pneumonia (COVID-19) \n", - "778 Novel Coronavirus Pneumonia (COVID-19) \n", - "\n", - " Intervention \\\n", - "0 survival group:none;died:none; \n", - "1 Case series:Treated with conventional treatmen... \n", - "2 experimental group:standardized comprehensive ... \n", - "3 control group:Western Medicine;experimental gr... \n", - "4 Diagnostic Test: Recombinase aided amplificati... \n", - ".. ... \n", - "774 Experimental treatment group:Oral chloroquine ... \n", - "775 Case series:?; \n", - "776 CM group:Xinguan No. 2 / Xinguan No. 3 alone o... \n", - "777 Suspected case treatment group:TCM formula 1 o... \n", - "778 experimental group:Fitness Qigong Yangfei pres... \n", - "\n", - " Primary outcome results date posted \\\n", - "0 duration of in hospital;in hospital mortality;... NaN \n", - "1 Length of hospital stay; NaN \n", - "2 Fatality rate; NaN \n", - "3 Time fo fever reduction;Time of nucleic acid n... NaN \n", - "4 Detection sensitivity is greater than 95%;Dete... NaN \n", - ".. ... ... \n", - "774 Clearance time of virus RNA; NaN \n", - "775 PT-PCR test; NaN \n", - "776 Body temperature returns to normal time;After ... NaN \n", - "777 Incidence of COVID-19 pneumonia;COVID-19 pneum... NaN \n", - "778 Oxygen Inhalation Frequency;Oxygen Intake Time... NaN \n", - "\n", - " results date completed results url link Retrospective flag \\\n", - "0 NaN NaN No \n", - "1 NaN NaN No \n", - "2 NaN NaN Yes \n", - "3 NaN NaN Yes \n", - "4 NaN NaN Yes \n", - ".. ... ... ... \n", - "774 NaN NaN No \n", - "775 NaN NaN Yes \n", - "776 NaN NaN No \n", - "777 NaN NaN No \n", - "778 NaN NaN Yes \n", - "\n", - " Bridging flag truefalse Bridged type results yes no \n", - "0 0 NaN \n", - "1 0 NaN \n", - "2 0 NaN \n", - "3 0 NaN \n", - "4 0 NaN \n", - ".. ... ... ... \n", - "774 0 NaN \n", - "775 0 NaN \n", - "776 0 NaN \n", - "777 0 NaN \n", - "778 0 NaN \n", - "\n", - "[779 rows x 40 columns]" - ] - }, - "execution_count": 31, - "metadata": {}, - "output_type": "execute_result" - } - ], - "source": [ - "internationalstudies" - ] - }, - { - "cell_type": "code", - "execution_count": 32, - "metadata": {}, - "outputs": [ - { - "data": { - "text/plain": [ - "{'FullStudiesResponse': {'APIVrs': '1.01.02',\n", - " 'DataVrs': '2020:04:03 00:51:56.804',\n", - " 'Expression': 'covid-19',\n", - " 'NStudiesAvail': 335064,\n", - " 'NStudiesFound': 318,\n", - " 'MinRank': 1,\n", - " 'MaxRank': 100,\n", - " 'NStudiesReturned': 100,\n", - " 'FullStudies': [{'Rank': 1,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04330261',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'REB18-0107_MOD9'},\n", - " 'Organization': {'OrgFullName': 'University of Calgary',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Clinical Characteristics and Outcomes of Pediatric COVID-19',\n", - " 'OfficialTitle': 'Clinical Characteristics and Outcomes of Children Potentially Infected by Severe Acute Respiratory Distress Syndrome (SARS)-CoV-2 Presenting to Pediatric Emergency Departments',\n", - " 'Acronym': 'PERN-COVID-19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 18, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 17, 2021',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'March 17, 2022',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 30, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 30, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 30, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'University of Calgary',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Rationale: The clinical manifestations of SARS-CoV-2 infection in children are poorly characterized. Preliminary findings indicate that they may be atypical. There is a need to identify the spectrum of clinical presentations, predictors of severe disease (COVID-19) outcomes, and successful treatment strategies in this population.\\n\\nGoals:\\n\\nPrimary - Describe and compare characteristics of confirmed SARS-CoV-2 infected children with symptomatic test-negative children.\\n\\nSecondary - 1) Describe and compare confirmed SARS-CoV-2 infected children with mild versus severe COVID-19 outcomes; 2) Describe healthcare resource utilization for, and outcomes of, screening and care of pediatric COVID-19 internationally, alongside regional public health policy changes.\\n\\nMethods: This prospective observational study will occur in 50 emergency departments across 11 countries. We will enroll 12,500 children who meet institutional screening guidelines and undergo SARS-CoV-2 testing. Data collection focuses on epidemiological risk factors, demographics, signs, symptoms, interventions, laboratory testing, imaging, and outcomes. Collection will occur at enrollment, 14 days, and 90 days.\\n\\nTimeline: Recruitment will last for 12 months (worst-case model) and will begin within 7-14 days of funding notification after ongoing expedited review of ethics and data sharing agreements.\\n\\nImpact: Results will be shared in real-time with key policymakers, enabling rapid evidence-based adaptations to pediatric case screening and management.',\n", - " 'DetailedDescription': \"Pediatric COVID-19: The characteristics of pediatric 2019 novel coronavirus disease (COVID-19) are not yet well understood. Preliminary findings indicate that atypical presentations of COVID-19 occur in children. Thus, there is an urgent need to identify risk factors for pediatric COVID-19 infection, the range of clinical manifestations, predictors of severe outcomes, and successful treatment strategies.\\n\\nObjectives: Primary: To contribute to the optimization of medical countermeasures to pediatric COVID-19 through describing and comparing the clinical characteristics of SARS-CoV-2 infected children (i.e. test positive) with children who were screened for SARS-CoV-2 but tested negative. We will also describe and compare SARS-CoV-2 infected children with mild versus those with severe outcomes. This study will also describe the health care resources utilized for screening, isolation, and care of pediatric COVID-19, examined alongside relevant public health policies.\\n\\nMethods: This is a two-year prospective observational study that will take place at 50 EDs across 19 countries. We will enroll children (<18 years old) presenting to participating study EDs who meet institutional screening guidelines and undergo testing for COVID-19. Data collection is aligned with WHO templates and focuses on epidemiological factors, demographics, signs, symptoms, exposures, interventions, and test results. Collection will occur at the time of enrolment, during the course of illness, at hospital discharge (if admitted), and at two weeks and three months following enrolment. Over a period of 18 months (starting March 31st, 2020) we aim to enroll and complete follow-up for a total of 5000 children with screened for suspected SARS-CoV-2 infection. Data will be entered into a centralized database, and analyzed using simple and multiple ordinal logistic regression models. Data will be interpreted alongside detailed, prospectively collected, information on the changes to case isolation, screening, and management policies that occur throughout the epidemic in each institution and study region.\\n\\nFeasibility: The Pediatric Emergency Research Networks (PERN) represents the largest international acute pediatric care collaboration in the world, including more than 200 hospitals across 35 countries. Currently, PERN is carrying out the PERN-Pneumonia prospective cohort study, designed to identify predictors of severe pneumonia at 70 hospitals around the globe, including at eight Canadian pediatric emergency departments (ED). This study will build onto the PERN-Pneumonia study infrastructure (e.g. ethics approvals, data sharing agreements, research teams) in order to facilitate a unique, rapid, and global response to the COVID-19 epidemic. Feasibility is enhanced by our design - we will not interfere with the existing COVID-19 screening and management procedures in-place in study EDs; we will not collect any biological specimens, and will not prescribe any interventions.\\n\\nProject Team: This international multidisciplinary team includes pediatric emergency medicine and infectious disease clinicians, epidemiologists, statisticians, and public health leaders from around the globe. Team members have led many landmark trials in pediatric emergency medicine, and lead large pediatric research networks and studies including the PERN-Pneumonia study. They also came together to study the H1N1 pandemic and identified predictors of severe outcomes. Team members also have expertise in pediatric lower respiratory tract infections, biostatistics, and epidemiology (including the CDC lead on the MERS-CoV outbreak). This study team also includes the Public Health Agency of Canada's senior medical/technical expert on COVID-19.\\n\\nImpact of the research: The results of this study, which will be shared in real-time with appropriate national and international authorities, will enable policymakers to make rapid evidence-based adaptations to case screening and management procedures that will then allow for the earlier identification of children likely to have confirmed infection with COVID-19 as well as to prioritize those children likely to have severe outcomes. Finally, the establishment of this global multi-site study will be the first trial of a rapid PERN networks response to a pandemic novel respiratory virus, which, applying lessons-learned, can be urgently reactivated for future public health emergencies.\"},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", - " 'SARS-CoV-2 Infection',\n", - " 'Pediatric ALL',\n", - " 'Pneumonia, Viral',\n", - " 'Pandemic Response']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '12500',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'SARS-CoV-2 Positive Children',\n", - " 'ArmGroupDescription': 'All children screened for SARS-CoV-2 and presenting to participating sites will be enrolled in this study. Children who are eventually test-positive for SARS-CoV-2 will be considered the exposed group in this study. These children will have exactly the same prospective follow-up as the other group.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: Exposure (not intervention) - SARS-CoV-2 infection']}},\n", - " {'ArmGroupLabel': 'SARS-CoV-2 Negative Children',\n", - " 'ArmGroupDescription': 'All children screened for SARS-CoV-2 and presenting to participating sites will be enrolled in this study. Children who are eventually test-negative for SARS-CoV-2 will be considered the unexposed (control) group in this study. These children will have exactly the same prospective follow-up as the other group.'}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", - " 'InterventionName': 'Exposure (not intervention) - SARS-CoV-2 infection',\n", - " 'InterventionDescription': 'Exposure is infection with the virus. There is no intervention',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['SARS-CoV-2 Positive Children']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Clinical characteristics of children with SARS-CoV-2',\n", - " 'PrimaryOutcomeDescription': \"Clinical characteristics among children presenting to a participating hospital's EDs who meet each site's local SARS-CoV-2 screening criteria, will be described and compared between children with confirmed SARS-CoV-2 (i.e. test-positive) versus suspected (i.e. test-negative) infections.\",\n", - " 'PrimaryOutcomeTimeFrame': '18 months'},\n", - " {'PrimaryOutcomeMeasure': 'Factors associated with severe COVID-19 outcomes',\n", - " 'PrimaryOutcomeDescription': 'Factors associated with severe outcomes [i.e. positive pressure ventilation (invasive or noninvasive) OR intensive care unit admission with ventilatory or inotropic support OR death; other outcomes may be added as the understanding of the epidemic evolves) will be identified in confirmed paediatric COVID-19 cases.',\n", - " 'PrimaryOutcomeTimeFrame': '18 months'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Health care resource utilization for COVID-19 patient management',\n", - " 'SecondaryOutcomeDescription': 'Health care resource utilization for patient management (e.g. frequencies of isolation, laboratory testing, imaging, and supportive care, with associated costs) of both suspected and confirmed SARS-CoV-2 infected children according to changes in national and regional policies.',\n", - " 'SecondaryOutcomeTimeFrame': '18 months'},\n", - " {'SecondaryOutcomeMeasure': 'Sensitivity and specificity of COVID-19 case screening policies',\n", - " 'SecondaryOutcomeDescription': 'The sensitivity and specificity of various case screening policies for the detection of confirmed symptomatic SARS-CoV-2 infection (i.e. COVID-19) in children (e.g. addition of vomiting/diarrhoea).',\n", - " 'SecondaryOutcomeTimeFrame': '18 months'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\n< 18 years-old, and\\nPresent to a participating ED for care, and\\nUndergo SARS-CoV-2 testing.\\n\\nExclusion Criteria:\\n\\n1) Refusal to participate (no informed consent)',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MaximumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Child', 'Adult']},\n", - " 'StudyPopulation': 'All children presenting to a participating ED who are screened (i.e. tested) for SARS-CoV-2 during the duration of the study. Children will be mainly from urban areas across Canada, United States of America, Italy, France, Spain, Switzerland, Australia, New Zealand, Argentina, and other countries.',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Stephen Freedman, MDCM, MSc',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '4039557740',\n", - " 'CentralContactEMail': 'stephen.freedman@ahs.ca'},\n", - " {'CentralContactName': 'Anna Funk, PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactEMail': 'anna.funk@ucalgary.ca'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Stephen Freedman, MD',\n", - " 'OverallOfficialAffiliation': 'University of Calgary',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': \"University of Calgary/Alberta Children's Hospital\",\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Calgary',\n", - " 'LocationState': 'Alberta',\n", - " 'LocationZip': 'T3B 6A8',\n", - " 'LocationCountry': 'Canada',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Stephen Freedman, MDCM, MSc',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '4039557740',\n", - " 'LocationContactEMail': 'stephen.freedman@ahs.ca'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", - " 'IPDSharingDescription': 'In keeping with the joint statement on sharing research data and findings relevant to the novel coronavirus (nCoV) outbreak, this study will share data rapidly with local governments as well as international stakeholders.',\n", - " 'IPDSharingInfoTypeList': {'IPDSharingInfoType': ['Study Protocol',\n", - " 'Statistical Analysis Plan (SAP)']},\n", - " 'IPDSharingTimeFrame': 'Ideally in real-time, over the next 18 months'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000011024',\n", - " 'ConditionMeshTerm': 'Pneumonia, Viral'},\n", - " {'ConditionMeshId': 'D000011014', 'ConditionMeshTerm': 'Pneumonia'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000008171',\n", - " 'ConditionAncestorTerm': 'Lung Diseases'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13547',\n", - " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Newborn',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13548',\n", - " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Adult',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M12487',\n", - " 'ConditionBrowseLeafName': 'Pneumonia',\n", - " 'ConditionBrowseLeafAsFound': 'Pneumonia',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M6379',\n", - " 'ConditionBrowseLeafName': 'Emergencies',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M26731',\n", - " 'ConditionBrowseLeafName': 'Acute Lung Injury',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M12497',\n", - " 'ConditionBrowseLeafName': 'Pneumonia, Viral',\n", - " 'ConditionBrowseLeafAsFound': 'Pneumonia, Viral',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M9751',\n", - " 'ConditionBrowseLeafName': 'Lung Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T4953',\n", - " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Infant',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T191',\n", - " 'ConditionBrowseLeafName': 'Acute Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T1141',\n", - " 'ConditionBrowseLeafName': 'Childhood Acute Lymphoblastic Leukemia',\n", - " 'ConditionBrowseLeafAsFound': 'Pediatric ALL',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC16',\n", - " 'ConditionBrowseBranchName': 'Diseases and Abnormalities at or Before Birth'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 2,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04333862',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '2020-00563'},\n", - " 'Organization': {'OrgFullName': 'University Hospital Inselspital, Berne',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Assessment of Covid-19 Infection Rates in Healthcare Workers Using a Desynchronization Strategy',\n", - " 'OfficialTitle': 'Assessment of Covid-19 Infection Rates in Healthcare Workers Using a Desynchronization Strategy',\n", - " 'Acronym': 'Covid-19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 19, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'June 30, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2021',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'April 1, 2020',\n", - " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 3, 2020',\n", - " 'StudyFirstPostDateType': 'Estimate'},\n", - " 'LastUpdateSubmitDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", - " 'LastUpdatePostDateType': 'Estimate'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'University Hospital Inselspital, Berne',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Desynchronization of infection rates in healthcare workers will potentially reduce the early infection rates and therefore maintain workforce for late time points of the epidemic. Given the current threat of the COVID-19 epidemic, the department for Visceral Surgery and Medicine, Bern University Hospital, has decided to limit its elective interventions to oncological and life-saving procedures only. At the same time, the medical team were split in two teams, each working for 7 days, followed by 7 days off, called a desynchronization strategy. Contacts between the two teams are avoided.\\n\\nThe main aim of present study is to determine, if the infection rate between the two populations (at work versus at home) is different. Secondary aims are to determine if the workforce can be maintained for longer periods compared standard of care, and if the infection rate among patients hospitalized for other reasons varies compared to the community.',\n", - " 'DetailedDescription': 'Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads rapidly and causes a pandemic of coronavirus disease 2019 (COVID-19, the disease caused by SARS-CoV-2). Protecting and supporting caregivers is essential to maintain the workforce in the hospital to treat patients.\\n\\nThe use of recommended barrier precautions such as masks, gloves and gowns is of highest priority in the care of all patients with respiratory symptoms. However, given the long incubation period of 5 days there will be undiagnosed but infected patients with clinically mild cases, atypical presentations or even no symptoms at all. Thus, healthcare workers are on the one side at risk to get infected by asymptomatic patients and on the other side are critically needed for later phases of the epidemic, when the resources will in all likelihood be scarce or depleted.\\n\\nOne potential strategy to maintain workforce throughout an epidemic is to reduce the workforce in the early phases. Reducing workforce at early phases might potentially reduce in-hospital infection of the caregivers and reduces early burnout. One way of reducing the active workforce is to postpone all elective and non-urgent medical interventions to later phases of the epidemic.\\n\\nDesynchronization of infection rates in healthcare workers will potentially reduce the early infection rates and therefore maintain workforce for late time points of the epidemic. Given the current threat of the COVID-19 epidemic, the department for Visceral Surgery and Medicine, Bern University Hospital, has decided to limit its elective interventions to oncological and life-saving procedures only. At the same time, the medical team were split in two teams, each working for 7 days followed by 7 days off, called a desynchronization strategy. Contacts between the two teams are avoided. This new regulation took effect on March 16th 2020.\\n\\nCurrently available resources to perform tests for SARS-CoV-2 infection are limited for the clinical routine and are therefore not available for research purposes. Thus, in the context of a clinical study the investigators aim to perform additional testing of SARS-CoV-2 of healthcare workers and patients in order to determine the clinical consequences of such desynchronization strategy, firstly within the current epidemic and secondly for future outbreaks.\\n\\nThe main aim of present study is to determine if the infection rate between the two populations (at work versus at home) is different. Secondary aims are to determine if the workforce can be maintained for longer periods compared standard of care, and if the infection rate among patients hospitalized for other reasons varies compared to the community.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['SARS-CoV-2']},\n", - " 'KeywordList': {'Keyword': ['SARS-CoV-2', 'COVID-19']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'BioSpec': {'BioSpecRetention': 'Samples With DNA',\n", - " 'BioSpecDescription': 'Collection of nasal swabs twice per week and blood.'},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '500',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Healthcare workers providing healthcare',\n", - " 'ArmGroupDescription': 'To determine the infection rate of healthcare workers providing healthcare versus those who are staying at home, in a desynchronization work strategy'},\n", - " {'ArmGroupLabel': 'Healthcare workers staying at home',\n", - " 'ArmGroupDescription': 'To determine the infection rate of healthcare workers providing healthcare versus those who are staying at home, in a desynchronization work strategy'},\n", - " {'ArmGroupLabel': 'Hospitalized patients',\n", - " 'ArmGroupDescription': 'To compare the infection rate of hospitalized patients versus healthcare workers'}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Fraction of healthcare workers infected with SARS-CoV-2',\n", - " 'PrimaryOutcomeDescription': 'To determine the infection rate of healthcare workers providing healthcare versus those who are staying at home, in a desynchronization work strategy',\n", - " 'PrimaryOutcomeTimeFrame': '90 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Fraction of healthcare workers with COVID-19',\n", - " 'SecondaryOutcomeDescription': 'To compare the infection rate of hospitalized patients versus healthcare workers',\n", - " 'SecondaryOutcomeTimeFrame': '90 days'},\n", - " {'SecondaryOutcomeMeasure': 'Number of patients infected in the hospital',\n", - " 'SecondaryOutcomeDescription': 'Tracing origins of infection in healthcare workers to distinguish between community versus hospital acquired.',\n", - " 'SecondaryOutcomeTimeFrame': '90 days'},\n", - " {'SecondaryOutcomeMeasure': 'Development of SARS-CoV2 specific antibody repertoire',\n", - " 'SecondaryOutcomeDescription': 'To determine the T and B cell specific antibody repertoire in the course of a COVID-19 infection.',\n", - " 'SecondaryOutcomeTimeFrame': '18 months'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\nHealthcare workers of the Department for Visceral Surgery and Medicine\\nPatients of the Department for Visceral Surgery and Medicine\\nWritten informed consent\\n\\nExclusion Criteria:\\n\\nNo informed consent\\nPatients with known COVID-19 infection before hospitalization in the investigators' department\",\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'Health care workers and patients of the Department for Visceral Surgery and Medicine',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Guido Beldi',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '0316328275',\n", - " 'CentralContactPhoneExt': '0316328275',\n", - " 'CentralContactEMail': 'Guido.Beldi@insel.ch'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Guido Beldi, Prof. Dr.',\n", - " 'OverallOfficialAffiliation': 'University Hospital Inselspital, Berne',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Guido Beldi',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Bern',\n", - " 'LocationCountry': 'Switzerland',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Guido Beldi',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '0316328275',\n", - " 'LocationContactPhoneExt': '0316328275',\n", - " 'LocationContactEMail': 'Guido.Beldi@insel.ch'}]}}]}}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", - " 'ConditionMeshTerm': 'Infection'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafAsFound': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", - " {'Rank': 3,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04332380',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'ABN011-1'},\n", - " 'Organization': {'OrgFullName': 'Universidad del Rosario',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Convalescent Plasma for Patients With COVID-19: A Pilot Study',\n", - " 'OfficialTitle': 'Convalescent Plasma for Patients With COVID-19: A Pilot Study',\n", - " 'Acronym': 'CP-COVID-19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'August 31, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 30, 2020',\n", - " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 2, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Juan Manuel Anaya Cabrera',\n", - " 'ResponsiblePartyInvestigatorTitle': 'MD, PhD, Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Universidad del Rosario'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Universidad del Rosario',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'CES University',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'Instituto Distrital de Ciencia Biotecnologia e Innovacion en salud',\n", - " 'CollaboratorClass': 'UNKNOWN'},\n", - " {'CollaboratorName': 'Fundación Universitaria de Ciencias de la Salud',\n", - " 'CollaboratorClass': 'OTHER'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy when there is no vaccine or treatment available for infectious diseases. In the latest viral epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization issued a document outlining a protocol for the use of whole blood or plasma collected from patients who have recovered from the Ebola virus disease by transfusion to empirically treat local infectious outbreaks.',\n", - " 'DetailedDescription': 'The process is based on obtaining plasma from patients recovered from COVID-19 in Colombia, and through a donation of plasma from the recovered, the subsequent transfusion of this to patients infected with coronavirus disease (COVID-19). Our group has reviewed the scientific evidence regarding the application of convalescent plasma for emergency viral outbreaks and has recommended the following protocol'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus',\n", - " 'Coronavirus Infection']},\n", - " 'KeywordList': {'Keyword': ['COVID-19', 'Coronavirus Disease 2019']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 2']},\n", - " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '10',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Intervention Group',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Participants included in the experimental group will receive 500 milliliters of convalescent plasma, distributed in two 250 milliliters transfusions on the first and second day after starting the protocol.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Plasma']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Plasma',\n", - " 'InterventionDescription': 'Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Intervention Group']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Convalescent Plasma COVID-19']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Change in Viral Load',\n", - " 'PrimaryOutcomeDescription': 'Copies of COVID-19 per ml',\n", - " 'PrimaryOutcomeTimeFrame': 'Days 0, 4, 7, 14 and 28'},\n", - " {'PrimaryOutcomeMeasure': 'Change in Immunoglobulin M COVID-19 antibodies Titers',\n", - " 'PrimaryOutcomeDescription': 'Immunoglobulin M COVID-19 antibodies',\n", - " 'PrimaryOutcomeTimeFrame': 'Days 0, 4, 7, 14 and 28'},\n", - " {'PrimaryOutcomeMeasure': 'Change in Immunoglobulin G COVID-19 antibodies Titers',\n", - " 'PrimaryOutcomeDescription': 'Immunoglobulin G COVID-19 antibodies',\n", - " 'PrimaryOutcomeTimeFrame': 'Days 0, 4, 7, 14 and 28'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Intensive Care Unit Admission',\n", - " 'SecondaryOutcomeDescription': 'Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28)',\n", - " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", - " {'SecondaryOutcomeMeasure': 'Length of Intensive Care Unit stay',\n", - " 'SecondaryOutcomeDescription': 'Days of Intensive Care Unit management (days 7, 14 and 28)',\n", - " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", - " {'SecondaryOutcomeMeasure': 'Length of hospital stay (days)',\n", - " 'SecondaryOutcomeDescription': 'Days of Hospitalization (days 7, 14 and 28)',\n", - " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", - " {'SecondaryOutcomeMeasure': 'Requirement of mechanical ventilation',\n", - " 'SecondaryOutcomeDescription': 'Proportion of patients with mechanical ventilation (days 7, 14 and 28)',\n", - " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", - " {'SecondaryOutcomeMeasure': 'Duration (days) of mechanical ventilation',\n", - " 'SecondaryOutcomeDescription': 'Days with mechanical ventilation (days 7, 14 and 28)',\n", - " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", - " {'SecondaryOutcomeMeasure': 'Clinical status assessed according to the World Health Organization guideline',\n", - " 'SecondaryOutcomeDescription': '1. Hospital discharge; 2. Hospitalization, not requiring supplemental oxygen; 3. Hospitalization, requiring supplemental oxygen (but not Noninvasive Ventilation/ HFNC); 4. Intensive care unit/hospitalization, requiring Noninvasive Ventilation/ HFNC therapy; 5. Intensive care unit, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 6. Death. (days 7, 14 and 28)',\n", - " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", - " {'SecondaryOutcomeMeasure': 'Mortality',\n", - " 'SecondaryOutcomeDescription': 'Proportión of death patients at days 7, 14 and 28',\n", - " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:Fulfilling all the following criteria\\n\\nAged between 18 and 60 years, male or female.\\nHospitalized participants with diagnosis for COVID 19 by Real Time - Polymerase Chain Reaction.\\nWithout treatment.\\nModerate cases according to the official guideline \"Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)\".\\nConfusion, Urea, Respiratory rate, Blood pressure-65 (CURB-65) >= 2.\\nSequential Organ Failure Assessment score (SOFA) < 6.\\nAbility to understand and the willingness to sign a written informed consent document.\\n\\nExclusion Criteria:\\n\\nFemale subjects who are pregnant or breastfeeding.\\nPatients with prior allergic reactions to transfusions.\\nCritical ill patients in intensive care units.\\nPatients with surgical procedures in the last 30 days.\\nPatients with active treatment for cancer (Radiotherapy or Chemotherapy).\\nHIV diagnosed patients with viral failure (detectable viral load> 1000 copies / ml persistent, two consecutive viral load measurements within a 3 month interval, with medication adherence between measurements after at least 6 months of starting a new regimen antiretrovirals).\\nPatients who have suspicion or evidence of coinfections.\\nEnd-stage chronic kidney disease (Glomerular Filtration Rate <15 ml / min / 1.73 m2).\\nChild Pugh C stage liver cirrhosis.\\nHigh cardiac output diseases.\\nAutoimmune diseases or Immunoglobulin A nephropathy.\\nPatients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '60 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Juan M Anaya Cabrera, MD, PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+57 321 233 9828',\n", - " 'CentralContactEMail': 'anayajm@gmail.com'},\n", - " {'CentralContactName': 'Manuel E Rojas Quintana, MD, MSc',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+57 315 459 9951',\n", - " 'CentralContactEMail': 'manuel_9316@hotmail.com'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Juan M Anaya Cabrera, MD, PhD',\n", - " 'OverallOfficialAffiliation': 'Universidad del Rosario',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Universidad del Rosario',\n", - " 'LocationCity': 'Bogota',\n", - " 'LocationState': 'Cundinamarca',\n", - " 'LocationZip': '11100',\n", - " 'LocationCountry': 'Colombia',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Gustavo Quintero, MD, MSc',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+57 318 3606458',\n", - " 'LocationContactEMail': 'gustavo.quintero@urosario.edu.co'},\n", - " {'LocationContactName': 'Juan M Anaya Cabrera, MD, PhD',\n", - " 'LocationContactRole': 'Principal Investigator'},\n", - " {'LocationContactName': 'Manuel E Rojas Quintana, MD, MSc',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Sara Velez Gomez',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Juan C Diaz Coronado, MD, MSc',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Anha M Robledo Moreno',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Juan E Gallo Bonilla, MSc, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Ruben D Manrique Hernández, MSc, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Oscar M Gómez Guzmán, MSc, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Isaura P Torres Gómez, MSc, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Paula A Pedroza Rodríguez',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Bernardo Camacho Rodríguez, MD, MSc',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Jeser S Grass Guaqueta, MSc',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Gustavo A Salguero López, MD, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Luisa P Duarte Correales',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Cristian A Ricaurte Perez, MSc',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Adriana Rojas Villarraga, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Heily C Ramírez Santana, MSc, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Diana M Monsalve Carmona, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Yhojan A Rodríguez Velandia, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Yeny Y Acosta Ampudia, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Carlos E Perez, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Ruben D Mantilla, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Paula Gaviria, MSc',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}}]}},\n", - " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '31986264',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:.'},\n", - " {'ReferencePMID': '32134116',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Wang Y, Wang Y, Chen Y, Qin Q. Unique epidemiological and clinical features of the emerging 2019 novel coronavirus pneumonia (COVID-19) implicate special control measures. J Med Virol. 2020 Mar 5. doi: 10.1002/jmv.25748. [Epub ahead of print] Review.'},\n", - " {'ReferencePMID': '32125362',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Young BE, Ong SWX, Kalimuddin S, Low JG, Tan SY, Loh J, Ng OT, Marimuthu K, Ang LW, Mak TM, Lau SK, Anderson DE, Chan KS, Tan TY, Ng TY, Cui L, Said Z, Kurupatham L, Chen MI, Chan M, Vasoo S, Wang LF, Tan BH, Lin RTP, Lee VJM, Leo YS, Lye DC; Singapore 2019 Novel Coronavirus Outbreak Research Team. Epidemiologic Features and Clinical Course of Patients Infected With SARS-CoV-2 in Singapore. JAMA. 2020 Mar 3. doi: 10.1001/jama.2020.3204. [Epub ahead of print]'},\n", - " {'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Infectious, D. & Outbreaks, D. Maintaining a safe and adequate blood supply during the pandemic outbreak of coronavirus disease ( COVID-19 ). OMS 1-5 (2020).'}]},\n", - " 'SeeAlsoLinkList': {'SeeAlsoLink': [{'SeeAlsoLinkLabel': 'FDA recommendations for convalescent plasma clinical research',\n", - " 'SeeAlsoLinkURL': 'https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", - " {'ConditionMeshId': 'D000045169',\n", - " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 4,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04303299',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'TH-DMS-COVID19 study'},\n", - " 'Organization': {'OrgFullName': 'Rajavithi Hospital',\n", - " 'OrgClass': 'OTHER_GOV'},\n", - " 'BriefTitle': 'Various Combination of Protease Inhibitors, Oseltamivir, Favipiravir, and Hydroxychloroquine for Treatment of COVID19 : A Randomized Control Trial',\n", - " 'OfficialTitle': 'A 6 Week Prospective, Open Label, Randomized, in Multicenter Study of, Oseltamivir Plus Hydroxychloroquine Versus Lopipinavir/ Ritonavir Plus Oseltamivir Versus Darunavir/ Ritonavir Plus Oseltamivir Plus Hydroxychloroquine in Mild COVID19 AND Lopipinavir/ Ritonavir Plus Oseltamivir Versus Favipiravir Plus Lopipinavir / Ritonavir Versus Darunavir/ Ritonavir Plus Oseltamivir Plus Hydroxychloroquine Versus Favipiravir Plus Darunavir and Ritonavir Plus Hydroxychloroquine in Moderate to Critically Ill COVID19',\n", - " 'Acronym': 'THDMS-COVID19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 15, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'October 31, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'November 30, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'February 24, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 8, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 11, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 23, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 25, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Dr Subsai Kongsaengdao',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Associate Professor',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Rajavithi Hospital'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Rajavithi Hospital',\n", - " 'LeadSponsorClass': 'OTHER_GOV'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No',\n", - " 'IsUSExport': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'A 6-Week Prospective, Open label, Randomized, in Multicenter Study of, Oseltamivir 300mg per day plus Hydroxychloroquine 800 mg per day versus Combination of Lopipinavir 800mg (or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Oseltamivir 300 mg ( or 4-6 mg /kg ) per day versus Combination of Darunavir 400 mg every 8 hours plus ritonavir 200 mg (or 2.5 mg/kg ) per day plus Oseltamivir 300mg ( or 4-6 mg /kg ) per day plus Hydroxychloroquine 400 mg per day in mild COVID 19 and Combination of Lopipinavir 800 mg (or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Oseltamivir 300 mg ( or 4-6 mg /kg ) per day versus Favipiravir 2400 mg, 2400 mg, and 1200 mg every 8 h on day 1, and a maintenance dose of 1200 mg twice a day plus Lopipinavir 800 mg ( or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day versus Combination of Darunavir 400 mg every 8 hours plus ritonavir 200 mg (or 2.5 mg/kg ) plus Oseltamivir 300 mg (or 4-6 mg /kg ) per day plus Hydroxychloroquine 400 mg per day versus Favipiravir 2400 mg, 2400 mg, and 1200 mg every 8 h on day 1, and a maintenance dose of 1200 mg twice a day plus Darunavir 400 mg every 8 hours Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Hydroxychloroquine 400 mg per day in moderate to critically illness in COVID 19',\n", - " 'DetailedDescription': 'Overall Study Design and Plan Various Combination of Protease inhibitors, Oseltamivir, Favipiravir, and Chloroquin for treatment of COVID19. Non parametric and parametric statistical analysis will be analysed in the efficacy of treatment. For the pair-wise comparison, 2-sided p-value was used to ensure that the overall Type I error=0.05. Beta error 80%. Demographic and safety analyses were based on the summary of descriptive statistics.\\n\\nPre-randomization Phase The pre-randomization phase consisted of a screening period (0 to 1 day prior to randomization).\\n\\nScreening Period (Day -1 to 0) At the screening visit and prior to performance of any study procedures, the investigators would explain the details of the study and the subject would have to sign on the written informed consent, exclusion criteria, and inclusion criteria Each subject who was willing to enrol into the study was asked about their medical history as well as their recent and current medications being taken. All enrolled subjects were asked to undertake an initial physical examination and had to satisfy the criteria for the inclusion /exclusion before being enrolled into the study.\\n\\nAll patients were asked to complete physical examination, CXR, CBC plt, proBNP, High sensitive C reactive protein and Laboratory blood (livers tests, haematology,) examinations, urine pregnancy test) were performed amount 5.5 mL for safety reasons. Nasopharyngeal swabs were collected to detect the ORF 1ab and E genes (sensitivity: 1000 copies per milliliter) by polymerase chain reactions. Will be performed The inclusion visit included the following examination and tests: - physical examination,- vital signs,- weight,- CBC laboratory test result,-Chest X ray or CT chest Blood for plasma cytokine assay -Pro BNP and High sensitive C reactive protein, D dimer Treatment period All patient will be treated with specific arm for 7-10 days or until negative for Nasopharyngeal swabs were collected to detect the ORF 1ab and E genes of SARS -CoV-2 for 3 consecutive tests every 24 -48 hours The quarantine period will be performed for 7-14 days after swab negative All cases may be treated with Antibiotics as prophylaxis or specific treatment Other standard treatment will be allowed for investigator judgments. CXR nasoparyngeal swab will be performed every 1-2 days or up to investigator judgments Follow up Visits Patient will be check up CXR CT scan nasoparyngeal swab will be performed every 1-2 weeks until 6 weeks or clinical complete recovery'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus Infections',\n", - " 'COVID19']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 3']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)',\n", - " 'DesignMaskingDescription': \"The study is described as 'open' unblinded, however all clinical, virological and laboratory data, as well as adverse events were reviewed by two independent physicians, and all radiological images were reviewed by two independent radiologists who were blinded to the treatment assignments.\\n\\nThe study outcomes assessed blinded to randomized group ( PROBE design - prospective randomised open blinded evaluation)\"}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '80',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Oseltamivir plus Chloroquine in Mild COVID19',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Oseltamivir 300mg ( or 4-6 mg/kg) per day plus Hydroxychloroquine 800 mg per day In mild COVID19',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Oral']}},\n", - " {'ArmGroupLabel': 'Darunavir and Ritonavir plus oseltamivir',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Darunavir 400 mg every 8 hours Ritonavir 200 mg (or 2.5 mg/kg ) per day plus plus Oseltamivir 300mg ( or 4-6 mg/kg) per day plus Hydroxychloroquine 400mg per day in Mild COVID19',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Oral']}},\n", - " {'ArmGroupLabel': 'Lopinavir and Ritonavir plus Oseltamivir in mild COVID19',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Lopinavir 800 mg ( or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Oseltamivir 300 mg ( or 4-6 mg /kg ) per day In mild COVID19',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Oral']}},\n", - " {'ArmGroupLabel': 'Lopinavir and Ritonavir Oseltamivir moderate to severe COVID19',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Lopinavir 800 mg ( or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Oseltamivir 300 mg ( or 4-6 mg /kg ) per day In moderate to critically ill COVID19',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Oral']}},\n", - " {'ArmGroupLabel': 'Favipiravir lopinavir /Ritonavir for mod. To severe',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Lopinavir 800 mg (or 10 mg/kg ) per day and Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Favipiravir 2400 mg, 2400 mg, and 1200 mg every 8 h on day 1, and a maintenance dose of 1200 mg twice a day in Mild COVID19 In moderate to critically ill COVID19',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Oral']}},\n", - " {'ArmGroupLabel': 'Darunavir /ritonavir oseltamivir chloroquine mod-severe',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Darunavir 400 mg every 8 hours Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Oseltamivir 300 mg (or 4-6 mg /kg ) per day plus Hydroxychloroquine 400 mg per day In moderate to critically ill COVID19',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Oral']}},\n", - " {'ArmGroupLabel': 'Darunavir /ritonavir favipiravir chloroquine mod-severe',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Darunavir 400 mg every 8 hours Ritonavir 200 mg ( or 2.5 mg/kg ) per day plus Favipiravir 2400 mg, 2400 mg, and 1200 mg every 8 h on day 1, and a maintenance dose of 1200 mg twice a day plus Hydroxychloroquine 400 mg per day In moderate to critically ill COVID19',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Oral']}},\n", - " {'ArmGroupLabel': 'Conventional Qurantine',\n", - " 'ArmGroupType': 'No Intervention',\n", - " 'ArmGroupDescription': 'Patient who unwilling to treatment and willing to quarantine in mild COVID19'}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Oral',\n", - " 'InterventionDescription': 'Anti virus treatment',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Darunavir /ritonavir favipiravir chloroquine mod-severe',\n", - " 'Darunavir /ritonavir oseltamivir chloroquine mod-severe',\n", - " 'Darunavir and Ritonavir plus oseltamivir',\n", - " 'Favipiravir lopinavir /Ritonavir for mod. To severe',\n", - " 'Lopinavir and Ritonavir Oseltamivir moderate to severe COVID19',\n", - " 'Lopinavir and Ritonavir plus Oseltamivir in mild COVID19',\n", - " 'Oseltamivir plus Chloroquine in Mild COVID19']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'SARS-CoV-2 eradication time',\n", - " 'PrimaryOutcomeDescription': 'Eradication of nasopharyngeal SARS-CoV-2',\n", - " 'PrimaryOutcomeTimeFrame': 'Up to 24 weeks'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Number of patient with Death',\n", - " 'SecondaryOutcomeDescription': 'Any death after treatment adjusted by initial severity in each arm',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 24 weeks'},\n", - " {'SecondaryOutcomeMeasure': 'Number of patient with Recovery adjusted by initial severity in each arm',\n", - " 'SecondaryOutcomeDescription': 'Normal pulmonary function, normal O2 saturation after treatment Adjusted by initial severity in each arm',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 24 weeks'},\n", - " {'SecondaryOutcomeMeasure': 'Number of day With ventilator dependent adjusted by initial severity in each arm',\n", - " 'SecondaryOutcomeDescription': 'Number of day with ventilator assistant',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 24 weeks'},\n", - " {'SecondaryOutcomeMeasure': 'Number of patient developed Acute Respiratory Distress Syndrome After treatment',\n", - " 'SecondaryOutcomeDescription': 'Number of patient developed new ARDS',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 24 weeks'}]},\n", - " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'Number of patient with Acute Respiratory Distress Syndrome Recovery',\n", - " 'OtherOutcomeDescription': 'Acute Respiratory Distress Syndrome Recovery rate',\n", - " 'OtherOutcomeTimeFrame': 'Up to 24 weeks'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nThe subject has to grant permission to enter into the study by signing and dating the informed consent form before completing any study-related procedure such as any assessment or evaluation not related to the normal medical care of the subject.\\nAble to give written inform consent and retained one copy of the consent form\\nMale or female subject, aged between 16 - 100 years old.\\nSubject diagnosed to be COVID19\\nFemale subject in good health and sexually active was instructed by the investigator to avoid pregnancy during the study and to use condom or other contraceptive measure if necessary. The subject was required to have a negative urine pregnancy test before being eligible for the study. (At each of the subsequent visit, a urine pregnancy test was performed).\\nSubject judged to be reliable for compliance for taking medication and capable of recording the effects of the medication and motivated in receiving benefits from the treatment.and compliance to quarantine procedure 7-14 days after treatment\\n\\nExclusion Criteria:\\n\\nThe subject was pregnant or lactating.\\nThe subject was a female at risk of pregnancy during the study and not taking adequate precautions against pregnancy.\\nThe subject had a known hypersensitivity to any of the test materials or related compounds.\\nThe subject was unable or unwilling to comply fully with the protocol.\\nTreatment with investigational drug (s) within 6 months before the screening visit.\\nThe subject had previously entered in this study.\\nPatient who planned to schedule elective surgery during the study\\nThe used of other antiviral agents',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '16 Years',\n", - " 'MaximumAge': '100 Years',\n", - " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Subsai Kongsaengdao, M.D.',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '66818180890',\n", - " 'CentralContactEMail': 'skhongsa@gmail.com'},\n", - " {'CentralContactName': 'Narumol Sawanpanyalert, M.D., M.P.H',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '66818424148',\n", - " 'CentralContactEMail': 'thailandemt2019@gmail.com'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Assistant Professor Subsai Kongsaengdao',\n", - " 'LocationCity': 'Bangkok',\n", - " 'LocationZip': '10400',\n", - " 'LocationCountry': 'Thailand'}]}},\n", - " 'ReferencesModule': {'AvailIPDList': {'AvailIPD': [{'AvailIPDId': 'Thai government data',\n", - " 'AvailIPDType': 'Data references',\n", - " 'AvailIPDURL': 'https://ddc.moph.go.th'},\n", - " {'AvailIPDType': 'News',\n", - " 'AvailIPDURL': 'https://world.kbs.co.kr/service/news_view.htm?lang=e&Seq_Code=151108'},\n", - " {'AvailIPDType': 'Reference News',\n", - " 'AvailIPDURL': 'https://world.kbs.co.kr/service/news_view.htm?lang=e&Seq_Code=151108'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000019438',\n", - " 'InterventionMeshTerm': 'Ritonavir'},\n", - " {'InterventionMeshId': 'D000061466',\n", - " 'InterventionMeshTerm': 'Lopinavir'},\n", - " {'InterventionMeshId': 'D000069454',\n", - " 'InterventionMeshTerm': 'Darunavir'},\n", - " {'InterventionMeshId': 'D000006886',\n", - " 'InterventionMeshTerm': 'Hydroxychloroquine'},\n", - " {'InterventionMeshId': 'D000002738',\n", - " 'InterventionMeshTerm': 'Chloroquine'},\n", - " {'InterventionMeshId': 'D000053139',\n", - " 'InterventionMeshTerm': 'Oseltamivir'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000017320',\n", - " 'InterventionAncestorTerm': 'HIV Protease Inhibitors'},\n", - " {'InterventionAncestorId': 'D000011480',\n", - " 'InterventionAncestorTerm': 'Protease Inhibitors'},\n", - " {'InterventionAncestorId': 'D000004791',\n", - " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000019380',\n", - " 'InterventionAncestorTerm': 'Anti-HIV Agents'},\n", - " {'InterventionAncestorId': 'D000044966',\n", - " 'InterventionAncestorTerm': 'Anti-Retroviral Agents'},\n", - " {'InterventionAncestorId': 'D000000998',\n", - " 'InterventionAncestorTerm': 'Antiviral Agents'},\n", - " {'InterventionAncestorId': 'D000000890',\n", - " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", - " {'InterventionAncestorId': 'D000065692',\n", - " 'InterventionAncestorTerm': 'Cytochrome P-450 CYP3A Inhibitors'},\n", - " {'InterventionAncestorId': 'D000065607',\n", - " 'InterventionAncestorTerm': 'Cytochrome P-450 Enzyme Inhibitors'},\n", - " {'InterventionAncestorId': 'D000000962',\n", - " 'InterventionAncestorTerm': 'Antimalarials'},\n", - " {'InterventionAncestorId': 'D000000981',\n", - " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", - " {'InterventionAncestorId': 'D000000977',\n", - " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'},\n", - " {'InterventionAncestorId': 'D000000563',\n", - " 'InterventionAncestorTerm': 'Amebicides'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M4562',\n", - " 'InterventionBrowseLeafName': 'Chloroquine',\n", - " 'InterventionBrowseLeafAsFound': 'Chloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M151035',\n", - " 'InterventionBrowseLeafName': 'Chloroquine diphosphate',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M8523',\n", - " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M19978',\n", - " 'InterventionBrowseLeafName': 'Ritonavir',\n", - " 'InterventionBrowseLeafAsFound': 'Ritonavir',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M28424',\n", - " 'InterventionBrowseLeafName': 'Lopinavir',\n", - " 'InterventionBrowseLeafAsFound': 'Lopinavir',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M25733',\n", - " 'InterventionBrowseLeafName': 'Oseltamivir',\n", - " 'InterventionBrowseLeafAsFound': 'Oseltamivir',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M18192',\n", - " 'InterventionBrowseLeafName': 'HIV Protease Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M12926',\n", - " 'InterventionBrowseLeafName': 'Protease Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M423',\n", - " 'InterventionBrowseLeafName': 'Darunavir',\n", - " 'InterventionBrowseLeafAsFound': 'Darunavir',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M19934',\n", - " 'InterventionBrowseLeafName': 'Anti-HIV Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M24015',\n", - " 'InterventionBrowseLeafName': 'Anti-Retroviral Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2895',\n", - " 'InterventionBrowseLeafName': 'Antiviral Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2795',\n", - " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M29151',\n", - " 'InterventionBrowseLeafName': 'Cytochrome P-450 CYP3A Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M29124',\n", - " 'InterventionBrowseLeafName': 'Cytochrome P-450 Enzyme Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2861',\n", - " 'InterventionBrowseLeafName': 'Antimalarials',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2879',\n", - " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2875',\n", - " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19188',\n", - " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", - " {'InterventionBrowseBranchAbbrev': 'Infl',\n", - " 'InterventionBrowseBranchName': 'Anti-Inflammatory Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'Analg',\n", - " 'InterventionBrowseBranchName': 'Analgesics'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", - " {'ConditionMeshId': 'D000045169',\n", - " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M17593',\n", - " 'ConditionBrowseLeafName': 'Critical Illness',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 5,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04332835',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'ABN011-2'},\n", - " 'Organization': {'OrgFullName': 'Universidad del Rosario',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Convalescent Plasma for Patients With COVID-19: A Randomized, Open Label, Parallel, Controlled Clinical Study',\n", - " 'OfficialTitle': 'Convalescent Plasma for Patients With COVID-19: A Randomized, Open Label, Parallel, Controlled Clinical Study',\n", - " 'Acronym': 'CP-COVID-19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'August 31, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 31, 2020',\n", - " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 3, 2020',\n", - " 'StudyFirstPostDateType': 'Estimate'},\n", - " 'LastUpdateSubmitDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", - " 'LastUpdatePostDateType': 'Estimate'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Juan Manuel Anaya Cabrera',\n", - " 'ResponsiblePartyInvestigatorTitle': 'MD, PhD, Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Universidad del Rosario'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Universidad del Rosario',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Fundación Universitaria de Ciencias de la Salud',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'CES University', 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'Instituto Distrital de Ciencia Biotecnología e Innovacion en Salud',\n", - " 'CollaboratorClass': 'UNKNOWN'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy when there is no vaccine or treatment available for infectious diseases. In the latest viral epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization issued a document outlining a protocol for the use of whole blood or plasma collected from patients who have recovered from the Ebola virus disease by transfusion to empirically treat local infectious outbreaks',\n", - " 'DetailedDescription': 'The process is based on obtaining plasma from patients recovered from COVID-19 in Colombia, and through a donation of plasma from the recovered, the subsequent transfusion of this to patients infected with coronavirus disease (COVID-19). Our group has reviewed the scientific evidence regarding the application of convalescent plasma for emergency viral outbreaks and has recommended the following protocol'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus',\n", - " 'Coronavirus Infection']},\n", - " 'KeywordList': {'Keyword': ['COVID-19', 'Coronavirus Disease 2019']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 2', 'Phase 3']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '80',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Intervention Group',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Participants included in the experimental group will receive 500 milliliters of convalescent plasma, distributed in two 250 milliliters transfusions on the first and second day after starting the protocol. Simultaneously, they will receive standard therapy Azithromycin (500 milligrams daily) and Hydroxychloroquine (400 milligrams each 12 hours) for 10 days.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Plasma',\n", - " 'Drug: Hydroxychloroquine',\n", - " 'Drug: Azithromycin']}},\n", - " {'ArmGroupLabel': 'Control Group',\n", - " 'ArmGroupType': 'Active Comparator',\n", - " 'ArmGroupDescription': 'Participants included in the control group will receive standard therapy Azithromycin (500 milligrams daily) and Hydroxychloroquine (400 milligrams each 12 hours) for 10 days.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine',\n", - " 'Drug: Azithromycin']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Plasma',\n", - " 'InterventionDescription': 'Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Intervention Group']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Convalescent Plasma COVID-19']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Hydroxychloroquine',\n", - " 'InterventionDescription': '400 milligrams each 12 hours for 10 days',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Control Group',\n", - " 'Intervention Group']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Azithromycin',\n", - " 'InterventionDescription': '500 milligrams daily for 10 days',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Control Group',\n", - " 'Intervention Group']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Change in Viral Load',\n", - " 'PrimaryOutcomeDescription': 'Copies of COVID-19 per ml',\n", - " 'PrimaryOutcomeTimeFrame': 'Days 0, 4, 7, 14 and 28'},\n", - " {'PrimaryOutcomeMeasure': 'Change in Immunoglobulin M COVID-19 Titers',\n", - " 'PrimaryOutcomeDescription': 'Immunoglobulin M COVID-19 antibodies',\n", - " 'PrimaryOutcomeTimeFrame': 'Days 0, 4, 7, 14 and 28'},\n", - " {'PrimaryOutcomeMeasure': 'Change in Immunoglobulin G COVID-19 Titers',\n", - " 'PrimaryOutcomeDescription': 'Immunoglobulin G COVID-19 antibodies',\n", - " 'PrimaryOutcomeTimeFrame': 'Days 0, 4, 7, 14 and 28'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Intensive Care Unit Admission',\n", - " 'SecondaryOutcomeDescription': 'Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28)',\n", - " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", - " {'SecondaryOutcomeMeasure': 'Length of Intensive Care Unit stay',\n", - " 'SecondaryOutcomeDescription': 'Days of Intensive Care Unit management (days 7, 14 and 28)',\n", - " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", - " {'SecondaryOutcomeMeasure': 'Length of hospital stay (days)',\n", - " 'SecondaryOutcomeDescription': 'Days of Hospitalization (days 7, 14 and 28)',\n", - " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", - " {'SecondaryOutcomeMeasure': 'Requirement of mechanical ventilation',\n", - " 'SecondaryOutcomeDescription': 'Proportion of patients with mechanical ventilation (days 7, 14 and 28)',\n", - " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", - " {'SecondaryOutcomeMeasure': 'Duration (days) of mechanical ventilation',\n", - " 'SecondaryOutcomeDescription': 'Days with mechanical ventilation (days 7, 14 and 28)',\n", - " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", - " {'SecondaryOutcomeMeasure': 'Clinical status assessed according to the World Health Organization guideline',\n", - " 'SecondaryOutcomeDescription': '1. Hospital discharge; 2. Hospitalization, not requiring supplemental oxygen; 3. Hospitalization, requiring supplemental oxygen (but not Noninvasive Ventilation/ HFNC); 4. Intensive care unit/hospitalization, requiring Noninvasive Ventilation/ HFNC therapy; 5. Intensive care unit, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 6. Death. (days 7, 14 and 28)',\n", - " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'},\n", - " {'SecondaryOutcomeMeasure': 'Mortality',\n", - " 'SecondaryOutcomeDescription': 'Proportion of death patients at days 7, 14 and 28',\n", - " 'SecondaryOutcomeTimeFrame': 'Days 7, 14 and 28'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:Fulfilling all the following criteria\\n\\nAged between 18 and 60 years, male or female.\\nHospitalized participants with diagnosis of COVID 19 by Real Time - Polymerase Chain Reaction.\\nModerate cases according to the official guideline \"Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)\".\\nConfusion, Urea, Respiratory rate, Blood pressure-65 (CURB-65) >= 2.\\nSequential Organ Failure Assessment score (SOFA) < 6.\\nAbility to understand and the willingness to sign a written informed consent document.\\n\\nExclusion Criteria:\\n\\nFemale subjects who are pregnant or breastfeeding.\\nPatients with prior allergic reactions to transfusions.\\nCritical ill patients in intensive care units.\\nPatients with surgical procedures in the last 30 days.\\nPatients with active treatment for cancer (Radiotherapy or Chemotherapy).\\nHIV diagnosed patients with viral failure (detectable viral load> 1000 copies / ml persistent, two consecutive viral load measurements within a 3 month interval, with medication adherence between measurements after at least 6 months of starting a new regimen antiretrovirals).\\nPatients who have suspicion or evidence of coinfections.\\nEnd-stage chronic kidney disease (Glomerular Filtration Rate <15 ml / min / 1.73 m2).\\nChild Pugh C stage liver cirrhosis.\\nHigh cardiac output diseases.\\nAutoimmune diseases or Immunoglobulin A nephropathy.\\nPatients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '60 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Juan M Anaya Cabrera, MD, PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+57 321 233 9828',\n", - " 'CentralContactEMail': 'anayajm@gmail.com'},\n", - " {'CentralContactName': 'Manuel E Rojas Quintana, MD, MSc',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+57 315 459 9951',\n", - " 'CentralContactEMail': 'manuel_9316@hotmail.com'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Juan M Anaya Cabrera, MD, PhD',\n", - " 'OverallOfficialAffiliation': 'Universidad del Rosario',\n", - " 'OverallOfficialRole': 'Study Director'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Universidad del Rosario',\n", - " 'LocationCity': 'Bogota',\n", - " 'LocationState': 'Cundinamarca',\n", - " 'LocationZip': '11100',\n", - " 'LocationCountry': 'Colombia',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Gustavo Quintero, MD, MSc',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+57 318 3606458',\n", - " 'LocationContactEMail': 'gustavo.quintero@urosario.edu.co'},\n", - " {'LocationContactName': 'Juan M Anaya Cabrera, MD, PhD',\n", - " 'LocationContactRole': 'Principal Investigator'},\n", - " {'LocationContactName': 'Manuel E Rojas Quintana, MD, MSc',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Sara Velez Gomez',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Juan C Diaz Coronado, MD, MSc',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Anha M Robledo Moreno',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Juan E Gallo Bonilla, MSc, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Ruben D Manrique Hernández, MSc, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Oscar M Gómez Guzmán, MSc, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Isaura P Torres Gómez, MSc, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Paula A Pedroza Rodríguez',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Bernardo Camacho Rodríguez, MD, MSc',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Jeser S Grass Guaqueta, MSc',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Gustavo A Salguero López, MD, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Luisa P Duarte Correales',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Cristian A Ricaurte Perez, MSc',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Adriana Rojas Villarraga, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Heily C Ramírez Santana, MSc, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Diana M Monsalve Carmona, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Yhojan A Rodríguez Velandia, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Yeny Y Acosta Ampudia, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Carlos E Perez, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Ruben D Mantilla, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Paula Gaviria, MSc',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}}]}},\n", - " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '31986264',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:.'},\n", - " {'ReferencePMID': '32134116',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Wang Y, Wang Y, Chen Y, Qin Q. Unique epidemiological and clinical features of the emerging 2019 novel coronavirus pneumonia (COVID-19) implicate special control measures. J Med Virol. 2020 Mar 5. doi: 10.1002/jmv.25748. [Epub ahead of print] Review.'},\n", - " {'ReferencePMID': '32125362',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Young BE, Ong SWX, Kalimuddin S, Low JG, Tan SY, Loh J, Ng OT, Marimuthu K, Ang LW, Mak TM, Lau SK, Anderson DE, Chan KS, Tan TY, Ng TY, Cui L, Said Z, Kurupatham L, Chen MI, Chan M, Vasoo S, Wang LF, Tan BH, Lin RTP, Lee VJM, Leo YS, Lye DC; Singapore 2019 Novel Coronavirus Outbreak Research Team. Epidemiologic Features and Clinical Course of Patients Infected With SARS-CoV-2 in Singapore. JAMA. 2020 Mar 3. doi: 10.1001/jama.2020.3204. [Epub ahead of print]'},\n", - " {'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Infectious, D. & Outbreaks, D. Maintaining a safe and adequate blood supply during the pandemic outbreak of coronavirus disease ( COVID-19 ). OMS 1-5 (2020)'}]},\n", - " 'SeeAlsoLinkList': {'SeeAlsoLink': [{'SeeAlsoLinkLabel': 'FDA recommendations for convalescent plasma clinical research',\n", - " 'SeeAlsoLinkURL': 'https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", - " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", - " 'InterventionAncestorTerm': 'Antimalarials'},\n", - " {'InterventionAncestorId': 'D000000981',\n", - " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", - " {'InterventionAncestorId': 'D000000977',\n", - " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", - " {'InterventionAncestorId': 'D000000890',\n", - " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", - " {'InterventionAncestorId': 'D000004791',\n", - " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", - " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M18715',\n", - " 'InterventionBrowseLeafName': 'Azithromycin',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2861',\n", - " 'InterventionBrowseLeafName': 'Antimalarials',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - 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" 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", - " {'ConditionMeshId': 'D000045169',\n", - " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 6,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04331574',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'SARS-RAS'},\n", - " 'Organization': {'OrgFullName': \"Societa Italiana dell'Ipertensione Arteriosa\",\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Renin-Angiotensin System Inhibitors and COVID-19',\n", - " 'OfficialTitle': 'Phase IV Observational Study to Associate Hypertension and Hypertensinon Treatment to COVID19',\n", - " 'Acronym': 'SARS-RAS'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 10, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 10, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'April 30, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 30, 2020',\n", - " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 2, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': \"Societa Italiana dell'Ipertensione Arteriosa\",\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Multicentric non-profit observational study, in patients with COVID-19 hospitalized in Italy, conducted through a pseudonymised survey.',\n", - " 'DetailedDescription': 'The recent SARS-CoV-2 Coronavirus pandemic and subsequent spread of the disease called COVID-19 brought back to the discussion a topic already highlighted during the SARS-CoV-4 crown-related SARS epidemic of 2002. In particular, the angiotensin converting enzyme 2 (ACE2) has been identified as a functional receptor for coronaviruses, therefore including SARS-CoV-2. ACE2 is strongly expressed in the heart and lungs. SARS-CoV-2 mainly invades alveolar epithelial cells, resulting in respiratory symptoms. These symptoms could be made more severe in the presence of increased expression of ACE2. ACE2 levels can be increased by the use of renin-angiotensin system inhibitors (RAS). This therapeutic class is particularly widespread, as it represents the most important pharmacological protection for widespread diseases such as high blood pressure, heart failure and ischemic heart disease. It is therefore possible to hypothesize that pharmacological treatment with RAS inhibitors may be associated with a more severe symptomatology and clinic than COVID-19.\\n\\nHowever, several observations from studies on SARSCoV, which are most likely also relevant for SARS-CoV-2 seem to suggest otherwise. Indeed, it has been shown that the binding of coronavirus to ACE2 leads to downregulation of ACE2, which in turn causes an ACE / ACE2 imbalance excessive production of angiotensin by the related ACE enzyme. Angiotensin II receptor 1 (AT1R) stimulated by angiotensin causes an increase in pulmonary vascular permeability, thereby mediating an increase in lung damage. Therefore, according to this hypothesis, the upregulation of ACE2, caused by the chronic intake of AT1R and ACE Inhibitors, could be protective through two mechanisms: the first, that of blocking in the AT1 receptor; second, increasing ACE2 levels decreases ACE production of angiotensin and increases ACE2 production of angiotensin 1-7.\\n\\nThe quickest approach to evaluating these two opposing hypotheses is to analyze the medical records of COVID-19 patients to determine whether patients on RAS antagonist therapy have a different disease outcome than patients without the above therapy.\\n\\nThis research aims to verify whether the chronic intake of RAS inhibitors modifies the prevalence and severity of the clinical manifestation of COVID-19.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", - " 'Hypertension',\n", - " 'Cardiovascular Diseases']},\n", - " 'KeywordList': {'Keyword': ['risk factors',\n", - " 'SARS',\n", - " 'ACE Inibitors',\n", - " 'ARB']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'Yes',\n", - " 'TargetDuration': '3 Months',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Case-Only']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Cross-Sectional']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '2000',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'covid-19 patients',\n", - " 'ArmGroupDescription': 'Patients with certified diagnosis of COVID-19 recruited in Italian hospitals'}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Numbers of COVID-19 patients enrolled that use ACE inhibitors and/or Angiotensin Receptor Blockers (ARB) as antihypertensive agents',\n", - " 'PrimaryOutcomeDescription': 'Using anamnestic data collected from the health record of the hospital or of the general practitioner, we will count the number of COVID-19 patients enrolled that were treated with ACE Inhibitors or ARB.',\n", - " 'PrimaryOutcomeTimeFrame': '3 months'},\n", - " {'PrimaryOutcomeMeasure': 'Numbers of COVID-19 patients enrolled with no symptoms, with moderate symptoms or with severe symptoms of pneumoni based on the WHO specification for ARDS that also used ACE inhibitors and/or Angiotensin Receptor Blockers (ARB) as antihypertensive agents',\n", - " 'PrimaryOutcomeDescription': 'This study want to observe whether the assumption of antihypertensive ACE inhibitors or ARB increases the severity of the clinical manifestation of COVID19',\n", - " 'PrimaryOutcomeTimeFrame': '3 months'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Number and type of anthropometric and clinical parameters that associate with COVID19 and COVID-19 severity',\n", - " 'SecondaryOutcomeDescription': 'Collecting selected data from the health record and hospital charts of the patients we will assess whether among the recorded parameters there are any that can predict COVID19 prevalence and severity',\n", - " 'SecondaryOutcomeTimeFrame': '3 months'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nPatients affected by COVID19 referring to italian outpatient clinics or hospitals\\n\\nExclusion Criteria:\\n\\n-',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '120 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'COVID-19 patients enrolled in infectious disease and resuscitation centers in Italy or in home isolation and health surveillance',\n", - " 'SamplingMethod': 'Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Guido Iaccarino, MD, PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+390817464717',\n", - " 'CentralContactEMail': 'guiaccar@unina.it'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Guido Iaccarino, MD',\n", - " 'OverallOfficialAffiliation': 'Federico II University',\n", - " 'OverallOfficialRole': 'Study Chair'},\n", - " {'OverallOfficialName': 'Guido Grassi, MD',\n", - " 'OverallOfficialAffiliation': 'Inversity of Milan, BICOCCA',\n", - " 'OverallOfficialRole': 'Study Director'},\n", - " {'OverallOfficialName': 'MariaLorenza Muiesan, MD',\n", - " 'OverallOfficialAffiliation': 'Università degli Studi di Brescia',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Claudio Borghi, MD',\n", - " 'OverallOfficialAffiliation': 'University of Bologna',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Claudio Ferri, MD',\n", - " 'OverallOfficialAffiliation': \"University of L'Aquila\",\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'MASSIMO VOLPE, MD',\n", - " 'OverallOfficialAffiliation': 'Univerity of Rome \"La Sapienza\"',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Leonardo Sechi',\n", - " 'OverallOfficialAffiliation': 'University of Udine',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Spedali Civili di Brescia',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Brescia',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Marialorenza Muiesan',\n", - " 'LocationContactRole': 'Contact'}]}}]}},\n", - " 'ReferencesModule': {'SeeAlsoLinkList': {'SeeAlsoLink': [{'SeeAlsoLinkLabel': 'Related Info',\n", - " 'SeeAlsoLinkURL': 'https://siia.it/notizie-siia/inibitori-del-sistema-renina-angiotensina-e-sars-cov-2-lindagine-della-siia/'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000006973',\n", - " 'ConditionMeshTerm': 'Hypertension'},\n", - " {'ConditionMeshId': 'D000002318',\n", - " 'ConditionMeshTerm': 'Cardiovascular Diseases'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000014652',\n", - " 'ConditionAncestorTerm': 'Vascular Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8607',\n", - " 'ConditionBrowseLeafName': 'Hypertension',\n", - " 'ConditionBrowseLeafAsFound': 'Hypertension',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M15983',\n", - " 'ConditionBrowseLeafName': 'Vascular Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC14',\n", - " 'ConditionBrowseBranchName': 'Heart and Blood Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", - " {'Rank': 7,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04318301',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'Zhenhuazen2018'},\n", - " 'Organization': {'OrgFullName': 'Nanfang Hospital of Southern Medical University',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Hypertension in Patients Hospitalized With COVID-19',\n", - " 'OfficialTitle': 'Hypertension in Patients Hospitalized With COVID-19 in Wuhan, China: A Single-center Retrospective Observational Study',\n", - " 'Acronym': 'HT-COVID19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Active, not recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 21, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 28, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'March 30, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 20, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 20, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 23, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 21, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 24, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor-Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Zhenhua Zen',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Associate Professor',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Nanfang Hospital of Southern Medical University'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Zhenhua Zen',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Some studies have shown that the main pathogenesis of patients with covid19 is related to ACE2 receptor. Lung is one of the main organs, and there are many ACE2 receptors in cardiovascular system. ACEI / ARB is the main target of antihypertensive drugs. Previous reports suggested that there were large number of patients with covid19 also suffered from hypertension, suggesting that patients with hypertension may be the susceptible to covid19. Therefore, we try to follow up the patients admitted to Hankou hospital to explore the impact of hypertension and hypertension treatment on the severity and prognosis of patients with covid19, so as to provide new methods for the treatment of patients with covid19 in the future.',\n", - " 'DetailedDescription': 'In December, 2019, a cluster of severe pneumonia cases of unknown cause emerged in Wuhan, China, with clinical presentations greatly resembling viral pneumonia1. Deep sequencing analysis from lower respiratory tract samples indicated a novel coronavirus, which was named 2019 novel coronavirus (2019-nCoV, then named COVID-19). Up to Mar 16, 2020, the total number of patients had risen sharply to 153,546 confirmed cases worldwide (http://2019ncov.chinacdc.cn/2019-nCoV/global.html). The data extracted from 1099 patients with laboratory-confirmed COVID-19 in China from January 29, 2020 showed that hypertension is the most common coexisting illness of COVID-19 patients, ranging from 13.4% in nonsevere patient vs. 23.4% in severe patients, and the total incidence is as high as 15%2. Interestingly, ACE2 is involved in the pathogenesis of both hypertension and SARS-COV-2 pneumonia. The above reasons prompted us to speculate that the organs attacked by SARS-COV-2 might not only be lungs, but also include other ACE2 expression organs, especially cardiovascular system. In addition, patients with comorbid hypertension, especially those with long-term oral ACEI/ARB medication for hypertension, might have different susceptibility and severity levels of pneumonia upon SARS-COV-2 attack. Therefore, we investigated and compared the demographic characteristics, coexisting disease, severity of pneumonia, and the effect of antihypertensive drugs (ACEI/ARB versus non-ACEI/ARB) in patients with COVID-19 coexisting hypertension, thereby, hopefully, to reduce the mortality and morbidity associated with hypertension in patients with COVID-19.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", - " 'Hypertension']},\n", - " 'KeywordList': {'Keyword': ['COVID-19', 'Hypertension', 'ACE2']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Case-Control']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Retrospective']}},\n", - " 'BioSpec': {'BioSpecRetention': 'None Retained',\n", - " 'BioSpecDescription': 'Blood'},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '275',\n", - " 'EnrollmentType': 'Actual'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'ACEI/ARB',\n", - " 'ArmGroupDescription': 'COVID-19 patients with hypertension who had previously taken ACEI/ARB for antihypertensive treatment'},\n", - " {'ArmGroupLabel': 'non ACEI/ARB',\n", - " 'ArmGroupDescription': 'COVID-19 patients with hypertension who had not previously taken ACEI/ARB for antihypertensive treatment'}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Rate of Death',\n", - " 'PrimaryOutcomeDescription': 'mortality in 28-day',\n", - " 'PrimaryOutcomeTimeFrame': 'From date of admission until the date of death from any cause, up to 60 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'the severity of pneumonia',\n", - " 'SecondaryOutcomeDescription': 'evaluate the severity of pneumonia according to CT scans and clinical manifestation',\n", - " 'SecondaryOutcomeTimeFrame': 'From date of admission until the date of discharge or death from any cause, up to 60 days'}]},\n", - " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'the length of hospital stay',\n", - " 'OtherOutcomeDescription': 'days from admission to discharge or death',\n", - " 'OtherOutcomeTimeFrame': 'From date of admission until the date of discharge or death from any cause, up to 60 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nCOVID-19 pneumonia patients diagnosed by WHO criteria\\n\\nExclusion Criteria:\\n\\nPatients who were younger than 18 years.\\nPatients whose entire stay lasted for less than 48 hours.',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '100 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'Patients with clinically confirmed COVID-19 admitted to Hankou Hospital, Wuhan, China from January 5 to March 8, 2020.',\n", - " 'SamplingMethod': 'Probability Sample'},\n", - " 'ContactsLocationsModule': {'LocationList': {'Location': [{'LocationFacility': 'Hankou Hospital',\n", - " 'LocationCity': 'Hankou',\n", - " 'LocationState': 'Hubei',\n", - " 'LocationZip': '430000',\n", - " 'LocationCountry': 'China'}]}},\n", - " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '31978945',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.'},\n", - " {'ReferencePMID': '14647384',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Li W, Moore MJ, Vasilieva N, Sui J, Wong SK, Berne MA, Somasundaran M, Sullivan JL, Luzuriaga K, Greenough TC, Choe H, Farzan M. Angiotensin-converting enzyme 2 is a functional receptor for the SARS coronavirus. Nature. 2003 Nov 27;426(6965):450-4.'},\n", - " {'ReferencePMID': '31986264',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:.'},\n", - " {'ReferencePMID': '29449338',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Wang Z, Chen Z, Zhang L, Wang X, Hao G, Zhang Z, Shao L, Tian Y, Dong Y, Zheng C, Wang J, Zhu M, Weintraub WS, Gao R; China Hypertension Survey Investigators. Status of Hypertension in China: Results From the China Hypertension Survey, 2012-2015. Circulation. 2018 May 29;137(22):2344-2356. doi: 10.1161/CIRCULATIONAHA.117.032380. Epub 2018 Feb 15.'},\n", - " {'ReferencePMID': '15897343',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Ferrario CM, Jessup J, Chappell MC, Averill DB, Brosnihan KB, Tallant EA, Diz DI, Gallagher PE. Effect of angiotensin-converting enzyme inhibition and angiotensin II receptor blockers on cardiac angiotensin-converting enzyme 2. Circulation. 2005 May 24;111(20):2605-10. Epub 2005 May 16.'},\n", - " {'ReferencePMID': '15165741',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Turner AJ, Hiscox JA, Hooper NM. ACE2: from vasopeptidase to SARS virus receptor. Trends Pharmacol Sci. 2004 Jun;25(6):291-4. Review.'}]},\n", - " 'SeeAlsoLinkList': {'SeeAlsoLink': [{'SeeAlsoLinkLabel': 'A Novel Coronavirus From Patients With Pneumonia in China, 2019',\n", - " 'SeeAlsoLinkURL': 'https://pubmed.ncbi.nlm.nih.gov/31978945/?from_single_result=31978945'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M2858',\n", - " 'InterventionBrowseLeafName': 'Antihypertensive Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2715',\n", - " 'InterventionBrowseLeafName': 'Angiotensin-Converting Enzyme Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000006973',\n", - " 'ConditionMeshTerm': 'Hypertension'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000014652',\n", - " 'ConditionAncestorTerm': 'Vascular Diseases'},\n", - " {'ConditionAncestorId': 'D000002318',\n", - " 'ConditionAncestorTerm': 'Cardiovascular Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8607',\n", - " 'ConditionBrowseLeafName': 'Hypertension',\n", - " 'ConditionBrowseLeafAsFound': 'Hypertension',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M15983',\n", - " 'ConditionBrowseLeafName': 'Vascular Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC14',\n", - " 'ConditionBrowseBranchName': 'Heart and Blood Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", - " {'Rank': 8,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04318418',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'DEP_012020'},\n", - " 'Organization': {'OrgFullName': 'Neuromed IRCCS', 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'ACE Inhibitors, Angiotensin II Type-I Receptor Blockers and Severity of COVID-19',\n", - " 'OfficialTitle': 'ACE Inhibitors, Angiotensin II Type-I Receptor Blockers and Severity of COVID-19',\n", - " 'Acronym': 'CODIV-ACE'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 23, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 10, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'April 30, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 19, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 19, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 24, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 19, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 24, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Augusto Di Castelnuovo',\n", - " 'ResponsiblePartyInvestigatorTitle': 'MSc, PhD',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Neuromed IRCCS'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Neuromed IRCCS',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Hypothesis Very recent evidences supports the hypothesis that the novel coronavirus 2019 (2019-nCoV) uses the SARS-1 coronavirus receptor angiotensin converting enzyme 2 (ACE2) for entry into target cells. The epidemiological association between Angiotensin receptor-blocker (ARB) or ACE inhibitors (ACE-I) use and severe sequelae of 2109-nCoV infection disease COVID-19 has not been yet conclusively demonstrated, but may have important consequences for population health.\\n\\nAim To retrospectively test whether 2019-nCoV patients treated with ACE-I or ARB, in comparison with patients who not, are at higher risk of having severe COVID-19 (including death).\\n\\nPopulation Hospitalized patients with confirmed COVID-19 infection (any type).\\n\\nStudy design Patients will be divided in two groups, a) controls: individuals who did not develop severe COVID-19 respiratory disease (including individuals who recovered from the infection) and b) cases: individuals who developed severe COVID-19 disease (including fatal events). Treatment with ACE-I or ARB, together with possible confounding will be assessed retrospectively.\\n\\nExposure Treatment for ACE-I or ARB.',\n", - " 'DetailedDescription': 'Background Very recent evidences support the hypothesis that the novel coronavirus 2019 (2019-nCoV) uses the SARS-1 coronavirus receptor ACE2 for gains entry into target cells. Angiotensin receptor-blocker (ARB) drugs, one of the most commonly used antihypertensive drug, typically increase ACE2 expression, often very markedly. With SARS-CoV-2 infection increased ACE2 expression very definitely would not be beneficial, and could be adverse. However, augmented ACE2 expression with ARBs has been demonstrated in the kidneys and heart but has not been tested in the lungs. So, the hypothesis that using of ARBS or ACE inhibitors (ACE-I) drugs during the COVID-19 may possibly be harmful is urgently to be verified in epidemiological studies.\\n\\nAim To retrospectively test whether 2019-nCoV patients treated with ARB or ACE-I, in comparison with patients who not, are at higher risk of having severe COVID-19 (including death).\\n\\nPopulation Hospitalized patients with confirmed COVID-19 infection (any type).\\n\\nOutcome The project will retrospectively collect data on the most severe manifestation of COVID-19 occurred in 2019-nCoV infected patients during hospitalization. Severity will be classified as: hospital discharge with healing, asymptomatic, mild complications but not pneumonia, not severe pneumonia, severe pneumonia, acute respiratory distress syndrome (ARDS) and death. Classification of pneumonia will follow WHO criteria. Data on severity will be obtained from medical record at one-point time (at the moment of inclusion in the study).\\n\\nExposure Treatment for ARB or ACE-I. When available, type of drugs will be recorded.\\n\\nStudy design Patients will be divided in two groups, a) controls: individuals who did not develop severe COVID-19 respiratory disease (including individuals who recovered from the infection) and b) cases: individuals who developed severe COVID-19 disease (including fatal events). Association between use of ACE-I or ARB and severity of COVID-19 will be assessed by using of multivariable logistic regression analysis. Data on potential confounders will be obtained by medical records: age, sex, time intervals from hospital admission to worse manifestation of COVID-19 and to eventual death or recovering, smoking, body mass index, history of myocardial infarction, diabetes, hypertension, cancer, respiratory disease, other morbidities, creatinine, insulin, glomerular filtration rate together with use of Tocilizumab, anti-aldosterone agents, diuretics, Kaletra, cortisone, Remdesevir, Chloroquine, Sacubitril or Valsartan.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", - " 'KeywordList': {'Keyword': ['Angiotensin receptor-blocker and ACE inhibitors drugs']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Case-Control']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Retrospective']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '5000',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Cases',\n", - " 'ArmGroupDescription': 'Patients who developed severe COVID-19 disease (including fatal events)'},\n", - " {'ArmGroupLabel': 'Controls',\n", - " 'ArmGroupDescription': 'Infected patients who did not develop severe COVID-19 respiratory disease (including individuals who recovered from the infection)'}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Severe COVID-19',\n", - " 'PrimaryOutcomeDescription': 'Severity pneumonia or acute respiratory distress syndrome by COVID-19',\n", - " 'PrimaryOutcomeTimeFrame': '1 month'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Death',\n", - " 'SecondaryOutcomeDescription': 'Death by COVID-19',\n", - " 'SecondaryOutcomeTimeFrame': '1 month'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nPatients hospitalized for COVID-19\\n\\nExclusion Criteria:\\n\\nnone',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'Hospitalized patients with confirmed COVID-19 infection (any type), recruited in Italian hospital',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Augusto Di Castelnuovo, MSc, PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '3289035621',\n", - " 'CentralContactEMail': 'dicastel@ngi.it'},\n", - " {'CentralContactName': 'Licia Iacoviello, MD, PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactEMail': 'licia.iacoviello@uninsubria.it'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Augusto Di Castelnuovo, MSc, PhD',\n", - " 'OverallOfficialAffiliation': 'IRCCS Neuromed',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'IRCCS Neuromed, Department of Epidemiology and Prevention',\n", - " 'LocationCity': 'Pozzilli',\n", - " 'LocationZip': '86077',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Augusto Di Castelnuovo',\n", - " 'LocationContactRole': 'Contact'},\n", - " {'LocationContactName': 'Licia Iacoviello',\n", - " 'LocationContactRole': 'Contact'}]}}]}}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000000804',\n", - " 'InterventionMeshTerm': 'Angiotensin II'},\n", - " {'InterventionMeshId': 'C000627694',\n", - " 'InterventionMeshTerm': 'Giapreza'},\n", - " {'InterventionMeshId': 'D000000806',\n", - " 'InterventionMeshTerm': 'Angiotensin-Converting Enzyme Inhibitors'},\n", - " {'InterventionMeshId': 'D000000808',\n", - " 'InterventionMeshTerm': 'Angiotensinogen'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000011480',\n", - " 'InterventionAncestorTerm': 'Protease Inhibitors'},\n", - " {'InterventionAncestorId': 'D000004791',\n", - " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000014662',\n", - " 'InterventionAncestorTerm': 'Vasoconstrictor Agents'},\n", - " {'InterventionAncestorId': 'D000015842',\n", - " 'InterventionAncestorTerm': 'Serine Proteinase Inhibitors'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M27503',\n", - " 'InterventionBrowseLeafName': 'Angiotensin Receptor Antagonists',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2715',\n", - " 'InterventionBrowseLeafName': 'Angiotensin-Converting Enzyme Inhibitors',\n", - " 'InterventionBrowseLeafAsFound': 'ACE inhibitor',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M2713',\n", - " 'InterventionBrowseLeafName': 'Angiotensin II',\n", - " 'InterventionBrowseLeafAsFound': 'Angiotensin II',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M269574',\n", - " 'InterventionBrowseLeafName': 'Giapreza',\n", - " 'InterventionBrowseLeafAsFound': 'Angiotensin II',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M2716',\n", - " 'InterventionBrowseLeafName': 'Angiotensinogen',\n", - " 'InterventionBrowseLeafAsFound': 'Angiotensin II',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M18192',\n", - " 'InterventionBrowseLeafName': 'HIV Protease Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M12926',\n", - " 'InterventionBrowseLeafName': 'Protease Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M15992',\n", - " 'InterventionBrowseLeafName': 'Vasoconstrictor Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M16974',\n", - " 'InterventionBrowseLeafName': 'Serine Proteinase Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'T18',\n", - " 'InterventionBrowseLeafName': 'Serine',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", - " {'InterventionBrowseBranchAbbrev': 'VaCoAg',\n", - " 'InterventionBrowseBranchName': 'Vasoconstrictor Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'AA',\n", - " 'InterventionBrowseBranchName': 'Amino Acids'}]}}}}},\n", - " {'Rank': 9,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04323800',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'IRB00245634'},\n", - " 'Organization': {'OrgFullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune Plasma) Among Adults Exposed to COVID-19',\n", - " 'OfficialTitle': 'Convalescent Plasma to Stem Coronavirus: A Randomized, Blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune Plasma) Among Adults Exposed to COVID-19',\n", - " 'Acronym': 'CSSC-001'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'December 31, 2022',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'January 2023',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 24, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 26, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 27, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 31, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No',\n", - " 'IsUSExport': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at day 28.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus',\n", - " 'Convalescence']},\n", - " 'KeywordList': {'Keyword': ['COVID-19']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 2']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignInterventionModelDescription': '1:1 ratio',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Triple',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", - " 'Care Provider',\n", - " 'Investigator']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '150',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'High titer anti-SARS-CoV-2 plasma',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Participants with High titer anti-SARS-CoV-2 plasma.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: Anti- SARS-CoV-2 Plasma']}},\n", - " {'ArmGroupLabel': 'SARS-CoV-2 non-immune plasma',\n", - " 'ArmGroupType': 'Active Comparator',\n", - " 'ArmGroupDescription': 'Participants with SARS-CoV-2 non-immune plasma.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: SARS-CoV-2 non-immune Plasma']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Biological',\n", - " 'InterventionName': 'Anti- SARS-CoV-2 Plasma',\n", - " 'InterventionDescription': 'SARS-CoV-2 convalescent plasma (1 unit; ~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and was found to have a titer of neutralizing antibody >1:64)',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['High titer anti-SARS-CoV-2 plasma']}},\n", - " {'InterventionType': 'Biological',\n", - " 'InterventionName': 'SARS-CoV-2 non-immune Plasma',\n", - " 'InterventionDescription': 'Standard plasma collected prior to December 2019',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['SARS-CoV-2 non-immune plasma']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Cumulative incidence of composite outcome of disease severity',\n", - " 'PrimaryOutcomeDescription': 'The cumulative incidence of composite outcome of disease severity will be used in assessing the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to COVID-19. This will be determined with the presence or occurrence of at least one of the following:\\n\\nDeath\\nRequiring mechanical ventilation and/or in ICU\\nnon-ICU hospitalization, requiring supplemental oxygen;\\nnon-ICU hospitalization, not requiring supplemental oxygen;\\nNot hospitalized, but with clinical and laboratory evidence of COVID-19 infection\\nNot hospitalized, no clinical evidence of COVID-19 infection, but with positive PCR for SARS-CoV-2',\n", - " 'PrimaryOutcomeTimeFrame': 'Day 28'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Anti-SARS-CoV-2 titers',\n", - " 'SecondaryOutcomeDescription': 'Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 0 (baseline).',\n", - " 'SecondaryOutcomeTimeFrame': 'Baseline'},\n", - " {'SecondaryOutcomeMeasure': 'Anti-SARS-CoV-2 titers',\n", - " 'SecondaryOutcomeDescription': 'Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 1.',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", - " {'SecondaryOutcomeMeasure': 'Anti-SARS-CoV-2 titers',\n", - " 'SecondaryOutcomeDescription': 'Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 3.',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", - " {'SecondaryOutcomeMeasure': 'Anti-SARS-CoV-2 titers',\n", - " 'SecondaryOutcomeDescription': 'Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 7.',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", - " {'SecondaryOutcomeMeasure': 'Anti-SARS-CoV-2 titers',\n", - " 'SecondaryOutcomeDescription': 'Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 14.',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 14'},\n", - " {'SecondaryOutcomeMeasure': 'Anti-SARS-CoV-2 titers',\n", - " 'SecondaryOutcomeDescription': 'Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 90.',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 90'},\n", - " {'SecondaryOutcomeMeasure': 'Rates of SARS-CoV-2 PCR positivity',\n", - " 'SecondaryOutcomeDescription': 'Compare the rates of SARS-CoV-2 PCR positivity (RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 and 28.',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to day 28'},\n", - " {'SecondaryOutcomeMeasure': 'Duration of SARS-CoV-2 PCR positivity',\n", - " 'SecondaryOutcomeDescription': 'Compare the duration (days) of SARS-CoV-2 PCR positivity (RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 and 28.',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to day 28'},\n", - " {'SecondaryOutcomeMeasure': 'Peak quantity levels of SARS-CoV-2 RNA',\n", - " 'SecondaryOutcomeDescription': 'Compare the peak quantity levels of SARS-CoV-2 RNA amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 days.',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to day 14'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nSubjects must be 18 years of age or older\\nClose contact* exposure to person with COVID-19 within 96 hours of enrollment (and 120 hours of receipt of plasma)\\n\\nIf female must not be pregnant and/or breastfeeding. Women of childbearing potential and men, must be willing to practice an effective contraceptive method or remain abstinent during the study period.\\n\\n*Close contact* is defined by the Centers for Disease Control and Prevention (CDC) as:\\n\\na) being within approximately 6 feet (2 meters) of a COVID-19 case for a prolonged period of time (without PPE); close contact can occur while caring for, living with, visiting, or sharing a healthcare waiting area or room with a COVID-19 case\\n\\nor -\\n\\nb) having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed on) without PPE\\n\\nExclusion Criteria:\\n\\nReceipt any blood product in past 120 days\\nPsychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance\\nSymptoms consistent with COVID-19 infection (fevers, acute onset cough, shortness of breath) at time of screening\\nNucleic acid testing evidence of COVID-19 infection at time of screening\\nHistory of prior reactions to transfusion blood products\\nInability to complete therapy with the study product within 24 hours after enrollment',\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Darin Ostrander, PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '410-614-6702',\n", - " 'CentralContactEMail': 'TOID_CRC@jhmi.edu'},\n", - " {'CentralContactName': 'Obi Ezennia, MPH',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '410-614-6702',\n", - " 'CentralContactEMail': 'TOID_CRC@jhmi.edu'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Darin Ostrander, PhD',\n", - " 'OverallOfficialAffiliation': 'Johns Hopkins University',\n", - " 'OverallOfficialRole': 'Study Director'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No',\n", - " 'IPDSharingDescription': 'Sharing is governed by Johns Hopkins University Institutional Guidelines'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M2806',\n", - " 'InterventionBrowseLeafName': 'Antibodies',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M8767',\n", - " 'InterventionBrowseLeafName': 'Immunoglobulins',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19718',\n", - " 'InterventionBrowseLeafName': 'Antibodies, Blocking',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", - " {'ConditionMeshId': 'D000003289',\n", - " 'ConditionMeshTerm': 'Convalescence'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'},\n", - " {'ConditionAncestorId': 'D000020969',\n", - " 'ConditionAncestorTerm': 'Disease Attributes'},\n", - " {'ConditionAncestorId': 'D000010335',\n", - " 'ConditionAncestorTerm': 'Pathologic Processes'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M5096',\n", - " 'ConditionBrowseLeafName': 'Convalescence',\n", - " 'ConditionBrowseLeafAsFound': 'Convalescence',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M21284',\n", - " 'ConditionBrowseLeafName': 'Disease Attributes',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 10,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04324463',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'PHRI.ACT.COVID19'},\n", - " 'Organization': {'OrgFullName': 'Population Health Research Institute',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Anti-Coronavirus Therapies to Prevent Progression of Coronavirus Disease 2019 (COVID-19) Trial',\n", - " 'OfficialTitle': 'Anti-Coronavirus Therapies to Prevent Progression of COVID-19, a Randomized Trial',\n", - " 'Acronym': 'ACT COVID19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'September 30, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 25, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 25, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 27, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 25, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 27, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Population Health Research Institute',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No',\n", - " 'IsUSExport': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'ACT is a randomized clinical trial to assess therapies to reduce the clinical progression of COVID-19.',\n", - " 'DetailedDescription': 'The ACT COVID-19 program consists of two parallel trials evaluating azithromycin and chloroquine therapy (ACT) versus usual care in outpatients and inpatients who have tested positive for COVID-19. The trial is an open-label, parallel group, randomized controlled trial with an adaptive design. Adaptive design features include adaptive intervention arms and adaptive sample size based on new and emerging data.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus',\n", - " 'Severe Acute Respiratory Syndrome']},\n", - " 'KeywordList': {'Keyword': ['COVID-19',\n", - " 'chloroquine',\n", - " 'azithromycin',\n", - " 'coronavirus']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 3']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignInterventionModelDescription': 'Open-label, parallel group randomized controlled trial',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '1500',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Azithromycin and Chloroquine Therapy (ACT)',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Chloroquine (Adults with a bodyweight ≥ 50 kg: 500 mg twice daily for 7 days; Adults with a bodyweight < 50 kg: 500 mg twice daily on days 1 and 2, followed by 500 mg once daily for days 3-7), plus Azithromycin (500 mg on day 1 followed by 250 mg daily for 4 days)',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Azithromycin',\n", - " 'Drug: Chloroquine']}},\n", - " {'ArmGroupLabel': 'Standard of Care',\n", - " 'ArmGroupType': 'No Intervention',\n", - " 'ArmGroupDescription': 'No constraints for treating physicians on the therapies within the standard of care arm. All key co-interventions will be documented.'}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Azithromycin',\n", - " 'InterventionDescription': 'oral medication',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Azithromycin and Chloroquine Therapy (ACT)']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Chloroquine',\n", - " 'InterventionDescription': 'oral medication',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Azithromycin and Chloroquine Therapy (ACT)']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Outpatients: Hospital Admission or Death',\n", - " 'PrimaryOutcomeDescription': 'In outpatients with COVID-19, the occurrence of hospital admission or death',\n", - " 'PrimaryOutcomeTimeFrame': 'Up to 6 weeks post randomization'},\n", - " {'PrimaryOutcomeMeasure': 'Inpatients: Invasive mechanical ventilation or mortality',\n", - " 'PrimaryOutcomeDescription': 'Patients intubated or requiring imminent intubation at the time of randomization will only be followed for the primary outcome of death.',\n", - " 'PrimaryOutcomeTimeFrame': 'Up to 6 weeks post randomization'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAge ≥ 18 years of age\\nInformed consent\\nCOVID-19 confirmed by established testing\\n\\nExclusion Criteria:\\n\\nKnown glucose-6-phosphate dehydrogenase (G6PD) deficiency\\nContra-indication to chloroquine or azithromycin\\nAlready receiving chloroquine or azithromycin',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'ACT COVID-19 Study Coordinator',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '905-297-3479',\n", - " 'CentralContactEMail': 'ACT.ProjectTeam@PHRI.ca'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Richard Whitlock, MD PhD',\n", - " 'OverallOfficialAffiliation': 'Population Health Research Institute',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Emilie Belley-Cote, MD PhD',\n", - " 'OverallOfficialAffiliation': 'Population Health Research Institute',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Hamilton Health Sciences',\n", - " 'LocationCity': 'Hamilton',\n", - " 'LocationState': 'Ontario',\n", - " 'LocationZip': 'L8L2X2',\n", - " 'LocationCountry': 'Canada',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'ACT COVID-19 Study Coordinator',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactEMail': 'ACT.ProjectTeam@PHRI.ca'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000002738',\n", - " 'InterventionMeshTerm': 'Chloroquine'},\n", - " {'InterventionMeshId': 'C000023676',\n", - " 'InterventionMeshTerm': 'Chloroquine diphosphate'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000563',\n", - " 'InterventionAncestorTerm': 'Amebicides'},\n", - " {'InterventionAncestorId': 'D000000981',\n", - " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", - " {'InterventionAncestorId': 'D000000977',\n", - " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", - " {'InterventionAncestorId': 'D000000890',\n", - " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", - " {'InterventionAncestorId': 'D000000962',\n", - " 'InterventionAncestorTerm': 'Antimalarials'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'},\n", - " {'InterventionAncestorId': 'D000000894',\n", - " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents, Non-Steroidal'},\n", - " {'InterventionAncestorId': 'D000018712',\n", - " 'InterventionAncestorTerm': 'Analgesics, Non-Narcotic'},\n", - " {'InterventionAncestorId': 'D000000700',\n", - " 'InterventionAncestorTerm': 'Analgesics'},\n", - " {'InterventionAncestorId': 'D000018689',\n", - " 'InterventionAncestorTerm': 'Sensory System Agents'},\n", - " {'InterventionAncestorId': 'D000018373',\n", - " 'InterventionAncestorTerm': 'Peripheral Nervous System Agents'},\n", - " {'InterventionAncestorId': 'D000045505',\n", - " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", - " {'InterventionAncestorId': 'D000000893',\n", - " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents'},\n", - " {'InterventionAncestorId': 'D000005369',\n", - " 'InterventionAncestorTerm': 'Filaricides'},\n", - " {'InterventionAncestorId': 'D000000969',\n", - " 'InterventionAncestorTerm': 'Antinematodal Agents'},\n", - " {'InterventionAncestorId': 'D000000871',\n", - 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" 'InterventionBrowseLeafName': 'Analgesics, Non-Narcotic',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2777',\n", - " 'InterventionBrowseLeafName': 'Anthelmintics',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", - " {'InterventionBrowseBranchAbbrev': 'Infl',\n", - " 'InterventionBrowseBranchName': 'Anti-Inflammatory Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'Analg',\n", - " 'InterventionBrowseBranchName': 'Analgesics'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", - " {'ConditionMeshId': 'D000045169',\n", - " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M19143',\n", - " 'ConditionBrowseLeafName': 'Disease Progression',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 11,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04329559',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'CHESS2002'},\n", - " 'Organization': {'OrgFullName': 'Hepatopancreatobiliary Surgery Institute of Gansu Province',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'COVID-19 in Patients With Pre-existing Cirrhosis (COVID-Cirrhosis-CHESS2002): A Multicentre Observational Study',\n", - " 'OfficialTitle': 'Clinical Characteristics of COVID-19 in Patients With Pre-existing Cirrhosis (COVID-Cirrhosis-CHESS2002): A Multicentre Observational Study'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 30, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'June 29, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'June 29, 2021',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 29, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 29, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 29, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Xiaolong Qi',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Chief, Institute of Portal Hypertension',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Hepatopancreatobiliary Surgery Institute of Gansu Province',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Renmin Hospital of Wuhan University',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'LanZhou University',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'Minda Hospital Affiliated to Hubei University for Nationalities',\n", - " 'CollaboratorClass': 'UNKNOWN'},\n", - " {'CollaboratorName': 'Wuhan Union Hospital, China',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture',\n", - " 'CollaboratorClass': 'UNKNOWN'},\n", - " {'CollaboratorName': \"Tianjin Second People's Hospital\",\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'Sixth People’s Hospital of Shenyang',\n", - " 'CollaboratorClass': 'UNKNOWN'},\n", - " {'CollaboratorName': 'Guangxi Zhuang Autonomous Region',\n", - " 'CollaboratorClass': 'UNKNOWN'},\n", - " {'CollaboratorName': \"Shenzhen Third People's Hospital\",\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'Ankang Central Hospital',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': \"Xingtai People's Hospital\",\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'Dalian Sixth People’s Hospital',\n", - " 'CollaboratorClass': 'UNKNOWN'},\n", - " {'CollaboratorName': 'The Central Hospital of Lishui City',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'The Affiliated Third Hospital of Jiangsu University',\n", - " 'CollaboratorClass': 'UNKNOWN'},\n", - " {'CollaboratorName': 'Suizhou Hospital, Hubei University of Medicine',\n", - " 'CollaboratorClass': 'UNKNOWN'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'COVID-19 pandemic with SARS-CoV-2 infection has become a global challenge. Though most cases of COVID-19 are mild, the disease can also be fatal. Patients with liver cirrhosis are more susceptible to damage from SARS-CoV-2 infection considering their immunocompromised status. The spectrum of disease and factors that influence the disease course in COVID-19 cases with liver cirrhosis are incompletely defined. This muilticentre observational study (COVID-Cirrhosis-CHESS2002) aims to study the clinical characteristics and risk factors associated with specific outcomes in COVID-19 patients with pre-existing liver cirrhosis.',\n", - " 'DetailedDescription': 'Coronavirus disease 2019 (COVID-19) pandemic with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has become a global challenge. Though most cases of COVID-19 are mild, the disease can also be fatal. Patients with liver cirrhosis are more susceptible to damage from SARS-CoV-2 infection considering their immunocompromised status. The spectrum of disease and factors that influence the disease course in COVID-19 cases with liver cirrhosis are incompletely defined. This muilticentre observational study (COVID-Cirrhosis-CHESS2002) aims to study the clinical characteristics and risk factors associated with specific outcomes in COVID-19 patients with pre-existing liver cirrhosis.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", - " 'Liver Cirrhosis']},\n", - " 'KeywordList': {'Keyword': ['COVID-19',\n", - " 'Liver cirrhosis',\n", - " 'Clinical outcome']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'Yes',\n", - " 'TargetDuration': '1 Year',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Cross-Sectional']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '50',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'All-cause mortality of COVID-19 patients with liver cirrhosis',\n", - " 'PrimaryOutcomeDescription': '7-day, 28-day, 60-day, 180-day and 365-day all-cause mortality of COVID-19 patients with liver cirrhosis',\n", - " 'PrimaryOutcomeTimeFrame': 'From illness onset of COVID-19 to death from any cause, up to 365 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Liver-related mortality of COVID-19 patients with liver cirrhosis',\n", - " 'SecondaryOutcomeDescription': '7-day, 28-day, 60-day, 180-day and 365-day liver-related mortality of COVID-19 patients with liver cirrhosis',\n", - " 'SecondaryOutcomeTimeFrame': 'From illness onset of COVID-19 to death from liver-related cause, up to 365 days'},\n", - " {'SecondaryOutcomeMeasure': 'Risk factors associated with specific outcomes of COVID-19 patients with liver cirrhosis',\n", - " 'SecondaryOutcomeDescription': 'Risk factors (laboratory findings, imaging findings, etc.) associated with specific outcomes (death, etc.) of COVID-19 patients with liver cirrhosis',\n", - " 'SecondaryOutcomeTimeFrame': 'From hospital admission to death, up to 365 days'},\n", - " {'SecondaryOutcomeMeasure': 'Baseline characteristics of COVID-19 patients with liver cirrhosis',\n", - " 'SecondaryOutcomeDescription': 'Baseline characteristics (laboratory findings, imaging findings, etc.) of COVID-19 patients with liver cirrhosis',\n", - " 'SecondaryOutcomeTimeFrame': '1 Day'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\n1) Aged 18 or above;\\n2) Laboratory-confirmed COVID-19 infection;\\n3) Pre-existing liver cirrhosis based on liver biopsy or clinical findings.\\n\\nExclusion Criteria:\\n\\n1) Pregnancy or unknown pregnancy status.',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'Patients with COVID-19 infection with pre-existing liver cirrhosis',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Xiaolong Qi, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+86-18588602600',\n", - " 'CentralContactPhoneExt': '+8618588602600',\n", - " 'CentralContactEMail': 'qixiaolong@vip.163.com'},\n", - " {'CentralContactName': 'Yanna Liu, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+86-15625076784',\n", - " 'CentralContactPhoneExt': '+8615625076784',\n", - " 'CentralContactEMail': 'lauyenna@126.com'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Mingkai Chen, MD',\n", - " 'OverallOfficialAffiliation': 'Renmin Hospital of Wuhan University',\n", - " 'OverallOfficialRole': 'Study Chair'},\n", - " {'OverallOfficialName': 'Xiaolong Qi, MD',\n", - " 'OverallOfficialAffiliation': 'LanZhou University',\n", - " 'OverallOfficialRole': 'Study Chair'},\n", - " {'OverallOfficialName': 'Fengmei Wang, MD',\n", - " 'OverallOfficialAffiliation': \"Tianjin Second People's Hospital\",\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Ye Gu, MD',\n", - " 'OverallOfficialAffiliation': 'Sixth People’s Hospital of Shenyang',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Zicheng Jiang, MD',\n", - " 'OverallOfficialAffiliation': 'Ankang Central Hospital',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Guo Zhang, MD',\n", - " 'OverallOfficialAffiliation': 'Guangxi Zhuang Autonomous Region',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Yong Zhang, MD',\n", - " 'OverallOfficialAffiliation': 'Dalian Sixth People’s Hospital',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Dengxiang Liu, MD',\n", - " 'OverallOfficialAffiliation': \"Xingtai People's Hospital\",\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Qing He, MD',\n", - " 'OverallOfficialAffiliation': \"Shenzhen Third People's Hospital\",\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Hua Yang, MD',\n", - " 'OverallOfficialAffiliation': 'Minda Hospital Affiliated to Hubei University for Nationalities',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Zhengyan Wang, MD',\n", - " 'OverallOfficialAffiliation': 'Suizhou Hospital, Hubei University of Medicine',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Bin Xiong, MD',\n", - " 'OverallOfficialAffiliation': 'Wuhan Union Hospital, China',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Xiaodan Li, MD',\n", - " 'OverallOfficialAffiliation': 'The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Hongguang Zhang, MD',\n", - " 'OverallOfficialAffiliation': 'The Affiliated Third Hospital of Jiangsu University',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Chuxiao Shao, MD',\n", - " 'OverallOfficialAffiliation': 'The Central Hospital of Lishui City',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Hongmei Yue, MD',\n", - " 'OverallOfficialAffiliation': 'LanZhou University',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': \"Dalian Sixth People's Hospital\",\n", - " 'LocationStatus': 'Not yet recruiting',\n", - " 'LocationCity': 'Dalian',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Yong Zhang, MD',\n", - " 'LocationContactRole': 'Contact'}]}},\n", - " {'LocationFacility': 'Minda Hospital Affiliated to Hubei University for Nationalities',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Enshi',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Hua Yang, MD',\n", - " 'LocationContactRole': 'Contact'}]}},\n", - " {'LocationFacility': 'The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Enshi',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Xiaodan Li, MD',\n", - " 'LocationContactRole': 'Contact'}]}},\n", - " {'LocationFacility': 'The First Hospital of Lanzhou University',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Lanzhou',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Hongmei Yue, MD',\n", - " 'LocationContactRole': 'Contact'}]}},\n", - " {'LocationFacility': 'The Central Hospital of Lishui City',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Lishui',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Chuxiao Shao, MD',\n", - " 'LocationContactRole': 'Contact'}]}},\n", - " {'LocationFacility': 'Guangxi Zhuang Autonomous Region',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Nanning',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Guo Zhang, MD',\n", - " 'LocationContactRole': 'Contact'}]}},\n", - " {'LocationFacility': 'The Sixth Peoples Hospital of Shenyang',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Shenyang',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Ye Gu, MD',\n", - " 'LocationContactRole': 'Contact'}]}},\n", - " {'LocationFacility': \"Shenzhen Third People's Hospital\",\n", - " 'LocationStatus': 'Not yet recruiting',\n", - " 'LocationCity': 'Shenzhen',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Qing He, MD',\n", - " 'LocationContactRole': 'Contact'}]}},\n", - " {'LocationFacility': 'Suizhou Hospital, Hubei University of Medicine',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Suizhou',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Zhengyan Wang, MD',\n", - " 'LocationContactRole': 'Contact'}]}},\n", - " {'LocationFacility': \"Tianjin Second People's Hospital\",\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Tianjin',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Fengmei Wang, MD',\n", - " 'LocationContactRole': 'Contact'}]}},\n", - " {'LocationFacility': 'Ankang Central Hospital',\n", - " 'LocationStatus': 'Not yet recruiting',\n", - " 'LocationCity': 'Wuhan',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Zicheng Jiang, MD',\n", - " 'LocationContactRole': 'Contact'}]}},\n", - " {'LocationFacility': 'Renmin Hospital of Wuhan University',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Wuhan',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Mingkai Chen, MD',\n", - " 'LocationContactRole': 'Contact'}]}},\n", - " {'LocationFacility': 'Wuhan Union Hospital',\n", - " 'LocationStatus': 'Not yet recruiting',\n", - " 'LocationCity': 'Wuhan',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Bin Xiong, MD',\n", - " 'LocationContactRole': 'Contact'}]}},\n", - " {'LocationFacility': \"Xingtai People's Hospital\",\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Xingtai',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Dengxiang Liu, MD',\n", - " 'LocationContactRole': 'Contact'}]}},\n", - " {'LocationFacility': 'The Affiliated Third Hospital of Jiangsu University',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Zhenjiang',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Hongguang Zhang, MD',\n", - " 'LocationContactRole': 'Contact'}]}}]}},\n", - " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '32091533',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648. [Epub ahead of print]'},\n", - " {'ReferencePMID': '32109013',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMoa2002032. [Epub ahead of print]'},\n", - " {'ReferencePMID': '32145190',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Zhang C, Shi L, Wang FS. Liver injury in COVID-19: management and challenges. Lancet Gastroenterol Hepatol. 2020 Mar 4. pii: S2468-1253(20)30057-1. doi: 10.1016/S2468-1253(20)30057-1. [Epub ahead of print]'},\n", - " {'ReferencePMID': '32203680',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Bangash MN, Patel J, Parekh D. COVID-19 and the liver: little cause for concern. Lancet Gastroenterol Hepatol. 2020 Mar 20. pii: S2468-1253(20)30084-4. doi: 10.1016/S2468-1253(20)30084-4. [Epub ahead of print]'},\n", - " {'ReferencePMID': '32170806',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Xu L, Liu J, Lu M, Yang D, Zheng X. Liver injury during highly pathogenic human coronavirus infections. Liver Int. 2020 Mar 14. doi: 10.1111/liv.14435. [Epub ahead of print] Review.'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M9693',\n", - " 'InterventionBrowseLeafName': 'Liver Extracts',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Hemat',\n", - " 'InterventionBrowseBranchName': 'Hematinics'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000008103',\n", - " 'ConditionMeshTerm': 'Liver Cirrhosis'},\n", - " {'ConditionMeshId': 'D000005355', 'ConditionMeshTerm': 'Fibrosis'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000010335',\n", - " 'ConditionAncestorTerm': 'Pathologic Processes'},\n", - " {'ConditionAncestorId': 'D000008107',\n", - " 'ConditionAncestorTerm': 'Liver Diseases'},\n", - " {'ConditionAncestorId': 'D000004066',\n", - " 'ConditionAncestorTerm': 'Digestive System Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M9686',\n", - " 'ConditionBrowseLeafName': 'Liver Cirrhosis',\n", - " 'ConditionBrowseLeafAsFound': 'Cirrhosis',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M7068',\n", - " 'ConditionBrowseLeafName': 'Fibrosis',\n", - " 'ConditionBrowseLeafAsFound': 'Cirrhosis',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M9690',\n", - " 'ConditionBrowseLeafName': 'Liver Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M7466',\n", - " 'ConditionBrowseLeafName': 'Gastrointestinal Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M5838',\n", - " 'ConditionBrowseLeafName': 'Digestive System Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC06',\n", - " 'ConditionBrowseBranchName': 'Digestive System Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'}]}}}}},\n", - " {'Rank': 12,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04298814',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'COVEI'},\n", - " 'Organization': {'OrgFullName': 'Tongji Hospital', 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Safety Related Factors of Endotracheal Intubation in Patients With Severe Covid-19 Pneumonia',\n", - " 'OfficialTitle': 'Analysis of Safety Related Factors of Endotracheal Intubation in Patients With Severe Covid-19 Pneumonia'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 7, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 30, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'July 30, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'February 26, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 4, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 6, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 4, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 6, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'aijun xu',\n", - " 'ResponsiblePartyInvestigatorTitle': 'associate professor',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Tongji Hospital'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Tongji Hospital',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'To analyze the intubation with severe covid-19 pneumonia, the infection rate of anesthesiologist after intubation, and summarizes the experience of how to avoid the infection of anesthesiologist and ensure the safety of patients with severe covid-19 pneumonia.',\n", - " 'DetailedDescription': 'To analyze the intubation time, intubation condition, intubation process, intubation times and success rate of patients with severe covid-19 pneumonia, the infection rate of anesthesiologist after intubation, the degree of respiratory improvement and survival rate of patients, and summarizes the experience of how to avoid the infection of anesthesiologist and ensure the safety of patients with severe covid-19 pneumonia.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", - " 'Endotracheal Intubation']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Case-Only']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '120',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", - " 'InterventionName': 'severe covid-19 pneumonia with ET',\n", - " 'InterventionDescription': 'severe covid-19 pneumonia undergoing endotracheal intubation'}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Success rate of intubation',\n", - " 'PrimaryOutcomeDescription': 'The data of Success rate of intubation with severe COVID-19 pneumonia patients',\n", - " 'PrimaryOutcomeTimeFrame': 'the time span between 1hour before intubation and 24h after intubation'},\n", - " {'PrimaryOutcomeMeasure': 'Infection rate of Anesthesiologist',\n", - " 'PrimaryOutcomeDescription': 'Infection rate of Anesthesiologist who performed the endotracheal intubation for severe COVID-19 pneumonia patients',\n", - " 'PrimaryOutcomeTimeFrame': 'the time span between 1hour before intubation and 14days after intubation'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Extubation time',\n", - " 'SecondaryOutcomeDescription': 'Extubation time of intubated severe COVID-19 pneumonia patients',\n", - " 'SecondaryOutcomeTimeFrame': 'the time span between 1hour before intubation and 30days after intubation'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\nWuhan residents;\\nnovel coronavirus pneumonia was found to be characterized by fever and cough. Laboratory tests revealed leukocyte or lymphocyte decrease, chest CT examination showed viral pneumonia changes, and was diagnosed as COVID-19 pneumonia according to the national health and Health Committee's new coronavirus pneumonia diagnosis and treatment plan (trial version fifth Revision).\\nSevere and critical patients with covid-19 pneumonia in urgent need of tracheal intubation;\\nSign informed consent.\\n\\nExclusion Criteria:\\n\\nSuspected patients with covid-19 pneumonia;\\nPatients who need emergency endotracheal intubation due to other causes of respiratory failure;\\nThe family refused to sign the informed consent.\",\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '90 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'Severe and critical patients with covid-19 pneumonia in urgent need of tracheal intubation',\n", - " 'SamplingMethod': 'Non-Probability Sample'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000011014',\n", - " 'ConditionMeshTerm': 'Pneumonia'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000008171',\n", - " 'ConditionAncestorTerm': 'Lung Diseases'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M12487',\n", - " 'ConditionBrowseLeafName': 'Pneumonia',\n", - " 'ConditionBrowseLeafAsFound': 'Pneumonia',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M9751',\n", - " 'ConditionBrowseLeafName': 'Lung Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'}]}}}}},\n", - " {'Rank': 13,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04325061',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '2020-001278-31'},\n", - " 'Organization': {'OrgFullName': 'Dr. Negrin University Hospital',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Efficacy of Dexamethasone Treatment for Patients With ARDS Caused by COVID-19',\n", - " 'OfficialTitle': 'Efficacy of Dexamethasone Treatment for Patients With ARDS Caused by COVID-19',\n", - " 'Acronym': 'DEXA-COVID19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'October 30, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'October 30, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 25, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 26, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 27, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 31, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Jesus Villar',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Senior scientist',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Dr. Negrin University Hospital'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Dr. Negrin University Hospital',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Li Ka Shing Knowledge Institute',\n", - " 'CollaboratorClass': 'UNKNOWN'},\n", - " {'CollaboratorName': 'Consorcio Centro de Investigación Biomédica en Red, M.P.',\n", - " 'CollaboratorClass': 'OTHER_GOV'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Background: There are no proven therapies specific for Covid-19. The full spectrum of Covid-19 ranges from asymptomatic disease to mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. The efficacy of corticosteroids in viral ARDS remains controversial.\\n\\nMethods: This is an internationally (Spain, Canada, China, USA) designed multicenter, randomized, controlled, open-label clinical trial testing dexamethasone in mechanically ventilated adult patients with established moderate-to-severe ARDS caused by confirmed Covid-19 infection, admitted in a network of Spanish ICUs. Eligible patients will be randomly assigned to receive either dexamethasone plus standard intensive care, or standard intensive care alone. Patients in the dexamethasone group will receive an intravenous dose of 20 mg once daily from day 1 to day 5, followed by 10 mg once daily from day 6 to day 10. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days at 28 days. All analyses will be done according to the intention-to-treat principle.',\n", - " 'DetailedDescription': 'The acute respiratory distress syndrome (ARDS) is a catastrophic illness of multifactorial etiology characterized by a diffuse, severe inflammatory process of the lung leading to acute hypoxemic respiratory failure requiring mechanical ventilation (MV). Pulmonary infections are the leading causes of ARDS. Clinical and experimental research has established a strong association between dysregulated systemic and pulmonary inflammation and progression or delayed resolution of ARDS.\\n\\nThe COVID-19 pandemic is a critical moment for the world. Severe pneumonia is the main condition leading to ARDS requiring weeks of MV with high mortality (40-60%) in COVID-19 patients. There is no specific therapy for Covid-19, although patients are receiving drugs that are already approved for treating other diseases. There has been great interest in the role of corticosteroids to attenuate the pulmonary and systemic damage in ARDS patients because of their potent anti-inflammatory and antifibrotic properties. However, the efficacy of corticosteroids in viral ARDS remains controversial.\\n\\nWe justify the need of this study based on the positive results of a recent clinical trial by our group, showing that dexamethasone for 10 days was able to reduce the duration of mechanical ventilation (MV) and increase hospital survival in patients with ARDS from multiple causes (Villar J et al. Lancet Respir Med 2020). Dexamethasone has never been evaluated in viral ARDS in a randomized controlled fashion. Our goal in this study is to examine the effects of dexamethasone on hospital mortality and on ventilator-free days in patients with moderate-to-severe ARDS due to confirmed COVID-19 infection admitted into a network of Spanish intensive care units (ICUs).'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Acute Respiratory Distress Syndrome Caused by COVID-19']},\n", - " 'KeywordList': {'Keyword': ['ARDS',\n", - " 'COVID-19',\n", - " 'multiple system organ failure']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 4']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignInterventionModelDescription': 'Multicenter, randomized, controlled, open-label trial involving mechanically ventilated adult patients with ARDS caused by confirmed COVID-19 infection',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '200',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Control group',\n", - " 'ArmGroupType': 'No Intervention',\n", - " 'ArmGroupDescription': 'Patients will be treated with standard intensive care'},\n", - " {'ArmGroupLabel': 'Dexamethasone',\n", - " 'ArmGroupType': 'Active Comparator',\n", - " 'ArmGroupDescription': 'Standard intensive care plus dexamethasone',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Dexamethasone']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Dexamethasone',\n", - " 'InterventionDescription': 'Dexamethasone (20 mg/iv/daily/from Day 1 of randomization during 5 days, followed by 10 mg/iv/daily from Day 6 to 10 of randomization',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Dexamethasone']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['dexamethasone Indukern']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': '60-day mortality',\n", - " 'PrimaryOutcomeDescription': 'All-cause mortality at 60 days after enrollment',\n", - " 'PrimaryOutcomeTimeFrame': '60 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Ventilator-free days',\n", - " 'SecondaryOutcomeDescription': 'Number of ventilator-free days (VFDs) at Day 28 (defined as days being alive and free from mechanical ventilation at day 28 after enrollment, For patients ventilated 28 days or longer and for subjects who die, VFD is 0.',\n", - " 'SecondaryOutcomeTimeFrame': '28 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\nage 18 years or older;\\npositive reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay for COVID-19 in a respiratory tract sample;\\nintubated and mechanically ventilated;\\nacute onset of ARDS, as defined by Berlin criteria as moderate-to-severe ARDS,3 which includes: (i) having pneumonia or worsening respiratory symptoms, (ii) bilateral pulmonary infiltrates on chest imaging (x-ray or CT scan), (iii) absence of left atrial hypertension, pulmonary capillary wedge pressure <18 mmHg, or no clinical signs of left heart failure, and (iv) hypoxemia, as defined by a PaO2/FiO2 ratio of ≤200 mmHg on positive end-expiratory pressure (PEEP) of ≥5 cmH2O, regardless of FiO2.\\n\\nExclusion Criteria:\\n\\nPatients with a known contraindication to corticosteroids,\\nDecision by a physician that involvement in the trial is not in the patient's best interest,\\nPregnancy and breast-feeding.\",\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Jesús Villar, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+34606860027',\n", - " 'CentralContactEMail': 'jesus.villar54@gmail.com'},\n", - " {'CentralContactName': 'Arthur Slutsky, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+14168244000',\n", - " 'CentralContactEMail': 'SLUTSKYA@smh.ca'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Jesús Villar, MD',\n", - " 'OverallOfficialAffiliation': 'Hospital Universitario Dr. Negrin',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Department of Anesthesia, Hospital Universitario de Cruces',\n", - " 'LocationCity': 'Barakaldo',\n", - " 'LocationState': 'Vizcaya',\n", - " 'LocationZip': '48903',\n", - " 'LocationCountry': 'Spain',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Gonzalo Tamayo, MD, PhD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+34655740637',\n", - " 'LocationContactEMail': 'gonzalotamayo@gmail.com'},\n", - " {'LocationContactName': 'Alberto Martínez-Ruiz, MD, PhD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+34610494664',\n", - " 'LocationContactEMail': 'alberto.martinezruiz@osakidetza.net'},\n", - " {'LocationContactName': 'Iñaki Bilbao-Villasante',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'Intensive Care Unit, Hospital Universitario de Cruces',\n", - " 'LocationCity': 'Barakaldo',\n", - " 'LocationState': 'Vizcaya',\n", - " 'LocationZip': '48903',\n", - " 'LocationCountry': 'Spain',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Tomás Muñoz, MD, PhD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+34619440485',\n", - " 'LocationContactEMail': 'tomas.munozmartinez@osakidetza.net'},\n", - " {'LocationContactName': 'Pablo Serna-Grande, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+34620686825',\n", - " 'LocationContactEMail': 'pablo.serna.grande@gmail.com'}]}},\n", - " {'LocationFacility': 'Department of Anesthesia, Hospital Clinic',\n", - " 'LocationCity': 'Barcelona',\n", - " 'LocationZip': '08036',\n", - " 'LocationCountry': 'Spain',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Carlos Ferrando, MD, PhD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+34659583815',\n", - " 'LocationContactEMail': 'cafeoranestesia@gmail.com'}]}},\n", - " {'LocationFacility': 'Intensive Care Unit, Hospital General de Ciudad Real',\n", - " 'LocationCity': 'Ciudad Real',\n", - " 'LocationZip': '13005',\n", - " 'LocationCountry': 'Spain',\n", - 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" {'LocationFacility': 'Intensive Care Unit, Hospital Universitario Virgen de la Arrixaca',\n", - " 'LocationCity': 'Murcia',\n", - " 'LocationZip': '30120',\n", - " 'LocationCountry': 'Spain',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Domingo Martínez, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+34670334050',\n", - " 'LocationContactEMail': 'dmbct1@gmail.com'},\n", - " {'LocationContactName': 'Juan A Soler, MD, PhD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+34661764387',\n", - " 'LocationContactEMail': 'juasobar@hotmail.com'}]}},\n", - " {'LocationFacility': 'Department of Anesthesia, Hospital Unversitario Montecelo',\n", - " 'LocationCity': 'Pontevedra',\n", - " 'LocationZip': '36071',\n", - " 'LocationCountry': 'Spain',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Marina Varela, MD, PhD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+34607358008',\n", - 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" {'InterventionBrowseBranchAbbrev': 'ANeo',\n", - " 'InterventionBrowseBranchName': 'Antineoplastic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'AnEm',\n", - " 'InterventionBrowseBranchName': 'Antiemetics'},\n", - " {'InterventionBrowseBranchAbbrev': 'Gast',\n", - " 'InterventionBrowseBranchName': 'Gastrointestinal Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", - " {'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000012127',\n", - " 'ConditionMeshTerm': 'Respiratory Distress Syndrome, Newborn'},\n", - " {'ConditionMeshId': 'D000012128',\n", - " 'ConditionMeshTerm': 'Respiratory Distress Syndrome, Adult'},\n", - " {'ConditionMeshId': 'D000055371',\n", - " 'ConditionMeshTerm': 'Acute Lung Injury'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000008171',\n", - " 'ConditionAncestorTerm': 'Lung Diseases'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", - " {'ConditionAncestorId': 'D000012120',\n", - " 'ConditionAncestorTerm': 'Respiration Disorders'},\n", - " {'ConditionAncestorId': 'D000007235',\n", - " 'ConditionAncestorTerm': 'Infant, Premature, Diseases'},\n", - " {'ConditionAncestorId': 'D000007232',\n", - " 'ConditionAncestorTerm': 'Infant, Newborn, Diseases'},\n", - " {'ConditionAncestorId': 'D000055370',\n", - " 'ConditionAncestorTerm': 'Lung Injury'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13547',\n", - " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Newborn',\n", - " 'ConditionBrowseLeafAsFound': 'Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M13548',\n", - " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Adult',\n", - " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M26731',\n", - " 'ConditionBrowseLeafName': 'Acute Lung Injury',\n", - " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M10642',\n", - " 'ConditionBrowseLeafName': 'Multiple Organ Failure',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M26730',\n", - " 'ConditionBrowseLeafName': 'Lung Injury',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M9751',\n", - " 'ConditionBrowseLeafName': 'Lung Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13540',\n", - " 'ConditionBrowseLeafName': 'Respiration Disorders',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M24456',\n", - " 'ConditionBrowseLeafName': 'Premature Birth',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8862',\n", - " 'ConditionBrowseLeafName': 'Infant, Premature, Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8859',\n", - " 'ConditionBrowseLeafName': 'Infant, Newborn, Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T4953',\n", - " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Infant',\n", - " 'ConditionBrowseLeafAsFound': 'Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'T191',\n", - " 'ConditionBrowseLeafName': 'Acute Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC16',\n", - " 'ConditionBrowseBranchName': 'Diseases and Abnormalities at or Before Birth'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC26',\n", - " 'ConditionBrowseBranchName': 'Wounds and Injuries'},\n", - " {'ConditionBrowseBranchAbbrev': 'BXS',\n", - " 'ConditionBrowseBranchName': 'Urinary Tract, Sexual Organs, and Pregnancy Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 14,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04321811',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'XC-PCOR-COVID19'},\n", - " 'Organization': {'OrgFullName': 'xCures', 'OrgClass': 'INDUSTRY'},\n", - " 'BriefTitle': 'Behavior, Environment And Treatments for Covid-19',\n", - " 'OfficialTitle': 'A PATIENT-CENTRIC OUTCOMES REGISTRY OF PATIENTS WITH KNOWN OR SUSPECTED NOVEL CORONAVIRUS INFECTION SARS-COV-2 (COVID-19)',\n", - " 'Acronym': 'BEAT19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 21, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 20, 2021',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'March 20, 2022',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 23, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 24, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 25, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 30, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'xCures',\n", - " 'LeadSponsorClass': 'INDUSTRY'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Genetic Alliance',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'LunaDNA', 'CollaboratorClass': 'UNKNOWN'},\n", - " {'CollaboratorName': 'Cancer Commons', 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'REDCap Cloud',\n", - " 'CollaboratorClass': 'UNKNOWN'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Background: During the current COVID-19 pandemic there is urgent need for information about the natural history of the infection in non-hospitalized patients, including the severity and duration of symptoms, and outcome from early in the infection, among different subgroups of patients. In addition, a large, real-world data registry can provide information about how different concomitant medications may differentially affect symptoms among patient subgroups. Such information can be invaluable for clinicians managing chronic diseases during this pandemic, as well as identify interventions undertaken in a naturalistic setting that have differential effects. Such factors may include patient diet, over the counter or prescription medications, and herbal and alternative treatments, among others. Identifying the natural disease history in patients from different demographic and disease subgroups will be important for identifying at-risk patients and effectiveness of interventions undertaken in the community.\\n\\nObjectives: The purpose of this study is to understand at the population level the symptomatic course of known or suspected COVID-19 patients while sheltering-in-place or under quarantine. Symptoms will be measured using a daily report derived from the CTCAE-PRO as well as free response. Outcomes will be assessed based on the duration and severity of infection, hospitalization, lost-to-follow-up, or death. As a patient-centric registry, patients themselves may propose, suggest, and/or submit evidence or ideas for relevant collection.',\n", - " 'DetailedDescription': \"Patients will be registered for through the study Web site. Following Web site registration, patients will receive an electronic informed consent form. Informed consent is a process that is initiated prior to the individual's agreeing to participate in the study and continues throughout the individual's study participation. Consent forms will be Institutional Review Board (IRB)-approved and the participant will read and review the document electronically. Participants must sign the informed consent document prior to participating in the registry. Participants will be informed that participation is voluntary and that they may withdraw from the study at any time, without prejudice by emailing the study team.\\n\\nAs a real-world data registry, any adult men and women currently in the United States and willing to provide written informed consent and:\\n\\nwho are feeling sick but have not tested positive for COVID-19, or\\nwho are feeling sick and have tested positive for COVID-19, or\\nwho are not feeling sick but want to participate can enroll\\n\\nPatients unwilling or unable to provide informed consent will be excluded.\\n\\nDATA MANAGEMENT A registry database will be maintained with identified registry data elements captured into the REDCap Cloud EDC system, a commercial eClinical Platform that is 21 CFR Part 11 Validated, HIPAA & FISMA compliant, and WHODrug and MedDRA certified. All access and activity in the system is tracked and can easily be monitored by the Administrator. The system has a login audit feature that tracks who has logged into the system, the date and time of login, and the IP address of the connection. The system also tracks failed logins and automatically locks a user's account after several failed attempts. The REDCap Cloud system has a robust audit trail that shows all changes to any records within the system including who made the change, the date and time of the change, the field that was changed, the old value of the field and the new value of the field. Access can be monitored via a dashboard or email alerts. Data management activities will follow standard operating procedures.\\n\\nSTUDY RECORDS RETENTION In the event that patient authorize the collection of additional medical records, those records will be maintained in xCures' HIPAA compliant box storage platform hosted on Amazon's HIPAA-compliant cloud servers. Source information, including medical records will be abstracted into a study database and not made available in their original format outside the study team. Study data including source records and case reports forms will be maintained in electronic format indefinitely. De-identified databases derived from the study records may be made available to other researchers and may be retained by those organizations indefinitely based on the terms of the agreement under which the data was provided.\\n\\nSOURCE DOCUMENTS Source data can include clinical findings and observations, or other information incorporated into the registry database to support analysis of data. Source data is all information from which information in the registry database is derived in original form (or certified copies of an original record). Examples of these original documents and records include but are not limited to the following: electronic medical records, clinical and office charts, laboratory notes, memoranda, correspondence, subjects' diaries or patient-reported questionnaires, data from automated instruments, such as ECG machines, photographs and other imaging (DICOM) files, slides, pharmacy records, and the reports documenting medical interpretation of those files.\\n\\nData may be entered into the eCRF either manually by the study team performing data abstraction from the EMR or electronically using direct entry of data into the or from an electronic import of data. Patients may also enter information directly into the eCRF using a patient-facing survey functionality either over the Web or using a smartphone app. Data elements originating in EMR may be automatically transmitted directly into the eCRF using a suitable API. Source data derived in that manner may have an intervening process, such as abstraction by third-party including software including processing using machine learning algorithms prior to transferring to the eCRF. xCures will retain source records in a secure that will be maintained separately and securely from the eCRF. However, metadata tagging may be employed to electronically map source data back from the eCRF to the source data record to create an audit trail.\\n\\nDISCONTINUATION OF PARTICIPATION\\n\\nParticipants can withdraw from the registry at any time by sending a written request to xCures. Withdrawal from the study means that no additional data will be collected from the patient and does not constitute revocation of the right to use the data collected prior to withdrawal for the purposes described herein. xCures may discontinue the study at any time for any reason. In the event the registry is discontinued enrolled participants may receive an email notification and a public posting on the study Web site will be made, if possible.\"},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus']},\n", - " 'KeywordList': {'Keyword': ['Coronavirus',\n", - " 'COVID19',\n", - " 'SARS-CoV-2',\n", - " 'COVID-19']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'Yes',\n", - " 'TargetDuration': '1 Year',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '100000',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Participants',\n", - " 'ArmGroupDescription': 'Adult men and women currently in the United States and willing to provide written informed consent and:\\n\\nwho are feeling sick but have not tested positive for COVID-19\\nwho are feeling sick and have tested positive for COVID-19\\nPeople who are not feeling sick but want to participate',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: Observation of patients with known, suspected, or at risk for COVID-19 infection']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", - " 'InterventionName': 'Observation of patients with known, suspected, or at risk for COVID-19 infection',\n", - " 'InterventionDescription': 'Participants will receive daily diary surveys to track the symptomatic course of known or suspected COVID-19 patients as well as use of any interventions or treatments.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Participants']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Define Natural Symptom Course',\n", - " 'PrimaryOutcomeDescription': 'Daily survey of symptoms known or reported to be associated with COVID-19 infection based including:\\n\\nHeadache, Sore throat, Runny nose, Stuffy nose, Gritty/itch eyes, Watery eyes, Nausea, Vomiting, Diarrhea, Sneezing, Coughing, Shortness of breath, Difficulty breathing, Pain or pressure in your chest, Fever, Chills, Body aches, Fatigue, or other issues. Symptoms are rated by participants on a scale of none, mild, moderate, severe, or very severe.',\n", - " 'PrimaryOutcomeTimeFrame': 'Cumulative symptom score from first onset of symptoms to resolution of symptoms (realistic timeframe of 14 days)'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Time to Hospitalization',\n", - " 'SecondaryOutcomeDescription': 'Time (in days) from onset of symptoms to hospitalization',\n", - " 'SecondaryOutcomeTimeFrame': 'Realistic timeframe of 14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Time to Symptomatic Recovery',\n", - " 'SecondaryOutcomeDescription': 'Time (in days) from onset of symptoms to resolution of symptoms',\n", - " 'SecondaryOutcomeTimeFrame': 'Realistic timeframe of 14 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nPeople who are feeling sick and have tested positive for COVID-19\\nPeople who are feeling sick but have not tested positive for COVID-19\\nPeople who are not feeling sick but want to participate\\n\\nExclusion Criteria:\\n\\n• People who are unwilling or unable to provide informed consent',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'Adults currently in the United States who may be infected or are at risk of infection with novel cornoavirus SARS-CoV-2 during the current pandemic.',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'BEAT19.org',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '(415) 754-9290',\n", - " 'CentralContactEMail': 'info@beat19.org'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Mark Shapiro',\n", - " 'OverallOfficialAffiliation': 'xCures',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'BEAT19.org',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'San Francisco',\n", - " 'LocationState': 'California',\n", - " 'LocationZip': '94022',\n", - " 'LocationCountry': 'United States',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'BEAT19.org',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactEMail': 'info@beat19.org'}]}}]}},\n", - " 'ReferencesModule': {'SeeAlsoLinkList': {'SeeAlsoLink': [{'SeeAlsoLinkLabel': 'Main registration page',\n", - " 'SeeAlsoLinkURL': 'http://www.beat19.org'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No',\n", - " 'IPDSharingDescription': 'De-identified datasets will be made available to qualified researchers in accordance with the study protocol.'}},\n", - " 'DocumentSection': {'LargeDocumentModule': {'LargeDocList': {'LargeDoc': [{'LargeDocTypeAbbrev': 'Prot_ICF',\n", - " 'LargeDocHasProtocol': 'Yes',\n", - " 'LargeDocHasSAP': 'No',\n", - " 'LargeDocHasICF': 'Yes',\n", - " 'LargeDocLabel': 'Study Protocol and Informed Consent Form',\n", - " 'LargeDocDate': 'March 20, 2020',\n", - " 'LargeDocUploadDate': '03/26/2020 16:27',\n", - " 'LargeDocFilename': 'Prot_ICF_000.pdf'}]}}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 15,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04316728',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'VivaDiag-2020'},\n", - " 'Organization': {'OrgFullName': 'Centro Studi Internazionali, Italy',\n", - " 'OrgClass': 'NETWORK'},\n", - " 'BriefTitle': 'Clinical Performance of the VivaDiag ™ COVID-19 lgM / IgG Rapid Test in Early Detecting the Infection of COVID-19',\n", - " 'OfficialTitle': 'Clinical Performance of the VivaDiag ™ COVID-19 lgM / IgG Rapid Test in a Cohort of Negative Patients for Coronavirus Infection for the Early Detection of Positive Antibodies for COVID-19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'September 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'November 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 14, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 19, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 20, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 19, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 20, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Centro Studi Internazionali, Italy',\n", - " 'LeadSponsorClass': 'NETWORK'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'VivaChek Laboratories, Inc.',\n", - " 'CollaboratorClass': 'UNKNOWN'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'This study aim to evaluate the immune response of negative patients during a COVID-19 outbreak.\\n\\nPatients are serially tested with a VivaDiag ™ COVID-19 lgM / IgG Rapid Test to evaluate the immune response in negative patients and the reliability of the test in those patients who develop clinical signs of COVID-19 during the trial.',\n", - " 'DetailedDescription': 'This study aim to evaluate the immune response of negative patients during a COVID-19 outbreak in patients with no symptoms and with no known exposure to the COVID-19.\\n\\nPatients are tested with a VivaDiag ™ COVID-19 lgM / IgG Rapid Test at day 0, day 7 and day 14. The investigators expect test to be negative on all the measurements in those patients that do not develop symptoms and that continue to have no known history of exposure to COVID-19\\n\\nPatients that develop symptoms (cough, fever or respiratory distress) and a possible contact with people positive for COVID-19 OR patients that show a positive VivaDiag test during the time frame of the test are asked to attend the COVID-19 RT - PCR &CT.\\n\\nSubsequently, the investigators will continue, repeating two tests seven days apart every 30 days (predefined times 0-7-14, then 30-37, 60-67) for the next six months. The investigators can evaluate to stop the test however before the six months if there are no new cases of COVID-19 for at least 21 days in the region where the enrolled patients live.\\n\\nThe test in use is the VivaDiag ™ COVID-19 lgM / IgG\\n\\nProcedure (as per the protocol in use for the administration of the test)\\n\\ntake out the test kit and leave it at least 30 minutes in the room where the test will be performed.\\nplace the test equipment on a clean and dust-free surface\\nFirst insert 10µL of whole blood or serum or plasma in the area reserved for blood (in the well) present on the test, then apply 2 drops of buffer.\\nread the result after 15 minutes\\n\\nInterpretation of test results\\n\\nPositive result\\n\\nThe anti-COVID-19 lgM antibody is detected if: the quality control band C and the lgM band are both colored and the lgG band does not stain. This means that the anti-COVID-19 lgM antibody is positive.\\nThe anti-COVID-19 lgG antibody is detected if: the quality control band C and the lgG band are both colored and the lgM band does not stain. This means that the COVID-19 lgG antibody is positive.\\nThe lgG and lgM anti-COVID-19 antibodies are detected if: the C band, the lgG band and the lgM band are all three colored. This means that the anti-COVID-19 lgG and lgM antibodies are both positive.\\n\\nNegative result The anti-COVID-19 lgG and lgM antibodies are not detected if only the quality control C band is stained but the lgG and lgM bands are not colored, this means that the test is negative.\\n\\nInvalid result\\n\\nIf the quality control band C does not color, regardless of whether the lgG and lgM bands are colored or not, the result is invalid and the test must be started again.\\n\\nSpecs of the test\\n\\nProduct Name VivaDiag™ COVID-19 IgM/IgG Rapid Test Test Principle Colloidal gold Sample Type Whole blood (from vein or fingertip), serum or plasma Sample Volume 10 μL Test Time 15 min Operation Temperature 18-25ºC Storage Temperature 2-30ºC Shelf Life (Unopened) 12 months'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus Infections']},\n", - " 'KeywordList': {'Keyword': ['COVID-19', 'IgM Test', 'IgG Test']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Not Applicable']},\n", - " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", - " 'DesignPrimaryPurpose': 'Diagnostic',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '200',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'negative Patients',\n", - " 'ArmGroupType': 'Other',\n", - " 'ArmGroupDescription': 'Adult HCWs with no signs or symptom of coronavirus infection and no known previous history of contact with patients positive for COVID-19, working in a primary care setting and Adult patients with at least 2 chronic medical conditions routinely attending a General Practioner (GP) practice or an outpatients departments or a primary care facility',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Device: VivaDiag™ COVID-19 lgM/IgG Rapid Test']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Device',\n", - " 'InterventionName': 'VivaDiag™ COVID-19 lgM/IgG Rapid Test',\n", - " 'InterventionDescription': 'VivaDiag™ COVID-19 lgM/IgG Rapid Test is an in vitro diagnostic for the qualitative determination of COVID-19 IgM and IgG antibodies in human whole blood (from vein or fingertip), serum or plasma',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['negative Patients']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Number of patients with constant negative results',\n", - " 'PrimaryOutcomeDescription': 'Number of patients with negative results in the three measurements, compared to the number of patients with at least one positive test',\n", - " 'PrimaryOutcomeTimeFrame': '30 days'},\n", - " {'PrimaryOutcomeMeasure': 'Number of patients with positive test with a positive PCR for COVID-19',\n", - " 'PrimaryOutcomeDescription': 'Number of patients that present at least one positive VivaDiag test that when subsequently tested with PCR remain positive',\n", - " 'PrimaryOutcomeTimeFrame': '30 days'},\n", - " {'PrimaryOutcomeMeasure': 'Overall Number of patients positive for COVID-19',\n", - " 'PrimaryOutcomeDescription': 'Where available, number of patients positive for COVID-19 IgG and IgM and positive for COVID-19 PCR',\n", - " 'PrimaryOutcomeTimeFrame': 'six months'},\n", - " {'PrimaryOutcomeMeasure': 'Overall Number of patients negative for COVID-19',\n", - " 'PrimaryOutcomeDescription': 'Where available, number of patients negative for COVID-19 IgG and IgM and negative for COVID-19 PCR',\n", - " 'PrimaryOutcomeTimeFrame': 'six months'},\n", - " {'PrimaryOutcomeMeasure': 'Number of patients with contrasting results',\n", - " 'PrimaryOutcomeDescription': 'Where available, number of patients positive for COVID-19 IgG and IgM and negative for COVID-19 PCR, or negative for COVID-19 IgG and IgM and positive for COVID-19 PCR',\n", - " 'PrimaryOutcomeTimeFrame': '30 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Reliability of the test',\n", - " 'SecondaryOutcomeDescription': 'Number of Invalid results',\n", - " 'SecondaryOutcomeTimeFrame': '30 days'},\n", - " {'SecondaryOutcomeMeasure': 'Positive HCW',\n", - " 'SecondaryOutcomeDescription': 'Number of healthcare workers that become positive for COVID-19 IgM or IgG',\n", - " 'SecondaryOutcomeTimeFrame': '60 days'},\n", - " {'SecondaryOutcomeMeasure': 'Number of Chronic Patients',\n", - " 'SecondaryOutcomeDescription': 'Number of Chronic Patients that become positive for COVID-19 IgM or IgG',\n", - " 'SecondaryOutcomeTimeFrame': '60 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAdults healthcare workers (HCW) OR\\nChronic patients with at least 2 chronic medical conditions\\n\\nExclusion Criteria:\\n\\nPeople that have been in contact with people positive for COVID-19 in the previous 14 days\\nPeople with body temperature >37.5°C\\nPeople with Dry cough\\nPeople with Respiratory distress (Respiratory Rate >25/min or O2 Saturation <92%)',\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Antonio V Gaddi, MD, MSc',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+393920039246',\n", - " 'CentralContactEMail': 'antonio.gaddi@ehealth.study'},\n", - " {'CentralContactName': 'Fabio V Capello, MD, PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactEMail': 'fabio.capello@ehealth.study'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Maurizio Cipolla, MD',\n", - " 'OverallOfficialAffiliation': 'Medical director of UCCP CATANZARO, Italy',\n", - " 'OverallOfficialRole': 'Study Director'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': \"Unità' Complesse di cure primarie (UCCP), ASP Catanzaro\",\n", - " 'LocationCity': 'Catanzaro',\n", - " 'LocationZip': '88100',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Maurizio Cipolla, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactEMail': 'maurizio.cipolla@ehealth.study'}]}}]}},\n", - " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '32035538',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Zarocostas J. What next for the coronavirus response? Lancet. 2020 Feb 8;395(10222):401. doi: 10.1016/S0140-6736(20)30292-0.'},\n", - " {'ReferencePMID': '31986257',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Wang C, Horby PW, Hayden FG, Gao GF. A novel coronavirus outbreak of global health concern. Lancet. 2020 Feb 15;395(10223):470-473. doi: 10.1016/S0140-6736(20)30185-9. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 29;:.'},\n", - " {'ReferencePMID': '31991079',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Phan LT, Nguyen TV, Luong QC, Nguyen TV, Nguyen HT, Le HQ, Nguyen TT, Cao TM, Pham QD. Importation and Human-to-Human Transmission of a Novel Coronavirus in Vietnam. N Engl J Med. 2020 Feb 27;382(9):872-874. doi: 10.1056/NEJMc2001272. Epub 2020 Jan 28.'},\n", - " {'ReferencePMID': '31978944',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Perlman S. Another Decade, Another Coronavirus. N Engl J Med. 2020 Feb 20;382(8):760-762. doi: 10.1056/NEJMe2001126. Epub 2020 Jan 24.'},\n", - " {'ReferencePMID': '31986264',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:.'},\n", - " {'ReferencePMID': '32109013',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMoa2002032. [Epub ahead of print]'},\n", - " {'ReferencePMID': '31991541',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Gralinski LE, Menachery VD. Return of the Coronavirus: 2019-nCoV. Viruses. 2020 Jan 24;12(2). pii: E135. doi: 10.3390/v12020135.'},\n", - " {'ReferencePMID': '32035509',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Ronco C, Navalesi P, Vincent JL. Coronavirus epidemic: preparing for extracorporeal organ support in intensive care. Lancet Respir Med. 2020 Mar;8(3):240-241. doi: 10.1016/S2213-2600(20)30060-6. Epub 2020 Feb 6.'},\n", - " {'ReferencePMID': '32105304',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Lan L, Xu D, Ye G, Xia C, Wang S, Li Y, Xu H. Positive RT-PCR Test Results in Patients Recovered From COVID-19. JAMA. 2020 Feb 27. doi: 10.1001/jama.2020.2783. [Epub ahead of print]'},\n", - " {'ReferencePMID': '32098019',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Kobayashi T, Jung SM, Linton NM, Kinoshita R, Hayashi K, Miyama T, Anzai A, Yang Y, Yuan B, Akhmetzhanov AR, Suzuki A, Nishiura H. Communicating the Risk of Death from Novel Coronavirus Disease (COVID-19). J Clin Med. 2020 Feb 21;9(2). pii: E580. doi: 10.3390/jcm9020580.'},\n", - " {'ReferencePMID': '32132196',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Chan JF, Yip CC, To KK, Tang TH, Wong SC, Leung KH, Fung AY, Ng AC, Zou Z, Tsoi HW, Choi GK, Tam AR, Cheng VC, Chan KH, Tsang OT, Yuen KY. Improved molecular diagnosis of COVID-19 by the novel, highly sensitive and specific COVID-19-RdRp/Hel real-time reverse transcription-polymerase chain reaction assay validated in vitro and with clinical specimens. J Clin Microbiol. 2020 Mar 4. pii: JCM.00310-20. doi: 10.1128/JCM.00310-20. [Epub ahead of print]'},\n", - " {'ReferencePMID': '32083985',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Zu ZY, Jiang MD, Xu PP, Chen W, Ni QQ, Lu GM, Zhang LJ. Coronavirus Disease 2019 (COVID-19): A Perspective from China. Radiology. 2020 Feb 21:200490. doi: 10.1148/radiol.2020200490. [Epub ahead of print]'},\n", - " {'ReferencePMID': '32145766',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Xiao Y, Torok ME. Taking the right measures to control COVID-19. Lancet Infect Dis. 2020 Mar 5. pii: S1473-3099(20)30152-3. doi: 10.1016/S1473-3099(20)30152-3. [Epub ahead of print]'},\n", - " {'ReferencePMID': '32096564',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Wang Y, Kang H, Liu X, Tong Z. Combination of RT-qPCR testing and clinical features for diagnosis of COVID-19 facilitates management of SARS-CoV-2 outbreak. J Med Virol. 2020 Feb 25. doi: 10.1002/jmv.25721. [Epub ahead of print]'},\n", - " {'ReferencePMID': '32130038',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Li Y, Xia L. Coronavirus Disease 2019 (COVID-19): Role of Chest CT in Diagnosis and Management. AJR Am J Roentgenol. 2020 Mar 4:1-7. doi: 10.2214/AJR.20.22954. [Epub ahead of print]'},\n", - " {'ReferencePMID': '32101510',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Ai T, Yang Z, Hou H, Zhan C, Chen C, Lv W, Tao Q, Sun Z, Xia L. Correlation of Chest CT and RT-PCR Testing in Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases. Radiology. 2020 Feb 26:200642. doi: 10.1148/radiol.2020200642. [Epub ahead of print]'},\n", - " {'ReferencePMID': '32097725',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Zhang S, Diao M, Yu W, Pei L, Lin Z, Chen D. Estimation of the reproductive number of novel coronavirus (COVID-19) and the probable outbreak size on the Diamond Princess cruise ship: A data-driven analysis. Int J Infect Dis. 2020 Feb 22;93:201-204. doi: 10.1016/j.ijid.2020.02.033. [Epub ahead of print]'},\n", - " {'ReferencePMID': '32119647',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Lippi G, Plebani M. Laboratory abnormalities in patients with COVID-2019 infection. Clin Chem Lab Med. 2020 Mar 3. pii: /j/cclm.ahead-of-print/cclm-2020-0198/cclm-2020-0198.xml. doi: 10.1515/cclm-2020-0198. [Epub ahead of print]'},\n", - " {'ReferencePMID': '32077933',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Binnicker MJ. Emergence of a Novel Coronavirus Disease (COVID-19) and the Importance of Diagnostic Testing: Why Partnership between Clinical Laboratories, Public Health Agencies, and Industry Is Essential to Control the Outbreak. Clin Chem. 2020 Feb 20. pii: hvaa071. doi: 10.1093/clinchem/hvaa071. [Epub ahead of print]'},\n", - " {'ReferencePMID': '32061311',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Habibi R, Burci GL, de Campos TC, Chirwa D, Cinà M, Dagron S, Eccleston-Turner M, Forman L, Gostin LO, Meier BM, Negri S, Ooms G, Sekalala S, Taylor A, Yamin AE, Hoffman SJ. Do not violate the International Health Regulations during the COVID-19 outbreak. Lancet. 2020 Feb 29;395(10225):664-666. doi: 10.1016/S0140-6736(20)30373-1. Epub 2020 Feb 13.'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", - " 'IPDSharingDescription': 'Still under development',\n", - " 'IPDSharingInfoTypeList': {'IPDSharingInfoType': ['Study Protocol',\n", - " 'Clinical Study Report (CSR)']},\n", - " 'IPDSharingTimeFrame': '12 months',\n", - " 'IPDSharingAccessCriteria': 'Still under development'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M2806',\n", - " 'InterventionBrowseLeafName': 'Antibodies',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M8767',\n", - " 'InterventionBrowseLeafName': 'Immunoglobulins',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", - " 'ConditionMeshTerm': 'Infection'},\n", - " {'ConditionMeshId': 'D000003141',\n", - " 'ConditionMeshTerm': 'Communicable Diseases'},\n", - " {'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", - " {'ConditionMeshId': 'D000045169',\n", - " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafAsFound': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafAsFound': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 16,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04323787',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '20-002610'},\n", - " 'Organization': {'OrgFullName': 'Mayo Clinic', 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Viral Infection and Respiratory Illness Universal Study[VIRUS]: COVID19 Registry',\n", - " 'OfficialTitle': 'Viral Infection and Respiratory Illness Universal Study[VIRUS]: COVID-19 Registry and Validation of C2D2 (Critical Care Data Dictionary)',\n", - " 'Acronym': 'VIRUS'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 30, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 30, 2021',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'April 30, 2021',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 24, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 25, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 27, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", - " 'LastUpdatePostDateType': 'Estimate'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Rahul Kashyap',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Mayo Clinic'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Mayo Clinic',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Researchers are creating a real time COVID-19 registry of current ICU/hospital care patterns to allow evaluations of safety and observational effectiveness of COVID-19 practices and to determine the variations in practice across hospitals.',\n", - " 'DetailedDescription': 'Investigators aim is to create a real time COVID-19 registry of current ICU/hospital care patterns to allow evaluations of safety and observational effectiveness of COVID-19 practices and to determine the variations in practice across hospitals.\\n\\nSuch a set of standards would increase the quality of single and multi-center studies, national registries as well as aggregation syntheses such as meta-analyses. It will also be of utmost importance in tiring times of public health emergencies and will help understand practice variability and outcomes during COVID-19 pandemic.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus']},\n", - " 'KeywordList': {'Keyword': ['COVID19']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Other']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '50000',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'COVID19 test positive/pending or high clinical suspicion',\n", - " 'ArmGroupDescription': 'COVID19 test positive/pending/high clinical suspicion- patient admitted to hospital',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: observational']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", - " 'InterventionName': 'observational',\n", - " 'InterventionDescription': 'No Intervention',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['COVID19 test positive/pending or high clinical suspicion']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['No Intervention']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'ICU and hospital mortality of COVID-19 patients',\n", - " 'PrimaryOutcomeDescription': 'Primary outcome will be to measure ICU and hospital mortality up to 7 days of COVID-19 patients',\n", - " 'PrimaryOutcomeTimeFrame': '7 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': '30 days mortality',\n", - " 'SecondaryOutcomeDescription': 'Secondary outcome will be to measure 30 days mortality from Hospital discharge',\n", - " 'SecondaryOutcomeTimeFrame': '30 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nCOVID-19 PCR positive (within 7 days)\\nCOVID-19 PCR pending\\nCOVID-19 high clinical suspicion\\n\\nExclusion Criteria:\\n\\nPatient without Prior Research Authorization (applicable to Mayo Clinic sites)\\nNon COVID-19 related admissions\\nRepeated Admission to ICUs/Hospital',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'COVID-19 Hospitalized patients',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Rahul Kashya, MBBS',\n", - " 'OverallOfficialAffiliation': 'Mayo Clinic',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Mayo Clinic in Arizona',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Scottsdale',\n", - " 'LocationState': 'Arizona',\n", - " 'LocationZip': '85259',\n", - " 'LocationCountry': 'United States',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Ayan Sen, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '480-342-2000',\n", - " 'LocationContactEMail': 'sen.ayan@mayo.edu'}]}},\n", - " {'LocationFacility': 'Mayo Clinic in Florida',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Jacksonville',\n", - " 'LocationState': 'Florida',\n", - " 'LocationZip': '32224',\n", - " 'LocationCountry': 'United States',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Devang Sanghavi, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '904-956-3331',\n", - " 'LocationContactEMail': 'Sanghavi.Devang@mayo.edu'}]}},\n", - " {'LocationFacility': 'Society of Critical Care Medicine (150+ sites)',\n", - " 'LocationStatus': 'Not yet recruiting',\n", - " 'LocationCity': 'Chicago',\n", - " 'LocationState': 'Illinois',\n", - " 'LocationZip': '60056',\n", - " 'LocationCountry': 'United States',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Vishakha Kumar, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '847-827-6869',\n", - " 'LocationContactEMail': 'vkumar@sccm.org'}]}},\n", - " {'LocationFacility': 'Rahul Kashyap',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Rochester',\n", - " 'LocationState': 'Minnesota',\n", - " 'LocationZip': '55905',\n", - " 'LocationCountry': 'United States',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Rahul Kashyap',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '507-255-7196',\n", - " 'LocationContactEMail': 'Kashyap.Rahul@mayo.edu'},\n", - " {'LocationContactName': 'Ognjen Gajic, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}}]}},\n", - " 'ReferencesModule': {'SeeAlsoLinkList': {'SeeAlsoLink': [{'SeeAlsoLinkLabel': 'Mayo Clinic Clinical Trials',\n", - " 'SeeAlsoLinkURL': 'https://www.mayo.edu/research/clinical-trials'},\n", - " {'SeeAlsoLinkLabel': 'SCCM Discovery VIRUS COVID19 Information Webpage',\n", - " 'SeeAlsoLinkURL': 'https://www.sccm.org/Research/Research/Discovery-Research-Network/VIRUS-COVID-19-Registry'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000014777',\n", - " 'ConditionMeshTerm': 'Virus Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafAsFound': 'Viral Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'}]}}}}},\n", - " {'Rank': 17,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04329611',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'ABCOV-01'},\n", - " 'Organization': {'OrgFullName': 'University of Calgary',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Hydroxychloroquine to Prevent Covid19 Pneumonia (ALBERTA HOPE-Covid19)',\n", - " 'OfficialTitle': 'A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Oral Hydroxychloroquine for the Treatment of SARS-CoV-2 Positive Patients for the Prevention of Severe COVID-19 Disease'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 8, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'July 31, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'August 31, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 29, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 31, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", - " 'LastUpdatePostDateType': 'Estimate'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor-Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Dr. Michael Hill',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Co-Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'University of Calgary'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Dr. Michael Hill',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Albertans with COVID-19 are at risk of deteriorating and developing severe illness. Those over age 40 and those with comorbid illness, including those with immunosuppressed states may be at highest risk.\\n\\nParticipants will be informed of the study by public health when they are tested for COVID-19. The study description and consent form will also be posted on the Alberta Covid-19 website for all Albertans to be aware of. Patients being tested for COVID-19 according to the guidance developed by Alberta Public Health will be referred to this website and those who indicate they do not have access to this information will be provided with written information at the time of testing.\\n\\nParticipants will be informed that they are potentially eligible for the study when a positive COVID-19 test is confirmed. They will be asked by public health for consent to be contacted by a study coordinator and their email address and phone number will be obtained. These will then be shared with the investigators. Potential participants will be reminded to review the study information and informed consent form on the website if possible.\\n\\nThe investigators will then initiate contact with potential participants by email (preferred) or telephone. The study requirements will be reviewed, and the potential participant will have an opportunity to ask questions. Consent for participation will preferably be obtained electronically; those without internet access may provide consent by telephone.\\n\\nParticipants will then be screened for inclusion and exclusion criteria by electronic questionnaire or telephone interview and Alberta Netcare medical record review. Follow-up questions to confirm eligibility by email or telephone may be required.\\n\\nThose who are eligible will be randomized to receive hydroxychloroquine or placebo for a total duration of 5 days. Those who are not eligible will be informed and the reasons for ineligibility will be explained why (generally it will be a safety exclusion and they should be aware). Study drug will be delivered to their residence by courier.\\n\\nOutcomes will be collected by electronic questionnaire, administrative data and review of Alberta Netcare. If follow-up questionnaires are not completed within 24 hours telephone follow-up will be attempted. Those completing the study who do not have internet access will be followed by telephone. Administrative data, and information on Alberta Netcare will also be used for follow-up. The duration of the followup is 30 days.',\n", - " 'DetailedDescription': 'This double-blind placebo-controlled, randomized clinical trial will determine if hydroxychloroquine for 5 days, initiated within 72 hours of a confirmed diagnosis of COVID-19, reduces the occurrence of severe COVID-19 disease. Severe disease is defined as the composite of mechanical ventilation or death at 30 days. This trial will enrol consenting Albertans who are not hospitalized, are over age 40, have no contraindication to treatment with hydroxychloroquine, who do not have a severe underlying comorbidity where treatment is not likely to be beneficial to the patient.\\n\\nSecondary outcomes will be the proportion requiring invasive mechanical ventilation, diagnosis of acute respiratory distress syndrome (ARDS), use of vasopressors, receipt of ECMO/ECLS, diagnosis of median length of stay, in-hospital and 30-day mortality, EQ5D at 30 days, disposition at 30 days.\\n\\nRandomization will be stratified by risk of severe disease. A pre-specified risk tool that includes classification by immunosuppression status will define patient strata.\\n\\nAlberta has a single publicly funded health care system with processes and administrative data that will allow complete capture of health system encounters and resource utilization. The population is ethnically diverse (ref) and most Albertans have internet access to allow electronic enrolment and data capture.\\n\\nThe current COVID-19 epidemic has also paused most ongoing research, thus providing access to a large number of experienced researchers and highly trained research staff.\\n\\nLack of any proven treatments for this severe condition makes it imperative that we use the resources we have to try to improve the lives of Albertans and determine if there is evidence for the use of hydroxychloroquine for confirmed COVID-19 disease, overall, and in high risk participants.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", - " 'KeywordList': {'Keyword': ['SARS-Cov2', 'viral pneumonia']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 3']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Single Group Assignment',\n", - " 'DesignInterventionModelDescription': 'Randomization will be stratified by risk of severe disease. A pre-specified risk tool that includes classification by immunosuppression status will define patient strata.\\n\\nIt is predicted that patients will want treatment. Further, immunosuppressed patients may be at the highest risk of fatal outcomes. Therefore, we will use 2:1 randomization (hydroxychloroquine: placebo), stratified by risk status (which includes immune status).\\n\\nRandomization will use a stratified minimal sufficient balance algorithm to ensure balance on age, provincial zone/geographic location',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Triple',\n", - " 'DesignMaskingDescription': 'A randomized, double-blind, placebo-controlled trial - trial staff and patients will all be blinded to the treatment allocation.',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", - " 'Care Provider',\n", - " 'Investigator']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '1660',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'hydroxychloroquine',\n", - " 'ArmGroupType': 'Active Comparator',\n", - " 'ArmGroupDescription': 'hydroxychloroquine 400 mg po bid loading dose for 1 day followed by 200 mg po twice daily for 4 days',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine']}},\n", - " {'ArmGroupLabel': 'Placebo',\n", - " 'ArmGroupType': 'Placebo Comparator',\n", - " 'ArmGroupDescription': 'Matching Placebo',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Hydroxychloroquine',\n", - " 'InterventionDescription': 'COVID19',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Placebo',\n", - " 'hydroxychloroquine']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['plaquenil']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Composite of hospitalization, invasive mechanical ventilation or death within 30 days',\n", - " 'PrimaryOutcomeDescription': 'The aim of this intervention is to prevent severe COVID-19 disease.\\n\\nThis trial aims to confirm that severe COVID-19 disease can be reduced by a relative risk reduction of 50% by the use of hydroxychloroquine.The aim of this intervention is to prevent severe COVID-19 disease.\\n\\nThis trial aims to confirm that severe COVID-19 disease can be reduced by a relative risk reduction of 50% by the use of hydroxychloroquine.The aim of this intervention is to prevent severe COVID-19 disease.\\n\\nThis trial aims to confirm that severe COVID-19 disease can be reduced by a relative risk reduction of 50% by the use of hydroxychloroquine.',\n", - " 'PrimaryOutcomeTimeFrame': 'Within 30 days of randomization'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'composite of invasive mechanical ventilation or death within 30 days',\n", - " 'SecondaryOutcomeDescription': 'Following patients admitted to ICU for mechanical ventilation for symptoms of COVID19',\n", - " 'SecondaryOutcomeTimeFrame': 'Within 30 days of randomization'},\n", - " {'SecondaryOutcomeMeasure': 'hospitalization within 30 days',\n", - " 'SecondaryOutcomeDescription': 'Admission to hospital as an inpatient within 30 days of randomization',\n", - " 'SecondaryOutcomeTimeFrame': 'Within 30 days of randomization'},\n", - " {'SecondaryOutcomeMeasure': 'mortality',\n", - " 'SecondaryOutcomeDescription': 'Mortality within 30 days of randomization',\n", - " 'SecondaryOutcomeTimeFrame': 'Within 30 days of randomization'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\nInclusion Criteria\\n\\nAll patients with a confirmed SARS-CoV-2 infection, defined as RT-PCR provincial laboratory confirmation.\\nSelf-reported symptoms of SARS-CoV-2 infection including any of the following: fever ≥37.5'C, cough, dyspnea, chest tightness, malaise, sore throat, myalgias, or coryza.\\nTime from being notified of a positive test result to day 1 of treatment < 96 hours\\nTime from patient reported first symptoms to day 1 of treatment <12 days\\nAdults, age 18 and over, with any risk factor for severe disease as per Table 1\\nResident of Alberta or if not a resident of Alberta able to provide complete follow-up data\\nInformed consent\\n\\nExclusion Criteria\\n\\nCurrently or imminently planned admission to hospital.\\nAny contraindication to hydroxychloroquine\\nParticipation in an ongoing interventional clinical trial within the previous 30 days.\\nCurrent treatment with hydroxychloroquine (Plaquenil), chloroquine, lumefantrine, mefloquine, or quinine.\\nInability to swallow pills or any other reason that compliance with the medical regimen is not likely.\\nPregnancy.\\nSevere underlying disease where treatment is not likely to be beneficial to the patient. This includes people requiring care in designated supported living facilities (SL4, nursing homes) and severe dementia.\",\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Dr. L Metz, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '403-944-4241',\n", - " 'CentralContactEMail': 'luanne.metz@ahs.ca'},\n", - " {'CentralContactName': 'Dr. M Hill, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '403-210-7786',\n", - " 'CentralContactEMail': 'michael.hill@ucalgary.ca'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Luanne Metz, MD',\n", - " 'OverallOfficialAffiliation': 'University of Calgary',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Michael D Hill, MD',\n", - " 'OverallOfficialAffiliation': 'University of Calgary',\n", - " 'OverallOfficialRole': 'Study Director'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'University of Calgary/Foothills Medical Centre',\n", - " 'LocationCity': 'Calgary',\n", - " 'LocationState': 'Alberta',\n", - " 'LocationZip': 'T2N 2T9',\n", - " 'LocationCountry': 'Canada',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Carol C Kenney, RN, CCRP',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '403-944-4286',\n", - " 'LocationContactEMail': 'ckenney@ucalgary.ca'},\n", - " {'LocationContactName': 'Michael D Hill, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '403-210-7786',\n", - " 'LocationContactEMail': 'michael.hill@ucalgary.ca'},\n", - " {'LocationContactName': 'Luanne M Metz, MD, FRCPC',\n", - " 'LocationContactRole': 'Principal Investigator'},\n", - " {'LocationContactName': 'Michael D Hill, MD.FRCPC',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", - " 'IPDSharingInfoTypeList': {'IPDSharingInfoType': ['Study Protocol',\n", - " 'Statistical Analysis Plan (SAP)',\n", - " 'Informed Consent Form (ICF)',\n", - " 'Clinical Study Report (CSR)',\n", - " 'Analytic Code']},\n", - " 'IPDSharingTimeFrame': '24 months after study close out.',\n", - " 'IPDSharingAccessCriteria': 'pending.'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", - " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", - " 'InterventionAncestorTerm': 'Antimalarials'},\n", - " {'InterventionAncestorId': 'D000000981',\n", - " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", - " {'InterventionAncestorId': 'D000000977',\n", - " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", - " {'InterventionAncestorId': 'D000000890',\n", - " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", - " {'InterventionAncestorId': 'D000004791',\n", - " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", - " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M2861',\n", - " 'InterventionBrowseLeafName': 'Antimalarials',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2879',\n", - " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2875',\n", - " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2795',\n", - " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19188',\n", - " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000011014',\n", - " 'ConditionMeshTerm': 'Pneumonia'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000008171',\n", - " 'ConditionAncestorTerm': 'Lung Diseases'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M12487',\n", - " 'ConditionBrowseLeafName': 'Pneumonia',\n", - " 'ConditionBrowseLeafAsFound': 'Pneumonia',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M12497',\n", - " 'ConditionBrowseLeafName': 'Pneumonia, Viral',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M9751',\n", - " 'ConditionBrowseLeafName': 'Lung Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'}]}}}}},\n", - " {'Rank': 18,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04331834',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'PrEP_COVID'},\n", - " 'Organization': {'OrgFullName': 'Barcelona Institute for Global Health',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic',\n", - " 'OfficialTitle': 'Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic: A Unicentric, Double-Blinded Randomized Controlled Trial',\n", - " 'Acronym': 'PrEP_COVID'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 3, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'October 3, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'October 30, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'April 1, 2020',\n", - " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 2, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Barcelona Institute for Global Health',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Hospital Clinic of Barcelona',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'Laboratorios Rubió',\n", - " 'CollaboratorClass': 'UNKNOWN'}]}},\n", - " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No',\n", - " 'IsUSExport': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'The investigators aim to evaluate the efficacy of pre-exposure prophylaxis with hydroxychloroquine in healthcare workers with high-risk of SARS-CoV-2 infection.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", - " 'KeywordList': {'Keyword': ['PrEP']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 3']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Prevention',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Quadruple',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", - " 'Care Provider',\n", - " 'Investigator',\n", - " 'Outcomes Assessor']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '440',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Pre-exposure prophylaxis of SARS-CoV-2',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Participants will receive hydroxychloroquine 400 mg daily during the first 4 days, followed by 400 mg weekly during 6 months',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine']}},\n", - " {'ArmGroupLabel': 'Control group with placebo',\n", - " 'ArmGroupType': 'Placebo Comparator',\n", - " 'ArmGroupDescription': 'Participants will receive placebo 400 mg daily during the first 4 days, followed by 400 mg weekly during 6 months',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebos']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Hydroxychloroquine',\n", - " 'InterventionDescription': 'Hydroxychloroquine with the following dosage:\\n\\nday 0: 400 mg (2 tablets)\\nday 1: 400 mg (2 tablets)\\nday 2: 400 mg (2 tablets)\\nday 3: 400 mg (2 tablets)\\nweekly: 400 mg (2 tablets) for a period of six months',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Pre-exposure prophylaxis of SARS-CoV-2']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Placebos',\n", - " 'InterventionDescription': 'Placebo with the following dosage:\\n\\nday 0: 400 mg (2 tablets)\\nday 1: 400 mg (2 tablets)\\nday 2: 400 mg (2 tablets)\\nday 3: 400 mg (2 tablets)\\nweekly: 400 mg (2 tablets) for a period of six months',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Control group with placebo']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Confirmed cases of a COVID-19',\n", - " 'PrimaryOutcomeDescription': 'Confirmed cases of a COVID-19 (defined by symptoms compatible with COVID-19 and/or a positive PCR for SARS-CoV-2) in the PrEP group compared to the placebo group at any time during the 6 months of the follow-up in healthcare workers with negative PCR for SARS-CoV-2 at day 0.',\n", - " 'PrimaryOutcomeTimeFrame': 'Up to 6 months after start of treatment'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'SARS-CoV-2 seroconversion',\n", - " 'SecondaryOutcomeDescription': 'SARS-CoV-2 seroconversion in the PrEP group compared to placebo in during 6 months of follow-up in healthcare workers with negative serology at day 0.',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 6 months after start of treatment'},\n", - " {'SecondaryOutcomeMeasure': 'Occurrence of any adverse event related with hydroxychloroquine treatment',\n", - " 'SecondaryOutcomeDescription': 'Incidence of clinical and/or laboratory adverse events will be compared in the PrEP group and in the placebo arm.',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 6 months after start of treatment'},\n", - " {'SecondaryOutcomeMeasure': 'Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers',\n", - " 'SecondaryOutcomeDescription': 'Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers will be estimated by the number of healthcare workers diagnosed with COVID-19 in the placebo group, among the total of healthcare workers included in the non-PrEP group during the study period.',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 6 months after start of treatment'},\n", - " {'SecondaryOutcomeMeasure': 'Risk ratio for the different clinical, analytical and microbiological conditions to develop COVID-19',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 6 months after start of treatment'},\n", - " {'SecondaryOutcomeMeasure': 'COVID-19 Biobank',\n", - " 'SecondaryOutcomeDescription': 'A repository (biobank) of serum samples obtained from healthcare workers confirmed COVID-19 cases for future research on blood markers to predict SARS-CoV-2 infection.',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 6 months after start of treatment'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAge ≥ 18 years\\nNegative PCR and negative serology at day 0\\nHealthcare worker at Hospital Clínic de Barcelona\\nFemale participants: negative for pregnancy test\\nWilling to participate in the study\\nAble to sign the informed consent form\\n\\nExclusion Criteria:\\n\\nAge <18 years\\nPregnancy or breastfeeding\\nOngoing antiviral or antiretroviral treatment or HIV positive\\nOngoing anti-inflammatory treatment (NSAID, corticosteroids)\\nOngoing chloroquine or hydroxychloroquine treatment\\nConfirmed case of SARS-CoV-2 infection (positive PCR) at day 0\\nPositive serology for SARS-CoV-1 infection at day 0\\nImpossibility of signing the informed consent form\\nRejection of participation\\nWorking less than 5 days a week in the Hospital Clinic of Barcelona.\\n\\nAny contraindication for hydroxychloroquine treatment:\\n\\nHydroxychloroquine hypersensitivity or 4-aminoquinoline hypersensitivity\\nRetinopathy, visual field or visual acuity disturbances\\nQT prolongation, bradycardia (<50bpm), ventricular tachycardia, other arrhythmias, as determined on day 0 ECG or medical history\\nPotassium < 3 mEq/L or AST or ALT > 5 upper normal limit, as determined on day 0 blood test\\nPrevious myocardial infarction\\nMyasthenia gravis\\nPsoriasis or porphyria\\nGlomerular clearance < 10ml/min\\nPrevious history of severe hypoglycaemia\\nOngoing treatment with: antimalarials, antiarrhythmic, tricyclic antidepressants, natalizumab, quinolones, macrolides, agalsidase alfa and beta.',\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Jose Muñoz Gutiérrez, MD, PhD',\n", - " 'OverallOfficialAffiliation': 'Barcelona Institute for Global Health',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'ISGlobal',\n", - " 'LocationCity': 'Barcelona',\n", - " 'LocationZip': '08036',\n", - " 'LocationCountry': 'Spain'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", - " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", - " 'InterventionAncestorTerm': 'Antimalarials'},\n", - " {'InterventionAncestorId': 'D000000981',\n", - " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", - " {'InterventionAncestorId': 'D000000977',\n", - " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", - " {'InterventionAncestorId': 'D000000890',\n", - " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", - " {'InterventionAncestorId': 'D000004791',\n", - " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", - " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M2861',\n", - " 'InterventionBrowseLeafName': 'Antimalarials',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2879',\n", - " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2875',\n", - " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2795',\n", - " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19188',\n", - " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}}}}},\n", - " {'Rank': 19,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04299724',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'GIMI-IRB-20002'},\n", - " 'Organization': {'OrgFullName': 'Shenzhen Geno-Immune Medical Institute',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Safety and Immunity of Covid-19 aAPC Vaccine',\n", - " 'OfficialTitle': 'Safety and Immunity Evaluation of A Covid-19 Coronavirus Artificial Antigen Presenting Cell Vaccine'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'February 15, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'July 31, 2023',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2024',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 5, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 6, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 9, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 6, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 9, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Lung-Ji Chang',\n", - " 'ResponsiblePartyInvestigatorTitle': 'President',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Shenzhen Geno-Immune Medical Institute'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Shenzhen Geno-Immune Medical Institute',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': \"Shenzhen Third People's Hospital\",\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': \"Shenzhen Second People's Hospital\",\n", - " 'CollaboratorClass': 'OTHER'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'In December 2019, viral pneumonia (Covid-19) caused by a novel beta-coronavirus (SARS-CoV-2) broke out in Wuhan, China. Some patients rapidly progressed and suffered severe acute respiratory failure and died, making it imperative to develop a safe and effective vaccine to treat and prevent severe Covid-19 pneumonia. Based on detailed analysis of the viral genome and search for potential immunogenic targets, a synthetic minigene has been engineered based on conserved domains of the viral structural proteins and a polyprotein protease. The infection of Covid-19 is mediated through binding of the Spike protein to the ACEII receptor, and the viral replication depends on molecular mechanisms of all of these viral proteins. This trial proposes to develop universal vaccine and test innovative Covid-19 minigenes engineered based on multiple viral genes, using an efficient lentiviral vector system (NHP/TYF) to express viral proteins and immune modulatory genes to modify artificial antigen presenting cells (aAPC) and to activate T cells. In this study, the safety and immune reactivity of this aAPC vaccine will be investigated.',\n", - " 'DetailedDescription': 'Background:\\n\\nThe 2019 discovered new coronavirus, SARS-CoV-2, is an enveloped positive strand single strand RNA virus. The number of SARS-CoV-2 infected people has increased rapidly and WHO has warned that the pandemic spread of Covid-19 is imminent and would have disastrous outcomes. Covid-19 could pose a serious threat to human health and the global economy. There is no vaccine available or clinically approved antiviral therapy as yet. This study aims to evaluate the safety and immune reactivity of a genetically modified aAPC universal vaccine to treat and prevent Covid-19.\\n\\nObjective:\\n\\nPrimary study objectives: Injection of Covid-19/aAPC vaccine to volunteers to evaluate the safety.\\n\\nSecondary study objectives: To evaluate the anti- Covid-19 reactivity of the Covid-19/aAPC vaccine.\\n\\nDesign:\\n\\nBased on the genomic sequence of the new coronavirus SARS-CoV-2, select conserved and critical structural and protease protein domains to engineer lentiviral minigenes to express SARS-CoV-2 antigens.\\nThe Covid-19/aAPC vaccine is prepared by applying lentivirus modification including immune modulatory genes and the viral minigenes, to the artificial antigen presenting cells (aAPCs). The Covid-19/aAPCs are then inactivated for proliferation and extensively safety tested.\\nThe subjects receive a total of 5x10^ 6 cells each time by subcutaneous injection at 0, 14 and 28 days. The subjects are followed-up with peripheral blood tests at 0, 14, 21, 28 and 60 days until the end of the test.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Treat and Prevent Covid-19 Infection']},\n", - " 'KeywordList': {'Keyword': ['Lentiviral vector, Covid-19/aAPC vaccine']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 1']},\n", - " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '100',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Injection of Covid-19/aAPC vaccine',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: Pathogen-specific aAPC']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Biological',\n", - " 'InterventionName': 'Pathogen-specific aAPC',\n", - " 'InterventionDescription': 'The subjects will receive three injections of 5x10^6 each Covid-19/aAPC vaccine via subcutaneous injections.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Injection of Covid-19/aAPC vaccine']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Frequency of vaccine events',\n", - " 'PrimaryOutcomeDescription': 'Frequency of vaccine events such as fever, rash, and abnormal heart function.',\n", - " 'PrimaryOutcomeTimeFrame': 'Measured from Day 0 through Day 28'},\n", - " {'PrimaryOutcomeMeasure': 'Frequency of serious vaccine events',\n", - " 'PrimaryOutcomeDescription': 'Frequency of serious vaccine events',\n", - " 'PrimaryOutcomeTimeFrame': 'Measured from Day 0 through Day 28'},\n", - " {'PrimaryOutcomeMeasure': 'Proportion of subjects with positive T cell response',\n", - " 'PrimaryOutcomeTimeFrame': '14 and 28 days after randomization'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': '28-day mortality',\n", - " 'SecondaryOutcomeDescription': 'Number of deaths during study follow-up',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured from Day 0 through Day 28'},\n", - " {'SecondaryOutcomeMeasure': 'Duration of mechanical ventilation if applicable',\n", - " 'SecondaryOutcomeDescription': 'Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured from Day 0 through Day 28'},\n", - " {'SecondaryOutcomeMeasure': 'Proportion of patients in each category of the 7-point scale',\n", - " 'SecondaryOutcomeDescription': 'Proportion of patients in each category of the 7-point scale, the 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death)',\n", - " 'SecondaryOutcomeTimeFrame': '7,14 and 28 days after randomization'},\n", - " {'SecondaryOutcomeMeasure': 'Proportion of patients with normalized inflammation factors',\n", - " 'SecondaryOutcomeDescription': 'Proportion of patients with different inflammation factors in normalization range',\n", - " 'SecondaryOutcomeTimeFrame': '7 and 14 days after randomization'},\n", - " {'SecondaryOutcomeMeasure': 'Clinical improvement based on the 7-point scale if applicable',\n", - " 'SecondaryOutcomeDescription': 'A decline of 2 points on the 7-point scale from admission means better outcome. The 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death)',\n", - " 'SecondaryOutcomeTimeFrame': '28 days after randomization'},\n", - " {'SecondaryOutcomeMeasure': 'Lower Murray lung injury score if applicable',\n", - " 'SecondaryOutcomeDescription': 'Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition',\n", - " 'SecondaryOutcomeTimeFrame': '7 days after randomization'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nHealthy and Covid-19-positive volunteers\\nThe interval between the onset of symptoms and randomized is within 7 days in Covid-19 patients. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used;\\nWhite blood cells ≥ 3,500/μl, lymphocytes ≥ 750/μl;\\nHuman immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or tuberculosis (TB) test negative;\\nSign the Informed Consent voluntarily;\\n\\nExclusion Criteria:\\n\\nSubject with active HCV, HBV or HIV infection.\\nSubject is albumin-intolerant.\\nSubject with life expectancy less than 4 weeks.\\nSubject participated in other investigational vaccine therapies within the past 60 days.\\nSubject with positive pregnancy test result.\\nResearchers consider unsuitable.',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '6 Months',\n", - " 'MaximumAge': '80 Years',\n", - " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Lung-Ji Chang',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+86(755)8672 5195',\n", - " 'CentralContactEMail': 'c@szgimi.org'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Lung-Ji Chang',\n", - " 'OverallOfficialAffiliation': 'Shenzhen Geno-Immune Medical Institute',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Shenzhen Geno-immune Medical Institute',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Shenzhen',\n", - " 'LocationState': 'Guangdong',\n", - " 'LocationZip': '518000',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Lung-Ji Chang',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '86-755-86725195',\n", - " 'LocationContactEMail': 'c@szgimi.org'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000014612',\n", - " 'InterventionMeshTerm': 'Vaccines'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000007155',\n", - " 'InterventionAncestorTerm': 'Immunologic Factors'},\n", - " {'InterventionAncestorId': 'D000045505',\n", - " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M15943',\n", - " 'InterventionBrowseLeafName': 'Vaccines',\n", - " 'InterventionBrowseLeafAsFound': 'Vaccine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M8784',\n", - " 'InterventionBrowseLeafName': 'Immunologic Factors',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", - " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'}]}}}}},\n", - " {'Rank': 20,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04322682',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'MHIPS-2020-001'},\n", - " 'Organization': {'OrgFullName': 'Montreal Heart Institute',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)',\n", - " 'OfficialTitle': 'Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)',\n", - " 'Acronym': 'COVID-19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 23, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'September 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'September 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 23, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 25, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 26, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 26, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 27, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Montreal Heart Institute',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'DACIMA Software',\n", - " 'CollaboratorClass': 'UNKNOWN'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No',\n", - " 'IsUSExport': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'This is a phase 3, multi-center, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of colchicine in adult patients diagnosed with COVID-19 infection and have at least one high-risk criterion. Approximately 6000 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either colchicine or placebo tablets for 30 days.',\n", - " 'DetailedDescription': 'The primary objective of this study is to determine whether short-term treatment with colchicine reduces the rate of death and lung complications related to COVID-19. The secondary objective is to determine the safety of treatment with colchicine in this patient population.\\n\\nApproximately 6000 patients will be enrolled to receive either colchicine or placebo (1:1 allocation ratio) for 30 days. Follow-up assessments will occur at 15 and 30 days following randomization for evaluation of the occurrence of any trial endpoints or other adverse events.\\n\\nSafety and efficacy will be based on data from randomized patients. An independent data and safety monitoring board (DSMB) will periodically review study results as well as the overall conduct of the study, and will make recommendations to the study Executive Steering Committee (ESC) to continue, stop or modify the study protocol.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Corona Virus Infection']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 3']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignInterventionModelDescription': 'This will be a randomized, double-blind, placebo-controlled, multi-center study. Following signature of the informed consent form, approximately 6000 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either colchicine or placebo (1:1 allocation ratio) for 30 days. Follow-up phone or video assessments will occur at 15 and 30 days following randomization for evaluation of the occurrence of any trial endpoints or other adverse events.',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Single',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '6000',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Colchicine 0.5 mg',\n", - " 'ArmGroupType': 'Active Comparator',\n", - " 'ArmGroupDescription': 'Patients will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Colchicine']}},\n", - " {'ArmGroupLabel': 'Placebo',\n", - " 'ArmGroupType': 'Placebo Comparator',\n", - " 'ArmGroupDescription': 'Patients will receive a placebo per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo oral tablet']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Colchicine',\n", - " 'InterventionDescription': 'Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Colchicine 0.5 mg']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Immuno-modulatory']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Placebo oral tablet',\n", - " 'InterventionDescription': 'Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Placebo']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Number of participants who die or require hospitalization due to COVID-19 infection',\n", - " 'PrimaryOutcomeDescription': 'The primary endpoint will be the composite of death or the need for hospitalization due to COVID-19 infection in the first 30 days after randomization.',\n", - " 'PrimaryOutcomeTimeFrame': '30 days post randomization'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Number of participants who die',\n", - " 'SecondaryOutcomeDescription': 'The secondary endpoint is the occurrence of death in the 30 days following randomization.',\n", - " 'SecondaryOutcomeTimeFrame': '30 days post randomization'},\n", - " {'SecondaryOutcomeMeasure': 'Number of participants requiring hospitalization due to COVID-19 infection',\n", - " 'SecondaryOutcomeDescription': 'The secondary endpoint is the need for hospitalization due to COVID-19 infection in the 30 days following randomization.',\n", - " 'SecondaryOutcomeTimeFrame': '30 days post randomization'},\n", - " {'SecondaryOutcomeMeasure': 'Number of participants requiring mechanical ventilation',\n", - " 'SecondaryOutcomeDescription': 'The secondary endpoint is the need for mechanical ventilation in the 30 days following randomization.',\n", - " 'SecondaryOutcomeTimeFrame': '30 days post randomization'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\nMales and females, at least 40 years of age, capable and willing to provide informed consent;\\nPatient must have received a diagnosis of COVID-19 infection within the last 24 hours;\\nOutpatient setting (not currently hospitalized or under immediate consideration for hospitalization);\\nPatient must possess at least one of the following high-risk criteria: 70 years or more of age, diabetes mellitus, uncontrolled hypertension (systolic blood pressure ≥150 mm Hg), known respiratory disease (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary disease, fever of ≥38.4°C within the last 48 hours, dyspnea at the time of presentation, bicytopenia, pancytopenia, or the combination of high neutrophil count and low lymphocyte count;\\nFemale patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing at least one method of contraception and preferably two complementary forms of contraception including a barrier method (e.g. male or female condoms, spermicides, sponges, foams, jellies, diaphragm, intrauterine device (IUD)) throughout the study and for 30 days after study completion;\\nPatient must be able and willing to comply with the requirements of this study protocol.\\n\\nExclusion Criteria:\\n\\nPatient currently hospitalized or under immediate consideration for hospitalization;\\nPatient currently in shock or with hemodynamic instability;\\nPatient with inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption;\\nPatient with pre-existent progressive neuromuscular disease;\\nEstimated Glomerular filtration rate (eGFR), using the MDRD equation for all subjects being considered for enrollment, with a cut-off of < 30 mL/m in/1.73m2;\\nPatient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease;\\nFemale patient who is pregnant, or breast-feeding or is considering becoming pregnant during the study or for 6 months after the last dose of study medication;\\nPatient currently taking colchicine for other indications (mainly chronic indications represented by Familial Mediterranean Fever or gout);\\nPatient with a history of an allergic reaction or significant sensitivity to colchicine;\\nPatient undergoing chemotherapy for cancer;\\nPatient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.\",\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '40 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Jean-Claude Tardif, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '514-376-3330',\n", - " 'CentralContactPhoneExt': '3612',\n", - " 'CentralContactEMail': 'jean-claude.tardif@icm-mhi.org'},\n", - " {'CentralContactName': 'Zohar Bassevitch, B.SC.',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '514-461-1300',\n", - " 'CentralContactPhoneExt': '2214',\n", - " 'CentralContactEMail': 'zohar.bassevitch@mhicc.org'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Jean-Claude Tardif, MD',\n", - " 'OverallOfficialAffiliation': 'Montreal Heart Institute',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Zohar Bassevitch, B.SC.',\n", - " 'OverallOfficialAffiliation': 'Montreal Health Innovations Coordinating Center',\n", - " 'OverallOfficialRole': 'Study Director'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Montreal Heart Institute',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Montreal',\n", - " 'LocationState': 'Quebec',\n", - " 'LocationZip': 'H1T 1C8',\n", - " 'LocationCountry': 'Canada',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Chantal Lacoste',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '514 376-3330',\n", - " 'LocationContactPhoneExt': '3604',\n", - " 'LocationContactEMail': 'chantal.lacoste@icm-mhi.org'},\n", - " {'LocationContactName': 'Jean-Claude Tardif, M.D',\n", - " 'LocationContactRole': 'Principal Investigator'}]}}]}}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000003078',\n", - " 'InterventionMeshTerm': 'Colchicine'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000006074',\n", - " 'InterventionAncestorTerm': 'Gout Suppressants'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'},\n", - " {'InterventionAncestorId': 'D000050257',\n", - " 'InterventionAncestorTerm': 'Tubulin Modulators'},\n", - " {'InterventionAncestorId': 'D000050256',\n", - " 'InterventionAncestorTerm': 'Antimitotic Agents'},\n", - " {'InterventionAncestorId': 'D000050258',\n", - " 'InterventionAncestorTerm': 'Mitosis Modulators'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000000970',\n", - " 'InterventionAncestorTerm': 'Antineoplastic Agents'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M4890',\n", - " 'InterventionBrowseLeafName': 'Colchicine',\n", - " 'InterventionBrowseLeafAsFound': 'Colchicine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M19188',\n", - " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M24783',\n", - " 'InterventionBrowseLeafName': 'Antimitotic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'ANeo',\n", - " 'InterventionBrowseBranchName': 'Antineoplastic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", - " {'ConditionMeshId': 'D000045169',\n", - " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'},\n", - " {'ConditionMeshId': 'D000014777',\n", - " 'ConditionMeshTerm': 'Virus Diseases'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Corona Virus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Corona Virus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafAsFound': 'Virus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Corona Virus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 21,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04312464',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'MD-COVID-19'},\n", - " 'Organization': {'OrgFullName': 'Wuhan Union Hospital, China',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Myocardial Damage in COVID-19',\n", - " 'OfficialTitle': 'Retrospective Study of Myocardial Damage in COVID-19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Enrolling by invitation',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'January 1, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 15, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'March 18, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 4, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 13, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 18, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 13, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 18, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Xiang Cheng',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Professor',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Wuhan Union Hospital, China'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Wuhan Union Hospital, China',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'This study aims to investigate the clinical characteristics, the incidence of myocardial injury, and the influence of myocardial injury on the prognosis in COVID-19 patients. There is no additional examination and treatment for this project.',\n", - " 'DetailedDescription': 'The epidemic of the COVID-19 has expanded from Wuhan through out China, and is being exported to a growing number of countries. Recently, investigators have revealed that acute myocardial injury is existed in 7.2% patients with COVID-19, and this proportion in patients admitted to the ICU (22.2%) is higher than patients not treated in the ICU (2.0%). Thus, cardiac troponin I (cTNI), the biomarker of cardiac injury, might be a clinical predictor of COVID-19 patient outcomes. This study aims to investigate the clinical characteristics, the incidence of myocardial injury, and the influence of myocardial injury on the prognosis in COVID-19 patients.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", - " 'Cardiovascular Diseases']},\n", - " 'KeywordList': {'Keyword': ['COVID-19', 'myocardial injury']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Case-Control']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Retrospective']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '500',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Discharged group',\n", - " 'ArmGroupDescription': 'The individual which is defined as patient discharged from hospital',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: non']}},\n", - " {'ArmGroupLabel': 'Dead group',\n", - " 'ArmGroupDescription': 'The individual which is defined as patient with all-cause death',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: non']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", - " 'InterventionName': 'non',\n", - " 'InterventionDescription': 'no intervention',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Dead group',\n", - " 'Discharged group']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'The myocardial injury incidence',\n", - " 'PrimaryOutcomeDescription': 'The myocardial injury incidence of COVID-19 patients',\n", - " 'PrimaryOutcomeTimeFrame': '75 days'},\n", - " {'PrimaryOutcomeMeasure': 'The risk factors analysis for the death',\n", - " 'PrimaryOutcomeDescription': 'The risk factors analysis for the death of COVID-19 patients',\n", - " 'PrimaryOutcomeTimeFrame': '75 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Clinical characteristics',\n", - " 'SecondaryOutcomeDescription': 'The clinical characteristics description of COVID-19 patients',\n", - " 'SecondaryOutcomeTimeFrame': '75 days'},\n", - " {'SecondaryOutcomeMeasure': 'Clinical course',\n", - " 'SecondaryOutcomeDescription': 'The clinical course description of COVID-19 patients',\n", - " 'SecondaryOutcomeTimeFrame': '75 days'},\n", - " {'SecondaryOutcomeMeasure': 'Cardiovascular comorbidity',\n", - " 'SecondaryOutcomeDescription': 'The clinical characteristics and prognosis analysis in different cardiovascular comorbidity of COVID-19 patients',\n", - " 'SecondaryOutcomeTimeFrame': '75 days'},\n", - " {'SecondaryOutcomeMeasure': 'Analysis of causes of death',\n", - " 'SecondaryOutcomeDescription': 'Analysis of causes of death in COVID-19 patients',\n", - " 'SecondaryOutcomeTimeFrame': '75 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\n(1) Age ≥18 years. (2) Laboratory (RT-PCR) confirmed infection with SARS-CoV-2. (3) Lung involvement confirmed with chest imaging.\\n\\nExclusion Criteria:\\n\\nNo cTnI test on admission',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'The laboratory-confirmed patients with confirmed COVID-19 admitted to headquarters, west campus and cancer center of Union Hospital, Tongji Medical College, Huazhong University of science and technology, from January 1st to March 15th, 2020',\n", - " 'SamplingMethod': 'Probability Sample'},\n", - " 'ContactsLocationsModule': {'LocationList': {'Location': [{'LocationFacility': 'Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology',\n", - " 'LocationCity': 'Wuhan',\n", - " 'LocationState': 'Hubei',\n", - " 'LocationZip': '430022',\n", - " 'LocationCountry': 'China'}]}}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000002318',\n", - " 'ConditionMeshTerm': 'Cardiovascular Diseases'}]}}}}},\n", - " {'Rank': 22,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04333225',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '020-132'},\n", - " 'Organization': {'OrgFullName': 'Baylor Research Institute',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Hydroxychloroquine in the Prevention of COVID-19 Infection in Healthcare Workers',\n", - " 'OfficialTitle': 'A Prospective Clinical Study of Hydroxychloroquine in the Prevention of SARS- CoV-2 (COVID-19) Infection in Healthcare Workers After High-risk Exposures'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 3, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'July 30, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'July 30, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'April 1, 2020',\n", - " 'StudyFirstSubmitQCDate': 'April 2, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 3, 2020',\n", - " 'StudyFirstPostDateType': 'Estimate'},\n", - " 'LastUpdateSubmitDate': 'April 2, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", - " 'LastUpdatePostDateType': 'Estimate'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Baylor Research Institute',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'Yes',\n", - " 'IsFDARegulatedDevice': 'No',\n", - " 'IsUSExport': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'In order to assess the efficacy of hydroxychloroquine treatment weekly for a total of 7 weeks in the prevention of COVID-19 infection, three hundred sixty (360) Healthcare workers with high risk exposure to patients infected with COVID-19 will be tested for COVID-19 infection via nasopharyngeal (NP) swab once weekly for 7 weeks. Of those, one hundred eighty (180) will receive weekly doses of hydroxychloroquine for the duration of the study. Subjects who opt not to receive the study drug will form the control group.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", - " 'KeywordList': {'Keyword': ['hydroxychloroquine']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 2']},\n", - " 'DesignInfo': {'DesignAllocation': 'Non-Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Prevention',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '360',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Treatment',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Oral hydroxychloroquine 400 mg twice a day (two 200 mg tabs twice a day) on day 1 followed by two 200 mg tablets once a week for a total of 7 weeks.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine']}},\n", - " {'ArmGroupLabel': 'Control',\n", - " 'ArmGroupType': 'No Intervention',\n", - " 'ArmGroupDescription': 'Subjects who opt not to receive the study drug will undergo all procedures to form the control group'}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Hydroxychloroquine',\n", - " 'InterventionDescription': 'Weekly treatment in individuals at high risk',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Treatment']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Rate of COVID-19 positive conversion',\n", - " 'PrimaryOutcomeDescription': 'Rate of COVID-19 positive conversion on weekly nasopharyngeal (NP) sampling',\n", - " 'PrimaryOutcomeTimeFrame': '7 weeks'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Time-to-first clinical event',\n", - " 'SecondaryOutcomeDescription': 'Time-to-first clinical event consisting of a persistent change for any of the following:\\n\\nOne positive NP sample\\nCommon clinical symptoms of COVID-19 infection including fever, cough, and shortness of breath\\nLess common signs and symptoms of COVID-19 infection including headache, muscle pain, abdominal pain, sputum production, and sore throat',\n", - " 'SecondaryOutcomeTimeFrame': '7 weeks'}]},\n", - " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'Time-to-first clinical worsening event',\n", - " 'OtherOutcomeDescription': 'Time-to-first clinical worsening event consisting of any of the following:\\n\\nHospitalization for COVID-19 infection\\nIntensive care unit admission for COVID-19 infection\\nAll cause death',\n", - " 'OtherOutcomeTimeFrame': '7 weeks'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAdult male and female healthcare workers ≥ 18 to ≤ 75 years of age upon study consent\\n\\nHealthcare workers with\\n\\n• One day or more of exposure to suspect and/or positive COVID-19 patients, including but not limited to those working in the Emergency Department or Intensive Care Unit.\\n\\nOR\\n\\n• Unprotected exposure to a known positive COVID-19 patient within 72 hours of screening.\\n\\nAfebrile with no constitutional symptoms\\nWilling and able to comply with scheduled visits, treatment plan, and other study procedures\\nEvidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures\\n\\nExclusion Criteria:\\n\\nParticipation in other investigational clinical trials for the treatment or prevention of SARS-COV-2 infection within 30days\\nUnwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) during Screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested Note: the following criteria follow standard clinical practice for FDA approved indications of this medication\\nHaving a prior history of blood disorders such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia\\nHaving a prior history of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency\\nHaving dermatitis, psoriasis or porphyria\\nTaking Digoxin, Mefloquine, methotrexate, cyclosporine, praziquantel, antacids and kaolin, cimetidine, ampicillin, Insulin or antidiabetic drugs, arrhythmogenic drugs, antiepileptic drugs, loop, thiazide, and related diuretics, laxatives and enemas, amphotericin B, high dose corticosteroids, and proton pump inhibitors, neostigmine, praziquantel, Pyridostigmine, tamoxifen citrate\\nAllergies: 4-Aminoquinolines\\nPre-existing retinopathy of the eye\\nHas a chronic liver disease or cirrhosis, including hepatitis B and/or untreated hepatitis\\nUntreated or uncontrolled active bacterial, fungal infection\\nKnown or suspected active drug or alcohol abuse, per investigator judgment\\nWomen who are pregnant or breastfeeding\\nKnown hypersensitivity to any component of the study drug\\nA known history of prolonged QT syndrome or history of additional risk factors for torsades de pointe (e.g., heart failure, requires a lab test , family history of Long QT Syndrome), or the use of concomitant medications that prolong the QT/QTc interval',\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '75 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Laura Clariday, CCRC',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '214-820-7224',\n", - " 'CentralContactEMail': 'Laura.Clariday@BSWHealth.org'},\n", - " {'CentralContactName': 'Rebecca Baker, MSN, APRN',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '214-820-7965',\n", - " 'CentralContactEMail': 'Rebecca.Baker2@BSWHealth.org'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Peter A McCullough, MD, MPH',\n", - " 'OverallOfficialAffiliation': 'Baylor Health Care System',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Baylor University Medical Center',\n", - " 'LocationCity': 'Dallas',\n", - " 'LocationState': 'Texas',\n", - " 'LocationZip': '75226',\n", - " 'LocationCountry': 'United States',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Laura Clariday, CCRC',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '214-820-7224',\n", - " 'LocationContactEMail': 'Laura.Clariday@BSWHealth.org'},\n", - " {'LocationContactName': 'Rebecca Baker, MSN, APRN',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '214-820-7965',\n", - " 'LocationContactEMail': 'Rebecca.Baker2@BSWHealth.org'},\n", - " {'LocationContactName': 'Peter A McCullough, MD, MPH',\n", - " 'LocationContactRole': 'Principal Investigator'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", - " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", - " 'InterventionAncestorTerm': 'Antimalarials'},\n", - " {'InterventionAncestorId': 'D000000981',\n", - " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", - " {'InterventionAncestorId': 'D000000977',\n", - " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", - " {'InterventionAncestorId': 'D000000890',\n", - " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", - " {'InterventionAncestorId': 'D000004791',\n", - " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", - " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M2861',\n", - " 'InterventionBrowseLeafName': 'Antimalarials',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2879',\n", - " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2875',\n", - " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2795',\n", - " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19188',\n", - " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", - " 'ConditionMeshTerm': 'Infection'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafAsFound': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", - " {'Rank': 23,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04333355',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'PC-TecSalud Fase I'},\n", - " 'Organization': {'OrgFullName': 'Hospital San Jose Tec de Monterrey',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Safety in Convalescent Plasma Transfusion to COVID-19',\n", - " 'OfficialTitle': 'Phase 1 Study to Evaluate the Safety of Convalescent Plasma as an Adjuvant Therapy in Patients With SARS-CoV-2 Infection'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 15, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'December 20, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'April 30, 2021',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 31, 2020',\n", - " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 3, 2020',\n", - " 'StudyFirstPostDateType': 'Estimate'},\n", - " 'LastUpdateSubmitDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", - " 'LastUpdatePostDateType': 'Estimate'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Servando Cardona-Huerta',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Director of Clinical Research',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Hospital San Jose Tec de Monterrey'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Hospital San Jose Tec de Monterrey',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Tecnologico de Monterrey',\n", - " 'CollaboratorClass': 'OTHER'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'There is currently no specific vaccine or treatment to treat critically ill patients with COVID-19. Different therapies are still under investigation and are use in different health institutions, however, a significant proportion of patients do not respond to these treatments, so it is important to seek new treatments. One of these alternatives is the use of convalescent plasma. The investigator will use plasma obtained from convalescent individuals with proven novel SARS-CoV-2 virus infection, diagnosed with coronavirus-19-induced disease and symptom-free for a period of not less than 10 days since they recovered from the disease. This plasma will be infused in patients affected by the same virus, but who have developed respiratory complications that have not responded favorably to usual treatment such as chloroquine, hydroxychloroquine, azithromycin, and other antivirals. The investigator will evaluate the safety of this procedure by accounting for any adverse event.',\n", - " 'DetailedDescription': 'There is currently no specific vaccine or treatment to treat critically ill patients with COVID-19. Different therapies are still under investigation and are use in different health institutions, however, a significant proportion of patients do not respond to these treatments, so it is important to seek new treatments. One of these alternatives is the use of convalescent plasma.\\n\\nThe investigator will use plasma obtained from convalescent individuals with proven novel SARS-CoV-2 virus infection, diagnosed with coronavirus-19-induced disease and symptom-free for a period of not less than 10 days since they recovered from the disease. Donors will be screened for infectious diseases including sARS-CoV-2 and will be programmed for apheresis the next day. The investigaotr will process one plasmatic volume per donor and this will be guarded in the blood bank until required by the principal investigator.\\n\\nPatients or receptors will be screened and selected by the research team according to eligibility criteria, including severe disease refractory to treatment such as chloroquine, hydroxychloroquine, azithromycin, and other antivirals. Plasma will be fractioned in 250ml. Infusion will start after a clinical evaluation and blood sampling. Patients will remain under careful observation. If no adverse event is present, infusion will be repeated after 24 hours and the investigator will evaluate patients again 48 hours after the second transfusion. A final evaluation will be performed at day 14. The investigator will evaluate the safety of this procedure by accounting for any adverse event.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", - " 'KeywordList': {'Keyword': ['COVID-19',\n", - " 'SARS-CoV-2',\n", - " 'Convalescent plasma']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 1']},\n", - " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '20',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'COVID-19 patients receiving Convalescent Plasma',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Convalescent Plasma from patients who recently recover from COVID-19',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: Convalescent Plasma']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Biological',\n", - " 'InterventionName': 'Convalescent Plasma',\n", - " 'InterventionDescription': 'Along with the administration of convalescent plasma, patients will continue to receive supportive standard care.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['COVID-19 patients receiving Convalescent Plasma']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Supportive standard care']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Side effects',\n", - " 'PrimaryOutcomeDescription': 'Identify possible adverse effects after the administration of convalescent plasma',\n", - " 'PrimaryOutcomeTimeFrame': '14 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Heart Failure',\n", - " 'SecondaryOutcomeDescription': 'Development of heart failure during convalescent plasma transfusion or after it.',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Pulmonary Edema',\n", - " 'SecondaryOutcomeDescription': 'Development of pulmonary edema during convalescent plasma transfusion or after it.',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Allergic Reaction',\n", - " 'SecondaryOutcomeDescription': 'Development of any allergic reaction during convalescent plasma transfusion or after it.',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Lung infiltrates',\n", - " 'SecondaryOutcomeDescription': 'Thorax Computer tomography',\n", - " 'SecondaryOutcomeTimeFrame': '48 hours'},\n", - " {'SecondaryOutcomeMeasure': 'Lung infiltrates',\n", - " 'SecondaryOutcomeDescription': 'Thorax Computer tomography',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Viral load of SARS-CoV-2',\n", - " 'SecondaryOutcomeDescription': 'RT PCR SARS-CoV-2',\n", - " 'SecondaryOutcomeTimeFrame': '48 hrs'},\n", - " {'SecondaryOutcomeMeasure': 'Viral load of SARS-CoV-2',\n", - " 'SecondaryOutcomeDescription': 'RT PCR SARS-CoV-2',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria\\n\\nPatients 18 years and older\\nConfirmed SARS-CoV-2 Infection by RT-PCR.\\n\\nSerious or life-threatening infection defined as:\\n\\nSerious:\\n\\nDyspnea\\nRespiratory rate greater than or equal to 30 cycles / minute.\\nBlood oxygen saturation less than or equal to 93% with an oxygen supply greater than 60%.\\nPartial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300\\n\\nA 50% increase in pulmonary infiltrates defined by computer tomography scans in 24 to 48 hours.\\n\\nLife-threatening infection:\\n\\nrespiratory failure.\\nseptic shock.\\ndysfunction or multiple organ failure.\\nRefractory to treatment with azithromycin / hydroxychloroquine or chloroquine / ritonavir / lopinavir defined as: 48 hours with no improvement in the modified parameters such as serious or clinically imminent infection.\\nSigned Informed consent by the patient or by the person responsible for the patient in the case of critically ill patients (spouse or parents).\\n\\nExclusion Criteria:\\n\\nPatients with a history of allergic reaction to any type of previous transfusion.\\nHeart failure patients at risk of volume overload.\\nPatients with a history of chronic kidney failure in the dialysis phase.\\nPatients with previous hematological diseases (anemia less than 10 grams of hemoglobin, platelets greater than 100,000 / µl).\\nAny case where the investigator decides that the patient is not suitable for the protocol.',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Servando Cardona-Huerta, MD., Ph. D.',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+5218112121946',\n", - " 'CentralContactEMail': 'servandocardona@tec.mx'},\n", - " {'CentralContactName': 'Sylvia De la Rosa, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+5218111832730',\n", - " 'CentralContactEMail': 'sylvia.delarosa@tec.mx'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'José Fe Castilleja-Leal, MD.',\n", - " 'OverallOfficialAffiliation': 'Hospital San José',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Hospital San José',\n", - " 'LocationCity': 'Monterrey',\n", - " 'LocationState': 'Nuevo Leon',\n", - " 'LocationZip': '64718',\n", - " 'LocationCountry': 'Mexico'}]}},\n", - " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '32167489',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Mar 13. pii: 138003. doi: 10.1172/JCI138003. [Epub ahead of print]'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", - " {'Rank': 24,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04323228',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'ONS_COVID-19'},\n", - " 'Organization': {'OrgFullName': 'King Saud University',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Anti-inflammatory/Antioxidant Oral Nutrition Supplementation in COVID-19',\n", - " 'OfficialTitle': 'Anti-inflammatory/Antioxidant Oral Nutrition Supplementation on the Cytokine Storm and Progression of COVID-19: A Randomized Controlled Trial',\n", - " 'Acronym': 'ONSCOVID19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'October 1, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'October 30, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 23, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 24, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 26, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 25, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 27, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Mahmoud Abulmeaty, M.D., FACN.',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Associate Professor',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'King Saud University'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'King Saud University',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'COVID-19 pandemic threatens patients, societies and healthcare systems around the world. The host immunity determines the progress of the disease and its lethality. The associated cytokine storm mainly affects the lungs; leading to acute lung injury with variable degrees. Modulation of cytokine production using Immunonutrition is a novel concept that has been applied to other diseases. Using specific nutrients such as n3- fatty acids and antioxidant vitamins in extraordinary doses modulate the host immune response and ameliorate the cytokine storm associated with viral diseases such as COVID-19. In this proposal, we will conduct a prospective double-blinded controlled trial for 14 days on 30 SARS-CoV-2 positive cases. The participant will be randomly assigned to two groups (n=15/each); intervention (IG) and placebo (PG) groups. The IG group will be provided with an anti-inflammatory and antioxidant oral nutrition supplement (ONS) on a daily basis, while the PG will be given an isocaloric placebo. Basal and weekly nutritional screening, as well as recording of anthropometric, clinical and biochemical parameters, will be done. The main biochemical parameters include serum ferritin level, cytokine storm parameters (interleukin-6, Tumor necrosis factor-α, and monocyte chemoattractant protein 1), C-reactive protein, total leukocyte count, differential lymphocytic count and neutrophil to lymphocyte ratio. It is expected that the anti-inflammatory-antioxidant ONS might help in the reduction of the COVID-19 severity with more preservation of the nutritional status of infected cases.',\n", - " 'DetailedDescription': \"Subjects: A total of 30 participants will be enrolled in this double-blinded prospective, randomized controlled trial. All participants will sign a written consent after details of the study have been fully explained to them. Later on, they will be randomly allocated into two study groups; intervention group (IG, n=15) and placebo group (PG, n=15). Computer-generated random numbers will be used to randomize the participants into one of two intervention groups. The study protocol will be approved by the IRB committee in King Khalid University Hospital, King Saud University Medical city. This clinical trial will be registered in the clinicaltrials.gov registry.\\n\\nSettings: All participants will be SARS-CoV-2 positive cases admitted to King Khalid University Hospital.\\n\\nStudy protocol: All study participants will be instructed to either consume 8 fl oz oral nutrition supplement (ONS) enriched in eicosapentaenoic acid, gamma-linolenic acid and antioxidants (Oxepa, Abbott Nutrition, Abbott Laboratories) or iso-caloric -isonitrogenous product (by the same manufacture). The ONS will be served in opaque glasses of the same shape and color and should be ingested in the morning under the supervision of a nurse. The ONS should not be consumed at the time of a meal. The composition of one can of the intervention-ONS includes: 14.8 g protein, 22.2 g fat, 25 g carbohydrate, 355 kcal, 1.1 g EPA, 450 mg DHA, 950 mg GLA, 2840 IU vitamin A as 1.2 mg β-carotene, 205 mg Vitamin C, 75 IU vitamin E, 18 ug Selenium, and 5.7 mg Zinc. The composition of the control-ONS will have the same macronutrient composition, calorie density, and normal concentrations of vitamin A, C, E, Selenium and zinc.\\n\\nAll participants will be assessed at the start and reassessed again after 1 week and after 14-days period. The assessment will include nutritional screening by Nutritional risk screening 2002 (NRS-2002), anthropometric measurements, clinical assessment, and biochemical data.\\n\\nStatistical analysis: The Statistical Package for the Social Sciences (SPSS) version 25 will be used for analysis. The descriptive statistics for continuous variables will be presented as mean ± standard deviation, while other categorical variables as percentages. The independent sample t-test will be used for comparison between the IG and PG groups. For repeated measures at multiple points of time will be tested by Friedman's two-way ANOVA. The Pearson correlation coefficient will be applied to correlate some relevant variables. All these tests were performed with 80% power and a 5% level of significance.\"},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", - " 'KeywordList': {'Keyword': ['COVID-19',\n", - " 'Anti-inflammatory, and antioxidant ONS',\n", - " 'Cytokine storm']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 4']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignInterventionModelDescription': 'Participants will be randomly allocated into two study groups; intervention group (IG, n=15) and placebo group (PG, n=15). Computer-generated random numbers will be used to randomize the participants into one of two intervention groups.',\n", - " 'DesignPrimaryPurpose': 'Supportive Care',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Double',\n", - " 'DesignMaskingDescription': 'The intervention-ONS and isocaloric-NOS will be served in opaque glasses of the same shape and color. the care providers (nurses, dietitians) will not know members of each groups or the nature or composition of the ONS.',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", - " 'Care Provider']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '30',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Intervention',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'the intervention groups will receive daily oral nutrition supplement (ONS) enriched in eicosapentaenoic acid, gamma-linolenic acid and antioxidants. The composition of one can (8 fl oz) of the intervention-ONS includes: 14.8 g protein, 22.2 g fat, 25 g carbohydrate, 355 kcal, 1.1 g EPA, 450 mg DHA, 950 mg GLA, 2840 IU vitamin A as 1.2 mg β-carotene, 205 mg Vitamin C, 75 IU vitamin E, 18 ug Selenium, and 5.7 mg Zinc.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Dietary Supplement: oral nutrition supplement (ONS) enriched in eicosapentaenoic acid, gamma-linolenic acid and antioxidants']}},\n", - " {'ArmGroupLabel': 'Placebo',\n", - " 'ArmGroupType': 'Placebo Comparator',\n", - " 'ArmGroupDescription': 'iso-caloric -isonitrogenous product (by the same manufacture) and served in cans with the same color and shape.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Dietary Supplement: isocaloric/isonutrigenous ONS']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Dietary Supplement',\n", - " 'InterventionName': 'oral nutrition supplement (ONS) enriched in eicosapentaenoic acid, gamma-linolenic acid and antioxidants',\n", - " 'InterventionDescription': 'the intervention group will receive a commercially available anti-inflammatory/antioxidant ONS, which will be given to patients with COVID-19 in the morning 3 hours after breakfast.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Intervention']}},\n", - " {'InterventionType': 'Dietary Supplement',\n", - " 'InterventionName': 'isocaloric/isonutrigenous ONS',\n", - " 'InterventionDescription': 'The placebo group will receive an isocaloric/isonutrigenous ONS at the same time in the same shape/size/color of the cans.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Placebo']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Change from baseline score of Nutrition risk screening-2002 (NRS-2002) at end of the trial',\n", - " 'PrimaryOutcomeDescription': 'Changes in scores of the NRS-2002 for patients with COVID-19 at the end of the study, from 0 to 7 scores, with those scores < 3 means no risk of malnutrition and >= 3 means malnutrition.',\n", - " 'PrimaryOutcomeTimeFrame': 'up to 3 months'},\n", - " {'PrimaryOutcomeMeasure': 'Change from baseline Serum ferritin level at end of the trial',\n", - " 'PrimaryOutcomeDescription': 'Change in serum ferritin at the end of the trial as ferritin is considered as a COVID-19 fatality predictor.',\n", - " 'PrimaryOutcomeTimeFrame': 'up to 3 months'},\n", - " {'PrimaryOutcomeMeasure': 'Change from baseline serum Interleukin-6 concentration at end of the trial',\n", - " 'PrimaryOutcomeDescription': 'Change in IL-6 at the end of the trial as it represent the cytokine storm and it is considered as a COVID-19 fatality predictor',\n", - " 'PrimaryOutcomeTimeFrame': 'up to 3 months'},\n", - " {'PrimaryOutcomeMeasure': 'Change from baseline serum C-reactive protein concentration at end of the trial',\n", - " 'PrimaryOutcomeDescription': 'Change in C-reactive protein in the serum at the end of the trial which reflect the acute phase',\n", - " 'PrimaryOutcomeTimeFrame': 'up to 3 months'},\n", - " {'PrimaryOutcomeMeasure': 'Change from baseline serum Tumor necrosis factor-α concentration at end of the trial',\n", - " 'PrimaryOutcomeDescription': 'Change in the TNF a in the serum at the end of study as it represent severity of the cytokine storm',\n", - " 'PrimaryOutcomeTimeFrame': 'up to 3 months'},\n", - " {'PrimaryOutcomeMeasure': 'Change from baseline serum monocyte chemoattractant protein 1 (MCP-1) at end of the trial',\n", - " 'PrimaryOutcomeDescription': 'plasma MCP-1 represent severity of the cytokine storm',\n", - " 'PrimaryOutcomeTimeFrame': 'up to 3 months'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Change from baseline Weight at end of the trial',\n", - " 'SecondaryOutcomeDescription': 'Body weight in Kg',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 3 months'},\n", - " {'SecondaryOutcomeMeasure': 'Height',\n", - " 'SecondaryOutcomeDescription': 'stature in cm',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 1 month'},\n", - " {'SecondaryOutcomeMeasure': 'Change from baseline BMI at end of the trial',\n", - " 'SecondaryOutcomeDescription': 'Claculation of BMI according to weight / square Height',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 3 months'},\n", - " {'SecondaryOutcomeMeasure': 'Change from baseline mid arm circumference at end of the trial',\n", - " 'SecondaryOutcomeDescription': 'changes of MAC in cm',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 3 months'},\n", - " {'SecondaryOutcomeMeasure': 'Change from baseline triceps skin-fold thickness at end of the trial',\n", - " 'SecondaryOutcomeDescription': 'changes of TSF in mm',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 3 months'},\n", - " {'SecondaryOutcomeMeasure': 'Change from baseline MAMA at end of the trial',\n", - " 'SecondaryOutcomeDescription': '). The mid-arm muscle area (MAMA) will be calculated according to the following equation: {MAMA= (MAC - π x TSF)2 / 4π}.',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 3 months'},\n", - " {'SecondaryOutcomeMeasure': 'Change from baseline percentage of peripheral O2 saturation at end of the trial',\n", - " 'SecondaryOutcomeDescription': 'changes in the percentage of peripheral O2 saturation by an oximeter',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 3 months'},\n", - " {'SecondaryOutcomeMeasure': 'Change from baseline degree of body temperature at end of the trial',\n", - " 'SecondaryOutcomeDescription': 'changes in the degree of body temperature by infrared thermometer',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 3 months'},\n", - " {'SecondaryOutcomeMeasure': 'Change from baseline count the total leukocyte at end of the trial',\n", - " 'SecondaryOutcomeDescription': 'change in the count from complete blood counts',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 3 months'},\n", - " {'SecondaryOutcomeMeasure': 'Change from baseline differential lymphocytic count at end of the trial',\n", - " 'SecondaryOutcomeDescription': 'change in the count from complete blood counts',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 3 months'},\n", - " {'SecondaryOutcomeMeasure': 'Change from baseline Neutrophil count at end of the trial',\n", - " 'SecondaryOutcomeDescription': 'change in the count from complete blood counts',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 3 months'},\n", - " {'SecondaryOutcomeMeasure': 'Change from baseline neutrophil to lymphocyte ratio at end of the trial',\n", - " 'SecondaryOutcomeDescription': 'change in the rations calculated by division of the neutrophil count by the lymphocyte count',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 3 months'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nConfirmed SARS-CoV-2 infection\\nCOVID-19 patient in stable condition (i.e., not requiring ICU admission).\\n\\nExclusion Criteria:\\n\\nTube feeding or parenteral nutrition.\\nPregnant or lactating women\\nAdmission to ICU > 24 hours\\nparticipation in another study including any forms of supplementation or disease specific ONS.',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '65 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Mahmoud M.A. Abulmeaty, M.D., FACN',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '00966548155983',\n", - " 'CentralContactEMail': 'mabulmeaty@ksu.edu.sa'}]}},\n", - " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '28397943',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Abulmeaty MM, Almajwal AM, Almadani NK, Aldosari MS, Alnajim AA, Ali SB, Hassan HM, Elkatawy HA. Anthropometric and central obesity indices as predictors of long-term cardiometabolic risk among Saudi young and middle-aged men and women. Saudi Med J. 2017 Apr;38(4):372-380. doi: 10.15537/smj.2017.4.18758.'},\n", - " {'ReferencePMID': '11895145',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Grimm H, Calder PC. Immunonutrition. Br J Nutr. 2002 Jan;87 Suppl 1:S1.'},\n", - " {'ReferencePMID': '17922951',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Calder PC. Immunonutrition in surgical and critically ill patients. Br J Nutr. 2007 Oct;98 Suppl 1:S133-9. Review.'},\n", - " {'ReferencePMID': '32150360',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Cascella M, Rajnik M, Cuomo A, Dulebohn SC, Di Napoli R. Features, Evaluation and Treatment Coronavirus (COVID-19). 2020 Mar 8. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/'},\n", - " {'ReferencePMID': '28877163',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Das SK, Chisti MJ, Sarker MHR, Das J, Ahmed S, Shahunja KM, Nahar S, Gibbons N, Ahmed T, Faruque ASG, Rahman M, J Fuchs G 3rd, Al Mamun A, John Baker P. Long-term impact of changing childhood malnutrition on rotavirus diarrhoea: Two decades of adjusted association with climate and socio-demographic factors from urban Bangladesh. PLoS One. 2017 Sep 6;12(9):e0179418. doi: 10.1371/journal.pone.0179418. eCollection 2017.'},\n", - " {'ReferencePMID': '30655992',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Harada K, Minami H, Ferdous T, Kato Y, Umeda H, Horinaga D, Uchida K, Park SC, Hanazawa H, Takahashi S, Ohota M, Matsumoto H, Maruta J, Kakutani H, Aritomi S, Shibuya K, Mishima K. The Elental(®) elemental diet for chemoradiotherapy-induced oral mucositis: A prospective study in patients with oral squamous cell carcinoma. Mol Clin Oncol. 2019 Jan;10(1):159-167. doi: 10.3892/mco.2018.1769. Epub 2018 Nov 16.'},\n", - " {'ReferencePMID': '31986264',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:.'},\n", - " {'ReferencePMID': '22028151',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Kim H. Glutamine as an immunonutrient. Yonsei Med J. 2011 Nov;52(6):892-7. doi: 10.3349/ymj.2011.52.6.892. Review.'},\n", - " {'ReferencePMID': '12880610',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Kondrup J, Allison SP, Elia M, Vellas B, Plauth M; Educational and Clinical Practice Committee, European Society of Parenteral and Enteral Nutrition (ESPEN). ESPEN guidelines for nutrition screening 2002. Clin Nutr. 2003 Aug;22(4):415-21.'},\n", - " {'ReferencePMID': '12663270',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'McCowen KC, Bistrian BR. Immunonutrition: problematic or problem solving? Am J Clin Nutr. 2003 Apr;77(4):764-70. Review.'},\n", - " {'ReferencePMID': '26315574',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Mariette C. Immunonutrition. J Visc Surg. 2015 Aug;152 Suppl 1:S14-7. doi: 10.1016/S1878-7886(15)30005-9. Review. Erratum in: J Visc Surg. 2016 Feb;153(1):83.'},\n", - " {'ReferencePMID': '29878555',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'McCarthy MS, Martindale RG. Immunonutrition in Critical Illness: What Is the Role? Nutr Clin Pract. 2018 Jun;33(3):348-358. doi: 10.1002/ncp.10102.'},\n", - " {'ReferencePMID': '32125452',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 Mar 3. doi: 10.1007/s00134-020-05991-x. [Epub ahead of print]'},\n", - " {'ReferencePMID': '22390970',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Tisoncik JR, Korth MJ, Simmons CP, Farrar J, Martin TR, Katze MG. Into the eye of the cytokine storm. Microbiol Mol Biol Rev. 2012 Mar;76(1):16-32. doi: 10.1128/MMBR.05015-11. Review.'},\n", - " {'ReferencePMID': '25516320',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Teo BW, Toh QC, Chan XW, Xu H, Li JL, Lee EJ. Assessment of muscle mass and its association with protein intake in a multi-ethnic Asian population: relevance in chronic kidney disease. Asia Pac J Clin Nutr. 2014;23(4):619-25. doi: 10.6133/apjcn.2014.23.4.01.'}]},\n", - " 'SeeAlsoLinkList': {'SeeAlsoLink': [{'SeeAlsoLinkLabel': 'Immunonutrition: Interactions of Diet, Genetics, and Inflammation - Google Books. In Immunonutrition: Interactions of Diet, Genetics, and Inflammation',\n", - " 'SeeAlsoLinkURL': 'https://books.google.com.sa/books?id=d2HvAgAAQBAJ&pg=PA17&lpg=PA17&dq=immunonutrition+virus&source=bl&ots=VUneSrxucb&sig=ACfU3U0bKU0mAdShOEvzIAMifj7SNE47Lw&hl=en&sa=X&redir_esc=y#v=onepage&q=immunonutrition%20virus&f=false'},\n", - " {'SeeAlsoLinkLabel': 'COVID-19: consider cytokine storm syndromes and immunosuppression',\n", - " 'SeeAlsoLinkURL': 'https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30628-0/fulltext'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", - " 'IPDSharingDescription': 'all IPD that underlie results in a publication will be shared',\n", - " 'IPDSharingInfoTypeList': {'IPDSharingInfoType': ['Study Protocol',\n", - " 'Statistical Analysis Plan (SAP)',\n", - " 'Clinical Study Report (CSR)']},\n", - " 'IPDSharingTimeFrame': 'starting 6 months after publication.',\n", - " 'IPDSharingAccessCriteria': 'Access will be available for any researcher interested in this type of research on considerable consent.'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'C000028498',\n", - " 'InterventionMeshTerm': 'Evening primrose oil'},\n", - " {'InterventionMeshId': 'D000000893',\n", - " 'InterventionMeshTerm': 'Anti-Inflammatory Agents'},\n", - " {'InterventionMeshId': 'D000000975',\n", - " 'InterventionMeshTerm': 'Antioxidants'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000020011',\n", - " 'InterventionAncestorTerm': 'Protective Agents'},\n", - " {'InterventionAncestorId': 'D000045505',\n", - " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", - " {'InterventionAncestorId': 'D000000894',\n", - " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents, Non-Steroidal'},\n", - " {'InterventionAncestorId': 'D000018712',\n", - " 'InterventionAncestorTerm': 'Analgesics, Non-Narcotic'},\n", - " {'InterventionAncestorId': 'D000000700',\n", - " 'InterventionAncestorTerm': 'Analgesics'},\n", - " {'InterventionAncestorId': 'D000018689',\n", - " 'InterventionAncestorTerm': 'Sensory System Agents'},\n", - " {'InterventionAncestorId': 'D000018373',\n", - " 'InterventionAncestorTerm': 'Peripheral Nervous System Agents'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'},\n", - " {'InterventionAncestorId': 'D000000960',\n", - " 'InterventionAncestorTerm': 'Hypolipidemic Agents'},\n", - " {'InterventionAncestorId': 'D000000963',\n", - " 'InterventionAncestorTerm': 'Antimetabolites'},\n", - " {'InterventionAncestorId': 'D000057847',\n", - " 'InterventionAncestorTerm': 'Lipid Regulating Agents'},\n", - " {'InterventionAncestorId': 'D000003879',\n", - " 'InterventionAncestorTerm': 'Dermatologic Agents'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M16141',\n", - " 'InterventionBrowseLeafName': 'Vitamins',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2798',\n", - " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents',\n", - " 'InterventionBrowseLeafAsFound': 'Anti-inflammatory',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M16351',\n", - " 'InterventionBrowseLeafName': 'Zinc',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M3094',\n", - " 'InterventionBrowseLeafName': 'Ascorbic Acid',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M16127',\n", - " 'InterventionBrowseLeafName': 'Vitamin A',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M4174',\n", - " 'InterventionBrowseLeafName': 'Carotenoids',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M268321',\n", - " 'InterventionBrowseLeafName': 'Evening primrose oil',\n", - " 'InterventionBrowseLeafAsFound': 'Gamma-linolenic acid',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M2873',\n", - " 'InterventionBrowseLeafName': 'Antioxidants',\n", - " 'InterventionBrowseLeafAsFound': 'Antioxidant',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M16136',\n", - " 'InterventionBrowseLeafName': 'Vitamin E',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M21556',\n", - " 'InterventionBrowseLeafName': 'Tocopherols',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M21559',\n", - " 'InterventionBrowseLeafName': 'Tocotrienols',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M21553',\n", - " 'InterventionBrowseLeafName': 'alpha-Tocopherol',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M217588',\n", - " 'InterventionBrowseLeafName': 'Retinol palmitate',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M14038',\n", - " 'InterventionBrowseLeafName': 'Selenium',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M20453',\n", - " 'InterventionBrowseLeafName': 'Protective Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2799',\n", - " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents, Non-Steroidal',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2613',\n", - " 'InterventionBrowseLeafName': 'Analgesics',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19370',\n", - " 'InterventionBrowseLeafName': 'Analgesics, Non-Narcotic',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19188',\n", - " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2859',\n", - " 'InterventionBrowseLeafName': 'Hypolipidemic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2862',\n", - " 'InterventionBrowseLeafName': 'Antimetabolites',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M27470',\n", - " 'InterventionBrowseLeafName': 'Lipid Regulating Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M5657',\n", - " 'InterventionBrowseLeafName': 'Dermatologic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'T437',\n", - " 'InterventionBrowseLeafName': 'Ascorbic Acid',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'T477',\n", - " 'InterventionBrowseLeafName': 'Vitamin C',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'T462',\n", - " 'InterventionBrowseLeafName': 'Retinol',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'T415',\n", - " 'InterventionBrowseLeafName': 'Omega 3 Fatty Acid',\n", - " 'InterventionBrowseLeafAsFound': 'Eicosapentaenoic acid',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'T480',\n", - " 'InterventionBrowseLeafName': 'Vitamin E',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'T466',\n", - " 'InterventionBrowseLeafName': 'Tocopherol',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'T467',\n", - " 'InterventionBrowseLeafName': 'Tocotrienol',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'T468',\n", - " 'InterventionBrowseLeafName': 'Vitamin A',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'T152',\n", - " 'InterventionBrowseLeafName': 'Evening Primrose',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Micro',\n", - " 'InterventionBrowseBranchName': 'Micronutrients'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", - " {'InterventionBrowseBranchAbbrev': 'Infl',\n", - " 'InterventionBrowseBranchName': 'Anti-Inflammatory Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'Analg',\n", - " 'InterventionBrowseBranchName': 'Analgesics'},\n", - " {'InterventionBrowseBranchAbbrev': 'Derm',\n", - " 'InterventionBrowseBranchName': 'Dermatologic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'Lipd',\n", - " 'InterventionBrowseBranchName': 'Lipid Regulating Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ANeo',\n", - " 'InterventionBrowseBranchName': 'Antineoplastic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'Vi',\n", - " 'InterventionBrowseBranchName': 'Vitamins'},\n", - " {'InterventionBrowseBranchAbbrev': 'Ot',\n", - " 'InterventionBrowseBranchName': 'Other Dietary Supplements'},\n", - " {'InterventionBrowseBranchAbbrev': 'HB',\n", - " 'InterventionBrowseBranchName': 'Herbal and Botanical'}]}},\n", - " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19143',\n", - " 'ConditionBrowseLeafName': 'Disease Progression',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", - " {'Rank': 25,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04330586',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'KUMC-COVID-19'},\n", - " 'Organization': {'OrgFullName': 'Korea University Guro Hospital',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'A Trial of Ciclesonide in Adults With Mild COVID-19',\n", - " 'OfficialTitle': 'A Trial of Ciclesonide Alone or in Combination With Hydroxychloroquine for Adults With Mild COVID-19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'June 30, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'September 30, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 31, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 31, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 31, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Woo Joo Kim',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Professor',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Korea University Guro Hospital'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Korea University Guro Hospital',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'According to In vitro studies, ciclesonide showed good antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although some cases were reported for the clinical effectiveness of ciclesonide in the treatment of COVID-19, there is no clinical trial to evaluate the antiviral effect on the reduction of viral load in patients with COVID-19. In this study, we aimed to investigate whether ciclesonide alone or in combination with hydroxychloroquine could eradicate SARS-CoV-2 from respiratory tract earlier in patients with mild COVID-19.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", - " 'KeywordList': {'Keyword': ['SARS-CoV-2',\n", - " 'Ciclesonide',\n", - " 'Hydroxychloroquine',\n", - " 'Viral load',\n", - " 'Coronavirus']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 2']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignInterventionModelDescription': 'This multicenter study is an open-labelled, randomized clinical trial for 1:1:1 ratio of ciclesonide, ciclesonide plus hydroxychloroquine or control arm',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '141',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Ciclesonide',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Ciclesonide 320ug oral inhalation q12h for 14 days',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Ciclesonide Metered Dose Inhaler [Alvesco]']}},\n", - " {'ArmGroupLabel': 'Ciclesonide plus hydroxychloroquine',\n", - " 'ArmGroupType': 'Active Comparator',\n", - " 'ArmGroupDescription': 'Ciclesonide 320ug oral inhalation q12h for 14 days\\n\\nHydroxychloroquine 400mg QD for 10 days',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Ciclesonide Metered Dose Inhaler [Alvesco]',\n", - " 'Drug: Hydroxychloroquine']}},\n", - " {'ArmGroupLabel': 'Control',\n", - " 'ArmGroupType': 'No Intervention',\n", - " 'ArmGroupDescription': 'No ciclesonide and hydroxychloroquine'}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Ciclesonide Metered Dose Inhaler [Alvesco]',\n", - " 'InterventionDescription': 'Ciclesonide 320ug oral inhalation q12h for 14 days',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Ciclesonide',\n", - " 'Ciclesonide plus hydroxychloroquine']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Hydroxychloroquine',\n", - " 'InterventionDescription': 'Hydroxychloroquine 400mg QD for 10 days',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Ciclesonide plus hydroxychloroquine']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Rate of SARS-CoV-2 eradication at day 14 from study enrollment',\n", - " 'PrimaryOutcomeDescription': 'Viral load',\n", - " 'PrimaryOutcomeTimeFrame': 'Hospital day 14'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Rate of SARS-CoV-2 eradication at day 7 from study enrollment',\n", - " 'SecondaryOutcomeDescription': 'Viral load',\n", - " 'SecondaryOutcomeTimeFrame': 'Hospital day 7'},\n", - " {'SecondaryOutcomeMeasure': 'Time to SARS-CoV-2 eradication (days)',\n", - " 'SecondaryOutcomeDescription': 'Viral load',\n", - " 'SecondaryOutcomeTimeFrame': 'Hospital day 1, 4, 7, 10, 14, 21'},\n", - " {'SecondaryOutcomeMeasure': 'Viral load area-under-the-curve (AUC) reduction versus control',\n", - " 'SecondaryOutcomeDescription': 'Viral load change',\n", - " 'SecondaryOutcomeTimeFrame': 'Hospital day 1, 4, 7, 10, 14, 21'},\n", - " {'SecondaryOutcomeMeasure': 'Time to clinical improvement (days)',\n", - " 'SecondaryOutcomeDescription': 'Resolution of all systemic and respiratory symptoms for ≥2 consecutive days',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 28 days'},\n", - " {'SecondaryOutcomeMeasure': 'Proportion of clinical failure',\n", - " 'SecondaryOutcomeDescription': 'ICU admission, mechanical ventilation or death',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 28 days'}]},\n", - " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'Safety and tolerability of study drug',\n", - " 'OtherOutcomeDescription': 'Number of adverse events, proportion of early discontinuance',\n", - " 'OtherOutcomeTimeFrame': 'Up to 28 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nPatients with mild COVID-19 (NEWS scoring system 0-4)\\nPatient within 7 days from symptom onset or Patient within 48 hous after laboratory diagnosis (SARS-CoV-2 RT-PCR)\\n\\nExclusion Criteria:\\n\\nUnable to take oral medication\\nUnable to use inhaler\\nPregnancy or breast feeding\\nImmunocompromising conditions\\nModerate/severe renal dysfunction : creatinine clearance (CCL) < 30 mL/min\\nModerate/severe liver dysfunction: AST or ALT > 5 times upper normal limit\\nAsthma or chronic obstructive lung disease',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '80 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Joon Young Song, MD, PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '82-2-2626-3052',\n", - " 'CentralContactEMail': 'infection@korea.ac.kr'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'C000120481',\n", - " 'InterventionMeshTerm': 'Ciclesonide'},\n", - " {'InterventionMeshId': 'D000006886',\n", - " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", - " 'InterventionAncestorTerm': 'Antimalarials'},\n", - " {'InterventionAncestorId': 'D000000981',\n", - " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", - " {'InterventionAncestorId': 'D000000977',\n", - " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", - " {'InterventionAncestorId': 'D000000890',\n", - " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", - " {'InterventionAncestorId': 'D000004791',\n", - " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'},\n", - " {'InterventionAncestorId': 'D000005938',\n", - " 'InterventionAncestorTerm': 'Glucocorticoids'},\n", - " {'InterventionAncestorId': 'D000006728',\n", - " 'InterventionAncestorTerm': 'Hormones'},\n", - " {'InterventionAncestorId': 'D000006730',\n", - " 'InterventionAncestorTerm': 'Hormones, Hormone Substitutes, and Hormone Antagonists'},\n", - " {'InterventionAncestorId': 'D000045505',\n", - " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", - " {'InterventionAncestorId': 'D000018926',\n", - " 'InterventionAncestorTerm': 'Anti-Allergic Agents'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", - " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M228767',\n", - " 'InterventionBrowseLeafName': 'Ciclesonide',\n", - " 'InterventionBrowseLeafAsFound': 'Ciclesonide',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M2861',\n", - " 'InterventionBrowseLeafName': 'Antimalarials',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2879',\n", - " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2875',\n", - " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2795',\n", - " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19188',\n", - " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M7630',\n", - " 'InterventionBrowseLeafName': 'Glucocorticoids',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M8372',\n", - " 'InterventionBrowseLeafName': 'Hormones',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M8371',\n", - " 'InterventionBrowseLeafName': 'Hormone Antagonists',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19546',\n", - " 'InterventionBrowseLeafName': 'Anti-Allergic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", - " {'InterventionBrowseBranchAbbrev': 'AAll',\n", - " 'InterventionBrowseBranchName': 'Anti-Allergic Agents'}]}},\n", - " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", - " {'Rank': 26,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04327531',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'turkishcovid19'},\n", - " 'Organization': {'OrgFullName': 'Kanuni Sultan Suleyman Training and Research Hospital',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Evaluation of Covid 19 Knowledge Anxiety and Expectation Levels of Turkish Physicians, Survey Study',\n", - " 'OfficialTitle': 'Evaluation of Covid 19 Knowledge Anxiety and Expectation Levels of Turkish Physicians, Survey Study'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Active, not recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 26, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 26, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'April 28, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 27, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 27, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 31, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 31, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Pınar Yalcin bahat',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Kanuni Sultan Suleyman Training and Research Hospital',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'It is aimed to measure the general health information of Turkish physicians about covid 19 pandemic, to evaluate anxiety levels and to evaluate future expectations in this period.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", - " 'Physician-Patient Relations']},\n", - " 'KeywordList': {'Keyword': ['covid-19', 'turkish physicians']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Ecologic or Community']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '200',\n", - " 'EnrollmentType': 'Actual'}},\n", - " 'ArmsInterventionsModule': {'InterventionList': {'Intervention': [{'InterventionType': 'Behavioral',\n", - " 'InterventionName': 'turkish physicians',\n", - " 'InterventionDescription': 'turkish physicians, who work active in pandemic hospital.'}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Evaluation of covid-19 knowledge level of turkish physicians',\n", - " 'PrimaryOutcomeDescription': 'beck depression scale\\n\\nThe BDI inventory has maximum of 63 and minimum of 0 scores:\\n\\n(0-10): Are considered normal ups and downs (11-16): Mild mood disturbance (17-20): Borderline clinical depression (21-30): Moderate depression, (31-40): Severe depression, Over 40: Extreme depression. A persistent score of !17, requires psychiatric treatment',\n", - " 'PrimaryOutcomeTimeFrame': '1 month'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'what they think about the future',\n", - " 'SecondaryOutcomeDescription': 'Turkish physicians write their thoughts about the health system after covid 19 with their own sentences',\n", - " 'SecondaryOutcomeTimeFrame': '1 month'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nturkish physicians\\nwork active in pandemic hospital\\n\\nExclusion Criteria:\\n\\nwork in another country\\nretired physicians',\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '25 Years',\n", - " 'MaximumAge': '55 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult']},\n", - " 'StudyPopulation': 'turkish physicians, who work active in pandemic hospital',\n", - " 'SamplingMethod': 'Probability Sample'},\n", - " 'ContactsLocationsModule': {'LocationList': {'Location': [{'LocationFacility': 'Pinar Yalcin Bahat',\n", - " 'LocationCity': 'Istanbul',\n", - " 'LocationState': 'İ̇stanbul',\n", - " 'LocationZip': '34000',\n", - " 'LocationCountry': 'Turkey'}]}}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M2905',\n", - " 'ConditionBrowseLeafName': 'Anxiety Disorders',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BXM',\n", - " 'ConditionBrowseBranchName': 'Behaviors and Mental Disorders'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", - " {'Rank': 27,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04318314',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '130852'},\n", - " 'Organization': {'OrgFullName': 'University College, London',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'COVID-19: Healthcare Worker Bioresource: Immune Protection and Pathogenesis in SARS-CoV-2',\n", - " 'OfficialTitle': 'COVID-19: Healthcare Worker Bioresource: Immune Protection and Pathogenesis in SARS-CoV-2',\n", - " 'Acronym': 'COVID19-HCW'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 18, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'December 31, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2021',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 17, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 19, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 23, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 25, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 26, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'University College, London',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': \"St. Bartholomew's Hospital\",\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'Royal Free Hospital NHS Foundation Trust',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'UCLH', 'CollaboratorClass': 'UNKNOWN'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Modelling repurposed from pandemic influenza is currently informing all strategies for SARS-CoV-2 and the disease COVID-19. A customized disease specific understanding will be important to understand subsequent disease waves, vaccine development and therapeutics. For this reason, ISARIC (the International Severe Acute Respiratory and Emerging Infection Consortium) was set up in advance. This focuses on hospitalised and convalescent serum samples to understand severe illness and associated immune response. However, many subjects are seroconverting with mild or even subclinical disease. Information is needed about subclinical infection, the significance of baseline immune status and the earliest immune changes that may occur in mild disease to compare with those of SARS-CoV-2. There is also a need to understand the vulnerability and response to COVID-19 of the NHS workforce of healthcare workers (HCWs). HCW present a cohort with likely higher exposure and seroconversion rates than the general population, but who can be followed up with potential for serial testing enabling an insight into early disease and markers of risk for disease severity. We have set up \"COVID-19: Healthcare worker Bioresource: Immune Protection and Pathogenesis in SARS-CoV-2\". This urgent fieldwork aims to secure significant (n=400) sampling of healthcare workers (demographics, swabs, blood sampling) at baseline, and weekly whilst they are well and attending work, with acute sampling (if hospitalised, via ISARIC, if their admission hospital is part of the ISARIC network) and convalescent samples post illness. These will be used to address specific questions around the impact of baseline immune function, the earliest immune responses to infection, and the biology of those who get non-hospitalized disease for local research and as a national resource. The proposal links directly with other ongoing ISARIC and community COVID projects sampling in children and the older age population. Reasonable estimates suggest the usable window for baseline sampling of NHS HCW is closing fast (e.g. baseline sampling within 3 weeks).',\n", - " 'DetailedDescription': \"The proposed study is a prospective observational cohort design which will be carried out across three different trusts: Barts Health NHS Trust (St Bartholomew's Hospital, The Royal London Hospital, Whipps Cross Hospital and Newham Hospital), Royal Free London NHS Foundation Trust (Royal Free Hospital) and University College London Hospitals NHS Foundation Trust (UCLH).\\n\\nParticipants will be asymptomatic front-facing HCWs who carry out their tasks in different areas of the corresponding hospital: Accident and Emergency, Adult Medical Admissions Unit, Medical and Surgical Wards and Intensive Care Units.\\n\\nThis study substantially uses existing infrastructure: Recruits into this study who are subsequently suspected to have COVID-19 can be co-recruited into ISARIC using ISARIC Ethics Ref: 13/SC/0149 (Oxford C Research Ethics Committee, UK CRN /CPMS ID 14152 IRAS ID126600 for acute samples and data collection. Sampling can be delivered via existing research personnel from furloughed projects (CLRN nurses, research fellows, Barts Bioresource). Convalescent sampling will be via an otherwise inactive Clinical Trials unit. It\"},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Health Care Worker Patient Transmission',\n", - " 'Coronavirus',\n", - " 'Coronavirus Infections',\n", - " 'Immunological Abnormality']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'Yes',\n", - " 'TargetDuration': '6 Months',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'BioSpec': {'BioSpecRetention': 'Samples With DNA',\n", - " 'BioSpecDescription': 'Blood samples Nasal and oropharygeal swabs'},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '400',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Healthy and asymptomatic healthcare workers',\n", - " 'ArmGroupDescription': 'Healthy and asymptomatic healthcare workers',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Diagnostic Test: COPAN swabbing and blood sample collection']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Diagnostic Test',\n", - " 'InterventionName': 'COPAN swabbing and blood sample collection',\n", - " 'InterventionDescription': 'COPAN swabbing of nostrils and/or oropharynx and blood sample collection',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Healthy and asymptomatic healthcare workers']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Seroconversion to SARS-CoV-2 positivity',\n", - " 'PrimaryOutcomeDescription': 'Home-isolation or hospital admission',\n", - " 'PrimaryOutcomeTimeFrame': 'Within 6 months'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nhealthy asymptomatic healthcare workers attending hospital (place of work)\\n\\nExclusion Criteria:\\n\\nSARS-CoV-2 positive or symptomatic healthcare workers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': \"Healthy asymptomatic healthcare workers attending their usual place of work that can be St Bartholomew's Hospital, Royal Free London or UCLH.\",\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'James C Moon, MD MBBS MRCP',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '07570911438',\n", - " 'CentralContactEMail': 'bartshealth.covid-hcw@nhs.net'},\n", - " {'CentralContactName': 'Mahdad Noursadeghi',\n", - " 'CentralContactRole': 'Contact'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'James C Moon',\n", - " 'OverallOfficialAffiliation': 'BHC & UCL',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Gabriella Captur',\n", - " 'OverallOfficialAffiliation': 'RFH & UCL',\n", - " 'OverallOfficialRole': 'Study Director'},\n", - " {'OverallOfficialName': 'Charlotte Manisty',\n", - " 'OverallOfficialAffiliation': 'BHC & UCL',\n", - " 'OverallOfficialRole': 'Study Director'},\n", - " {'OverallOfficialName': \"Ben O'Brien\",\n", - " 'OverallOfficialAffiliation': 'BHC & QMUL',\n", - " 'OverallOfficialRole': 'Study Chair'},\n", - " {'OverallOfficialName': 'Hugh Montgomery',\n", - " 'OverallOfficialAffiliation': 'UCL',\n", - " 'OverallOfficialRole': 'Study Chair'},\n", - " {'OverallOfficialName': 'Steffen Petersen',\n", - " 'OverallOfficialAffiliation': 'BHC & QMUL',\n", - " 'OverallOfficialRole': 'Study Chair'},\n", - " {'OverallOfficialName': 'Thomas Treibel',\n", - " 'OverallOfficialAffiliation': 'Barts Heart Center',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Barts Heart Center',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'London',\n", - " 'LocationCountry': 'United Kingdom',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'James Moon',\n", - " 'LocationContactRole': 'Contact'},\n", - " {'LocationContactName': 'James Moon',\n", - " 'LocationContactRole': 'Principal Investigator'}]}},\n", - " {'LocationFacility': 'Royal Free London NHS Foundation Trust',\n", - " 'LocationStatus': 'Active, not recruiting',\n", - " 'LocationCity': 'London',\n", - " 'LocationCountry': 'United Kingdom'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", - " 'IPDSharingDescription': 'Publication of results in open access journals; sharing of results in scientific databases.',\n", - " 'IPDSharingInfoTypeList': {'IPDSharingInfoType': ['Study Protocol',\n", - " 'Statistical Analysis Plan (SAP)',\n", - " 'Informed Consent Form (ICF)']}}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", - " {'ConditionMeshId': 'D000045169',\n", - " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M12',\n", - " 'ConditionBrowseLeafName': 'Congenital Abnormalities',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC16',\n", - " 'ConditionBrowseBranchName': 'Diseases and Abnormalities at or Before Birth'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 28,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04331860',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'C19REG'},\n", - " 'Organization': {'OrgFullName': 'RAD-AID International',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'COVID-19 Public Image Registry',\n", - " 'OfficialTitle': 'COVID-19 Public Image Registry',\n", - " 'Acronym': 'C19REG'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 30, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 30, 2025',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'March 30, 2025',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 30, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 31, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 2, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 31, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'RAD-AID International',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'BioClinica, Inc.',\n", - " 'CollaboratorClass': 'INDUSTRY'},\n", - " {'CollaboratorName': 'Google Inc.',\n", - " 'CollaboratorClass': 'INDUSTRY'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'The COVID-19 Public Image Registry is a global de-identified medical image registry for patients suspected/confirmed to have Covid-19 infection.',\n", - " 'DetailedDescription': \"This project is an observational registry where the patient's images are already acquired as part of standard clinical care. The data undergoes 100% de-identification with multiple confirmation steps. Therefore ,no patient identifiers will be collected and the images cannot be linked back to the patient.\\n\\nThe image repository will be made an open public health resource for researchers under a Creative Commons license similar to the ACR's various National Radiology Data Registries. There are no commercial aspects to this project. All sponsors are donating their services as a humanitarian effort.\"},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", - " 'KeywordList': {'Keyword': ['covid-19',\n", - " 'coronavirus',\n", - " 'registry',\n", - " 'imaging']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'Yes',\n", - " 'TargetDuration': '5 Years',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Other']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '500000',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", - " 'InterventionName': 'No intervention',\n", - " 'InterventionDescription': 'There is no intervention, this is an observational registry'}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'CT or Xray images from COVID-19 patients',\n", - " 'PrimaryOutcomeDescription': 'DICOM format, de-identified images',\n", - " 'PrimaryOutcomeTimeFrame': 'through study completion, an average of 2 years'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\n18 years or older\\nSuspected or known Covid-19 infection (currently or previously)\\nImage procedure performed as part of a Covid-19 exam with the images available in DICOM format\\n\\nExclusion Criteria:\\n\\n• Under age 18',\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '100 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'Suspected or known Covid-19 infection (currently or previously), 18 or over, undergoing a medical imaging exam',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Dan Gebow, PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '415-244-1481',\n", - " 'CentralContactEMail': 'dgebow@gmail.com'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Daniel Mollura, MD',\n", - " 'OverallOfficialAffiliation': 'Rad-AID',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'To be determined',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'San Francisco',\n", - " 'LocationState': 'California',\n", - " 'LocationZip': '94960',\n", - " 'LocationCountry': 'United States',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'TBD TBD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '415-244-1481',\n", - " 'LocationContactEMail': 'TBD@TBD.com'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No',\n", - " 'IPDSharingDescription': 'All data will be shared, but in a de-identified state.'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", - " {'Rank': 29,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04329507',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '282014'},\n", - " 'Organization': {'OrgFullName': 'NHS Lothian', 'OrgClass': 'OTHER_GOV'},\n", - " 'BriefTitle': 'Non-invasive Detection of Pneumonia in Context of Covid-19 Using Gas Chromatography - Ion Mobility Spectrometry (GC-IMS)',\n", - " 'OfficialTitle': 'Non-invasive Detection of Pneumonia in Context of Covid-19 Using Gas Chromatography - Ion Mobility Spectrometry (GC-IMS)'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 25, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 25, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'March 25, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 26, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 30, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 30, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'NHS Lothian',\n", - " 'LeadSponsorClass': 'OTHER_GOV'}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'On Dec 31, 2019, a number of viral pneumonia cases were reported in China. The virus causing pneumonia was then identified as a new coronavirus called SARS-CoV-2. Since this time, the infection called coronavirus disease 2019 (COVID-19) has spread around the world, causing huge stress for health care systems. To diagnose this infection, throat and nose swabs are taken. Unfortunately, the results often take more than 24 hrs to return from a laboratory. Speeding diagnosis up would be of great help.\\n\\nThis study aims to look at the breath to find signs that might allow clinicians to diagnose the coronavirus infection at the bedside, without needing to send samples to the laboratory. To do this, the team will be using a machine called a BreathSpec which has been adapted to fit in the hospital for this purpose.',\n", - " 'DetailedDescription': 'Analysis of volatile organic compounds (VOCs) in exhaled breath is of increasing interest in the diagnosis of lung infection. Over 2,000 VOCs can be detected through gas chromatography and mass spectrometry (GC-MS); patterns of VOC detected can offer information on chronic obstructive pulmonary disease, asthma, lung cancer and interstitial lung disease. Unfortunately, GC-MS while highly sensitive cannot be done at the bedside and at best takes hours to prepare samples, run the analysis and then interpret the results.\\n\\nCompared with other methods of breath analysis, ion mobility spectrometry (IMS) offers a tenfold higher detection rate of VOCs. By coupling an ion mobility spectrometer with a GC column, GC-IMS offers immediate twofold separation of VOCs with visualisation in a three-dimensional chromatogram. The total analysis time is about 300 seconds and the equipment has been miniaturised to allow bedside analysis.\\n\\nThe BreathSpec machine has been previously used to study both radiation injury in patients undergoing radiotherapy at the Edinburgh Cancer Centre (REC ref 16-SS-0059, as part of the H2020 TOXI-triage project, http://www.toxi-triage.eu/) and pneumonia in patients presenting to the ED of the Royal Infirmary of Edinburgh (REC ref 18-LO-1029). This work has developed artificial intelligence methodology that allows rapid analysis of the vast amount of data collected from these breath samples to identify signatures that may indicate a particular pathological process such as pneumonia or radiation injury.\\n\\nThe TOXI-triage project showed that the BreathSpec GC-IMS could rapidly triage individuals to identify those who had been exposed to particular volatile liquids in a mass casualty situation (http://www.toxi-triage.eu/).\\n\\nA pilot trial assessed chest infections at the Acute Medical Unit of the Royal Liverpool University Hospital. The final diagnostic model permitted fair discrimination between bacterial chest infections and chest infections due to other agents with an area under the receiver operator characteristic curve (AUC-ROC) of 0.73 (95% CI 0.61-0.86). The summary test characteristics were a sensitivity of 62% (95% CI 41-80%) and specificity of 80% (95% CI 64 - 91%) [8].\\n\\nThis was expanded in the EU H2020 funded \"Breathspec Study\" which aimed to differentiate breath samples from patients with bacterial or viral upper or lower respiratory tract infection. Over 1220 patients were recruited, with 191 patients identified as definitely bacterial infection and 671 classed as definitely not bacterial. Virology was undertaken on all patients, with 259 patients confirmed viral infection. Date processing is still on going to determine how well they can be distinguished using this methodology. More than 100 patients were recruited to this study in Edinburgh. Since then, artificial intelligence has been incorporated into our analytical processes, permitting faster and more refined analysis.\\n\\nOur ambition is that this technology will identify a signature of Covid-19 pneumonia or within 10 min in non-invasively collected breath samples to allow triage of patients into high and low risk categories for Covid-19. This will allow targeting of scarce resources and complex protocols associated with high risk patients including personal protective equipment (PPE), cohorting, and dedicated medical and nursing personel.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", - " 'Respiratory Disease']},\n", - " 'KeywordList': {'Keyword': ['COVID-19']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '200',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'InterventionList': {'Intervention': [{'InterventionType': 'Diagnostic Test',\n", - " 'InterventionName': 'Breath test',\n", - " 'InterventionDescription': 'collection of an exhaled breath sample'}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'To perform a study in patients with clinical features of pneumonia/chest infection to identify a signature of Covid-19 pneumonia in patients exposed to SARS-CoV-2, compared to unexposed patients or those without.',\n", - " 'PrimaryOutcomeDescription': 'breath sample collection',\n", - " 'PrimaryOutcomeTimeFrame': 'up to daily during hospital admission'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Detection of markers of Covid-19 pneumonia in non-invasive breath samples.',\n", - " 'SecondaryOutcomeDescription': 'breath sample collection',\n", - " 'SecondaryOutcomeTimeFrame': 'daily until the patient has ben discharged from hospital or it is deemed inappropriate to continue'},\n", - " {'SecondaryOutcomeMeasure': 'Relationship of this biomarker signature to the presence of SARS-CoV-2 in nasal and throat swabs.',\n", - " 'SecondaryOutcomeDescription': 'breath sample collection',\n", - " 'SecondaryOutcomeTimeFrame': 'daily until the patient has ben discharged from hospital or it is deemed inappropriate to continue'},\n", - " {'SecondaryOutcomeMeasure': \"Subsequently, the signature's relationship to other biomarkers of SARS-CoV-2 infection which are currently being explored\",\n", - " 'SecondaryOutcomeDescription': 'breath sample collection',\n", - " 'SecondaryOutcomeTimeFrame': 'daily until the patient has ben discharged from hospital or it is deemed inappropriate to continue'},\n", - " {'SecondaryOutcomeMeasure': 'In a smaller group of participants, ideally daily non-invasive breath samples will be collected to determine if there are changes between SARS-CoV-2 positive patients and those that are negative until hospital discharge or undue participant burden .',\n", - " 'SecondaryOutcomeDescription': 'breath sample collection',\n", - " 'SecondaryOutcomeTimeFrame': 'daily until the patient has ben discharged from hospital or it is deemed inappropriate to continue'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\n≥18 years old with clinical features consistent with pneumonia or chest infection due to SARS-CoV-2 AND\\n\\npresenting to the Royal Infirmary of Edinburgh where they are swabbed and triaged for Covid-19.\\n\\nExclusion Criteria:\\n\\nInability to provide informed consent\\nAge 17 years or less',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'Patients presenting to hospital with respiratory signs and tested for SARS-CoV-2',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Michael Eddleston',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '0131 242 3867',\n", - " 'CentralContactEMail': 'm.eddleston@ed.ac.uk'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided',\n", - " 'IPDSharingDescription': 'no plan made as yet - this research needs to be expedited during the pandemic'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000011014',\n", - " 'ConditionMeshTerm': 'Pneumonia'},\n", - " {'ConditionMeshId': 'D000012120',\n", - " 'ConditionMeshTerm': 'Respiration Disorders'},\n", - " {'ConditionMeshId': 'D000012140',\n", - " 'ConditionMeshTerm': 'Respiratory Tract Diseases'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000008171',\n", - " 'ConditionAncestorTerm': 'Lung Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M12487',\n", - " 'ConditionBrowseLeafName': 'Pneumonia',\n", - " 'ConditionBrowseLeafAsFound': 'Pneumonia',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M13540',\n", - " 'ConditionBrowseLeafName': 'Respiration Disorders',\n", - " 'ConditionBrowseLeafAsFound': 'Respiratory Disease',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafAsFound': 'Respiratory Disease',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M9751',\n", - " 'ConditionBrowseLeafName': 'Lung Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'}]}}}}},\n", - " {'Rank': 30,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04328285',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '20PH061'},\n", - " 'SecondaryIdInfoList': {'SecondaryIdInfo': [{'SecondaryId': '2020-001188-96',\n", - " 'SecondaryIdType': 'EudraCT Number'}]},\n", - " 'Organization': {'OrgFullName': 'Centre Hospitalier Universitaire de Saint Etienne',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers',\n", - " 'OfficialTitle': 'Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers : A Randomized Double-blind Placebo-controlled Clinical Trial',\n", - " 'Acronym': 'COVIDAXIS'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 30, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'November 30, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'November 30, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 25, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 27, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 31, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 27, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 31, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Centre Hospitalier Universitaire de Saint Etienne',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Institut Pasteur',\n", - " 'CollaboratorClass': 'INDUSTRY'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Since December 2019, the emergence of a new coronavirus named SARS-Cov-2 in the city of Wuhan in China has been responsible for a major epidemic of respiratory infections, including severe pneumonia. Within weeks, COVID-19 became a pandemic.\\n\\nIn the absence of specific antiviral treatment, a special attention should be given to prevention. Personal protection equipments may be insufficiently protective, including in healthcare workers, a significant proportion of whom (around 4%) having been infected in the outbreaks described in China and more recently in Italy. Infection in healthcare workers could result from the contact with COVID-19 people in community or with infected colleagues or patients.\\n\\nAs it will take at least a year before vaccines against SARS-CoV-2 becomes available, chemoprophylaxis is an option that should be considered in this setting where prevention of SARS-CoV-2 infection in Health Care Workers.\\n\\nThe COVIDAXIS trial evaluates a chemoprophylaxis of SARS-CoV-2 infection in Health Care Workers. This trial is divided into two distinct studies that could start independently each with its own randomization process: COVIDAXIS 1 will study Hydroxychloroquine (HCQ) versus placebo; COVIDAXIS 2 will study Lopinavir/ritonavir (LPV/r) versus placebo.\\n\\nUpon randomization healthcare workers (HCWs) involved in the management of suspected or confirmed COVID-19 cases will be assigned to one of the following 2 treatment groups:',\n", - " 'DetailedDescription': 'The study COVIDAXIS 1( Hydroxychloroquine (HCQ) versus placebo) will be realized on 600 participants and will be implemented first in as many centers as possible.\\n\\nUpon randomization healthcare workers involved in the management of suspected or confirmed COVID-19 cases will be assigned to one of the following 2 treatment groups:\\n\\nGroup 1.1: HCQ 400 mg, 2 tablets twice daily at Day 1 and 200 mg, 1 tablet once daily afterwards\\nGroup 1.2: Placebo of HCQ, 2 tablets twice daily at Day 1 and 1 tablet once daily afterwards).\\n\\nCOVIDAXIS 1\\n\\nThe COVIDAXIS 2 (Lopinavir/ritonavir (LPV/r) versus placebo will be realized on 600 participants and will be implemented in already participating and newer centers in a second step (when LPV/r becomes available).\\n\\nUpon randomization healthcare workers involved in the management of suspected or confirmed COVID-19 cases will be assigned to one of the following 2 treatment groups:\\n\\nGroup 2.1: LPV/r 400/100 mg, 2 tablets twice daily\\nGroup 2.2: Placebo of LPV/r, 2 tablets twice daily\\n\\nParticipants will receive the randomized treatment for 2 months and will be followed upon a 2.5 months period.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", - " 'KeywordList': {'Keyword': ['SARS-CoV-2',\n", - " 'COVID-19',\n", - " 'nasopharyngeal swab',\n", - " 'pneumonia',\n", - " 'Hydroxychloroquine',\n", - " 'Lopinavir/ritonavir']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 3']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignInterventionModelDescription': 'A randomized double-blind placebo-controlled clinical trial',\n", - " 'DesignPrimaryPurpose': 'Prevention',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Triple',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", - " 'Investigator',\n", - " 'Outcomes Assessor']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '1200',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Hydroxychloroquine (HCQ) vs Placebo',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Group 1.1: HCQ 400 mg, 2 tablets twice daily at Day 1 and 200 mg, 1 tablet once daily afterwards\\n\\nGroup 1.2: Placebo of HCQ, 2 tablets twice daily at Day 1 and 1 tablet once daily afterwards.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine',\n", - " 'Drug: Placebo of Hydroxychloroquine']}},\n", - " {'ArmGroupLabel': 'Lopinavir/ritonavir (LPV/r) vs Placebo',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Group 2.1: LPV/r 400/100 mg, 2 tablets twice daily\\n\\nGroup 2.2: Placebo of LPV/r, 2 tablets twice daily',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Lopinavir and ritonavir',\n", - " 'Drug: Placebo of LPV/r Tablets']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Hydroxychloroquine',\n", - " 'InterventionDescription': 'Hydroxychloroquine Oral Tablets',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Hydroxychloroquine (HCQ) vs Placebo']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Plaquenil']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Placebo of Hydroxychloroquine',\n", - " 'InterventionDescription': 'Placebo of Hydroxychloroquine Oral Tablets Placebo manufactured to mimic Hydroxychloroquine tablets',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Hydroxychloroquine (HCQ) vs Placebo']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Lopinavir and ritonavir',\n", - " 'InterventionDescription': 'LPV/r Oral Tablets',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Lopinavir/ritonavir (LPV/r) vs Placebo']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Kaletra']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Placebo of LPV/r Tablets',\n", - " 'InterventionDescription': 'Placebo of LPV/r Oral Tablets Placebo manufactured to mimic LPV/r tablets',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Lopinavir/ritonavir (LPV/r) vs Placebo']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Occurrence of an symptomatic or asymptomatic SARS-CoV-2 infection among healthcare workers (HCWs)',\n", - " 'PrimaryOutcomeDescription': 'An infection by SARS-CoV-2 is defined by either:\\n\\na positive specific Reverse Transcription - Polymerase Chain Reaction (RT-PCR) on periodic systematic nasopharyngeal swab during follow-up OR\\na positive specific RT-PCR on a respiratory sample in case of onset of symptoms consistent with COVID-19 during follow-up OR\\na seroconversion to SARS-CoV-2 after randomization.',\n", - " 'PrimaryOutcomeTimeFrame': 'Up to 2.5 months'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Evaluation of the occurrence of adverse events in each arm,',\n", - " 'SecondaryOutcomeDescription': 'Number of adverse events expected or unexpected, related and unrelated to the treatment, notably grades 2, 3 and 4 (moderate, severe and lifethreatening, according to the Adverse National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0) in each arm.',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 2.5 months'},\n", - " {'SecondaryOutcomeMeasure': 'Evaluation of the discontinuation rates of the investigational drug in each arm,',\n", - " 'SecondaryOutcomeDescription': 'Number of treatment discontinuations in each arm',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 2 months'},\n", - " {'SecondaryOutcomeMeasure': 'Evaluation of the adherence of participants to study drug,',\n", - " 'SecondaryOutcomeDescription': 'Treatment adherence rate will be assessed by:\\n\\nmeasurement of LPV and HCQ plasma concentrations using LC-MS/MS or LC-Fluorimetric detection\\nthe count of returned drugs at each visit.',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 2 months'},\n", - " {'SecondaryOutcomeMeasure': 'Evaluation of the incidence of symptomatic cases of SARS-CoV-2 infection in each arm,',\n", - " 'SecondaryOutcomeDescription': 'Number of incident cases of symptomatic SARS-CoV-2 infections among HCWs in each arm.\\n\\nSymptomatic infection is defined as :\\n\\na positive specific RT-PCR on a respiratory or non respiratory sample OR\\na thoracic CT scan with imaging abnormalities consistent with COVID-19.\\n\\nThese investigations being performed in case of signs/symptoms consistent with COVID-19 during follow-up.',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 2.5 months'},\n", - " {'SecondaryOutcomeMeasure': 'Evaluation of the incidence of asymptomatic cases of SARS-CoV-2 infection in each arm',\n", - " 'SecondaryOutcomeDescription': 'Number of incident cases of asymptomatic SARS-CoV-2 infection among HCWs in each randomization arm.\\n\\nAsymptomatic infection is defined as :\\n\\na positive specific RT-PCR on periodic systematic nasopharyngeal swab during clinical follow-up without consistent clinical signs/symptoms during follow-up OR\\nas seroconversion to SARS-CoV-2 between start and end of the study in HCWs that did not reported any consistent clinical symptoms during follow-up',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 2.5 months'},\n", - " {'SecondaryOutcomeMeasure': 'Evaluation of the incidence of severe cases of SARS-CoV-2 infection in each arm.',\n", - " 'SecondaryOutcomeDescription': 'Number of incident cases of severe SARS-CoV-2 infections among HCWs in each randomization arm, defined as :\\n\\na positive specific RT-PCR on a respiratory sample OR\\na thoracic CT scan with imaging abnormalities consistent with COVID-19 performed in case of onset of symptoms consistent with COVID-19 during follow-up in a participant who need to be hospitalized for respiratory distress. Respiratory distress defined as dyspnea with a respiratory frequency > 30/min, blood oxygen saturation <93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300 and/or lung infiltrates >50% (1).',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 2.5 months'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAdult healthcare workers (HCWs) (physicians, nurses, assistant nurses, dentists, physiotherapists, and midwives)\\nHCW involved at the time of enrolment in the care of patients with confirmed or suspected SARS-CoV-2 infection in hospital settings, in outpatient care settings or in geriatric long-term care facilities\\nHCW tested negative for HIV\\nHCW affiliated to the French health insurance system\\nHCW women of childbearing age with an effective contraception (ethinylestradiol-containing contraceptive pills are not regarded as effective in the context of LPV/r treatment)\\nWilling to comply to study design and the follow-up\\n\\nExclusion Criteria:\\n\\nHCW with positive SARS-CoV-2 RT-PCR of nasopharyngeal swab at the inclusion visit.\\nHCW with past history of confirmed SARS-CoV-2 infection\\nHCW with positive SARS-CoV-2 serology at the inclusion visit (if the serology is available at inclusion time, if SARS-CoV-2 serology is not available, it will be a secondary exclusion criteria)\\nHCW with comorbidities such as chronic hepatitis C virus (HCV) infection treated by direct antiviral drugs or with hypothyroidism that need hormonal substitution, or retinopathy, or known to have hypercholesterolemia hypertriglyceridemia\\nPregnant HCW\\nBreastfeeding HCW\\nHCW taking comedications known to have interactions with HCQ according to the official characteristics of the product',\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Arnauld Garcin',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '33 4 77 12 02 85',\n", - " 'CentralContactEMail': 'Arnauld.Garcin@chu-st-etienne.fr'},\n", - " {'CentralContactName': 'Nathalie Jolly',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '33 1 40 61 38 74',\n", - " 'CentralContactEMail': 'nathalie.jolly@pasteur.fr'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Elisabeth Botelho-Nevers, MD, PhD',\n", - " 'OverallOfficialAffiliation': 'CHU de Saint-Etienne',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Bruno Hoen, MD, PhD',\n", - " 'OverallOfficialAffiliation': 'Institut Pasteur',\n", - " 'OverallOfficialRole': 'Study Director'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': \"CHU d'Angers\",\n", - " 'LocationCity': 'Angers',\n", - " 'LocationCountry': 'France',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Vincent DUBEE',\n", - " 'LocationContactRole': 'Contact'},\n", - " {'LocationContactName': 'Vincent DUBEE',\n", - " 'LocationContactRole': 'Principal Investigator'},\n", - " {'LocationContactName': 'Marc-Antoine CUSTAUD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Isabelle PELLIER',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'AP-HP - Hôpital Bichat',\n", - " 'LocationCity': 'Paris',\n", - " 'LocationCountry': 'France',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Xavier DUVAL',\n", - " 'LocationContactRole': 'Contact'},\n", - " {'LocationContactName': 'Xavier DUVAL',\n", - " 'LocationContactRole': 'Principal Investigator'}]}},\n", - " {'LocationFacility': 'CHU de Saint-Etienne',\n", - " 'LocationCity': 'Saint-Étienne',\n", - " 'LocationCountry': 'France',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Elisabeth BOTELHO-NEVERS',\n", - " 'LocationContactRole': 'Contact'},\n", - " {'LocationContactName': 'Elisabeth BOTELHO-NEVERS',\n", - " 'LocationContactRole': 'Principal Investigator'},\n", - " {'LocationContactName': 'Bernard TARDY',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Amandine GAGNEUX-BRUNON',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Sandrine ACCASSAT',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000019438',\n", - " 'InterventionMeshTerm': 'Ritonavir'},\n", - " {'InterventionMeshId': 'D000061466',\n", - " 'InterventionMeshTerm': 'Lopinavir'},\n", - " {'InterventionMeshId': 'D000006886',\n", - " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000017320',\n", - " 'InterventionAncestorTerm': 'HIV Protease Inhibitors'},\n", - " {'InterventionAncestorId': 'D000011480',\n", - " 'InterventionAncestorTerm': 'Protease Inhibitors'},\n", - " {'InterventionAncestorId': 'D000004791',\n", - " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000019380',\n", - " 'InterventionAncestorTerm': 'Anti-HIV Agents'},\n", - " {'InterventionAncestorId': 'D000044966',\n", - " 'InterventionAncestorTerm': 'Anti-Retroviral Agents'},\n", - " {'InterventionAncestorId': 'D000000998',\n", - " 'InterventionAncestorTerm': 'Antiviral Agents'},\n", - " {'InterventionAncestorId': 'D000000890',\n", - " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", - " {'InterventionAncestorId': 'D000065692',\n", - " 'InterventionAncestorTerm': 'Cytochrome P-450 CYP3A Inhibitors'},\n", - " {'InterventionAncestorId': 'D000065607',\n", - " 'InterventionAncestorTerm': 'Cytochrome P-450 Enzyme Inhibitors'},\n", - " {'InterventionAncestorId': 'D000000962',\n", - " 'InterventionAncestorTerm': 'Antimalarials'},\n", - " {'InterventionAncestorId': 'D000000981',\n", - " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", - " {'InterventionAncestorId': 'D000000977',\n", - " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", - " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M19978',\n", - " 'InterventionBrowseLeafName': 'Ritonavir',\n", - " 'InterventionBrowseLeafAsFound': 'Ritonavir',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M28424',\n", - " 'InterventionBrowseLeafName': 'Lopinavir',\n", - " 'InterventionBrowseLeafAsFound': 'Lopinavir',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M18192',\n", - " 'InterventionBrowseLeafName': 'HIV Protease Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M12926',\n", - " 'InterventionBrowseLeafName': 'Protease Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19934',\n", - " 'InterventionBrowseLeafName': 'Anti-HIV Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M24015',\n", - " 'InterventionBrowseLeafName': 'Anti-Retroviral Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2895',\n", - " 'InterventionBrowseLeafName': 'Antiviral Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2795',\n", - " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M29151',\n", - " 'InterventionBrowseLeafName': 'Cytochrome P-450 CYP3A Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M29124',\n", - " 'InterventionBrowseLeafName': 'Cytochrome P-450 Enzyme Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2861',\n", - " 'InterventionBrowseLeafName': 'Antimalarials',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2879',\n", - " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2875',\n", - " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19188',\n", - " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", - " 'ConditionMeshTerm': 'Infection'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafAsFound': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M12487',\n", - " 'ConditionBrowseLeafName': 'Pneumonia',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'}]}}}}},\n", - " {'Rank': 31,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04324489',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'DAS181-SARS-CoV-2'},\n", - " 'Organization': {'OrgFullName': 'Renmin Hospital of Wuhan University',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'DAS181 for Severe COVID-19: Compassionate Use',\n", - " 'OfficialTitle': 'DAS181 for Severe COVID-19: Compassionate Use'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 6, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 25, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'April 30, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 25, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 25, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 27, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 31, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Gong Zuojiong',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Director, Department of Infectious Disease',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Renmin Hospital of Wuhan University'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Renmin Hospital of Wuhan University',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Ansun Biopharma, Inc.',\n", - " 'CollaboratorClass': 'INDUSTRY'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No',\n", - " 'IsUSExport': 'Yes'},\n", - " 'DescriptionModule': {'BriefSummary': 'The objective of the study is to investigate the safety and potential efficacy of DAS181 for the treatment of severe COVID-19.',\n", - " 'DetailedDescription': 'Each eligible subject is treated with DAS181 for 10 days and observed for 28 days from the first day of administration.\\n\\nFrom day 1 to 10, once or twice a day, for 10 consecutive days, a total of 9 mg (7 ml) nebulized DAS181 is given. If DAS181 is given by twice a day, one vial containing 4.5 mg (3.5m1) DAS181 should be delivered with about 12-hour interval.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", - " 'KeywordList': {'Keyword': ['COVID-19',\n", - " 'SARS-CoV-2',\n", - " 'DAS181',\n", - " 'Hypoxemia']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Not Applicable']},\n", - " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '4',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'DAS181 Treatment',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Nebulized DAS181 9mg/day (4.5 mg bid/day) for 10 days',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: DAS181']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'DAS181',\n", - " 'InterventionDescription': 'Patient receives nebulized DAS181 (4.5 mg BID/day, a total 9 mg/day) for 10 days.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['DAS181 Treatment']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Improved clinical status',\n", - " 'PrimaryOutcomeDescription': 'Percent of subjects with improved clinical status',\n", - " 'PrimaryOutcomeTimeFrame': 'Day 14'},\n", - " {'PrimaryOutcomeMeasure': 'Return to room air',\n", - " 'PrimaryOutcomeDescription': 'Percent of subjects return to room air',\n", - " 'PrimaryOutcomeTimeFrame': 'Day 14'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'SARS-CoV-2 RNA',\n", - " 'SecondaryOutcomeDescription': 'time to SARS-CoV-2 RNA in the respiratory specimens being undetectable',\n", - " 'SecondaryOutcomeTimeFrame': '28 days'},\n", - " {'SecondaryOutcomeMeasure': 'Discharge',\n", - " 'SecondaryOutcomeDescription': 'Percent of patients discharge from hospital',\n", - " 'SecondaryOutcomeTimeFrame': 'Days 14, 21, 28'},\n", - " {'SecondaryOutcomeMeasure': 'Death',\n", - " 'SecondaryOutcomeDescription': 'All-cause mortality rate',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 14, 21, 28'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Key Inclusion Criteria:\\n\\nPositive for RNA of SARS-CoV-2 from respiratory specimens or blood specimens\\nHypoxemic\\nSevere COVID-19\\nIf female, subject must not be pregnant or nursing.\\nNon-vasectomized males are required to practice effective birth control methods\\nCapable of understanding and complying with procedures as outlined in the protocol as judged by the Investigator and able to sign informed consent form prior to the initiation of any screening or study-specific procedures.\\n\\nExclusion Criteria:\\n\\nALT or AST> 8 x ULN\\n(ALT or AST> 3 x ULN) and (Total bilirubin> 2.5 x ULN or INR> 2.0 x ULN)\\nFemale subjects who have a positive pregnancy test and are breastfeeding\\nSubjects using any other investigational antiviral drugs during the hospitalization before enrollment.\\nSubjects participating in other clinical trials\\nSubjects may be transferred to a non-participating hospital within 72 hours\\nPeople who cannot cooperate well due to mental illness, have no self-control, and cannot express clearly\\nSevere underlying diseases affecting survival\\nCritical COVID-19 requiring mechanical ventilator at the time enrolled',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '70 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Zuojiong Gong, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '027-88999120',\n", - " 'CentralContactEMail': 'zjgong@163.com'},\n", - " {'CentralContactName': 'Ke Hu, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '027-88999120',\n", - " 'CentralContactEMail': 'hukejx@163.com'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Zuojiong Gong, MD',\n", - " 'OverallOfficialAffiliation': 'Renmin Hospital of Wuhan University',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Renmin Hospital of Wuhan University',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Wuhan',\n", - " 'LocationState': 'Hubei',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Zuojiong Guong, MD',\n", - " 'LocationContactRole': 'Contact'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'}}}},\n", - " {'Rank': 32,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04312243',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'NOpreCOVID-19'},\n", - " 'Organization': {'OrgFullName': 'Massachusetts General Hospital',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'NO Prevention of COVID-19 for Healthcare Providers',\n", - " 'OfficialTitle': 'Nitric Oxide Gas Inhalation for Prevention of COVID-19 in Healthcare Providers',\n", - " 'Acronym': 'NOpreventCOVID'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 2, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 20, 2021',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'March 20, 2022',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 15, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 16, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 18, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", - " 'LastUpdatePostDateType': 'Estimate'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Lorenzo Berra, MD',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Massachusetts General Hospital'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Massachusetts General Hospital',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'IsFDARegulatedDrug': 'Yes',\n", - " 'IsFDARegulatedDevice': 'No',\n", - " 'IsUSExport': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Thousands of healthcare workers have been infected with SARS-CoV-2 and contracted COVID-19 despite their best efforts to prevent contamination. No proven vaccine is available to protect healthcare workers against SARS-CoV-2.\\n\\nThis study will enroll 470 healthcare professionals dedicated to care for patients with proven SARS-CoV-2 infection. Subjects will be randomized either in the observational (control) group or in the inhaled nitric oxide group. All personnel will observe measures on strict precaution in accordance with WHO and the CDC regulations.',\n", - " 'DetailedDescription': 'In their efforts to provide care for patients with novel coronavirus (SARS-CoV-2) disease (COVID-19) infection, many healthcare workers around the globe exposed to SARS-CoV-2 got infected and died over the past two months. Quarantined nurses and physicians have become the norm in regions with COVID-19 patients, putting at risk the overall functionality of the regional healthcare system. Other than strict contact-precautions, no proven vaccination or targeted therapy is available to prevent COVID-19 in healthcare workers. Inhaled nitric oxide gas (NO) has shown in a small clinical study to have antiviral activity against a Coronavirus during the 2003 SARS outbreak. We have designed this study to assess whether intermittent inhaled NO in healthcare workers might prevent their infection with SARS-CoV-2.\\n\\nBackground: After almost two months of fight against COVID-19 infection, on February 24, more than 3,000 physicians and nurses were reported as contracting COVID-19 disease in Wuhan (China). Fatalities among those healthcare workers were reported to be related to SARS-CoV-2 infection. Implementation of strict contact protections for all healthcare personnel is essential to decrease and contain the risks of exposure. However, despite best efforts, dozens of thousands of healthcare providers have been quarantined for at least 14 consecutive days in Wuhan alone. Similarly data have been reported in Italy, several healthcare providers have been quarantined, developed pneumonia and died. Most recent information from Italy reported that 12% of healthcare workers are infected.\\n\\nThe shortage of hospital personnel, especially in the critical care and anesthesiology domains, led many hospitals to postpone indefinitely scheduled surgical procedures, including cardiac surgery or oncological procedures. Only urgent and emergent cases are performed in patients without symptoms (i.e., absence of fever, cough or dyspnea), no signs (i.e., negative chest CT for consolidations, normal complete blood count) and a negative test on SARS-CoV-2 reverse transcriptase (rt)-PCR. If time does not allow for thorough screening (i.e., after traumatic injury), such patients are considered to be infected and medical staff in the OR are fully protected with third degree protections (i.e., N95 masks, goggles, protective garments and a gown and double gloving).\\n\\nRationale. In 2004 in a collaborative study between the virology laboratory at the University of Leuven (Belgium), the Clinical Physiology Laboratory of Uppsala University (Sweden) and the General Airforce Hospital of China (Beijing, China), nitric oxide (NO) donors (e.g. S-nitroso-N-acetylpenicillamine) greatly increased the survival rate of infected eukaryotic cells with the coronavirus responsible for SARS (SARS-CoV-1), suggesting direct antiviral effects of NO. These authors suggest that oxidation is the antiviral mechanism of nitric oxide. A later work by Akerstrom and colleagues showed that NO or its derivatives reduce palmitoylation SARS-CoV spike (S) protein affecting its fusion with angiotensin converting enzyme 2. Furthermore, NO or its derivatives reduce viral RNA synthesis in the infected cells. Future in-vitro studies should confirm that NO donors are equally effective against SARS-CoV-2, as the current virus shares 88% of its genome with the SARS-CoV [3]. However, at present it is reasonable to assess that a high dose of inhaled NO might be anti-viral against SARS-CoV-2 in the lung. The virus is transmitted by human-to-human contact and occurs primarily via respiratory droplets from coughs and sneezes within a range of about 1.5 meters. The incubation period ranges from 1 to 14 days with an estimated median incubation period of 5 to 6 days according to the World Health Organization [1]. COVID-19 disease is mainly a respiratory system disease, but in the most severe forms can progress to impair also other organ function (i.e., kidneys, liver, heart). Nitric oxide gas inhalation has been successfully and safely used for decades (since 1990) in thousands of newborns and adults to decrease pulmonary artery pressure and improve systemic oxygenation.\\n\\nRecently at the Massachusetts General Hospital, a high dose of inhaled NO (160 ppm) for 30 - 60 minutes was delivered twice a day to an adolescent with cystic fibrosis and pulmonary infection due to multi-resistant Burkholderia cepacia. There were no adverse events to this patient, blood methemoglobin remained below 5% and lung function and overall well-being improved.\\n\\nClinical Gap. Thousands of healthcare workers have been infected with SARS-CoV-2 and contracted COVID-19 despite their best efforts to prevent contamination. No proven vaccine is available to protect healthcare workers against SARS-CoV-2.\\n\\nHypothesis. Due to genetic similarities with the Coronavirus responsible for SARS, it is expected that inhaled NO gas retains potent antiviral activity against the SARS-CoV-2 responsible for COVID-19.\\n\\nAim. To assess whether intermittent delivery of inhaled NO gas in air at a high dose may protect healthcare workers from SARS-CoV-2 infection.\\n\\nObservational group: daily symptoms and body temperature monitoring. SARS-CoV-2 RT-PCR test will be performed if fever or COVID-19 symptoms.\\n\\nTreatment group: the subjects will breathe NO at 160 parts per million (ppm) for two cycles of 15 minutes each at the beginning of each shift and before leaving the hospital. Daily symptoms and body temperature monitoring. SARS-CoV-2 RT-PCR test will be performed if fever or COVID-19 symptoms. Safety: Oxygenation and methemoglobin levels will be monitored via a non-invasive CO-oximeter. If methemoglobin levels rise above 5% at any point of the gas delivery, inhaled NO will be stopped. NO2 gas will be monitored and maintained below 5 ppm.\\n\\nBlinding. The treatment is not masked.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus Infections',\n", - " 'Healthcare Associated Infection']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 2']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Prevention',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '470',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Treatment Group',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Inhaled NO (160 ppm) before and after the work shift. Daily monitoring of body temperature and symptoms. SARS-CoV-2 RT-PCR test if fever or COVID-19 symptoms.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Inhaled nitric oxide gas']}},\n", - " {'ArmGroupLabel': 'Control Group',\n", - " 'ArmGroupType': 'No Intervention',\n", - " 'ArmGroupDescription': 'Daily monitoring of body temperature and symptoms. SARS-CoV-2 RT-PCR test if fever or COVID-19 symptoms.'}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Inhaled nitric oxide gas',\n", - " 'InterventionDescription': 'Control group: a SARS-CoV2 rt-PCR will be performed if symptoms arise. Treatment group: the subjects will breathe NO at the beginning of the shift and before leaving the hospital. Inspired NO will be delivered at 160 parts per million (ppm) for 15 minutes in each cycle. A SARS-CoV-2 rt-PCR will be performed if symptoms arise. Safety: Oxygenation and methemoglobin levels will be monitored via a non-invasive CO-oximeter. If methemoglobin levels rise above 5% at any point of the gas delivery, inhaled NO will be halvened. NO2 gas will be monitored and maintained below 5 ppm.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Treatment Group']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'COVID-19 diagnosis',\n", - " 'PrimaryOutcomeDescription': 'Percentage of subjects with COVID-19 diagnosis in the two groups',\n", - " 'PrimaryOutcomeTimeFrame': '14 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Positive SARS-CoV-2 rt-PCR test',\n", - " 'SecondaryOutcomeDescription': 'Percentage of subjects with a positive test in the two groups',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'}]},\n", - " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'Total number of quarantine days',\n", - " 'OtherOutcomeDescription': 'Mean/ Median in the two groups',\n", - " 'OtherOutcomeTimeFrame': '14 days'},\n", - " {'OtherOutcomeMeasure': 'Proportion of healthcare providers requiring quarantine',\n", - " 'OtherOutcomeDescription': 'Percentage in the two groups',\n", - " 'OtherOutcomeTimeFrame': '14 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAge ≥18 years\\nScheduled to work with SARS-CoV-2 infected patients for at least 3 days in a week.\\n\\nExclusion Criteria:\\n\\nPrevious documented SARS-CoV-2 infections and subsequent negative SARS-CoV-2 rt-PCR test.\\nPregnancy\\nKnown hemoglobinopathies.\\nKnown anemia',\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '99 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Lorenzo Berra, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+16176437733',\n", - " 'CentralContactEMail': 'lberra@mgh.harvard.edu'}]}},\n", - " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '19800091',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Akerström S, Gunalan V, Keng CT, Tan YJ, Mirazimi A. Dual effect of nitric oxide on SARS-CoV replication: viral RNA production and palmitoylation of the S protein are affected. Virology. 2009 Dec 5;395(1):1-9. doi: 10.1016/j.virol.2009.09.007. Epub 2009 Oct 1.'},\n", - " {'ReferencePMID': '15234326',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Keyaerts E, Vijgen L, Chen L, Maes P, Hedenstierna G, Van Ranst M. Inhibition of SARS-coronavirus infection in vitro by S-nitroso-N-acetylpenicillamine, a nitric oxide donor compound. Int J Infect Dis. 2004 Jul;8(4):223-6.'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000009569',\n", - " 'InterventionMeshTerm': 'Nitric Oxide'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000001993',\n", - " 'InterventionAncestorTerm': 'Bronchodilator Agents'},\n", - " {'InterventionAncestorId': 'D000001337',\n", - " 'InterventionAncestorTerm': 'Autonomic Agents'},\n", - " {'InterventionAncestorId': 'D000018373',\n", - " 'InterventionAncestorTerm': 'Peripheral Nervous System Agents'},\n", - " {'InterventionAncestorId': 'D000045505',\n", - " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", - " {'InterventionAncestorId': 'D000018927',\n", - " 'InterventionAncestorTerm': 'Anti-Asthmatic Agents'},\n", - " {'InterventionAncestorId': 'D000019141',\n", - " 'InterventionAncestorTerm': 'Respiratory System Agents'},\n", - " {'InterventionAncestorId': 'D000016166',\n", - " 'InterventionAncestorTerm': 'Free Radical Scavengers'},\n", - " {'InterventionAncestorId': 'D000000975',\n", - " 'InterventionAncestorTerm': 'Antioxidants'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000018377',\n", - " 'InterventionAncestorTerm': 'Neurotransmitter Agents'},\n", - " {'InterventionAncestorId': 'D000045462',\n", - " 'InterventionAncestorTerm': 'Endothelium-Dependent Relaxing Factors'},\n", - " {'InterventionAncestorId': 'D000014665',\n", - " 'InterventionAncestorTerm': 'Vasodilator Agents'},\n", - " {'InterventionAncestorId': 'D000064426',\n", - " 'InterventionAncestorTerm': 'Gasotransmitters'},\n", - " {'InterventionAncestorId': 'D000020011',\n", - " 'InterventionAncestorTerm': 'Protective Agents'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M11090',\n", - " 'InterventionBrowseLeafName': 'Nitric Oxide',\n", - " 'InterventionBrowseLeafAsFound': 'Nitric Oxide',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M3851',\n", - " 'InterventionBrowseLeafName': 'Bronchodilator Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M3219',\n", - " 'InterventionBrowseLeafName': 'Autonomic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19547',\n", - " 'InterventionBrowseLeafName': 'Anti-Asthmatic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19721',\n", - " 'InterventionBrowseLeafName': 'Respiratory System Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M17210',\n", - " 'InterventionBrowseLeafName': 'Free Radical Scavengers',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2873',\n", - 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" 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", - " 'ConditionMeshTerm': 'Infection'},\n", - " {'ConditionMeshId': 'D000003141',\n", - " 'ConditionMeshTerm': 'Communicable Diseases'},\n", - " {'ConditionMeshId': 'D000003428',\n", - " 'ConditionMeshTerm': 'Cross Infection'},\n", - " {'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", - " {'ConditionMeshId': 'D000045169',\n", - " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", - " {'ConditionAncestorId': 'D000007049',\n", - " 'ConditionAncestorTerm': 'Iatrogenic Disease'},\n", - " {'ConditionAncestorId': 'D000020969',\n", - " 'ConditionAncestorTerm': 'Disease Attributes'},\n", - " {'ConditionAncestorId': 'D000010335',\n", - " 'ConditionAncestorTerm': 'Pathologic Processes'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafAsFound': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafAsFound': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M25724',\n", - " 'ConditionBrowseLeafName': 'Respiratory Aspiration',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M5225',\n", - " 'ConditionBrowseLeafName': 'Cross Infection',\n", - " 'ConditionBrowseLeafAsFound': 'Healthcare Associated Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8682',\n", - " 'ConditionBrowseLeafName': 'Iatrogenic Disease',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M21284',\n", - " 'ConditionBrowseLeafName': 'Disease Attributes',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 33,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04331899',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '55619'},\n", - " 'Organization': {'OrgFullName': 'Stanford University',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Mild COVID-19 Peginterferon Lambda',\n", - " 'OfficialTitle': 'A Phase 2 Randomized, Open Label Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19',\n", - " 'Acronym': 'COVID-Lambda'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 15, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 31, 2021',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'May 31, 2022',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 27, 2020',\n", - " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 2, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Upinder Singh',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Professor (Medicine -Infectious Diseases)',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Stanford University'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Stanford University',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'Yes',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'To evaluate the efficacy of subcutaneous injections of 180 ug of Peginterferon Lambda-1a once weekly, for up to two weeks (2 injections at most), compared with standard supportive care, in reducing the duration of oral shedding of SARS-CoV-2 virus in patients with uncomplicated COVID-19 disease.',\n", - " 'DetailedDescription': 'Patients will attend up to 8 study visits over a period of up to 28 days.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 2']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Single Group Assignment',\n", - " 'DesignInterventionModelDescription': 'An open-label randomized controlled trial. Study participants will be randomly assigned 1:1 to a single subcutaneous dose of Peginterferon Lambda-1a or standard of care.',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '120',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Study drug Peginterferon Lambda-1a',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Study participants assigned to study drug will receive a single subcutaneous dose of Peginterferon Lambda-1a in addition to standard of care treatment.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Peginterferon Lambda-1a',\n", - " 'Other: Standard of Care Treatment']}},\n", - " {'ArmGroupLabel': 'Standard of care',\n", - " 'ArmGroupType': 'Active Comparator',\n", - " 'ArmGroupDescription': 'Study participants will receive standard of care treatment.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: Standard of Care Treatment']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Peginterferon Lambda-1a',\n", - " 'InterventionDescription': 'Peginterferon Lambda-1a (180 ug subcutaneous injection) single dose',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Study drug Peginterferon Lambda-1a']}},\n", - " {'InterventionType': 'Other',\n", - " 'InterventionName': 'Standard of Care Treatment',\n", - " 'InterventionDescription': 'Standard of Care Treatment for COVID-19 Infection',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Standard of care',\n", - " 'Study drug Peginterferon Lambda-1a']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Duration of Viral shedding of SARS-CoV-2 by qRT-PCR',\n", - " 'PrimaryOutcomeDescription': 'Time to first of two consecutive negative respiratory secretions obtained by nasopharyngeal and/or oropharyngeal and/or salivary swabs tests for SARS-CoV-2 by qRT-PCR.',\n", - " 'PrimaryOutcomeTimeFrame': '28 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAge ≥ 18 years and ≤ 64 years at the time of the assessment\\nAble and willing to understand the study, adhere to all study procedures, and provide written informed consent\\nInitial diagnosis of COVID-19 disease as defined by a FDA-cleared molecular diagnostic assay positive for SARS-CoV-2\\nDisplay symptoms of COVID respiratory infection without respiratory distress\\n\\nExclusion Criteria:\\n\\nPatients who are hospitalized for inpatient treatment or currently being evaluated for potential hospitalization at the time of initiation of informed consent\\n\\nPatients with a known allergy to Peginterferon Lambda-1a or any component thereof\\nRoom air oxygen saturation of <92%\\nParticipation in a clinical trial with or use of any investigational agent within 30 days before screening, or treatment with interferons (IFN) or immunomodulators within 12 months before screening\\nPrevious use of Peginterferon Lambda-1a\\nHistory or evidence of any intolerance or hypersensitivity to IFNs or other substances contained in the study medication.\\nFemale patients who are pregnant or breastfeeding. Male patients must confirm that their female sexual partners are not pregnant.\\nCurrent or previous history of decompensated liver disease (Child-Pugh Class B or C) or hepatocellular carcinoma\\nCo-infected with human immunodeficiency virus (HIV) or hepatitis C virus (HCV)\\nSignificant abnormal laboratory test results at screening.\\nSignificant concurrent illnesses and other comorbidities that may require intervention during the study\\n\\nConcurrent use of any of the following medications:\\n\\nTherapy with an immunomodulatory agent\\nCurrent use of heparin or Coumadin\\nReceived blood products within 30 days before study randomization\\nUse of hematologic growth factors within 30 days before study randomization\\nSystemic antibiotics, antifungals, or antivirals for treatment of active infection within 14 days before study randomization\\nAny prescription or herbal product that is not approved by the investigator\\nLong-term treatment (> 2 weeks) with agents that have a high risk for nephrotoxicity or hepatotoxicity unless it is approved by the medical monitor\\nReceipt of systemic immunosuppressive therapy within 3 months before screening',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '64 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Upinder Singh',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '6507234045',\n", - " 'CentralContactEMail': 'usingh@stanford.edu'},\n", - " {'CentralContactName': 'Julie Parsonnet',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '6507254561',\n", - " 'CentralContactEMail': 'parsonnt@stanford.edu'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Upinder Singh',\n", - " 'OverallOfficialAffiliation': 'Professor (Medicine -Infectious Diseases)',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No',\n", - " 'IPDSharingDescription': 'No current plan to share the data.'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'}}}},\n", - " {'Rank': 34,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04320017',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'CIC1421-20-05'},\n", - " 'Organization': {'OrgFullName': 'Groupe Hospitalier Pitie-Salpetriere',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Joint Use of Electrocardiogram and Transthoracic Echocardiography in an Observational Study to Monitor Cardio-vascular Events in Patients Diagnosed With COVID-19',\n", - " 'OfficialTitle': 'Joint Use of Electrocardiogram and Transthoracic Echocardiography in an Observational Study to Monitor Cardio-vascular Events in Patients Diagnosed With COVID-19',\n", - " 'Acronym': 'JOCOVID'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 20, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 20, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'May 20, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 20, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 23, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 24, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 23, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 24, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Joe Elie Salem',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Head of Investigations in Clinical Investigation Centers Paris-Est',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Groupe Hospitalier Pitie-Salpetriere'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Groupe Hospitalier Pitie-Salpetriere',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'COVID-19 outbreak is often lethal. Morality has been associated with several cardio-vascular risk factors such as diabetes, obesity, hypertension and tobacco use. Furthermore, cases of myocarditis have been reported with COVID-19.\\n\\nCardio-vascular events have possibly been highly underestimated. The study proposes to systematically collect cardio-vascular data to study the incidence of myocarditis and coronaropathy events during COVID-19 infection.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", - " 'Myocardial Injury',\n", - " 'Myocarditis']},\n", - " 'KeywordList': {'Keyword': ['Coronavirus',\n", - " 'Heart conditions',\n", - " 'Cardio-vascular outcomes']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '500',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'COVID-19 patients',\n", - " 'ArmGroupDescription': 'Patients diagnosed with COVID-19 by PCR done on nasal sample.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Diagnostic Test: Electrocardiogram and transthoracic echocardiography']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Diagnostic Test',\n", - " 'InterventionName': 'Electrocardiogram and transthoracic echocardiography',\n", - " 'InterventionDescription': '12 derivations electrocardiogram done at baseline transthoracic echocardiography',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['COVID-19 patients']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Incidence of acute myocardial events in COVID-19 population at baseline and during hospital stay',\n", - " 'PrimaryOutcomeDescription': 'Viral myocarditis or myocardial infarction or stenosis detected with ST segment elevation or depression associated with troponine elevation and transthoracic echocardiography',\n", - " 'PrimaryOutcomeTimeFrame': 'ECG and concomitant troponine at day 1 after admission and twice a week after admission and until patient is discharged, transthoracic echocardiography at day 1 and day 7, t'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Description of cardiovascular outcomes in the cohort',\n", - " 'SecondaryOutcomeDescription': 'Cardio-vascular events including but not limited to: myocardial infarction or stenosis, stroke, pulmonary embolism, deep vein thrombosis, ventricular dysfunctio, conduction disorders and sudden death',\n", - " 'SecondaryOutcomeTimeFrame': 'During hospital admission'},\n", - " {'SecondaryOutcomeMeasure': 'Prognosis role of baseline cardio-vascular caracteristics on patients survival',\n", - " 'SecondaryOutcomeDescription': 'Biological biomarkers including but not limited to: baseline troponine T, D-dimers, NT-proBNP, creatinine phosphokinase, creatininemia, ionogram, renine-angiotensin aldosterone system profiling, glycemia (fasting), HbA1c, steroid profiling, lipid profiling',\n", - " 'SecondaryOutcomeTimeFrame': '1st day of admission'},\n", - " {'SecondaryOutcomeMeasure': 'Prediction of cardio-vascular events with baseline characteristics',\n", - " 'SecondaryOutcomeTimeFrame': 'Baseline on first day of admission'},\n", - " {'SecondaryOutcomeMeasure': 'Characterization of inflammation on cardio-vascular outcomes',\n", - " 'SecondaryOutcomeDescription': 'Biological markers including but not limited to: C reactive protein, procalcitonine, fibrinogen, interleukin-6',\n", - " 'SecondaryOutcomeTimeFrame': 'Baseline and every 2 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\n- COVID-19 positive patients admitted in a ward identified by positive PCR on nasal swab samples\\n\\nExclusion Criteria:\\n\\n- Patients for which electrocardiogram or transthoracic echocardiography is not technically feasible',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '16 Years',\n", - " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'All patients admitted in Pitié-Salpêtrière hospital will be eligible, if the electrocardiogram and the transthoracic echocardiography is technically feasible.',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Joe-Elie Salem, MD-PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '01 42 17 85 31',\n", - " 'CentralContactPhoneExt': '+33',\n", - " 'CentralContactEMail': 'joe-elie.salem@aphp.fr'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Clinical Investigation Center Pitié-Salpêtrière',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Paris',\n", - " 'LocationZip': '75013',\n", - " 'LocationCountry': 'France',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Joe-Elie Salem, MD-PhD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '01 42 17 85 31',\n", - " 'LocationContactPhoneExt': '+33',\n", - " 'LocationContactEMail': 'joe-elie.salem@aphp.fr'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000009205',\n", - " 'ConditionMeshTerm': 'Myocarditis'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000009202',\n", - " 'ConditionAncestorTerm': 'Cardiomyopathies'},\n", - " {'ConditionAncestorId': 'D000006331',\n", - " 'ConditionAncestorTerm': 'Heart Diseases'},\n", - " {'ConditionAncestorId': 'D000002318',\n", - " 'ConditionAncestorTerm': 'Cardiovascular Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M10740',\n", - " 'ConditionBrowseLeafName': 'Myocarditis',\n", - " 'ConditionBrowseLeafAsFound': 'Myocarditis',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M10737',\n", - " 'ConditionBrowseLeafName': 'Cardiomyopathies',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8002',\n", - " 'ConditionBrowseLeafName': 'Heart Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T4031',\n", - " 'ConditionBrowseLeafName': 'Myocarditis',\n", - " 'ConditionBrowseLeafAsFound': 'Myocarditis',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC14',\n", - " 'ConditionBrowseBranchName': 'Heart and Blood Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 35,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04331509',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'COVID-19 Symptom tracker'},\n", - " 'Organization': {'OrgFullName': \"King's College London\",\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'COVID-19 Symptom Tracker',\n", - " 'OfficialTitle': 'COVID-19 Symptom Tracker'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 23, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 23, 2022',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'March 23, 2022',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 31, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 31, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 2, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 31, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': \"King's College London\",\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Zoe Global Limited',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'Massachusetts General Hospital',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'Harvard School of Public Health',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'Stanford University',\n", - " 'CollaboratorClass': 'OTHER'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': \"The viral Covid-19 outbreak is now considered a pandemic according to the World Health Organisation (WHO). A free monitoring app 'COVID-19 Symptom Tracker' has been developed to record and monitor the symptoms of the COVID-19 coronavirus infection; tracking in real time how the disease progresses. The app also records how measures aimed at controlling the pandemic including self-isolation and distancing are affecting the mental health and well-being of participants. The data from the study will reveal important information about the symptoms and progress of COVID-19 infection in different people, and why some go on to develop more severe or fatal disease while others have only mild symptoms do not.\",\n", - " 'DetailedDescription': \"A free monitoring app 'COVID-19 Symptom Tracker' has been developed by health technology company Zoe Global Limited in collaboration with scientists at King's College London, Harvard Medical School, Massachusetts General Hospital and Stanford University. A web-based equivalent is being developed for those unable to download this app. This new app records and monitors the symptoms of COVID-19 coronavirus infection; tracking in real time how the disease progresses. The app also records how measures aimed at controlling the pandemic including self-isolation and distancing affect the mental health and well-being of participants. The app also allows self-reporting where no symptoms are experienced such that it records any users that feel healthy and normal.\\n\\nThe app, has been launched in both the UK and the US. Researchers in other countries are encouraged to obtain the required approvals from Apple and Google to make the app available in their territories.\\n\\nThe data from the study will reveal important information about the symptoms and progress of COVID-19 infection in different people, and why some go on to develop more severe or fatal disease while others have only mild symptoms do not.\\n\\nIt is also hoped that the data generated from this study will help the urgent clinical need to distinguish mild coronavirus symptoms from seasonal coughs and colds, which may be leading people to unnecessarily self-isolate when they aren't infected or inadvertently go out and spread the disease when they are.\\n\\nUsers download the free app COVID-19 Symptom Tracker and record information about their health on a daily basis, including temperature, tiredness and symptoms such as coughing, breathing problems or headaches.\\n\\nThe app is available internationally to the general population and will also be used in two large epidemiological cohorts: The TwinsUK cohort (n=15,000) and Nurses Health Study (n=280,000).\\n\\nThe app will allow scientists to study the spread and development of symptoms across whole populations, both in the UK and abroad, as well as detailed genetic and other studies, particularly with the twins cohort\\n\\nAny data gathered from the app and study will be used strictly for public health or academic research and will not be used commercially or sold.\"},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", - " 'KeywordList': {'Keyword': ['COVID-19',\n", - " 'Coronovirus',\n", - " 'Symptom tracker',\n", - " 'Virus',\n", - " 'Pandemic']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '10000000',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Symptom tracker users',\n", - " 'ArmGroupDescription': 'No Intervention',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: No Intervention']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", - " 'InterventionName': 'No Intervention',\n", - " 'InterventionDescription': 'No Intervention',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Symptom tracker users']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Physical health symptoms',\n", - " 'PrimaryOutcomeDescription': 'Self reported as physically healthy',\n", - " 'PrimaryOutcomeTimeFrame': '1 day'},\n", - " {'PrimaryOutcomeMeasure': 'Lack of physical health symptoms',\n", - " 'PrimaryOutcomeDescription': 'Self reported as physically not feeling healthy',\n", - " 'PrimaryOutcomeTimeFrame': '1 day'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Fever',\n", - " 'SecondaryOutcomeDescription': 'Self reported remperature',\n", - " 'SecondaryOutcomeTimeFrame': '1 day'}]},\n", - " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'Cough',\n", - " 'OtherOutcomeDescription': 'Self reported cough',\n", - " 'OtherOutcomeTimeFrame': '1 day'},\n", - " {'OtherOutcomeMeasure': 'Fatigue',\n", - " 'OtherOutcomeDescription': 'Self reported fatigue',\n", - " 'OtherOutcomeTimeFrame': '1 day'},\n", - " {'OtherOutcomeMeasure': 'Headache',\n", - " 'OtherOutcomeDescription': 'Self reported headache',\n", - " 'OtherOutcomeTimeFrame': '1 day'},\n", - " {'OtherOutcomeMeasure': 'Shortness of breath',\n", - " 'OtherOutcomeDescription': 'Self reported shortness of breath',\n", - " 'OtherOutcomeTimeFrame': '1 day'},\n", - " {'OtherOutcomeMeasure': 'Sore throat',\n", - " 'OtherOutcomeDescription': 'Self reported sore throat',\n", - " 'OtherOutcomeTimeFrame': '1 day'},\n", - " {'OtherOutcomeMeasure': 'Loss of smell/ taste',\n", - " 'OtherOutcomeDescription': 'Self reported loss of smell/ taste',\n", - " 'OtherOutcomeTimeFrame': '1 day'},\n", - " {'OtherOutcomeMeasure': 'Hoarse voice',\n", - " 'OtherOutcomeDescription': 'Self reported hoarse voice',\n", - " 'OtherOutcomeTimeFrame': '1 day'},\n", - " {'OtherOutcomeMeasure': 'Chest pain or tightness',\n", - " 'OtherOutcomeDescription': 'Self reported chest pain or tightness',\n", - " 'OtherOutcomeTimeFrame': '1 day'},\n", - " {'OtherOutcomeMeasure': 'Abdominal pain',\n", - " 'OtherOutcomeDescription': 'Self reported abdominal pain',\n", - " 'OtherOutcomeTimeFrame': '1 day'},\n", - " {'OtherOutcomeMeasure': 'Diarrhoea',\n", - " 'OtherOutcomeDescription': 'Self reported diarrhoea',\n", - " 'OtherOutcomeTimeFrame': '1 day'},\n", - " {'OtherOutcomeMeasure': 'Confusion',\n", - " 'OtherOutcomeDescription': 'Self reported confusion',\n", - " 'OtherOutcomeTimeFrame': '1 day'},\n", - " {'OtherOutcomeMeasure': 'Skipping meals',\n", - " 'OtherOutcomeDescription': 'Self reported skipping meals',\n", - " 'OtherOutcomeTimeFrame': '1 day'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAdults of 18 years and above, both in the UK and internationally where the app has been approved for download from the Apple App store and Google Play. The web-based equivalent to the app will also be made available via a link for those unable to download.\\n\\nExclusion Criteria:\\n\\nAnyone below the age of 18; anyone unable to provide informed consent.',\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'Anyone who is able to download the app or use the web-based equivalent tool to self-report their symptoms.',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Victoria Vazquez',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '02071886765',\n", - " 'CentralContactEMail': 'victoria.vazquez@kcl.ac.uk'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Tim D Spector',\n", - " 'OverallOfficialAffiliation': \"King's College London\",\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Massachusetts General Hospital',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Boston',\n", - " 'LocationState': 'Massachusetts',\n", - " 'LocationZip': '02114',\n", - " 'LocationCountry': 'United States',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'David A Drew, PhD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactEMail': 'predict@mgh.harvard.edu'},\n", - " {'LocationContactName': 'Andrew T. Chan, MD',\n", - " 'LocationContactRole': 'Contact'},\n", - " {'LocationContactName': 'Andrew Chan',\n", - " 'LocationContactRole': 'Principal Investigator'}]}},\n", - " {'LocationFacility': \"King's College London\",\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'London',\n", - " 'LocationZip': 'SE1 7EH',\n", - " 'LocationCountry': 'United Kingdom',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Victoria Vazquez',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '020 7188 6765',\n", - " 'LocationContactEMail': 'victoria.vazquez@kcl.ac.uk'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", - " 'IPDSharingDescription': 'Access to the COVID-19 Symptom Tracker data will be given to members of the clinical or scientific community as outlined below in accordance with the following privacy policies:\\n\\nhttps://covid.joinzoe.com/privacy-notice\\n\\nhttps://storage.googleapis.com/covid-symptom-tracker-public/privacy-policy-us.pdf',\n", - " 'IPDSharingTimeFrame': 'Immediately',\n", - " 'IPDSharingAccessCriteria': 'Request to access the COVID-19 Symptom Tracker data should made by submitting an online Data Access Application Form. The form is available on the TwinsUK website.\\n\\nhttps://dtr.eu.qualtrics.com/jfe/form/SV_81U9lmshTofiFeZ\\n\\nDecision Process & Outcome:\\n\\nUpon submission of the Covid-19 Data Application Form, the TwinsUK data management team will review the application forms received and information on the outcome will be provided within a week. Decisions on the most complex applications will be overseen by the TwinsUK Resource Executive Committee.\\n\\nAll applicants must belong to the clinical or scientific community, present a valid rationale and must have\\n\\nA healthcare email address\\nAn educational email address\\nA track of peer reviewed publications',\n", - " 'IPDSharingURL': 'https://dtr.eu.qualtrics.com/jfe/form/SV_81U9lmshTofiFeZ'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", - " {'Rank': 36,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04318015',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'ProfilaxisCOVID'},\n", - " 'Organization': {'OrgFullName': 'National Institute of Respiratory Diseases, Mexico',\n", - " 'OrgClass': 'OTHER_GOV'},\n", - " 'BriefTitle': 'Hydroxychloroquine Chemoprophylaxis in Healthcare Personnel in Contact With COVID-19 Patients (PHYDRA Trial)',\n", - " 'OfficialTitle': 'Chemoprophylaxis With Hydroxychloroquine in Healthcare Personnel in Contact With COVID-19 Patients: A Randomized Controlled Trial (PHYDRA Trial)',\n", - " 'Acronym': 'PHYDRA'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'December 31, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'March 31, 2021',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 19, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 19, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 23, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 19, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 23, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'National Institute of Respiratory Diseases, Mexico',\n", - " 'LeadSponsorClass': 'OTHER_GOV'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Sanofi',\n", - " 'CollaboratorClass': 'INDUSTRY'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': \"Triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) aiming to prove hydroxychloroquine's security and efficacy as prophylaxis treatment for healthcare personnel exposed to COVID-19 patients.\",\n", - " 'DetailedDescription': 'Healthcare personnel infection with COVID-19 is a major setback in epidemiological emergencies. Hydroxychloroquine has proven to inhibit coronavirus in-vitro but no data to date has proven in-vivo effects. Nevertheless, hydroxychloroquine is a low cost, limited toxicity and broadly used agent. Since there is currently no treatment for COVID-19 exposure prophylaxis, the investigators will implement a triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) for 60 days.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", - " 'Severe Acute Respiratory Syndrome']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 3']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignInterventionModelDescription': 'Triple blinded, randomized controlled trial',\n", - " 'DesignPrimaryPurpose': 'Prevention',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Quadruple',\n", - " 'DesignMaskingDescription': 'Randomization will happen after previous assignment of recruited individual to high-risk or low-risk exposure according to he or her activities. An independent member of the team will randomly assign treatment or placebo following a computer based program. Blinding will end in case elimination criteria are met.',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", - " 'Care Provider',\n", - " 'Investigator',\n", - " 'Outcomes Assessor']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '400',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'High-risk Treatment',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Hydroxychloroquine 200mg per day for 60 days.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine']}},\n", - " {'ArmGroupLabel': 'High-risk Placebo',\n", - " 'ArmGroupType': 'Placebo Comparator',\n", - " 'ArmGroupDescription': 'Placebo tablet per day for 60 days.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo oral tablet']}},\n", - " {'ArmGroupLabel': 'Low-risk Treatment',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Hydroxychloroquine 200mg per day for 60 days',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine']}},\n", - " {'ArmGroupLabel': 'Low-risk Placebo',\n", - " 'ArmGroupType': 'Placebo Comparator',\n", - " 'ArmGroupDescription': 'Placebo tablet per day for 60 days.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo oral tablet']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Hydroxychloroquine',\n", - " 'InterventionDescription': 'All treatment will be administered orally.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['High-risk Treatment',\n", - " 'Low-risk Treatment']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Plaquenil']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Placebo oral tablet',\n", - " 'InterventionDescription': 'All placebo will be administered orally',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['High-risk Placebo',\n", - " 'Low-risk Placebo']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Placebo']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Symptomatic COVID-19 infection rate',\n", - " 'PrimaryOutcomeDescription': 'Symptomatic infection rate by COVID-19 defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive COVID-19 real-time polymerase chain reaction test.',\n", - " 'PrimaryOutcomeTimeFrame': 'From date of randomization until the appearance of symptoms or study completion 60 days after treatment start'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Symptomatic non-COVID viral infection rate',\n", - " 'SecondaryOutcomeDescription': 'Symptomatic infection rate by other non-COVID-19 viral etiologies defined as cough, dyspnea, fever, myalgia, arthralgias or rhinorrhea along with a positive viral real time polymerase chain reaction test.',\n", - " 'SecondaryOutcomeTimeFrame': 'From date of randomization until the appearance of symptoms or study completion 60 days after treatment start'},\n", - " {'SecondaryOutcomeMeasure': 'Days of labor absenteeism',\n", - " 'SecondaryOutcomeDescription': 'Number of days absent from labor due to COVID-19 symptomatic infection',\n", - " 'SecondaryOutcomeTimeFrame': 'From date of randomization until study completion 60 days after treatment start'},\n", - " {'SecondaryOutcomeMeasure': 'Rate of labor absenteeism',\n", - " 'SecondaryOutcomeDescription': 'Absenteeism from labor rate due to COVID-19 symptomatic infection',\n", - " 'SecondaryOutcomeTimeFrame': 'From date of randomization until study completion 60 days after treatment start'},\n", - " {'SecondaryOutcomeMeasure': 'Rate of severe respiratory COVID-19 disease in healthcare personnel',\n", - " 'SecondaryOutcomeDescription': 'Rate of severe respiratory COVID-19 disease in healthcare personnel',\n", - " 'SecondaryOutcomeTimeFrame': 'From date of randomization until the appearance of symptoms or study completion 60 days after treatment start'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\n18 years old upon study start\\nHealthcare personnel exposed to patients with COVID-19 respiratory disease: physicians, nurses, chemists, pharmacists, janitors, stretcher-bearer, administrative and respiratory therapists.\\nSigned consent for randomization to any study arm.\\n\\nExclusion Criteria:\\n\\nKnown hypersensitivity to hydroxychloroquine manifested as anaphylaxis\\nCurrent treatment to chloroquine or hydroxychloroquine\\nWomen with last menstruation date farther than a month without negative pregnancy test.\\nWomen with positive pregnancy test\\nBreastfeeding women\\nChronic hepatic disease history (Child-Pugh B or C)\\nChronic renal disease (GFR less or equal to 30)',\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Felipe Camacho-Jurado, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+52 55871700',\n", - " 'CentralContactPhoneExt': '5305',\n", - " 'CentralContactEMail': 'lfjcamacho@comunidad.unam.mx'},\n", - " {'CentralContactName': 'Rogelio Perez-Padilla, MD. PhD.',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+52 55871700',\n", - " 'CentralContactPhoneExt': '5305',\n", - " 'CentralContactEMail': 'perezpad@gmail.com'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Jorge Rojas-Serrano, MD, PhD.',\n", - " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Rogelio Perez-Padilla, MD',\n", - " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", - " 'OverallOfficialRole': 'Study Director'},\n", - " {'OverallOfficialName': 'Felipe Jurado-Camacho, MD. 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" {'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 37,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04303507',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'VIR20001'},\n", - " 'Organization': {'OrgFullName': 'University of Oxford',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting',\n", - " 'OfficialTitle': 'Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting; a Randomised, Placebo-controlled Prophylaxis Study (COPCOV)',\n", - " 'Acronym': 'COPCOV'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 2021',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'April 2021',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 6, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 10, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 11, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 25, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 27, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'University of Oxford',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'The study is a double-blind, randomised, placebo-controlled trial that will be conducted in health care settings. After obtaining fully informed consent, the investigator will recruit healthcare workers, or other individuals at significant risk who can be followed reliably for 5 months. 40,000 participants will be recruited and the investigator predict an average of 400-800 participants per site in 50-100 sites.\\n\\nThe participant will be randomised to receive either chloroquine/ hydroxychloroquine or placebo (1:1 randomisation). A loading dose of 10mg base/kg, followed by 155 mg daily (250mg chloroquine phosphate salt or 200mg hydroxychloroquine sulphate) will be taken for 3 months. Subsequent episodes of symptomatic respiratory illness, including symptomatic COVID-19, clinical outcomes, and asymptomatic infection with the virus causing COVID-19 will be recorded during the follow-up period. If they are diagnosed with COVID-19 during the period of prophylaxis, they will continue their prophylaxis unless advised to do so by their healthcare professional until they run out of their current supply of chloroquine/ hydroxychloroquine or placebo at home. They will not collect more. They will be followed up for 28 days (up until a maximum of 60 days if not recovered at 28 days).'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID19',\n", - " 'Coronavirus',\n", - " 'Acute Respiratory Illnesses']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Not Applicable']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Prevention',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Double',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", - " 'Investigator']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '40000',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Chloroquine or Hydroxychloroquine',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'In Asia, the participant will receive chloroquine.\\n\\nIn Europe, the participant will receive hydroxychloroquine',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Chloroquine or Hydroxychloroquine']}},\n", - " {'ArmGroupLabel': 'Placebo',\n", - " 'ArmGroupType': 'Placebo Comparator',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Chloroquine or Hydroxychloroquine',\n", - " 'InterventionDescription': 'A loading dose of 10 mg base/ kg followed by 155 mg daily (250mg chloroquine phosphate salt or 200mg of or hydroxychloroquine sulphate) will be taken for 3 months',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Chloroquine or Hydroxychloroquine']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Placebo',\n", - " 'InterventionDescription': 'Placebo',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Placebo']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Number of symptomatic COVID-19 infections',\n", - " 'PrimaryOutcomeDescription': 'Number of symptomatic COVID-19 infections will be compared between the chloroquine or hydroxychloroquine and placebo groups',\n", - " 'PrimaryOutcomeTimeFrame': 'Approximately 100 days'},\n", - " {'PrimaryOutcomeMeasure': 'Symptoms severity of COVID-19',\n", - " 'PrimaryOutcomeDescription': 'Symptoms severity of COVID-19 will be compared between the two groups using a respiratory severity score.',\n", - " 'PrimaryOutcomeTimeFrame': 'Approximately 100 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Number of asymptomatic cases of COVID-19',\n", - " 'SecondaryOutcomeDescription': 'Number of asymptomatic cases of COVID-19 will be determined by comparing acute and convalescent serology in the two groups.',\n", - " 'SecondaryOutcomeTimeFrame': 'Approximately 100 days'},\n", - " {'SecondaryOutcomeMeasure': 'Number of symptomatic acute respiratory illnesses',\n", - " 'SecondaryOutcomeDescription': 'Number of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.',\n", - " 'SecondaryOutcomeTimeFrame': 'Approximately 100 days'},\n", - " {'SecondaryOutcomeMeasure': 'Severity of symptomatic acute respiratory illnesses',\n", - " 'SecondaryOutcomeDescription': 'Severity of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.',\n", - " 'SecondaryOutcomeTimeFrame': 'Approximately 100 days'}]},\n", - " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, ARI and disease severity.',\n", - " 'OtherOutcomeDescription': 'Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, ARI and disease severity.',\n", - " 'OtherOutcomeTimeFrame': 'Approximately 100 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Study Participants\\n\\nThese are of two types:\\n\\nA. Adult volunteers (exact age is dependent on countries) working as a healthcare worker or frontline (i.e. patient contact) in a healthcare facility or similar institution\\n\\nB. Provided that they are willing to participate in the trial and can be followed adequately for up to 5 months, we may also enrol hospitalised patients or relatives exposed or potentially exposed to the SARS-CoV-2 virus or other high-risk groups\\n\\nInclusion Criteria:\\n\\nParticipant is willing and able to give informed consent for participation in the study and agrees with the study and its conduct\\nAgrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals\\nAdults (exact age is dependent on countries)\\nNot previously diagnosed with COVID-19\\nNot currently symptomatic with an Acute Respiratory Infection\\nParticipant A. works in healthcare facility or other well characterised high-risk environment, OR B. is an inpatient or relative of a patient in a participating hospital and likely exposed to COVID-19 infection or another high-risk group\\nPossesses an internet-enabled smartphone (Android or iOS)\\n\\nExclusion Criteria:\\n\\nHypersensitivity reaction to chloroquine, hydroxychloroquine or 4-aminoquinolines\\nContraindication to taking chloroquine as prophylaxis e.g. known epileptic, known creatinine clearance < 10 ml/min\\nAlready taking chloroquine, hydroxychloroquine or 4-aminoquinolines\\nTaking a concomitant medication (Abiraterone acetate, Agalsidase, Conivaptan, Dabrafenib, Dacomitinib, Enzalutamide, Idelalisib, Mifepristone, Mitotane, tiripentol) which cannot be safely stopped\\nKnown retinal disease\\nInability to be followed up for the trial period\\nKnown prolonged QT syndrome (however ECG is not required at baseline)',\n", - 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" {'InterventionBrowseBranchAbbrev': 'Analg',\n", - " 'InterventionBrowseBranchName': 'Analgesics'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 38,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04331600',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'QUARANTINE2020'},\n", - " 'Organization': {'OrgFullName': 'Wroclaw Medical University',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'ChloroQUine As antiviRal treAtmeNT In coroNavirus infEction 2020',\n", - " 'OfficialTitle': 'Multicenter, Randomized, Open-label, Non-commercial, Investigator-initiated Study to Evaluate the Effectiveness and Safety of Chloroquine Phosphate in Combination With Telemedicine in the Reduction of Risk of Disease-related Hospitalization or Death, in Ambulatory Patients With COVID-19 at Particular Risk of Serious Complications',\n", - " 'Acronym': 'QUARANTINE2020'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 6, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'September 30, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 30, 2020',\n", - " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 2, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Wroclaw Medical University',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No',\n", - " 'IsUSExport': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'The aim of the study is to evaluate whether the therapy with chloroquine phosphate (CQ, in combination with telemedical approach) in addition to standard care is effective and safe in reducing composite endpoint of COVID-19-related hospitalization or all cause death, in ambulatory patients with SARS-SoV-2 infection at particular risk of serious complications due to advanced age and/or comorbid conditions (in comparison with subjects not treated with CQ but receiving standard care and supervised telemedically).',\n", - " 'DetailedDescription': 'Until now there are no evidence-based, good-quality data from sufficiently powered clinical trials supporting the use of any antiviral medicines or immunomodulatory therapies in the management or prophylaxis of COVID-19; however there are currently being initiated studies in Europe and U.S., and a few registered studies are ongoing in China. Currently two groups of medicines are hypothesized to be effective therapeutic options in COVID-19: (1) classical antiviral drugs interfering with pathogen dissemination / replication, and (2) compounds inhibiting host inflammatory reactions, especially (and potentially selectively) in respiratory tract / system (cytokine inhibitors and specific antibodies). Special hopes are placed in quinoline derivatives such as chloroquine (CQ), based on some unpublished data from China and a few experiments in vitro. CQ is an old antimalarial drug that has been used for more than 50 years in the therapy and prevention of this parasitosis. Anti-inflammatory features of quinolone derivatives such as CQ or hydroxychloroquine have also been used in rheumatology (for the therapy of lupus erythematosus or rheumatoid arthritis) due to the inhibition of the production of proinflammatory cytokines. The effectiveness (and safety) of CQ in COVID-19 has not been investigated in sufficiently powered RCTs until now.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", - " 'KeywordList': {'Keyword': ['COVID-19']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 4']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '400',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'CHLOROQUINE',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Standard of care + chloroquine phosphate + telemedical approach.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Chloroquine phosphate',\n", - " 'Other: Telemedicine']}},\n", - " {'ArmGroupLabel': 'CONTROL GROUP',\n", - " 'ArmGroupType': 'Other',\n", - " 'ArmGroupDescription': 'Standard of care + telemedical approach.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: Telemedicine']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Chloroquine phosphate',\n", - " 'InterventionDescription': 'Oral chloroquine phosphate for 14 days',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['CHLOROQUINE']}},\n", - " {'InterventionType': 'Other',\n", - " 'InterventionName': 'Telemedicine',\n", - " 'InterventionDescription': 'Telemedical supervision for 42 days',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['CHLOROQUINE',\n", - " 'CONTROL GROUP']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'COVID-19-related hospitalization or all-cause death',\n", - " 'PrimaryOutcomeDescription': 'Composite endpoint of COVID-19-related hospitalization or all-cause death',\n", - " 'PrimaryOutcomeTimeFrame': '15 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Decrease in COVID-19 symptoms',\n", - " 'SecondaryOutcomeDescription': 'Decrease in self-reported symptoms of novel coronavirus infection. Non-dichotomous symptoms (e.g. syncope is dichotomous - yes or no) such as dyspnoea will be self-evaluated by patients using the 0-3 scale with the severity increasing with the punctation (0-no symptoms, 1-mild symptoms, 2-moderate symptoms, 3-severe symptoms).',\n", - " 'SecondaryOutcomeTimeFrame': '15 days and 42 days'},\n", - " {'SecondaryOutcomeMeasure': 'Development of pneumonia',\n", - " 'SecondaryOutcomeDescription': 'Based on X-ray, microbiology and laboratory results',\n", - " 'SecondaryOutcomeTimeFrame': '42 days'},\n", - " {'SecondaryOutcomeMeasure': 'Development of coronavirus infection-related complications',\n", - " 'SecondaryOutcomeDescription': 'Acute respiratory distress syndrome, bacterial infection, shock, sepsis, etc',\n", - " 'SecondaryOutcomeTimeFrame': '42 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'INCLUSION CRITERIA\\n\\nage >=60 years OR age 18-59 years with one of the following conditions:\\n\\nchronic lung disease\\nchronic cardiovascular disease\\ndiabetes\\nmalignancy diagnosed within 5 years prior to enrollment\\nchronic kidney disease\\nSARS-CoV-2 infection confirmed in RT-PCR (nasopharyngeal swab)\\nHospitalization not required based on clinical judgement\\nAbility to participate in telemedical care\\n\\nEXCLUSION CRITERIA\\n\\nLack of written informed consent\\nPossible failure to comply with the protocol\\nChloroquine, hydroxychloroquine or other antiviral therapy within 3 months prior to enrollment\\nContraindications to chloroquine (pregnancy, breast-feeding, severe renal insufficiency, amiodarone or anticolvunsants therapy, alcohol disease, haematological disorders, epilepsia, porphyria, liver disease/cirrhosis, retinopathy, fainting/syncope, myasthenia)\\nHIV infection\\nConcurrent participation in another interventional clinical trial\\nHypersensitivity to chloroquine or drug excipients\\nOther relevant circumstances/conditions based on clinical judgement',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Marta Duda-Sikula, MBA',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '48 71 784 00 34',\n", - " 'CentralContactEMail': 'marta.duda-sikula@umed.wroc.pl'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000002738',\n", - " 'InterventionMeshTerm': 'Chloroquine'},\n", - " {'InterventionMeshId': 'C000023676',\n", - " 'InterventionMeshTerm': 'Chloroquine diphosphate'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000563',\n", - " 'InterventionAncestorTerm': 'Amebicides'},\n", - " {'InterventionAncestorId': 'D000000981',\n", - " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", - " {'InterventionAncestorId': 'D000000977',\n", - " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", - " {'InterventionAncestorId': 'D000000890',\n", - " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", - " {'InterventionAncestorId': 'D000000962',\n", - " 'InterventionAncestorTerm': 'Antimalarials'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'},\n", - " {'InterventionAncestorId': 'D000000894',\n", - " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents, Non-Steroidal'},\n", - " {'InterventionAncestorId': 'D000018712',\n", - " 'InterventionAncestorTerm': 'Analgesics, Non-Narcotic'},\n", - " {'InterventionAncestorId': 'D000000700',\n", - " 'InterventionAncestorTerm': 'Analgesics'},\n", - " {'InterventionAncestorId': 'D000018689',\n", - " 'InterventionAncestorTerm': 'Sensory System Agents'},\n", - " {'InterventionAncestorId': 'D000018373',\n", - " 'InterventionAncestorTerm': 'Peripheral Nervous System Agents'},\n", - " {'InterventionAncestorId': 'D000045505',\n", - " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", - " {'InterventionAncestorId': 'D000000893',\n", - " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents'},\n", - " {'InterventionAncestorId': 'D000005369',\n", - " 'InterventionAncestorTerm': 'Filaricides'},\n", - " {'InterventionAncestorId': 'D000000969',\n", - " 'InterventionAncestorTerm': 'Antinematodal Agents'},\n", - " {'InterventionAncestorId': 'D000000871',\n", - " 'InterventionAncestorTerm': 'Anthelmintics'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M4562',\n", - " 'InterventionBrowseLeafName': 'Chloroquine',\n", - " 'InterventionBrowseLeafAsFound': 'Chloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M151035',\n", - " 'InterventionBrowseLeafName': 'Chloroquine diphosphate',\n", - " 'InterventionBrowseLeafAsFound': 'Chloroquine phosphate',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M2895',\n", - " 'InterventionBrowseLeafName': 'Antiviral Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2879',\n", - " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2875',\n", - " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2795',\n", - " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2861',\n", - " 'InterventionBrowseLeafName': 'Antimalarials',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19188',\n", - " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2798',\n", - " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2799',\n", - " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents, Non-Steroidal',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2613',\n", - " 'InterventionBrowseLeafName': 'Analgesics',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19370',\n", - " 'InterventionBrowseLeafName': 'Analgesics, Non-Narcotic',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2777',\n", - " 'InterventionBrowseLeafName': 'Anthelmintics',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", - " {'InterventionBrowseBranchAbbrev': 'Infl',\n", - " 'InterventionBrowseBranchName': 'Anti-Inflammatory Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'Analg',\n", - " 'InterventionBrowseBranchName': 'Analgesics'}]}},\n", - " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M5428',\n", - " 'ConditionBrowseLeafName': 'Death',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 39,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04323514',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '3143'},\n", - " 'Organization': {'OrgFullName': 'University of Palermo',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Use of Ascorbic Acid in Patients With COVID 19',\n", - " 'OfficialTitle': 'Use of Ascorbic Acid in Patients With COVID 19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 13, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 13, 2021',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'March 13, 2021',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 18, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 24, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 26, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 24, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 26, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Salvatore Corrao, MD',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Professor',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'University of Palermo'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'University of Palermo',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Different studies showed that ascorbic acid (vitaminC) positively affects the development and maturation of T-lymphocytes, in particular NK (natural Killer) cells involved in the immune response to viral agents. It also contributes to the inhibition of ROS production and to the remodulation of the cytokine network typical of systemic inflammatory syndrome.\\n\\nRecent studies have also demonstrated the effectiveness of vitamin C administration in terms of reducing mortality, in patients with sepsis hospitalized in intensive care wards.\\n\\nGiven this background, in the light of the current COVID-19 emergency, since the investigators cannot carry out a randomized controlled trial, it is their intention to conduct a study in the cohort of hospitalized patients with covid-19 pneumonia, administering 10 gr of vitamin C intravenously in addition to conventional therapy.',\n", - " 'DetailedDescription': 'The Sars-COV-2, has spread all over the world, in two months after its discovery in China. Outbreaks have been reported in more than 50 countries with more than 118,223 confirmed cases and 4,291 deaths worldwide. In Italy, the scenario is progressively worsening with 8514 confirmed cases and 631 deaths at 10/3/2020.\\n\\nAlong with the spread of this new virus there has been an increase in the number of pneumonia identified with the term novel coronavirus (2019-nCoV)-infected pneumonia (NCIP), which are characterized by fever, asthenia, dry cough, lymphopenia, prolonged prothrombin time, elevated lactic dehydrogenase, and a tomographic imaging indicative of interstitial pneumonia (ground glass and patchy shadows).\\n\\nRecent studies have shown the efficacy of vitamin C and thiamine administration in patients hospitalized for sepsis in the setting of intensive wards in terms of mortality reduction. The use of intravenously vitamin C arises from the experimental evidence of its anti-inflammatory and antioxidant properties. Vitamin C causes a greater proliferation of natural killers without affecting their functionality. Moreover, the vitamin C reduces the production of ROS (reactive oxygen species) that contribute to the activation of the inflammosomi and, in particular, the NLRP3 that affetcs the maturation and secretion of cytokines such as IL1beta and IL-18 that are involved in the inflammatory systemic syndrome that characterized sepsis. Vitamin C blocks the expression of ICAM-1 and activation of NFKappaB that are involved in inflammatory, neoplastic, and apoptotic processes by the inhibition of TNFalfa.\\n\\nFor this reason, the use of vitamin C could be effective in terms of mortality and secondary outcomes in the cohort of patients with covid-19 pneumonia.\\n\\nIn view of the emergency of SARS-VOC-2 and the impossibility of carrying out a randomized controlled study, it is their intention to conduct an intervention protocol (administration of 10 grams of vitamin C intravenously in addition to conventional therapy) involving the cohort of hospitalized patients with covid-19 pneumonia.\\n\\nMethods:\\n\\nAn uncontrolled longitudinal study will be conducted at the Arnas Civico-di Cristina-Benfratelli National Relevance Hospital in Palermo. This study will include all patients consecutively hospitalized with positive swab test of SARS-CoV-2 and interstitial pneumonia or with interstitial pneumonia with indication of intubation. At the admission, data will be collected: personal and anamnestic information, clinical and laboratory findings such as Gender, Age, Ethnicity, Comorbidities, Drugs, blood urea nitrogen, Creatinine, Electrolytes, Blood cell count, Clearance of the lactates, PCR, PCT, SOFA score, liver function, Coagulation, Blood gas analysis, Systolic and Diastolic Blood Pressure, Sp02, Glycaemia, Body Mass Index (BMI). Length of hospital stay will be recorded. After written informed consent, 10 grams of vitamin C in 250 ml of saline to infuse at a rate of 60 drops / minute will be administered. In-hospital mortality, reduction of PCR levels > 50% in comparison with PCR levels at the admission within 72 hours after the administration, lactate clearance, length of hospital stay, resolution of symptoms, duration of positive swab (days). Resolution of the CT imaging will be analysed. Stata Statistical Software: Release 14.1. College Station, TX: StataCorp LP) was used for database management and analysis.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Hospitalized Patients With Covid-19 Pneumonia']},\n", - " 'KeywordList': {'Keyword': ['pneumonia',\n", - " 'covid-19',\n", - " 'hospitalized patients',\n", - " 'vitamin C']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Not Applicable']},\n", - " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '500',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Patients with COVID-19 pneumonia',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Consecutive patients with COVID-19 pneumonia admitted to ARNAS Civico-Di Cristina-Benfratelli, Palermo',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Dietary Supplement: Vitamin C']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Dietary Supplement',\n", - " 'InterventionName': 'Vitamin C',\n", - " 'InterventionDescription': '10 gr of vitamin C intravenously in addition to conventional therapy.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Patients with COVID-19 pneumonia']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'In-hospital mortality',\n", - " 'PrimaryOutcomeDescription': 'Change of hospital mortality',\n", - " 'PrimaryOutcomeTimeFrame': '72 hours'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'PCR levels',\n", - " 'SecondaryOutcomeDescription': 'Reduction of PCR levels > 50% in comparison with PCR levels at the admission, within 72 hours after the administration',\n", - " 'SecondaryOutcomeTimeFrame': '72 hours'},\n", - " {'SecondaryOutcomeMeasure': 'Lactate clearance',\n", - " 'SecondaryOutcomeDescription': 'Change of the lactate clearance',\n", - " 'SecondaryOutcomeTimeFrame': '72 hours'},\n", - " {'SecondaryOutcomeMeasure': 'Hospital stay',\n", - " 'SecondaryOutcomeDescription': 'Change of hospital stay days',\n", - " 'SecondaryOutcomeTimeFrame': '72 hours'},\n", - " {'SecondaryOutcomeMeasure': 'Symptoms',\n", - " 'SecondaryOutcomeDescription': 'Resolution of symptoms (Fever, Cough, Shortness of breath or difficulty breathing)',\n", - " 'SecondaryOutcomeTimeFrame': '72 hours'},\n", - " {'SecondaryOutcomeMeasure': 'Positive swab',\n", - " 'SecondaryOutcomeDescription': 'Change of duration of positive swab (nasopharynx and throat)',\n", - " 'SecondaryOutcomeTimeFrame': '72 hours'},\n", - " {'SecondaryOutcomeMeasure': 'Tomography imaging',\n", - " 'SecondaryOutcomeDescription': 'Resolution of tomography imaging (example, patches located in the subpleural regions of the lung)',\n", - " 'SecondaryOutcomeTimeFrame': '72 hours'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nIn case of doubt of interstitial pneumonia with indications for intubation\\nPositive swab test of SARS-CoV-2\\nInterstitial pneumonia\\nSignature of informed consent\\n\\nExclusion Criteria:\\n\\nUnsigned informed consent\\nNegative swab test of SARS-CoV-2',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Salvatore Corrao, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+390916662717',\n", - " 'CentralContactEMail': 's.corrao@tiscali.it'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'A.R.N.A.S. Civico - Di Cristina - Benfratelli',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Palermo',\n", - " 'LocationZip': '90127',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Salvatore Corrao, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+390916662717',\n", - " 'LocationContactEMail': 's.corrao@tiscali.it'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DocumentSection': {'LargeDocumentModule': {'LargeDocList': {'LargeDoc': [{'LargeDocTypeAbbrev': 'Prot_SAP_ICF',\n", - " 'LargeDocHasProtocol': 'Yes',\n", - " 'LargeDocHasSAP': 'Yes',\n", - " 'LargeDocHasICF': 'Yes',\n", - " 'LargeDocLabel': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form',\n", - " 'LargeDocDate': 'March 12, 2020',\n", - " 'LargeDocUploadDate': '03/24/2020 05:48',\n", - " 'LargeDocFilename': 'Prot_SAP_ICF_000.pdf'}]}}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000014815',\n", - " 'InterventionMeshTerm': 'Vitamins'},\n", - " {'InterventionMeshId': 'D000001205',\n", - " 'InterventionMeshTerm': 'Ascorbic Acid'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000018977',\n", - " 'InterventionAncestorTerm': 'Micronutrients'},\n", - " {'InterventionAncestorId': 'D000078622',\n", - " 'InterventionAncestorTerm': 'Nutrients'},\n", - " {'InterventionAncestorId': 'D000006133',\n", - " 'InterventionAncestorTerm': 'Growth Substances'},\n", - " {'InterventionAncestorId': 'D000045505',\n", - " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", - " {'InterventionAncestorId': 'D000000975',\n", - " 'InterventionAncestorTerm': 'Antioxidants'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000020011',\n", - " 'InterventionAncestorTerm': 'Protective Agents'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M16141',\n", - " 'InterventionBrowseLeafName': 'Vitamins',\n", - " 'InterventionBrowseLeafAsFound': 'Vitamin',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M3094',\n", - " 'InterventionBrowseLeafName': 'Ascorbic Acid',\n", - " 'InterventionBrowseLeafAsFound': 'Vitamin C',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M15468',\n", - " 'InterventionBrowseLeafName': 'Trace Elements',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19593',\n", - " 'InterventionBrowseLeafName': 'Micronutrients',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M1986',\n", - " 'InterventionBrowseLeafName': 'Nutrients',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2873',\n", - " 'InterventionBrowseLeafName': 'Antioxidants',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M20453',\n", - " 'InterventionBrowseLeafName': 'Protective Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'T437',\n", - " 'InterventionBrowseLeafName': 'Ascorbic Acid',\n", - " 'InterventionBrowseLeafAsFound': 'Ascorbic acid',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'T477',\n", - " 'InterventionBrowseLeafName': 'Vitamin C',\n", - " 'InterventionBrowseLeafAsFound': 'Vitamin C',\n", - " 'InterventionBrowseLeafRelevance': 'high'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Micro',\n", - " 'InterventionBrowseBranchName': 'Micronutrients'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", - " {'InterventionBrowseBranchAbbrev': 'Vi',\n", - " 'InterventionBrowseBranchName': 'Vitamins'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000011014',\n", - " 'ConditionMeshTerm': 'Pneumonia'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000008171',\n", - " 'ConditionAncestorTerm': 'Lung Diseases'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M12487',\n", - " 'ConditionBrowseLeafName': 'Pneumonia',\n", - " 'ConditionBrowseLeafAsFound': 'Pneumonia',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M9751',\n", - " 'ConditionBrowseLeafName': 'Lung Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'}]}}}}},\n", - " {'Rank': 40,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04292327',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'KY-2020-24.01'},\n", - " 'Organization': {'OrgFullName': 'Fujian Provincial Hospital',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Clinical Progressive Characteristics and Treatment Effects of 2019-novel Coronavirus',\n", - " 'OfficialTitle': 'Clinical Progressive Characteristics and Treatment Effects of 2019-novel Coronavirus(2019-nCoV)',\n", - " 'Acronym': '2019-nCoV'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'February 2020',\n", - " 'OverallStatus': 'Active, not recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'January 1, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 30, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'July 31, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'February 23, 2020',\n", - " 'StudyFirstSubmitQCDate': 'February 29, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 3, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'February 29, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 3, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Xiuling Shang',\n", - " 'ResponsiblePartyInvestigatorTitle': 'associate chief physician',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Fujian Provincial Hospital'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Fujian Provincial Hospital',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': \"Objects: The purpose of this study was to observe the characteristics of morbidity, disease progression and therapeutic effects of 2019-novel coronavirus pneumonia patients with different clinical types.\\n\\nMethod: A single center, retrospective and observational study was used to collect COVID-19 patients admitted to Wuhan Infectious Diseases Hospital (Wuhan JinYinTan Hospital) from January 2020 to March 2020. The general information, first clinical symptoms, hospitalization days, laboratory examination, CT examination, antiviral drugs, immune enhancers, traditional Chinese medicine treatment and other clinical intervention measures were recorded, and the nutritional status and prognosis of the patients were recorded. confirm COVID-19 's disease progression, clinical characteristics, disease severity and treatment effects. To compare the characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19.\\n\\nOutcomes: The characteristics of disease progression, clinical features, disease severity and therapeutic effect of different types of COVID-19.\\n\\nConclusion: The characteristics of disease progression, clinical features and therapeutic effect of different types of COVID-19.\",\n", - " 'DetailedDescription': \"Since December 2019, patients with unexplained pneumonia have appeared in some medical institutions in Wuhan, China. Nucleic acid testing was completed on January 10, 2020, which was confirmed to be caused by 2019-novel coronavirus. In 2020, the World Health Organization(WHO) named the virus 2019-novel coronavirus(2019-nCoV). The WHO announced that the pneumonia caused by 2019-nCoV is officially called COVID-19. Today, more than 70,000 cases have been confirmed and more than 2,000 patients have died.\\n\\nAt present, the epidemiological characteristics, laboratory indicators, imaging features and clinical treatment effects of COVID-19 should be reported, but the sample size is small. Large sample studies are still needed to further confirm COVID-19 's disease progression, clinical characteristics, disease severity and treatment effects, so as to provide a scientific basis for future clinical treatment. Therefore, it is particularly important to further review the relationship between the characteristics and prognosis of such patients.\"},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Pneumonia Caused by Human Coronavirus']},\n", - " 'KeywordList': {'Keyword': ['2019-novel coronavirus', 'Pneumonia']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Other']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Retrospective']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '400',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'The ordinary COVID-19',\n", - " 'ArmGroupDescription': 'Consistent with the diagnosis of ordinary COVID-19.'},\n", - " {'ArmGroupLabel': 'The heavy COVID-19.',\n", - " 'ArmGroupDescription': 'Consistent with the diagnosis of heavy COVID-19.'},\n", - " {'ArmGroupLabel': 'The critical COVID-19',\n", - " 'ArmGroupDescription': 'Consistent with the diagnosis of critical COVID-19'}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Mortality',\n", - " 'PrimaryOutcomeDescription': 'The mortality of COVID-19 in 28 days',\n", - " 'PrimaryOutcomeTimeFrame': '28 day'},\n", - " {'PrimaryOutcomeMeasure': 'The time interval of Nucleic acid detection become negative',\n", - " 'PrimaryOutcomeDescription': 'The time interval of COVID-19 form nucleic acid confirmed to the nucleic acid detection turn into negative.',\n", - " 'PrimaryOutcomeTimeFrame': '28 day'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion criteria.\\n\\n2019-nCov (SARA-Cov-2) nucleic acid positive detected by PCR.\\nOlder than 18 years old and younger than 75 years old.\\nMeet the diagnostic criteria of COVID-19 for different types (including ordinary type, heavy type and critical type)\\n\\nExclusion criteria.\\n\\nthe age is less than 18 years old;\\npregnant or lactating women;\\nsevere underlying diseases, such as advanced malignant tumor, end-stage lung disease, etc.',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '75 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'Collect COVID-19 patients admitted to Wuhan Infectious Diseases Hospital (Wuhan JinYinTan Hospital) from January 2020 to March 2020',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Xiuling Shang',\n", - " 'OverallOfficialAffiliation': 'Fujian Provincial Hospital',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Fujian Provincial Hospital',\n", - " 'LocationCity': 'Fuzhou',\n", - " 'LocationState': 'Fujian',\n", - " 'LocationZip': '350000',\n", - " 'LocationCountry': 'China'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", - " {'ConditionMeshId': 'D000011014', 'ConditionMeshTerm': 'Pneumonia'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000008171',\n", - " 'ConditionAncestorTerm': 'Lung Diseases'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", - " {'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M12487',\n", - " 'ConditionBrowseLeafName': 'Pneumonia',\n", - " 'ConditionBrowseLeafAsFound': 'Pneumonia',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M9751',\n", - " 'ConditionBrowseLeafName': 'Lung Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 41,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04313023',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'PUL-042-501'},\n", - " 'Organization': {'OrgFullName': 'Pulmotect, Inc.',\n", - " 'OrgClass': 'INDUSTRY'},\n", - " 'BriefTitle': 'The Use PUL-042 Inhalation Solution to Prevent COVID-19 in Adults Exposed to SARS-CoV-2',\n", - " 'OfficialTitle': 'A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing COVID-19 Infection in Adults Exposed to COVID-19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'September 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'October 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 16, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 16, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 18, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 22, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 24, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Pulmotect, Inc.',\n", - " 'LeadSponsorClass': 'INDUSTRY'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'Yes',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Subjects who have documented exposure to SARS-CoV-2 (COVID-19) and test negative for SARS-CoV-2 infection will receive 4 doses of PUL-042 Inhalation Solution or 4 doses of a placebo solution by inhalation over 2 weeks. Subjects must be under quarantine in a controlled facility or hospital (home quarantine is not sufficient). Subjects will be under observation and tested for infection with SARS-CoV-2 over a 14 day period.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 2']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Prevention',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Quadruple',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", - " 'Care Provider',\n", - " 'Investigator',\n", - " 'Outcomes Assessor']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '200',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'PUL-042 Inhalation Solution',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'PUL-042 Inhalation Solution given by nebulization on study days 1,3, 6, and 10',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: PUL-042 Inhalation Solution']}},\n", - " {'ArmGroupLabel': 'Sterile normal saline for inhalation',\n", - " 'ArmGroupType': 'Placebo Comparator',\n", - " 'ArmGroupDescription': 'Sterile normal saline for inhalation given by nebulization on study days 1, 3, 6, and 10',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'PUL-042 Inhalation Solution',\n", - " 'InterventionDescription': '20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042) PUL-042 Inhalation Solution will be given by nebulization on study days 1, 3, 6, and 10',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['PUL-042 Inhalation Solution']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Placebo',\n", - " 'InterventionDescription': 'Sterile normal saline for inhalation',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Sterile normal saline for inhalation']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Prevention of COVID-19',\n", - " 'PrimaryOutcomeDescription': 'Difference in the incidence of infection with SARS-CoV-2',\n", - " 'PrimaryOutcomeTimeFrame': '14 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\n1. Subjects must have documented exposure to COVID-19 and have a documented negative test for the virus within 72 hours of the administration of study drug\\n2. Subjects must be free of clinical symptoms (fever, cough, shortness of breath) of a potential COVID-19 infection\\n3. Subjects must be under quarantine in a controlled facility or hospital (home quarantine is not sufficient)\\n4. Spirometry (forced expiratory volume in one second [FEV1] and forced vital capacity [FVC]) ≥70% of predicted value\\n5. If female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception must be: practicing two effective methods of birth control (acceptable methods include intrauterine device, spermicide, barrier, male partner surgical sterilization, and hormonal contraception) during the study and through 30 days after completion of the study. Abstinence is not classified as an effective method of birth control.\\n6. If female, must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study. A pregnancy test must be negative at the Screening Visit, prior to dosing on Day 1.\\n7. If male, must be surgically sterile or willing to practice two effective methods of birth control (acceptable methods include barrier, spermicide, or female partner surgical sterilization) during the study and through 30 days after completion of the study. Abstinence is not classified as an effective method of birth control.\\n8. Ability to understand and give informed consent.\\n\\nExclusion Criteria:\\n\\n1. Documented infection with COVID-19\\n2. Clinical signs and symptoms consistent with COVID-19 infection (fever, cough, shortness of breath) at the time of screening\\n3. Known history of chronic pulmonary disease (e.g., asthma [including atopic asthma, exercise-induced asthma, or asthma triggered by respiratory infection], chronic pulmonary disease, pulmonary fibrosis, COPD), pulmonary hypertension, or heart failure.\\n4. Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints.\\n5. Previous exposure to PUL-042 Inhalation Solution',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Colin Broom, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '713-579-9226',\n", - " 'CentralContactEMail': 'clinicaltrials@pulmotect.com'},\n", - " {'CentralContactName': 'Brenton Scott, Ph D',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '713-579-9226',\n", - " 'CentralContactEMail': 'clincaltrials@pulmotect.com'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Colin Broom, MD',\n", - " 'OverallOfficialAffiliation': 'Pulmotect, Inc.',\n", - " 'OverallOfficialRole': 'Study Director'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'C000627946',\n", - " 'InterventionMeshTerm': 'PUL-042'},\n", - " {'InterventionMeshId': 'D000019999',\n", - " 'InterventionMeshTerm': 'Pharmaceutical Solutions'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000019141',\n", - " 'InterventionAncestorTerm': 'Respiratory System Agents'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M20444',\n", - " 'InterventionBrowseLeafName': 'Pharmaceutical Solutions',\n", - " 'InterventionBrowseLeafAsFound': 'Solution',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M266568',\n", - " 'InterventionBrowseLeafName': 'PUL-042',\n", - " 'InterventionBrowseLeafAsFound': 'PUL-042',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M19721',\n", - " 'InterventionBrowseLeafName': 'Respiratory System Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", - " {'InterventionBrowseBranchAbbrev': 'Resp',\n", - " 'InterventionBrowseBranchName': 'Respiratory System Agents'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000053120',\n", - " 'ConditionMeshTerm': 'Respiratory Aspiration'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000012120',\n", - " 'ConditionAncestorTerm': 'Respiration Disorders'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", - " {'ConditionAncestorId': 'D000010335',\n", - " 'ConditionAncestorTerm': 'Pathologic Processes'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M25724',\n", - " 'ConditionBrowseLeafName': 'Respiratory Aspiration',\n", - " 'ConditionBrowseLeafAsFound': 'Inhalation',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M13540',\n", - " 'ConditionBrowseLeafName': 'Respiration Disorders',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'}]}}}}},\n", - " {'Rank': 42,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04313322',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'COVID-19'},\n", - " 'Organization': {'OrgFullName': 'Stem Cells Arabia',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': \"Treatment of COVID-19 Patients Using Wharton's Jelly-Mesenchymal Stem Cells\",\n", - " 'OfficialTitle': \"Treatment of COVID-19 Patients Using Wharton's Jelly-Mesenchymal Stem Cells\"},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 16, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'June 30, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'September 30, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 15, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 15, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 18, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 15, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 18, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Adeeb Al Zoubi',\n", - " 'ResponsiblePartyInvestigatorTitle': 'President, Chief Scientific Officer',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Stem Cells Arabia'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Stem Cells Arabia',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': \"The purpose of this study is to investigate the potential use of Wharton's Jelly Mesenchymal stem cells (WJ-MSCs) for treatment of patient diagnosed with Corona Virus SARS-CoV-2 infection, and showing symptoms of COVID-19.\",\n", - " 'DetailedDescription': 'COVID-19 is a condition caused by infection with Coronoa Virus (SARS-CoV-2). This virus has a high transmission rate and is spreading at very high rates. causing a worldwide pandemic. Patients diagnosed with COVID-19 and confirmed positive with the virus, will be given three IV doses of WJ-MSCs consisting of 1X10e6/kg. The three doses will be 3 days apart form each other.\\n\\nPatients will be followed up for a period of three weeks to assess the severity of the condition and measure the viral titers.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Use of Stem Cells for COVID-19 Treatment']},\n", - " 'KeywordList': {'Keyword': ['Stem Cells, COVID-19, SARS CoV2, WJ MSCs, Immunomodulation,']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 1']},\n", - " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", - " 'DesignInterventionModelDescription': 'Patients positively diagnosed with COVID-19',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)',\n", - " 'DesignMaskingDescription': 'None. This is a direct study for the potential effects of WJ-MSCs on COVID-19 outcome.'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '5',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'WJ-MSCs',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'WJ-MSCs will be derived from cord tissue of newborns, screened for HIV1/2, HBV, HCV, CMV, Mycoplasma, and cultured to enrich for MSCs.\\n\\nWJ-MSCs will be counted and suspended in 25 ml of Saline solution containing 0.5% human serum Albumin, and will be given to patient intravenously.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: WJ-MSCs']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Biological',\n", - " 'InterventionName': 'WJ-MSCs',\n", - " 'InterventionDescription': 'WJ-MSCs will be derived from cord tissue of newborns, screened for HIV1/2, HBV, HCV, CMV, Mycoplasma, and cultured to enrich for MSCs.\\n\\nWJ-MSCs will be counted and suspended in 25 ml of Saline solution containing 0.5% human serum Albumin, and will be given to patient intravenously.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['WJ-MSCs']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Clinical outcome',\n", - " 'PrimaryOutcomeDescription': 'Improvement of clinical symptoms including duration of fever, respiratory destress, pneumonia, cough, sneezing, diarrhea.',\n", - " 'PrimaryOutcomeTimeFrame': '3 weeks'},\n", - " {'PrimaryOutcomeMeasure': 'CT Scan',\n", - " 'PrimaryOutcomeDescription': 'Side effects measured by Chest Readiograph',\n", - " 'PrimaryOutcomeTimeFrame': '3 weeks'},\n", - " {'PrimaryOutcomeMeasure': 'RT-PCR results',\n", - " 'PrimaryOutcomeDescription': 'Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative',\n", - " 'PrimaryOutcomeTimeFrame': '3 weeks'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'RT-PCR results',\n", - " 'SecondaryOutcomeDescription': 'Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative',\n", - " 'SecondaryOutcomeTimeFrame': '8 weeks'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nCOVID-19 positive according to diagnosis and clinical management of COVID-19 criteria.\\n\\nExclusion Criteria:\\n\\nParticipants in other clinical trials\\npatients with malignant tumors\\npregnant and lactating women\\nco-infection with other infectious viruses or bacteria\\nHistory of several allergies\\nPatients with history of pulmonary embolism\\nany liver or kidney diseases\\nHIV positive patients\\nConsidered by researchers to be not suitable to participate in this clinical trial\\nChronic heart failure with ejection fraction less than 30%.',\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Adeeb M AlZoubi, Ph.D.',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+962795337575',\n", - " 'CentralContactEMail': 'adeebalzoubi@stemcellsarabia.net'},\n", - " {'CentralContactName': 'Ahmad Y AlGhadi, M.Sc.',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+962796624217',\n", - " 'CentralContactEMail': 'ahmed.alghadi@stemcellsarabia.net'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Stem Cells Arabia',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Amman',\n", - " 'LocationZip': '11953',\n", - " 'LocationCountry': 'Jordan',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Adeeb M Alzoubi, Ph.D.',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+962795337575',\n", - " 'LocationContactEMail': 'adeebalzoubi@stemcellsarabia.net'},\n", - " {'LocationContactName': 'Ahmad AlGhadi, M.Sc.',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+962796624217',\n", - " 'LocationContactEMail': 'ahmed.alghadi@stemcellsarabia.net'},\n", - " {'LocationContactName': 'Ahmad Y AlGhadi, M.Sc.',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Sumaya H Aldajah, M.Sc.',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Marwa E Tapponi, Pharm.D.',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Sameh N AlBakheet, B.Sc.',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Mahasen Zalloum, B.Sc.',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M20444',\n", - " 'InterventionBrowseLeafName': 'Pharmaceutical Solutions',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}}}}},\n", - " {'Rank': 43,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04328961',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'STUDY00009750'},\n", - " 'Organization': {'OrgFullName': 'University of Washington',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Hydroxychloroquine for COVID-19 PEP',\n", - " 'OfficialTitle': 'Efficacy of Hydroxychloroquine for Post-exposure Prophylaxis (PEP) to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection Among Adults Exposed to Coronavirus Disease (COVID-19): a Blinded, Randomized Study'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'September 30, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'October 31, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 23, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 29, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 29, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Ruanne Barnabas',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Associate Professor, School of Medicine: Global Health',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'University of Washington'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'University of Washington',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'New York University',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'Bill and Melinda Gates Foundation',\n", - " 'CollaboratorClass': 'OTHER'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'Yes',\n", - " 'IsFDARegulatedDevice': 'No',\n", - " 'IsUSExport': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'This is a clinical study for the prevention of SARS-CoV-2 infection in adults exposed to the virus. This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) who are close contacts of persons with laboratory confirmed SARS-CoV-2 or clinically suspected COVID-19. Eligible participants will be enrolled and randomized to receive the intervention or placebo at the level of the household (all eligible participants in one household will receive the same intervention).',\n", - " 'DetailedDescription': 'This is a randomized, multi-center, placebo-equivalent (ascorbic acid) controlled, blinded study of Hydroxychloroquine (HCQ) post-exposure prophylaxis (PEP) for the prevention of SARS-CoV-2 infection in adults exposed to the virus.The overarching goal of this study is to assess the effectiveness of HCQ PEP on the incidence of SARS-CoV-2 detection by polymerase chain reaction (PCR) to inform public health control strategies.This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) at baseline who are close contacts of persons with PCR-confirmed SARS-CoV-2 or clinically suspected COVID-19 and a pending SARS-CoV-2 PCR test. Eligible participants will be enrolled and randomized 1:1 to HCQ or ascorbic acid at the level of the household (all eligible participants in one household will receive the same intervention). Participants will be counseled about the preliminary in vitro data on HCQ activity against SARS CoV-2 and equipoise regarding efficacy in humans.The duration of study participation will be approximately 28 days.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", - " 'Corona Virus Infection',\n", - " 'SARS (Severe Acute Respiratory Syndrome)']},\n", - " 'KeywordList': {'Keyword': ['novel coronavirus',\n", - " 'post-exposure prophylaxis']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 1']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Prevention',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Single',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '2000',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Ascorbic Acid',\n", - " 'ArmGroupType': 'Placebo Comparator',\n", - " 'ArmGroupDescription': 'Ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Ascorbic Acid']}},\n", - " {'ArmGroupLabel': 'Hydroxychloroquine',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine Sulfate']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Hydroxychloroquine Sulfate',\n", - " 'InterventionDescription': 'Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Hydroxychloroquine']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['HCQ arm']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Ascorbic Acid',\n", - " 'InterventionDescription': 'Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Ascorbic Acid']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Placebo arm']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection',\n", - " 'PrimaryOutcomeDescription': 'Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected daily for 14 days',\n", - " 'PrimaryOutcomeTimeFrame': 'Day 1 through Day 14 after enrolment'},\n", - " {'PrimaryOutcomeMeasure': 'Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection',\n", - " 'PrimaryOutcomeDescription': 'Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected at study exit',\n", - " 'PrimaryOutcomeTimeFrame': 'Day 28 after enrolment'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Rate of participant-reported adverse events',\n", - " 'SecondaryOutcomeDescription': 'Safety and tolerability of Hydroxychloroquine as SARS-CoV-2 PEP in adults',\n", - " 'SecondaryOutcomeTimeFrame': '28 days from start of Hydroxychloroquine therapy'},\n", - " {'SecondaryOutcomeMeasure': 'Incidence rates of COVID-19 through study completion',\n", - " 'SecondaryOutcomeDescription': 'PCR-confirmed COVID-19 diagnosis',\n", - " 'SecondaryOutcomeTimeFrame': '28 days from enrolment'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nMen or women 18 to 80 years of age inclusive, at the time of signing the informed consent\\nWilling and able to provide informed consent\\n\\nHad a close contact of a person (index) with known PCR-confirmed SARS-CoV-2 infection or who is currently being assessed for COVID-19. Close contact defined as:\\n\\nHousehold contact (i.e., residing with the index case in the 14 days prior to index diagnosis)\\nMedical staff, first responders, or other care persons who cared for the index case without personal protection (mask and gloves)\\nLess than 4 days since last exposure (close contact with a person with SARS-CoV-2 infection) to the index case\\nBody weight < 100 kg (self-reported)\\nAccess to device and internet for Telehealth visits\\n\\nExclusion Criteria:\\n\\nKnown hypersensitivity to HCQ or other 4-aminoquinoline compounds\\nCurrently hospitalized\\nSymptomatic with subjective fever, cough, or sore throat\\nCurrent medications exclude concomitant use of HCQ\\nConcomitant use of other anti-malarial treatment or chemoprophylaxis\\nHistory of retinopathy of any etiology\\nPsoriasis\\nPorphyria\\nKnown bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes < 1500) or thrombocytopenia (< 100 K)\\nConcomitant use of digoxin, cyclosporin, cimetidine, or tamoxifen\\nKnown liver disease\\nKnown long QT syndrome\\nUse of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of the study drugs, or planned use during the study period',\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '80 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Meighan Krows',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '206-520-3833',\n", - " 'CentralContactEMail': 'meigs@uw.edu'},\n", - " {'CentralContactName': 'Justice Quame-Amaglo',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '206-520-3866',\n", - " 'CentralContactEMail': 'quamaglo@uw.edu'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Ruanne V. Barnabas, MBChB, DPhil',\n", - " 'OverallOfficialAffiliation': 'University of Washington',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Anna Bershteyn, PhD',\n", - " 'OverallOfficialAffiliation': 'NYU Langone Health',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'NYU Langone Health',\n", - " 'LocationCity': 'New York',\n", - " 'LocationState': 'New York',\n", - " 'LocationZip': '10016',\n", - " 'LocationCountry': 'United States',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Anna Bershteyn, PhD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactEMail': 'anna.bershteyn@nyulangone.org'},\n", - " {'LocationContactName': 'Anna Bershteyn, PhD',\n", - " 'LocationContactRole': 'Principal Investigator'}]}},\n", - " {'LocationFacility': 'University of Washington, Coordinating Center',\n", - " 'LocationCity': 'Seattle',\n", - " 'LocationState': 'Washington',\n", - " 'LocationZip': '98104',\n", - " 'LocationCountry': 'United States'},\n", - " {'LocationFacility': 'UW Virology Research Clinic',\n", - " 'LocationCity': 'Seattle',\n", - " 'LocationState': 'Washington',\n", - " 'LocationZip': '98104',\n", - " 'LocationCountry': 'United States',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Helen Stankiewicz Karita, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '206-520-4340',\n", - " 'LocationContactEMail': 'helensk@uw.edu'},\n", - " {'LocationContactName': 'Kirsten Hauge',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '206-520-4341',\n", - " 'LocationContactEMail': 'kahauge@uw.edu'},\n", - " {'LocationContactName': 'Christine Johnston, MD',\n", - " 'LocationContactRole': 'Principal Investigator'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", - " 'IPDSharingDescription': \"De-identified data from the study will be made available in accordance with the funder's open access policy.\",\n", - " 'IPDSharingInfoTypeList': {'IPDSharingInfoType': ['Study Protocol',\n", - " 'Informed Consent Form (ICF)',\n", - " 'Analytic Code']},\n", - " 'IPDSharingTimeFrame': 'Within 3 months of publication of primary results.',\n", - " 'IPDSharingAccessCriteria': \"De-identified data from the study will be made available in accordance with the funder's open access policy.\",\n", - " 'IPDSharingURL': 'https://www.gatesfoundation.org/how-we-work/general-information/open-access-policy'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000001205',\n", - " 'InterventionMeshTerm': 'Ascorbic Acid'},\n", - " {'InterventionMeshId': 'D000006886',\n", - " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", - " 'InterventionAncestorTerm': 'Antimalarials'},\n", - " {'InterventionAncestorId': 'D000000981',\n", - " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", - " {'InterventionAncestorId': 'D000000977',\n", - " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", - " {'InterventionAncestorId': 'D000000890',\n", - " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", - " {'InterventionAncestorId': 'D000004791',\n", - " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'},\n", - " {'InterventionAncestorId': 'D000000975',\n", - " 'InterventionAncestorTerm': 'Antioxidants'},\n", - " {'InterventionAncestorId': 'D000020011',\n", - " 'InterventionAncestorTerm': 'Protective Agents'},\n", - " {'InterventionAncestorId': 'D000045505',\n", - " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", - " {'InterventionAncestorId': 'D000014815',\n", - " 'InterventionAncestorTerm': 'Vitamins'},\n", - " {'InterventionAncestorId': 'D000018977',\n", - " 'InterventionAncestorTerm': 'Micronutrients'},\n", - " {'InterventionAncestorId': 'D000078622',\n", - " 'InterventionAncestorTerm': 'Nutrients'},\n", - " {'InterventionAncestorId': 'D000006133',\n", - " 'InterventionAncestorTerm': 'Growth Substances'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", - " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M3094',\n", - " 'InterventionBrowseLeafName': 'Ascorbic Acid',\n", - " 'InterventionBrowseLeafAsFound': 'Ascorbic acid',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M2861',\n", - " 'InterventionBrowseLeafName': 'Antimalarials',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2879',\n", - " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2875',\n", - " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2795',\n", - " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19188',\n", - " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2873',\n", - " 'InterventionBrowseLeafName': 'Antioxidants',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M20453',\n", - " 'InterventionBrowseLeafName': 'Protective Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M16141',\n", - " 'InterventionBrowseLeafName': 'Vitamins',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M15468',\n", - " 'InterventionBrowseLeafName': 'Trace Elements',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19593',\n", - " 'InterventionBrowseLeafName': 'Micronutrients',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M1986',\n", - " 'InterventionBrowseLeafName': 'Nutrients',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'T437',\n", - " 'InterventionBrowseLeafName': 'Ascorbic Acid',\n", - " 'InterventionBrowseLeafAsFound': 'Ascorbic acid',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'T477',\n", - " 'InterventionBrowseLeafName': 'Vitamin C',\n", - " 'InterventionBrowseLeafAsFound': 'Ascorbic acid',\n", - " 'InterventionBrowseLeafRelevance': 'high'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", - " {'InterventionBrowseBranchAbbrev': 'Micro',\n", - " 'InterventionBrowseBranchName': 'Micronutrients'},\n", - " {'InterventionBrowseBranchAbbrev': 'Vi',\n", - " 'InterventionBrowseBranchName': 'Vitamins'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", - " 'ConditionMeshTerm': 'Infection'},\n", - " {'ConditionMeshId': 'D000045169',\n", - " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'},\n", - " {'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", - " {'ConditionMeshId': 'D000013577', 'ConditionMeshTerm': 'Syndrome'},\n", - " {'ConditionMeshId': 'D000014777',\n", - " 'ConditionMeshTerm': 'Virus Diseases'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000004194',\n", - " 'ConditionAncestorTerm': 'Disease'},\n", - " {'ConditionAncestorId': 'D000010335',\n", - " 'ConditionAncestorTerm': 'Pathologic Processes'},\n", - " {'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafAsFound': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafAsFound': 'Virus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 44,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04304053',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'HCQ4COV19'},\n", - " 'SecondaryIdInfoList': {'SecondaryIdInfo': [{'SecondaryId': '2020-001031-27',\n", - " 'SecondaryIdType': 'EudraCT Number'}]},\n", - " 'Organization': {'OrgFullName': 'Fundacio Lluita Contra la SIDA',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts as Prevention',\n", - " 'OfficialTitle': 'Treatment of Non-severe Confirmed Cases of COVID-19 and Chemoprophylaxis of Their Contacts as Prevention Strategy: a Cluster Randomized Clinical Trial (PEP CoV-2 Study)',\n", - " 'Acronym': 'HCQ4COV19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 18, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'June 15, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'June 15, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 5, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 7, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 11, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 22, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 24, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Oriol Mitja',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Prof (Ass) Infectious Disease and Global Health',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Germans Trias i Pujol Hospital'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Fundacio Lluita Contra la SIDA',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Germans Trias i Pujol Hospital',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'Department of Health, Generalitat de Catalunya',\n", - " 'CollaboratorClass': 'OTHER_GOV'},\n", - " {'CollaboratorName': 'FUNDACIÓN FLS DE LUCHA CONTRA EL SIDA, LAS ENFERMEDADES INFECCIOSAS Y LA PROMOCIÓN DE LA SALUD Y LA CIENCIA',\n", - " 'CollaboratorClass': 'UNKNOWN'},\n", - " {'CollaboratorName': 'Laboratorios Gebro Pharma SA',\n", - " 'CollaboratorClass': 'UNKNOWN'},\n", - " {'CollaboratorName': 'Laboratorios Rubió',\n", - " 'CollaboratorClass': 'UNKNOWN'},\n", - " {'CollaboratorName': 'Institut Catala de Salut',\n", - " 'CollaboratorClass': 'OTHER_GOV'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': \"The investigators plan to evaluate the efficacy of the 'test and treat' strategy of infected patients and prophylactic chloroquine treatment to all contacts. The strategy entails decentralized COVID-19 testing and starting antiviral darunavir/cobicistat plus chloroquine treatment immediately in all who are found to be infected. As viral loads decline to undetectable levels, the probability of onward transmission is reduced to very low levels. Such evaluation will require prospective surveillance to assess the population-level effect of transmission prevention.\\n\\nDrug interventions in this protocol will follow the Spanish law about off-label use of medicines.\",\n", - " 'DetailedDescription': \"Previous research on influenza has indicated that antiviral drugs administered before o short after symptom onset can reduce infectiousness to others by reducing viral loads in the respiratory secretions of patients.\\n\\nLopinavir/ritonavir, a protease inhibitor used to treat HIV/AIDS, was found to block COVID-19 infection in vitro at low-micromolar concentration, with a half-maximal effective concentration (EC50) of 8.5 μM. China's guidelines were set up in January 2020 and treated hospitalized patients with lopinavir/ritonavir, either alone or with various combinations. Darunavir (DRV)/Cobicistat, is also a protease inhibitor used to treat and prevent HIV/AIDS. Its as effective as lopinavir/ritonavir for the treatment of HIV/AIDS and better tolerated because the adverse effects rate is lower (diarrhea 2% vs 27%).\\n\\nAnother promising drug is chloroquine, that showed excellent in vitro results and strong antiviral effects on SARS-CoV infection of primate cells. Results from n=100 patients have shown superiority to the control treatment in improving lung imaging findings, promoting virus reversion to negative and shortening the disease.\"},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 3']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignInterventionModelDescription': 'Cluster-randomized clinical trial',\n", - " 'DesignPrimaryPurpose': 'Prevention',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)',\n", - " 'DesignMaskingDescription': 'Open label'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '3040',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'No Intervention- SARS-CoV-2 surveillance',\n", - " 'ArmGroupType': 'Active Comparator',\n", - " 'ArmGroupDescription': 'Subjects exhibiting Acute Respiratory Infection (ARI) symptoms at a participating health care services complete a survey collecting demographic and clinical data and provide a swab for RT-PCR testing. Isolation of patient and contact tracing as per guidelines.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: Standard Public Health measures']}},\n", - " {'ArmGroupLabel': 'Testing, treatment and prophylaxis of SARS-CoV-2',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Subjects exhibiting ARI symptoms at a participating hospital complete a survey collecting demographic and clinical data and provide a swab to be tested on-site with a molecular assay. Isolation of patient and contact tracing as per guidelines. Case receive an antiviral if tested positive (Chloroquine and darunavir/cobicistat). Contacts receive Chloroquine prophylaxis',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Antiviral treatment and prophylaxis',\n", - " 'Other: Standard Public Health measures']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Antiviral treatment and prophylaxis',\n", - " 'InterventionDescription': 'darunavir 800 mg / cobicistat 150 mg tablets (oral, 1 tablet q24h, taking for 7 days) and hydroxychloroquine (200mg tablets) 800mg on day 1, and 400mg on days 2,3,4, 5, 6 and 7.\\n\\nContacts will be offered a prophylactic regimen of hydroxychloroquine (200mg tablets) 800mg on day 1, and 400mg on days 2,3,4.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Testing, treatment and prophylaxis of SARS-CoV-2']}},\n", - " {'InterventionType': 'Other',\n", - " 'InterventionName': 'Standard Public Health measures',\n", - " 'InterventionDescription': 'Isolation of patient and contact tracing as per national guidelines.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['No Intervention- SARS-CoV-2 surveillance',\n", - " 'Testing, treatment and prophylaxis of SARS-CoV-2']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Effectiveness of chemoprophylaxis assessed by incidence of secondary COVID-19 cases',\n", - " 'PrimaryOutcomeDescription': 'Incidence of secondary cases among contacts of a case and contacts of contacts',\n", - " 'PrimaryOutcomeTimeFrame': 'Up to 14 days after start of treatment'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at days 3',\n", - " 'SecondaryOutcomeTimeFrame': '3 days after start of treatment'},\n", - " {'SecondaryOutcomeMeasure': 'The mortality rate of subjects at weeks 2',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 14 days after start of treatment'},\n", - " {'SecondaryOutcomeMeasure': 'Proportion of participants that drop out of study',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 14 days after start of treatment'},\n", - " {'SecondaryOutcomeMeasure': 'Proportion of participants that show non-compliance with study drug',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 14 days after start of treatment'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria for a case:\\n\\nPatients who meet the requirements of the New Coronavirus Infection Diagnosis (Acute respiratory infection symptoms or acute cough alone and positive PCR)\\nAged ≥18 years male or female;\\nIn women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study.\\nWilling to take study medication\\nWilling to comply with all study procedures, including repeat nasal swab at day 3\\nAble to provide oral and written informed consent\\n\\nExclusion Criteria for a case:\\n\\nSerious condition meeting one of the following: (1) respiratory distress with respiratory rate >=30 breaths/min; (2) oxygen saturation<=93% on quiet status; (3) Arterial partial pressure of oxygen (PaO2)/oxygen concentration<=300mmHg;\\nCritically ill patients meeting one of the following: (1) Experience respiratory failure and need to receive mechanical ventilation; (2) Experience shock; (3) Complicated with other organs failure and need intensive care and therapy in ICU;\\nParticipants under treatment with medications likely to interfere with experimental drugs\\nUnable to take drugs by mouth;\\nWith significantly abnormal liver function (Child Pugh C)\\nNeed of dialysis treatment, or GFR≤30 mL/min/1.73 m2;\\nParticipants with psoriasis, myasthenia, haematopoietic and retinal diseases,CNS-related hearing loss or glucose-6-phosphate dehydrogenase deficit\\nParticipants with severe neurological and mental illness;\\nPregnant or lactating women;\\nInability to consent and/or comply with study protocol;\\nIndividuals with known hypersensitivity to the study drugs.\\nPersons already treated with any of the study drugs during the last 30 days.\\nConcomitant administration of enzyme inducers (such as carbamazepine) which could lead to ineffectiveness of darunavir; and those who receive CYP3A4 substrates (such as statins) because of the risk of increased toxicity.\\nHIV patients (because these are already on antiretroviral treatment)\\nAny contraindications as per the Data Sheet of Rezolsta or Hydroxychloroquine.\\n\\nInclusion Criteria for a contact:\\n\\nPatients who meet the definition of a contact according to the Catalan Public Health Department Guidelines\\nAged ≥18 years male or female;\\nIn women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study.\\nWilling to take study medication;\\nWilling to comply with all study procedures;\\nAble to provide oral, informed consent and/or assent.\\n\\nExclusion Criteria for a contact:\\n\\nWith known history of cardiac arrhythmia (or QT prolongation syndrome);\\nUnable to take drugs by mouth;\\nWith significantly abnormal liver function (Child Pugh C)\\nNeed of dialysis treatment, or GFR≤30 mL/min/1.73 m2;\\nParticipants with psoriasis, myasthenia, haematopoietic and retinal diseases,CNS-related hearing loss or glucose-6-phosphate dehydrogenase deficit;\\nPersons already treated with any of the study drugs during the last 30 days;\\nPregnant or lactating women;\\nAny contraindications as per the Data Sheet of Hydroxychloroquine.',\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'oriol Mitja, PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '0034 934651072',\n", - " 'CentralContactEMail': 'oriolmitja@hotmail.com'},\n", - " {'CentralContactName': 'Laia Bertran',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '0034 934651072'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'CAP II Sant Fèlix',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Sabadell',\n", - " 'LocationState': 'Barcelona',\n", - " 'LocationZip': '08204',\n", - " 'LocationCountry': 'Spain'},\n", - " {'LocationFacility': 'Gerència Territorial Catalunya Central',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Sant Fruitós De Bages',\n", - " 'LocationState': 'Barcelona',\n", - " 'LocationZip': '08272',\n", - " 'LocationCountry': 'Spain'},\n", - " {'LocationFacility': 'Centre de Salut Isabel Roig-Casernes de Sant Andreu',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Barcelona',\n", - " 'LocationZip': '08030',\n", - " 'LocationCountry': 'Spain'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000000998',\n", - " 'InterventionMeshTerm': 'Antiviral Agents'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000890',\n", - " 'InterventionAncestorTerm': 'Anti-Infective Agents'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M4562',\n", - " 'InterventionBrowseLeafName': 'Chloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M151035',\n", - " 'InterventionBrowseLeafName': 'Chloroquine diphosphate',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M8523',\n", - " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2895',\n", - " 'InterventionBrowseLeafName': 'Antiviral Agents',\n", - " 'InterventionBrowseLeafAsFound': 'Antiviral',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M459',\n", - " 'InterventionBrowseLeafName': 'Cobicistat',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M423',\n", - " 'InterventionBrowseLeafName': 'Darunavir',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2795',\n", - " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", - " {'InterventionBrowseBranchAbbrev': 'Infl',\n", - " 'InterventionBrowseBranchName': 'Anti-Inflammatory Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'Analg',\n", - " 'InterventionBrowseBranchName': 'Analgesics'}]}}}}},\n", - " {'Rank': 45,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04328129',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '2020-009'},\n", - " 'Organization': {'OrgFullName': 'Institut Pasteur',\n", - " 'OrgClass': 'INDUSTRY'},\n", - " 'BriefTitle': 'Household Transmission Investigation Study for COVID-19 in French Guiana',\n", - " 'OfficialTitle': 'Household Transmission Investigation Study for Coronavirus Disease 2019 (COVID-19) in French Guiana',\n", - " 'Acronym': 'EPI-COVID-19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 23, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 23, 2022',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'March 23, 2022',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 23, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 27, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 31, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 27, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 31, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Institut Pasteur',\n", - " 'LeadSponsorClass': 'INDUSTRY'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Institut Pasteur de la Guyane',\n", - " 'CollaboratorClass': 'UNKNOWN'},\n", - " {'CollaboratorName': 'Centre Hospitalier Andrée Rosemon de Cayenne',\n", - " 'CollaboratorClass': 'UNKNOWN'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'This study is a interventional study that present minimal risks and constraints to evaluate the presence of novel coronavirus (SARS-CoV-2) or antibodies among individuals living in households where there is a confirmed coronavirus case in order to provide useful information on the proportion of symptomatic forms and the extent of the virus transmission in a territory such as French Guiana.',\n", - " 'DetailedDescription': 'This study is a interventional study that present minimal risks and constraints to evaluate the presence of novel coronavirus (SARS-CoV-2) or antibodies among individuals living in households where there is a confirmed coronavirus case in order to provide useful information on the proportion of symptomatic forms and the extent of the virus transmission in a territory such as French Guiana.\\n\\nSubjects will be assessed (questionnaires and sampling) in their homes. Subjects will be asked to attend study visits at days 0, 7, 14 and 28.\\n\\nThe primary objective of the study is to evaluate the rate of intra-household secondary transmission of the virus.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus Infections',\n", - " 'Severe Acute Respiratory Syndrome',\n", - " 'SARS-CoV Infection']},\n", - " 'KeywordList': {'Keyword': ['SARS-CoV-2',\n", - " 'COVID-19',\n", - " 'Serology',\n", - " 'French Guiana']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Not Applicable']},\n", - " 'DesignInfo': {'DesignAllocation': 'Non-Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Screening',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '450',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Primary case',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Subject with laboratory-confirmed coronavirus SARS-CoV-2 infection by polymerase chain reaction (PCR)',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Procedure: Human biological samples']}},\n", - " {'ArmGroupLabel': 'Family contact',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Subject who lived in the household of the primary case while the primary case was symptomatic',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Procedure: Human biological samples']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Procedure',\n", - " 'InterventionName': 'Human biological samples',\n", - " 'InterventionDescription': 'Blood sample\\nNasopharyngeal swab.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Family contact',\n", - " 'Primary case']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Evaluation of the extent of the virus transmission within households',\n", - " 'PrimaryOutcomeDescription': 'The extent of the virus transmission within households will be assessed by evaluating the rate of intra-household secondary transmission of the virus',\n", - " 'PrimaryOutcomeTimeFrame': '2 years'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Characterization of the secondary cases',\n", - " 'SecondaryOutcomeDescription': 'The characterization of the secondary cases will be assessed by evaluating the proportion of asymptomatic forms within the household',\n", - " 'SecondaryOutcomeTimeFrame': '2 years'},\n", - " {'SecondaryOutcomeMeasure': 'Characterization of the secondary cases',\n", - " 'SecondaryOutcomeDescription': 'The characterization of the secondary cases will be assessed by characterizing the risk factors for coronavirus infection.',\n", - " 'SecondaryOutcomeTimeFrame': '2 years'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nPrimary case: laboratory-confirmed coronavirus SARS-CoV-2 infection by polymerase chain reaction (PCR), or Family contact: person who lived in the same household as the primary case of COVID-19 when the primary case was symptomatic. A household is defined as a group of people (2 or more) living in the same accommodation (excluding residential institutions such as boarding schools, dormitories, hostels, prisons, other communities hosting grouped people)\\nAffiliated or beneficiary of a social security system\\nInformed consent prior to initiation of any study procedures from subject (or legally authorized representative)\\nState of health compatible with a blood sample as defined in the protocol.\\n\\nExclusion Criteria:\\n\\nPregnant woman or breast feeding\\nInability to consent\\nPerson under guardianship or curatorship\\nKnown pathology or a health problem contraindicated with the collect of blood sample.',\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Claude Flamand, Phd',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+33 5 94 29 26 15',\n", - " 'CentralContactEMail': 'cflamand@pasteur-cayenne.fr'},\n", - " {'CentralContactName': 'Dominique Rousset, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+33 5 94 29 26 09',\n", - " 'CentralContactEMail': 'drousset@pasteur-cayenne.fr'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Claude Flamand, PhD',\n", - " 'OverallOfficialAffiliation': 'Institut Pasteur de la Guyane, Head of Epidemiology Unit',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Centre Hospitalier Andrée Rosemon',\n", - " 'LocationStatus': 'Enrolling by invitation',\n", - " 'LocationCity': 'Cayenne',\n", - " 'LocationCountry': 'French Guiana'},\n", - " {'LocationFacility': 'Institut Pasteur de la Guyane',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Cayenne',\n", - " 'LocationCountry': 'French Guiana',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Claude Flamand, PhD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+33 5 94 29 26 15',\n", - " 'LocationContactEMail': 'cflamand@pasteur-cayenne.fr'},\n", - " {'LocationContactName': 'Dominique Rousset, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+33 5 94 29 26 09',\n", - " 'LocationContactEMail': 'drousset@pasteur-cayenne.fr'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", - " 'ConditionMeshTerm': 'Infection'},\n", - " {'ConditionMeshId': 'D000003141',\n", - " 'ConditionMeshTerm': 'Communicable Diseases'},\n", - " {'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", - " {'ConditionMeshId': 'D000045169',\n", - " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafAsFound': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafAsFound': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 46,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04326036',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'GARM COVID19'},\n", - " 'Organization': {'OrgFullName': 'Healeon Medical Inc',\n", - " 'OrgClass': 'INDUSTRY'},\n", - " 'BriefTitle': 'Use of cSVF Via IV Deployment for Residual Lung Damage After Symptomatic COVID-19 Infection',\n", - " 'OfficialTitle': 'Use of cSVF For Residual Lung Damage (COPD/Fibrotic Lung Disease After Symptomatic COVID-19 Infection For Residual Pulmonary Injury or Post-Adult Respiratory Distress Syndrome Following Viral (SARS-Co-2) Infection',\n", - " 'Acronym': 'GARM-COVID19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Enrolling by invitation',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 25, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'November 1, 2021',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2021',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 26, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 26, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 30, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 30, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 31, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Healeon Medical Inc',\n", - " 'LeadSponsorClass': 'INDUSTRY'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Robert W. Alexander, MD',\n", - " 'CollaboratorClass': 'UNKNOWN'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'Yes',\n", - " 'IsFDARegulatedDevice': 'No',\n", - " 'IsUSExport': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure and functionality. A short review includes:\\n\\nEarly December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office.\\nJanuary 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern.\\nFebruary 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus.\\nFebruary 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19.\\nFebruary 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives..\\nMarch 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland.\\nMarch 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control.\" March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up..\\n\\nMarch 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New York-New Jersey, Washington, and California.\\n\\nImmediate attention is turned to testing, diagnosis, epidemiological containment, clinical trials for drug testing started, and work on a long-term vaccine started.\\n\\nThe recovering patients are presenting with mild to severe lung impairment as a result of the viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary function appears to be a permanent finding as a direct result of the interstitial lung damage and inflammatory changes that accompanied.\\n\\nThis Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascular fraction (cSVF) deployed intravenously to examine the anti-inflammatory and structural potential to improve the residual, permanent damaged alveolar tissues of the lungs.',\n", - " 'DetailedDescription': 'COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure and functionality. A short review includes:\\n\\nEarly December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office.\\nJanuary 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern.\\nFebruary 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus.\\nFebruary 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19.\\nFebruary 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives..\\nMarch 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland.\\nMarch 11th, 2020 - As of this date, Over 60% of all COVID-19 deaths in the U.S. can be traced to that single nursing home in Seattle.\\nMarch 11th, 2020 - Dr. Fauci from the National Institutes of Health (NIH) states, \"If you count all the estimated cases of people who may have it but haven\\'t been diagnosed yet, the mortality rate is probably closer to 1%,\" he said, \"which means it\\'s 10 times more lethal than the seasonal flu.\"\\nMarch 21st, 2020 - The U.S. has 24,105 active cases, 301 deaths, and 171 patients declared recovered, a number which has since massively increased within the United States and Globally.\\nMarch 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control.\" March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up..\\n\\nMarch 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New York-New Jersey, Washington, and California\\n\\nImmediate attention is turned to testing, diagnosis, epidemiological containment, clinical trials for drug testing started, and work on a long-term vaccine started.\\n\\nThe recovering patients are presenting with mild to severe lung impairment as a result of the viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary function appears to be a permanent finding as a direct result of the interstitial lung damage and inflammatory changes that accompanied.\\n\\nThis Phase 0, first-in-kind for humans, is use of autologous, cSVF deployed intravenously to examine the anti-inflammatory and structural potential to improve the residual damaged tissues.\\n\\nPrevious utilization of cSVF remains in Clinical Trials at this moment for uses in Chronic Obstructive Pulmonary Disease (COPD) and Idiopathic Pulmonary Fibrotic Lung disorders, showing encouraging safety profile and clinical efficacy. It is the intention of this study, driven by the ongoing pandemic as a direct causative etiology for permanent lung damage within the oxygen/carbon dioxide exchange resulting the the direct alveolar disruption and scarring reaction.\\n\\nThe inflammatory mediation, autoimmune modulatory capabilities, and revascularization potentials of the cSVF is becoming well recognized and documented in peer-reviewed literature and in scientific studies.\\n\\nDue to the urgency presented from the ongoing CoronaVirus pandemic, many patients that survive experience demonstrate direct pulmonary damage residua. There is available a relative new technology offered by Fluidda Inc in European Union (EU) known as \"Functional Respiratory Imaging (FRI) and examines pulmonary function and vascular capabilities in damaged lung tissues. This study examines the lung baseline (post-infection), and at 3 and 6 month intervals post-cSVF treatment to examine the functional airway configuration and efficiency at those intervals.\\n\\nSporadic reports of use of stem cells or stem/stromal cells have revealed some positive clinical outcomes, although not within a traditional randomized trial format at this point in time. This study proposed in the specific situation of permanent residual dysfunction created by the SARS-Co2 (Coronavirus) infection is felt to warrant a pilot study using the cSVF that is in current Clinical Trials, which, at this point presents a very good safety profile with the absence of adverse event (AE) or severe adverse events (SAE) as yet reported by the trials.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Pulmonary Alveolar Proteinosis',\n", - " 'COPD',\n", - " 'Idiopathic Pulmonary Fibrosis',\n", - " 'Viral Pneumonia',\n", - " 'Coronavirus Infection',\n", - " 'Interstitial Lung Disease']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Early Phase 1']},\n", - " 'DesignInfo': {'DesignAllocation': 'Non-Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '10',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Lipoaspiration',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Closed sterile, disposable microcannula of small volume adipose tissue, including the stromal vascular fraction (SVF) (cells and stromal tissue',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Procedure: Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF)']}},\n", - " {'ArmGroupLabel': 'Isolation & Concentration of cSVF',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Isolation & Concentration of cellular stromal vascular fraction (cSVF) using Healeon Centricyte 1000 Centrifuge, incubator and shaker plate with sterile Liberase enzyme (Roche Medical) per manufacturer protocols',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Device: Centricyte 1000',\n", - " 'Drug: Liberase Enzyme (Roche)']}},\n", - " {'ArmGroupLabel': 'Delivery cSVF via Intravenous',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'cSVF from Arm 2 is suspended in a 250 cc of sterile Normal Saline IV solution and deployed though 150 micron in-line filtration and intravenous route over 30-60 minute timeframe',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution',\n", - " 'Drug: Sterile Normal Saline for Intravenous Use']}},\n", - " {'ArmGroupLabel': 'Liberase TM',\n", - " 'ArmGroupType': 'Other',\n", - " 'ArmGroupDescription': 'Use of sterile Liberase TM enzyme to allow cSVF separation and isolation',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Device: Centricyte 1000',\n", - " 'Drug: Liberase Enzyme (Roche)']}},\n", - " {'ArmGroupLabel': 'Sterile Normal Saline',\n", - " 'ArmGroupType': 'Other',\n", - " 'ArmGroupDescription': '250 cc of sterile Normal Saline for Intravenous with sterile 150 micron in-line filtration for suspension of the concentrated cSVF and deployment IV',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution',\n", - " 'Drug: Sterile Normal Saline for Intravenous Use']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Procedure',\n", - " 'InterventionName': 'Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF)',\n", - " 'InterventionDescription': 'Use of Disposable Microcannula Closed System (Tulip Med, 2.2 mm) Harvest of Autologous Adipose Stroma and Stem/Stromal Cell Content',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Lipoaspiration']}},\n", - " {'InterventionType': 'Device',\n", - " 'InterventionName': 'Centricyte 1000',\n", - " 'InterventionDescription': 'Centricyte 1000 (Healeon Medical) Digestive (sterile Roche Liberase TM) Isolation/Concentration Protocol, Rinsing/Neutralization, and Pelletize the cSVF For Deployment Via Sterile Saline IV fluid Standard Protocol',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Isolation & Concentration of cSVF',\n", - " 'Liberase TM']}},\n", - " {'InterventionType': 'Procedure',\n", - " 'InterventionName': 'IV Deployment Of cSVF In Sterile Normal Saline IV Solution',\n", - " 'InterventionDescription': 'Sterile Normal Saline Suspension cSVF in 250cc for Intravenous Delivery Including Use of 150 micron in-line filtration',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Delivery cSVF via Intravenous',\n", - " 'Sterile Normal Saline']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Liberase Enzyme (Roche)',\n", - " 'InterventionDescription': 'Sterile Collagenase Blend to separate cSVF from the AD-SVF',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Isolation & Concentration of cSVF',\n", - " 'Liberase TM']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Proteolytic Emzyme']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Sterile Normal Saline for Intravenous Use',\n", - " 'InterventionDescription': 'Sterile Normal Saline IV solution to provide suspension of cSVF in 250 cc via standard IV line, including sterile 150 micron in-line standard filter',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Delivery cSVF via Intravenous',\n", - " 'Sterile Normal Saline']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Suspensory Fluid for cSVF']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Incidence of Treatment-Emergent Adverse Events',\n", - " 'PrimaryOutcomeDescription': 'Reporting of Adverse Events or Severe Adverse Events Assessed by CTCAE v4.0',\n", - " 'PrimaryOutcomeTimeFrame': '1 month'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Pulmonary Function Analysis',\n", - " 'SecondaryOutcomeDescription': 'High Resolution Computerized Tomography of Lung (HRCT Lung) for Fluidda Analysis comparative at baseline and 3 and 6 months post-treatment comparative analytics',\n", - " 'SecondaryOutcomeTimeFrame': 'baseline, 3 Month, 6 months'},\n", - " {'SecondaryOutcomeMeasure': 'Digital Oximetry',\n", - " 'SecondaryOutcomeDescription': 'Finger Pulse Oximetry taken before and after 6 minute walk on level ground, compare desaturation tendency',\n", - " 'SecondaryOutcomeTimeFrame': '3 months, 6 months'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nMust have confirmed and documented Coronaviral (COVID-19) infection history with involvement of lung tissues\\nMust be clear of any viral shed residual confirmed by negative viral testing protocol accepted by the Center for Disease Control (CDC) and/or the FDA\\nMust have discharge confirmation from infectious disease managing Provider declaring freedom of viral load or active infection\\nMust have a written Medical History of Physical and discharge summary (if hospitalized) from appropriate Center or Licensed Medical Provider\\nMust agree to provide a HRCT LUNG study done at baseline (before), 3 months and 6 months\\nMust be able to provide full Informed Consent (ICF)\\n\\nExclusion Criteria:\\n\\nActive or positive testing of COVID-19 With Clinical Report and Discharge Summary from Hospital or Treatment Facility\\nLung disorder without prior confirmation by approved test protocol of history of COVID-19\\nPatient health or condition deemed dangerous or inappropriate for transport, exceeding acceptable stress for transport or care needed to achieve access to the clinical facility, at the discretion of the Providers\\nExpected lifespan of < 6 months\\nSerious of life threatening co-morbidities, that in the opinion of the investigators, may compromise the safety or compliance with the study guidelines and tracking',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '90 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Robert W Alexander, MD',\n", - " 'OverallOfficialAffiliation': 'Global Alliance Regenerative Medicine',\n", - " 'OverallOfficialRole': 'Study Chair'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Robert W. Alexander, MD, FICS, LLC',\n", - " 'LocationCity': 'Stevensville',\n", - " 'LocationState': 'Montana',\n", - " 'LocationZip': '59870',\n", - " 'LocationCountry': 'United States'}]}},\n", - " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Alexander, Robert W., Overview of Cellular Stromal Vascular Fraction (cSVF) & Biocellular Uses of Stem/Stromal Cells & Matrix (tSVF + HD-PRP) in Regenerative Medicine, Aesthetic Medicine and Plastic Surgery. 2019, S1003, DOI: 10.24966/SRDT-2060/S1003.'},\n", - " {'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Alexander, Robert W., Understanding Adipose-Derived Stromal Vascular Fraction (AD-SVF) Cell Biology and Use on the Basis of Cellular, Chemical, Structural and Paracrine Components. (2012), J of Prolotherapy, 4: 855-869.'},\n", - " {'ReferencePMID': '32105632',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 Feb 24. pii: S2213-2600(20)30079-5. doi: 10.1016/S2213-2600(20)30079-5. [Epub ahead of print] Erratum in: Lancet Respir Med. 2020 Feb 28;:.'},\n", - " {'ReferencePMID': '32064853',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Novel Coronavirus Pneumonia Emergency Response Epidemiology Team. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 17;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. [Epub ahead of print] Chinese.'},\n", - " {'ReferencePMID': '32127666',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Li G, De Clercq E. Therapeutic options for the 2019 novel coronavirus (2019-nCoV). Nat Rev Drug Discov. 2020 Mar;19(3):149-150. doi: 10.1038/d41573-020-00016-0.'},\n", - " {'ReferencePMID': '22291007',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Wu K, Peng G, Wilken M, Geraghty RJ, Li F. Mechanisms of host receptor adaptation by severe acute respiratory syndrome coronavirus. J Biol Chem. 2012 Mar 16;287(12):8904-11. doi: 10.1074/jbc.M111.325803. Epub 2012 Jan 30.'},\n", - " {'ReferencePMID': '32015507',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3.'},\n", - " {'ReferencePMID': '15141376',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Ding Y, He L, Zhang Q, Huang Z, Che X, Hou J, Wang H, Shen H, Qiu L, Li Z, Geng J, Cai J, Han H, Li X, Kang W, Weng D, Liang P, Jiang S. Organ distribution of severe acute respiratory syndrome (SARS) associated coronavirus (SARS-CoV) in SARS patients: implications for pathogenesis and virus transmission pathways. J Pathol. 2004 Jun;203(2):622-30.'},\n", - " {'ReferencePMID': '22496216',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Kawase M, Shirato K, van der Hoek L, Taguchi F, Matsuyama S. Simultaneous treatment of human bronchial epithelial cells with serine and cysteine protease inhibitors prevents severe acute respiratory syndrome coronavirus entry. J Virol. 2012 Jun;86(12):6537-45. doi: 10.1128/JVI.00094-12. Epub 2012 Apr 11.'},\n", - " {'ReferencePMID': '25945397',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Zhang R, Pan Y, Fanelli V, Wu S, Luo AA, Islam D, Han B, Mao P, Ghazarian M, Zeng W, Spieth PM, Wang D, Khang J, Mo H, Liu X, Uhlig S, Liu M, Laffey J, Slutsky AS, Li Y, Zhang H. Mechanical Stress and the Induction of Lung Fibrosis via the Midkine Signaling Pathway. Am J Respir Crit Care Med. 2015 Aug 1;192(3):315-23. doi: 10.1164/rccm.201412-2326OC.'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No',\n", - " 'IPDSharingDescription': 'In discussion phase'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000019999',\n", - " 'InterventionMeshTerm': 'Pharmaceutical Solutions'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M20444',\n", - " 'InterventionBrowseLeafName': 'Pharmaceutical Solutions',\n", - " 'InterventionBrowseLeafAsFound': 'Solution',\n", - " 'InterventionBrowseLeafRelevance': 'high'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", - " 'ConditionMeshTerm': 'Infection'},\n", - " {'ConditionMeshId': 'D000003141',\n", - " 'ConditionMeshTerm': 'Communicable Diseases'},\n", - " {'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", - " {'ConditionMeshId': 'D000045169',\n", - " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'},\n", - " {'ConditionMeshId': 'D000011024',\n", - " 'ConditionMeshTerm': 'Pneumonia, Viral'},\n", - " {'ConditionMeshId': 'D000008171',\n", - " 'ConditionMeshTerm': 'Lung Diseases'},\n", - " {'ConditionMeshId': 'D000011658',\n", - " 'ConditionMeshTerm': 'Pulmonary Fibrosis'},\n", - " {'ConditionMeshId': 'D000054990',\n", - " 'ConditionMeshTerm': 'Idiopathic Pulmonary Fibrosis'},\n", - " {'ConditionMeshId': 'D000017563',\n", - " 'ConditionMeshTerm': 'Lung Diseases, Interstitial'},\n", - " {'ConditionMeshId': 'D000011649',\n", - " 'ConditionMeshTerm': 'Pulmonary Alveolar Proteinosis'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000011014',\n", - " 'ConditionAncestorTerm': 'Pneumonia'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", - " {'ConditionAncestorId': 'D000054988',\n", - " 'ConditionAncestorTerm': 'Idiopathic Interstitial Pneumonias'},\n", - " {'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafAsFound': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - 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" 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Newborn',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13548',\n", - " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Adult',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M12487',\n", - " 'ConditionBrowseLeafName': 'Pneumonia',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M26731',\n", - " 'ConditionBrowseLeafName': 'Acute Lung Injury',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M18396',\n", - " 'ConditionBrowseLeafName': 'Lung Diseases, Interstitial',\n", - " 'ConditionBrowseLeafAsFound': 'Interstitial Lung Disease',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M7068',\n", - " 'ConditionBrowseLeafName': 'Fibrosis',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M12497',\n", - " 'ConditionBrowseLeafName': 'Pneumonia, Viral',\n", - " 'ConditionBrowseLeafAsFound': 'Viral Pneumonia',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M26730',\n", - " 'ConditionBrowseLeafName': 'Lung Injury',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13095',\n", - " 'ConditionBrowseLeafName': 'Pulmonary Fibrosis',\n", - " 'ConditionBrowseLeafAsFound': 'Pulmonary Fibrosis',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M26576',\n", - " 'ConditionBrowseLeafName': 'Idiopathic Pulmonary Fibrosis',\n", - " 'ConditionBrowseLeafAsFound': 'Idiopathic Pulmonary Fibrosis',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M13086',\n", - " 'ConditionBrowseLeafName': 'Pulmonary Alveolar Proteinosis',\n", - " 'ConditionBrowseLeafAsFound': 'Pulmonary Alveolar Proteinosis',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M26574',\n", - " 'ConditionBrowseLeafName': 'Idiopathic Interstitial Pneumonias',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'T4953',\n", - " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Infant',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T191',\n", - " 'ConditionBrowseLeafName': 'Acute Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T3014',\n", - " 'ConditionBrowseLeafName': 'Idiopathic Pulmonary Fibrosis',\n", - " 'ConditionBrowseLeafAsFound': 'Idiopathic Pulmonary Fibrosis',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC16',\n", - " 'ConditionBrowseBranchName': 'Diseases and Abnormalities at or Before Birth'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC26',\n", - " 'ConditionBrowseBranchName': 'Wounds and Injuries'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 47,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04320732',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'REK-124170'},\n", - " 'Organization': {'OrgFullName': 'Oslo University Hospital',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Risk Factors for Community- and Workplace Transmission of COVID-19',\n", - " 'OfficialTitle': 'Risk Factors for Community- and Workplace Transmission of COVID-19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 27, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 27, 2022',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'March 20, 2030',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 23, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 23, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 25, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 27, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 31, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Arne Vasli Lund Søraas',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Principal Investigator, MD, PhD',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Oslo University Hospital'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Oslo University Hospital',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Age Labs AS',\n", - " 'CollaboratorClass': 'UNKNOWN'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'The project is an epidemiological observational study based on an electronic questionnaire on risk factors for COVID-19 in the community and healthcare setting.',\n", - " 'DetailedDescription': 'Summary The data collected will identify real-life risk factors for getting the COVID-19 diagnosis.\\n\\nThe Oslo University Hospital/University of Oslo web-based solution \"nettskjema\" will be used to collect data and consent forms.\\n\\nThe impact of knowing the risk factors for COVID-19 is tremendous because it can enable governments to conduct more targeted public health measurements than today to reduce the spread of the virus.\\n\\nDetailed description Research into an ongoing COVID-19 outbreak is difficult because patients are isolated, and supplies of personal protective equipment (PPE) supplies are limited. The risk of transmission to study personal is non-negligible even when PPE is available.\\n\\nA study design based on an electronic questionnaire and consent from delivered from the Oslo University Hospital/University of Oslo, GDPR (General Data Protection Regulation) compliant \"TSD\" service has therefore been chosen.\\n\\nThe study will be a case-control study based on a combined electronic consent form and questionnaire that the participants will fill in using a smartphone and electronic identification.\\n\\nThe groups that will be included are:\\n\\nHospitalized and non-hospitalized patients/persons with COVID-19 at all stages of the disease and after the disease\\nHospitalized patients without COVID-19\\nHealthcare personal or other groups with an increased risk of COVID-19\\nHealthy volunteers\\n\\nParticipants may be followed with repeated questionnaires prospectively.\\n\\nBiological samples Biological samples may hold crucial information about the susceptibility to COVID-19 and for susceptibility to the progression of the disease. It is within the scope of the study to analyze such samples from a limited number of participants which will be asked to provide such samples or hospitalized patients that have surplus material. The material will be analyzed with non-genetic methods most suitable to provide such information.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Case-Control']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'BioSpec': {'BioSpecRetention': 'Samples With DNA',\n", - " 'BioSpecDescription': 'Blood and upper repiratory samples will be collected from some participants.'},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '50000',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Individuals with COVID-19 infection',\n", - " 'ArmGroupDescription': 'Confirmed by routine laboratory diagnosis. All types of COVID-19 disease from asymptomatic carriers to hospitalized patients can be included.\\n\\nOnly subjects >18 years old will be included in the study.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Behavioral: Observation of behavior and COVID-19 infection will be conducted.']}},\n", - " {'ArmGroupLabel': 'Individuals tested for COVID-19 infection with negative test',\n", - " 'ArmGroupDescription': 'Confirmed by routine laboratory diagnosis',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Behavioral: Observation of behavior and COVID-19 infection will be conducted.']}},\n", - " {'ArmGroupLabel': 'Healthy individuals',\n", - " 'ArmGroupDescription': 'Recruitet from the general population',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Behavioral: Observation of behavior and COVID-19 infection will be conducted.']}},\n", - " {'ArmGroupLabel': 'Risk groups for COVID-19 exposure',\n", - " 'ArmGroupDescription': 'Including, but not limited to healthcare workers.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Behavioral: Observation of behavior and COVID-19 infection will be conducted.']}},\n", - " {'ArmGroupLabel': 'Patients admitted to hospital',\n", - " 'ArmGroupDescription': 'Without COVID-19 infection.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Behavioral: Observation of behavior and COVID-19 infection will be conducted.']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Behavioral',\n", - " 'InterventionName': 'Observation of behavior and COVID-19 infection will be conducted.',\n", - " 'InterventionDescription': 'No intervention, only prospective observation of behavior will be conducted by a questionnaire.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Healthy individuals',\n", - " 'Individuals tested for COVID-19 infection with negative test',\n", - " 'Individuals with COVID-19 infection',\n", - " 'Patients admitted to hospital',\n", - " 'Risk groups for COVID-19 exposure']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Rate of COVID-19 infection',\n", - " 'PrimaryOutcomeDescription': 'Diagnosed with serology or direct viral detection',\n", - " 'PrimaryOutcomeTimeFrame': '1 year'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nNorwegian adult\\n\\nExclusion Criteria:\\n\\nUnable to consent',\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'The study will be a combined retrospective and prospective case-control study based on a combined electronic consent form and questionnaire that the study groups will fill in using a smartphone and electronic identification.\\n\\nThe groups that will be included are:\\n\\nHospitalized and non-hospitalized patients/persons with COVID-19 at all stages of the disease and after the disease\\nHospitalized patients without COVID-19\\nHealthcare personal or other groups with an increased risk of COVID-19\\nHealthy volunteers\\n\\nProbability sampling will be conducted, but not solely.',\n", - " 'SamplingMethod': 'Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Arne Søraas, MD, PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+4790652904',\n", - " 'CentralContactEMail': 'Arne.Vasli.Lund.Soraas@rr-research.no'},\n", - " {'CentralContactName': 'John Arne Dahl, PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactEMail': 'j.a.dahl@medisin.uio.no'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Oslo University Hospital',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Oslo',\n", - " 'LocationZip': '0424',\n", - " 'LocationCountry': 'Norway',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Arne Søraas, PhD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+4790652904',\n", - " 'LocationContactEMail': 'Arne.Vasli.Lund.Soraas@rr-research.no'},\n", - " {'LocationContactName': 'John A Dahl, PhD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+4741456596',\n", - " 'LocationContactEMail': 'j.a.dahl@medisin.uio.no'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No',\n", - " 'IPDSharingDescription': 'European GDPR regulations severely limits IPD, but the study will share data to the largest extent possible within GDPR.'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 48,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04323332',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '2020XLA015-1'},\n", - " 'Organization': {'OrgFullName': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Traditional Chinese Medicine for Severe COVID-19',\n", - " 'OfficialTitle': 'A Retrospective Cohort Study to Evaluate the Efficacy and Safety of Traditional Chinese Medicine as an Adjuvant Treatment for Patients With Severe COVID-19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'April 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 8, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 24, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 26, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 24, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 26, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Li Hao',\n", - " 'ResponsiblePartyInvestigatorTitle': 'professor',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': \"In December 2019, a new type of pneumonia, COVID-2019 outbroke in Wuhan ,China, and currently the infected has been reported in more than at least 75 countries.\\n\\nPatients with severe COVID-19 have rapid disease progression and high mortality rate. This may attribute to the excessive immune response caused by cytokine storm. Strategies based on anti-virus drugs and treatments against symptoms have now been employed. However, these managements can't effectively treat the lethal lung injury and uncontrolled immune responses, especially in the elderly with severe COVID-19. Traditional Chinese Medicine (TCM), which treats the disease from anther perspective, has achieved satisfactory results. National Health Commission of China released a series of policies to enhance the administration of TCM prescriptions.\\n\\nThis study is aimed to evaluate the efficacy and safety of Traditional Chinese Medicine as an adjuvant treatment for severe COVID-19.\"},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", - " 'KeywordList': {'Keyword': ['COVID-19',\n", - " 'Traditional Chinese Medicine',\n", - " 'Pneumonia',\n", - " 'Coronavirus']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 3']},\n", - " 'DesignInfo': {'DesignAllocation': 'Non-Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '50',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Traditional Chinese Medicine',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'TCM prescription and conventional treatments',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Traditional Chinese Medicine Prescription']}},\n", - " {'ArmGroupLabel': 'Control',\n", - " 'ArmGroupType': 'No Intervention',\n", - " 'ArmGroupDescription': 'conventional treatments'}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Traditional Chinese Medicine Prescription',\n", - " 'InterventionDescription': 'Traditional Chinese Medicine Prescriptions have been recommended according to the Guidelines for the treatment of COVID-19 issued by National Health Commission of the PRC.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Traditional Chinese Medicine']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Length of hospital stay (days)',\n", - " 'PrimaryOutcomeTimeFrame': 'First treatment date up to 3 months'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Duration (days) of supplemental oxygenation',\n", - " 'SecondaryOutcomeTimeFrame': 'First treatment date up to 3 months'},\n", - " {'SecondaryOutcomeMeasure': 'CT imaging changes',\n", - " 'SecondaryOutcomeTimeFrame': 'First treatment date up to 3 months'},\n", - " {'SecondaryOutcomeMeasure': 'Mortality rate',\n", - " 'SecondaryOutcomeTimeFrame': 'First treatment date up to 3 months'},\n", - " {'SecondaryOutcomeMeasure': 'Time to Clinical Improvement (TTCI)',\n", - " 'SecondaryOutcomeTimeFrame': 'First treatment date up to 3 months'},\n", - " {'SecondaryOutcomeMeasure': 'The pneumonia severity index scores',\n", - " 'SecondaryOutcomeDescription': 'The pneumonia severity index is a clinical tool helping in the risk stratification of patients with community-acquired pneumonia. It ranges from 0-395 scores and a higher score indicates higher death risk.',\n", - " 'SecondaryOutcomeTimeFrame': 'First treatment date up to 3 months'},\n", - " {'SecondaryOutcomeMeasure': 'Time to COVID-19 nucleic acid testing negativity in throat swab',\n", - " 'SecondaryOutcomeTimeFrame': 'First treatment date up to 3 months'},\n", - " {'SecondaryOutcomeMeasure': 'Blood immune cell count',\n", - " 'SecondaryOutcomeDescription': 'Changes in leukocyte, neutral, lymphocyte counts and absolute lymphocyte count from baseline',\n", - " 'SecondaryOutcomeTimeFrame': 'Baseline, 7 and/ or 14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Serum inflammatory markers',\n", - " 'SecondaryOutcomeDescription': 'Changes in blood interleukin-6, c-reactive protein,SS-A/Ro antibodies and serum ferritin from baseline.',\n", - " 'SecondaryOutcomeTimeFrame': 'Baseline, 7 and/ or 14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Erythrocyte sedimentation rate',\n", - " 'SecondaryOutcomeDescription': 'Changes in erythrocyte sedimentation rate from baseline.',\n", - " 'SecondaryOutcomeTimeFrame': 'Baseline, 7 and/ or 14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Platelet and D-dimer changes',\n", - " 'SecondaryOutcomeDescription': 'Changes in platelets and D-dimers from baseline.',\n", - " 'SecondaryOutcomeTimeFrame': 'Baseline, 7 and/ or 14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Creatinine changes',\n", - " 'SecondaryOutcomeDescription': 'Changes in serum creatinine from baseline.',\n", - " 'SecondaryOutcomeTimeFrame': 'Baseline, 7 and/ or 14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Muscle enzymes changes',\n", - " 'SecondaryOutcomeDescription': 'Changes in serum muscle enzymes from baseline, including alanine aminotransferase , AST, creatine kinase, LDH.',\n", - " 'SecondaryOutcomeTimeFrame': 'Baseline, 7 and/ or 14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Usage of antibiotics',\n", - " 'SecondaryOutcomeDescription': 'Dosing time and amounts of antibiotics；the categories of the antibiotics',\n", - " 'SecondaryOutcomeTimeFrame': 'First treatment date up to 3 months'},\n", - " {'SecondaryOutcomeMeasure': 'Usage of glucocorticoids',\n", - " 'SecondaryOutcomeDescription': 'Dosing time and amounts of glucocorticoids',\n", - " 'SecondaryOutcomeTimeFrame': 'First treatment date up to 3 months'},\n", - " {'SecondaryOutcomeMeasure': 'Frequency of adverse events',\n", - " 'SecondaryOutcomeTimeFrame': 'First treatment date up to 3 months'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Key Inclusion Criteria:\\n\\nPatients were diagnosed as severe COVID-19 according to the Coronavirus disease (COVID-19) Treatment Guidance (Six edition)\\nPatients received a combined treatment of TCM and conventional therapy, or only conventional therapy.\\n\\nKey Exclusion Criteria:\\n\\nAge ＞85 years\\nAfter cardiopulmonary resuscitation\\nPatients combined with other organ failure or conditions need ICU monitoring and treatment, such as severe liver disease, severe renal dysfunction, upper gastrointestinal hemorrhage, disseminated intravascular coagulation.\\nRespiratory failure and need mechanical ventilation',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MaximumAge': '85 Years',\n", - " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Hao Li, Professor',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+0086-133113382093',\n", - " 'CentralContactEMail': 'xyhplihao1965@126.com'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Hao Li, Professor',\n", - " 'OverallOfficialAffiliation': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences',\n", - " 'OverallOfficialRole': 'Study Chair'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Hao Li',\n", - " 'LocationCity': 'Beijing',\n", - " 'LocationState': 'Beijing',\n", - " 'LocationZip': '100091',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Hao Li, Prof.',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '01062835088',\n", - " 'LocationContactEMail': 'xyhplihao1965@126.com'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", - " 'IPDSharingInfoTypeList': {'IPDSharingInfoType': ['Study Protocol']}}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M12487',\n", - " 'ConditionBrowseLeafName': 'Pneumonia',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'}]}}}}},\n", - " {'Rank': 49,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04331665',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'U-DEPLOY: RUX-COVID'},\n", - " 'SecondaryIdInfoList': {'SecondaryIdInfo': [{'SecondaryId': '20-5315',\n", - " 'SecondaryIdType': 'Other Identifier',\n", - " 'SecondaryIdDomain': 'University Health Network'}]},\n", - " 'Organization': {'OrgFullName': 'University Health Network, Toronto',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Study of the Efficacy and Safety of Ruxolitinib to Treat COVID-19 Pneumonia',\n", - " 'OfficialTitle': 'A Single Arm Open-label Clinical Study to Investigate the Efficacy and Safety of Ruxolitinib for the Treatment of COVID-19 Pneumonia'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 6, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'October 30, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'January 31, 2021',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'April 1, 2020',\n", - " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 2, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'April 2, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", - " 'LastUpdatePostDateType': 'Estimate'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'University Health Network, Toronto',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'The purpose of this study is to determine the safety and efficacy of the drug ruxolitinib in people diagnosed with COVID-19 pneumonia by determining the number of people whose conditions worsen (requiring machines to help with breathing or needing supplemental oxygen) while receiving the drug.\\n\\nThis is a sub-study of the U-DEPLOY study: UHN Umbrella Trial Defining Coordinated Approach to Pandemic Trials of COVID-19 and Data Harmonization to Accelerate Discovery. U-DEPLOY helps to facilitate timely conduct of studies across the University Health Network and other centers.',\n", - " 'DetailedDescription': 'Multifocal interstitial pneumonia is the most common cause of deterioration in people with COVID-19. This is attributed to a severe reaction where releases too many cytokines (proteins that play an important role in immune responses) which rush into the lungs resulting in lung inflammation and fluid buildup. This can lead to damage to the lungs and leading to breathing problems. Ruxolitinib when given early in the disease, may prevent the overproduction of cytokines which, in turn, may prevent lung damage.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", - " 'Pneumonia']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Not Applicable']},\n", - " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '64',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Ruxolitinib to prevent COVID-19 pneumonia',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'All participants will receive ruxolitinib at at 10 mg, twice a day, for 14 days, followed by 5 mg, twice a day, for 2 days and 5 mg, once daily, for 1 day.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Ruxolitinib']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Ruxolitinib',\n", - " 'InterventionDescription': 'Ruxolitinib is an inhibitor of JAK1 and JAK2 (proteins important in cell signalling) approved for the treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Ruxolitinib to prevent COVID-19 pneumonia']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['JAKAVI']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Proportion of patients with COVID-19 pneumonia who become critically ill (defined as requiring mechanical ventilation and/or FiO2 of 60% of more)',\n", - " 'PrimaryOutcomeTimeFrame': '6 months'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'All cause mortality rate',\n", - " 'SecondaryOutcomeTimeFrame': '9 months'},\n", - " {'SecondaryOutcomeMeasure': 'Average duration of hospital stay',\n", - " 'SecondaryOutcomeTimeFrame': '9 months'},\n", - " {'SecondaryOutcomeMeasure': 'Number of occurrence of secondary infections',\n", - " 'SecondaryOutcomeTimeFrame': '9 months'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nCOVID-19 infection diagnosed by nasopharyngeal sample\\nNeed for supplemental oxygen to maintain oxygen saturation > 93%\\n12 years of age or older\\n\\nExclusion Criteria:\\n\\nNeutrophils < 1 x 10^9/L\\nPlatelets < 50 x 10^9/L\\nTotal bilirubin, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) > 5x upper limit of normal (ULN)\\nCreatinine clearance (CrCl) < 15 mL/minute\\nPregnant women\\nPatients requiring invasive mechanical ventilation. Patients requiring non-invasive mechanical ventilation (e.g., BiPAP) are eligible.\\nPatients who require supplemental oxygen support prior to COVID-19 infection.\\nPatients who are on ruxolitinib.',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '12 Years',\n", - " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Steven Chan, M.D.',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '416-946-4501',\n", - " 'CentralContactPhoneExt': '2253',\n", - " 'CentralContactEMail': 'steven.chan@uhn.ca'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Steven Chan, M.D.',\n", - " 'OverallOfficialAffiliation': 'Princess Margaret Cancer Centre',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Vikas Gupta, M.D.',\n", - " 'OverallOfficialAffiliation': 'Princess Margaret Cancer Centre',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Princess Margaret Cancer Centre',\n", - " 'LocationCity': 'Toronto',\n", - " 'LocationState': 'Ontario',\n", - " 'LocationZip': 'M5G 2M9',\n", - " 'LocationCountry': 'Canada',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Steven Chan, M.D.',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '416-946-4501',\n", - " 'LocationContactPhoneExt': '2253',\n", - " 'LocationContactEMail': 'steven.chan@uhn.ca'},\n", - " {'LocationContactName': 'Steven Chan, M.D.',\n", - " 'LocationContactRole': 'Principal Investigator'},\n", - " {'LocationContactName': 'Vikas Gupta, M.D.',\n", - " 'LocationContactRole': 'Principal Investigator'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000011014',\n", - " 'ConditionMeshTerm': 'Pneumonia'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000008171',\n", - " 'ConditionAncestorTerm': 'Lung Diseases'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M12487',\n", - " 'ConditionBrowseLeafName': 'Pneumonia',\n", - " 'ConditionBrowseLeafAsFound': 'Pneumonia',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M9751',\n", - " 'ConditionBrowseLeafName': 'Lung Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'}]}}}}},\n", - " {'Rank': 50,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04327505',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'K-2020-2611'},\n", - " 'SecondaryIdInfoList': {'SecondaryIdInfo': [{'SecondaryId': '2020-001349-37',\n", - " 'SecondaryIdType': 'EudraCT Number'},\n", - " {'SecondaryId': '4-1199/2020',\n", - " 'SecondaryIdType': 'Registry Identifier',\n", - " 'SecondaryIdDomain': 'Karolinska Institutet'}]},\n", - " 'Organization': {'OrgFullName': 'Karolinska University Hospital',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Safety and Efficacy of Hyperbaric Oxygen for ARDS in Patients With COVID-19',\n", - " 'OfficialTitle': 'Safety and Efficacy of Hyperbaric Oxygen for Improvement of Acute Respiratory Distress Syndrome in Adult Patients With COVID-19; a Randomized, Controlled, Open Label, Multicentre Clinical Trial',\n", - " 'Acronym': 'COVID-19-HBO'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 25, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'October 31, 2021',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2022',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 25, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 27, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 31, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 27, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 31, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Anders Kjellberg, MD',\n", - " 'ResponsiblePartyInvestigatorTitle': 'ICU Consultant, head of hyperbaric medicine',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Karolinska University Hospital'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Karolinska University Hospital',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Karolinska Institutet',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'University of California, San Diego',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'Blekinge County Council Hospital',\n", - " 'CollaboratorClass': 'OTHER'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'We hypothesize that hyperbaric oxygen (HBO) is safe for patients with COVID-19 and that HBO reduces the inflammatory reaction in Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19.\\n\\nAlso known as SARS-CoV-2, COVID-19 is declared a pandemic by World Health Organization (WHO). No specific treatment has been successful as of March 2020. Mortality rates in patients that develop ARDS is extremely high, 61.5-90%, almost double the mortality of ARDS of any cause. ARDS associated with COVID-19 is associated with pulmonary edema, rapidly progressing respiratory failure and fibrosis. The mechanism behind the rapid progress is still an enigma but theories have evolved around severe inflammatory involvement with a cytokine storm. Macrophage activation is involved in the early phase of ARDS and cytokine modulators have been tried in experimental settings without proven clinical benefits. HBO significantly reduces inflammatory cytokines and and oedema in other clinical settings. HBO has been used for almost a century, nowadays mainly used for its anti-inflammatory effects. Several randomized clinical trials show beneficial effects in variety of inflammatory diseases including diabetic foot ulcers and radiation injury. HBO is generally regarded as safe with very few adverse events and extensive experimental and clinical evidence suggest that HBO is a promising drug to ameliorate ARDS associated with COVID-19.',\n", - " 'DetailedDescription': 'COVID-19 also known as CoV-2 is declared a pandemic by WHO. More than 400 articles have been published and more than 160 clinical trials are registered but no specific treatment has been successful as of March 2020. Antiviral drugs Lopinavir-Ritonavir did not show any significant benefit compared to standard care in a Chinese randomized controlled study with 199 patients. Even though the overall mortality is low (0.2-7.2% the figures from critical care are fearsome. Mortality rates have been reported as high as 90% in patients developing Acute Respiratory Distress Syndrome (ARDS) in early reports from the Wuhan province and more recent reports has reported overall 28-d mortality rates of 61,5% in ICU patients with acute respiratory illness (ALI), almost double the mortality of ARDS of any cause. ARDS associated with COVID-19 differs from other described ARDS with rapidly progressing respiratory failure and fibrosis. The mechanism behind the rapid progress is still an enigma but theories have evolved around severe inflammatory involvement with a cytokine storm. Macrophage activation is involved in the early phase of ARDS and cytokine modulators such as Interleukin-6 (IL-6) inhibitors have been tried in experimental settings but no proper clinical trials have proven positive outcome. Hyperbaric oxygen (HBO) significantly reduces inflammatory cytokines including IL-1β, IL-6 and TNF-α through several transcription factors regulating inflammation, including Hypoxia Inducible Factor 1 (HIF-1), Nrf2 and NFkB. Hyperbaric oxygen (HBO) has been used for almost a century, initially for decompression sickness, but it nowadays mainly used for its anti-inflammatory effects. Several randomized clinical trials have been conducted on humans for a variety of inflammatory diseases including diabetic foot ulcers and radiation injury. HBO is generally regarded as safe with very few adverse events. The broad and physiological anti-inflammatory effects of HBO shown in extensive experimental and clinical evidence suggest that HBO is a promising drug to ameliorate ARDS associated with COVID-19.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)',\n", - " 'Cytokine Storm',\n", - " 'Infection Viral']},\n", - " 'KeywordList': {'Keyword': ['COVID-19',\n", - " 'Hyperbaric oxygen',\n", - " 'ARDS',\n", - " 'SARS-CoV-2']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 2', 'Phase 3']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignInterventionModelDescription': 'Randomized controlled, open label, multi-centre clinical trial',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '200',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Hyperbaric oxygen',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Hyperbaric oxygen 2.4 Bar for 30 minutes (with 5 min compression time and 5 minutes decompression time, according to local routines)',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hyperbaric oxygen']}},\n", - " {'ArmGroupLabel': 'Control',\n", - " 'ArmGroupType': 'No Intervention',\n", - " 'ArmGroupDescription': 'Standard care'}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Hyperbaric oxygen',\n", - " 'InterventionDescription': '2.4 Bar (2.4 ATA), 30 min (excluding compression/recompression)',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Hyperbaric oxygen']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['HBO']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'PO2/FiO2 (Safety)',\n", - " 'PrimaryOutcomeDescription': 'Oxygen requirement (Arterial bloodgas (pO2) and recorded Fraction inspired oxygen within 1 hour before and after HBO and 6 hours after each HBO treatment)',\n", - " 'PrimaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", - " {'PrimaryOutcomeMeasure': 'PO2/FiO2 (Efficacy)',\n", - " 'PrimaryOutcomeDescription': 'Oxygen requirement (Arterial bloodgas (pO2) and recorded Fraction inspired oxygen) At baseline, daily for 7 days, Day 14 and Day 30 (or last day in hospital if patient is discharged earlier, or at withdrawal) irrespective of HBO treatments.',\n", - " 'PrimaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", - " {'PrimaryOutcomeMeasure': 'Early Warning Score (NEWS) (Safety)',\n", - " 'PrimaryOutcomeDescription': 'NEWS within 1 hour before and after and 6h after HBO',\n", - " 'PrimaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", - " {'PrimaryOutcomeMeasure': 'Early Warning Score (NEWS) (Efficacy)',\n", - " 'PrimaryOutcomeDescription': 'Mean NEWS at baseline, daily for 7 days, Day 14 and Day 30 (or last day in hospital if patient is discharged earlier, or at withdrawal) irrespective of HBO treatments.',\n", - " 'PrimaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", - " {'PrimaryOutcomeMeasure': 'Immunological response (Efficacy)',\n", - " 'PrimaryOutcomeDescription': 'Measurement of clinically available markers; Baseline, daily for 7 days, Day 14, Day 30 or last day in ICU if patient have left ICU earlier, or at withdrawal)\\n\\nFull Blood cell count including WBC count + differentiation (number/ml)\\nC-Reactive protein\\nProcalcitonin\\nCytokines including but not limited to IL-6',\n", - " 'PrimaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", - " {'PrimaryOutcomeMeasure': 'Mechanical ventilation (Efficacy)',\n", - " 'PrimaryOutcomeDescription': 'Days free of invasive mechanical ventilation',\n", - " 'PrimaryOutcomeTimeFrame': 'Through study completion 30 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'SAE',\n", - " 'SecondaryOutcomeDescription': 'Serious Adverse Events (number of events)',\n", - " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", - " {'SecondaryOutcomeMeasure': 'Serious ADR',\n", - " 'SecondaryOutcomeDescription': 'Serious Adverse Drug Reaction (number of events)',\n", - " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", - " {'SecondaryOutcomeMeasure': 'AE',\n", - " 'SecondaryOutcomeDescription': 'Adverse Event (number of events )',\n", - " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", - " {'SecondaryOutcomeMeasure': 'Oxygen dose',\n", - " 'SecondaryOutcomeDescription': 'Mean oxygen dose/day including HBO and cumulative potential oxygen toxicity calculated as Oxygen Tolerance Units (OTU)',\n", - " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", - " {'SecondaryOutcomeMeasure': 'Pulmonary CT (low-dose CT)',\n", - " 'SecondaryOutcomeDescription': 'Changes in Pulmonary CT (low-dose CT), within before and after HBO and Day 0,7,14 and 28/30 (in selected patients if clinically indicated)',\n", - " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", - " {'SecondaryOutcomeMeasure': 'Chest X-ray',\n", - " 'SecondaryOutcomeDescription': 'Changes on Chest X-ray, before and after HBO and Day 0,7,14 and 28/30 (in selected patients if clinically indicated)',\n", - " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", - " {'SecondaryOutcomeMeasure': 'Chest ultrasound',\n", - " 'SecondaryOutcomeDescription': 'Changes in Chest ultrasound (Atelectasis/b-lines), before and after HBO, Day 0,7,14 and 28/30 (in selected patients when available)',\n", - " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", - " {'SecondaryOutcomeMeasure': 'Secondary infections',\n", - " 'SecondaryOutcomeDescription': 'Secondary infections (VAP, CLABSI, other) (number of events)',\n", - " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", - " {'SecondaryOutcomeMeasure': 'Mortality',\n", - " 'SecondaryOutcomeDescription': '30-day all-cause mortality',\n", - " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", - " {'SecondaryOutcomeMeasure': 'ICU free days',\n", - " 'SecondaryOutcomeDescription': 'Time not admitted to ICU during the study.',\n", - " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", - " {'SecondaryOutcomeMeasure': 'ICU mortality',\n", - " 'SecondaryOutcomeDescription': 'Mortality of any cause in ICU (% of patients admitted to ICU)',\n", - " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", - " {'SecondaryOutcomeMeasure': 'Hospital mortality',\n", - " 'SecondaryOutcomeDescription': 'Mortality of any cause in Hospital (% of patients admitted to Hospital)',\n", - " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", - " {'SecondaryOutcomeMeasure': 'Micro RNA plasma (Biomarker)',\n", - " 'SecondaryOutcomeDescription': 'Change in expression of Micro RNA in plasma (qPCR) Baseline, Day 3, Day 5, Day 7, Day 14, Day 30. First 20 patients.',\n", - " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", - " {'SecondaryOutcomeMeasure': 'MicroRNA/RNA PBMC (Explanatory)',\n", - " 'SecondaryOutcomeDescription': 'Change in gene expression and Micro RNA interactions in Peripheral Blood Mononuclear Cells (qPRC and Micro array) Baseline, Day 3, Day 5, Day 7, Day 14, Day 30. First 20 patients.',\n", - " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", - " {'SecondaryOutcomeMeasure': 'Immunological response (Explanatory)',\n", - " 'SecondaryOutcomeDescription': 'Immunological response, Baseline, Day 3, Day 5, Day 7. In first 20 patients Cytokines extended including (IL-1β, IL-2, IL-6, IL33 and TNFα) Lymphocyte profile Flowcytometry with identification of monocyte/lymphocyte sub sets including but not limited to CD3+/CD4+/CD8+ Monocyte proliferation markers',\n", - " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'},\n", - " {'SecondaryOutcomeMeasure': 'Viral load',\n", - " 'SecondaryOutcomeDescription': 'Viral load (quantitative PCR) (Baseline, Day 7, Day 14, Day 30)',\n", - " 'SecondaryOutcomeTimeFrame': 'Through study completion 30 days'}]},\n", - " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'Staff safety',\n", - " 'OtherOutcomeDescription': 'SAE or AE in staff associated with treatment of patient',\n", - " 'OtherOutcomeTimeFrame': 'Through study completion 30 days'},\n", - " {'OtherOutcomeMeasure': 'HBO Feasibility',\n", - " 'OtherOutcomeDescription': 'Number of HBO treatments given/planned first 10 days\\nReceived HBO treatment within 24h of enrolment (Yes/No)',\n", - " 'OtherOutcomeTimeFrame': 'Through study completion 30 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAged 18-90 years\\nThe patient is likely to fulfill the ARDS criteria (Berlin definition) and need intubation, ventilator-assisted or ECMO-assisted treatment within 7 days of admission to hospital\\nSuspected or verified COVID-19 infection\\nAt least one risk factor for increased mortality in COVID-19: currently published e.g. Smoking, Hypertension, Diabetes, Cardiovascular disease\\nDocumented informed consent according to ICH-GCP and national regulations\\n\\nExclusion Criteria:\\n\\nARDS caused by other viral infections (negative SARS-CoV-2)\\nARDS caused by other non-viral infections or trauma\\nKnown pregnancy or positive pregnancy test in women\\nPatients with previous lung fibrosis\\nCT- or Spirometry-verified severe COPD with Emphysema\\nContraindication for HBO according to local guidelines\\nDo Not Resuscitate (DNR) or other restrictions in escalation of level of care',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'GenderBased': 'Yes',\n", - " 'GenderDescription': 'Adults, all genders',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '90 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Anders Kjellberg, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+46812375212',\n", - " 'CentralContactEMail': 'anders.kjellberg@ki.se'},\n", - " {'CentralContactName': 'Peter Lindholm, MD, PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactEMail': 'peter.lindholm@ki.se'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Anders Kjellberg, MD',\n", - " 'OverallOfficialAffiliation': 'Karolinska University Hospital (and karolinska Insitutet)',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000012127',\n", - " 'ConditionMeshTerm': 'Respiratory Distress Syndrome, Newborn'},\n", - " {'ConditionMeshId': 'D000012128',\n", - " 'ConditionMeshTerm': 'Respiratory Distress Syndrome, Adult'},\n", - " {'ConditionMeshId': 'D000055371',\n", - " 'ConditionMeshTerm': 'Acute Lung Injury'},\n", - " {'ConditionMeshId': 'D000055370', 'ConditionMeshTerm': 'Lung Injury'},\n", - " {'ConditionMeshId': 'D000013577', 'ConditionMeshTerm': 'Syndrome'},\n", - " {'ConditionMeshId': 'D000014777',\n", - " 'ConditionMeshTerm': 'Virus Diseases'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000004194',\n", - " 'ConditionAncestorTerm': 'Disease'},\n", - " {'ConditionAncestorId': 'D000010335',\n", - " 'ConditionAncestorTerm': 'Pathologic Processes'},\n", - " {'ConditionAncestorId': 'D000008171',\n", - " 'ConditionAncestorTerm': 'Lung Diseases'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", - " {'ConditionAncestorId': 'D000012120',\n", - " 'ConditionAncestorTerm': 'Respiration Disorders'},\n", - " {'ConditionAncestorId': 'D000007235',\n", - " 'ConditionAncestorTerm': 'Infant, Premature, Diseases'},\n", - " {'ConditionAncestorId': 'D000007232',\n", - " 'ConditionAncestorTerm': 'Infant, Newborn, Diseases'},\n", - " {'ConditionAncestorId': 'D000013898',\n", - " 'ConditionAncestorTerm': 'Thoracic Injuries'},\n", - " {'ConditionAncestorId': 'D000014947',\n", - " 'ConditionAncestorTerm': 'Wounds and Injuries'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13547',\n", - " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Newborn',\n", - " 'ConditionBrowseLeafAsFound': 'Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M13548',\n", - " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Adult',\n", - " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M26731',\n", - " 'ConditionBrowseLeafName': 'Acute Lung Injury',\n", - " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M26730',\n", - " 'ConditionBrowseLeafName': 'Lung Injury',\n", - " 'ConditionBrowseLeafAsFound': 'Lung Injury',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafAsFound': 'Infection Viral',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M9751',\n", - " 'ConditionBrowseLeafName': 'Lung Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13540',\n", - " 'ConditionBrowseLeafName': 'Respiration Disorders',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M24456',\n", - " 'ConditionBrowseLeafName': 'Premature Birth',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8862',\n", - " 'ConditionBrowseLeafName': 'Infant, Premature, Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8859',\n", - " 'ConditionBrowseLeafName': 'Infant, Newborn, Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M15240',\n", - " 'ConditionBrowseLeafName': 'Thoracic Injuries',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16268',\n", - " 'ConditionBrowseLeafName': 'Wounds and Injuries',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T4953',\n", - " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Infant',\n", - " 'ConditionBrowseLeafAsFound': 'Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'T191',\n", - " 'ConditionBrowseLeafName': 'Acute Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC16',\n", - " 'ConditionBrowseBranchName': 'Diseases and Abnormalities at or Before Birth'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC26',\n", - " 'ConditionBrowseBranchName': 'Wounds and Injuries'},\n", - " {'ConditionBrowseBranchAbbrev': 'BXS',\n", - " 'ConditionBrowseBranchName': 'Urinary Tract, Sexual Organs, and Pregnancy Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 51,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04256395',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'RWS-BTCH-002'},\n", - " 'Organization': {'OrgFullName': 'Beijing Tsinghua Chang Gung Hospital',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Efficacy of a Self-test and Self-alert Mobile Applet in Detecting Susceptible Infection of COVID-19',\n", - " 'OfficialTitle': 'Registry Study on the Efficacy of a Self-test and Self-alert Applet in Detecting Susceptible Infection of COVID-19 ——a Population Based Mobile Internet Survey',\n", - " 'Acronym': 'COVID-19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'February 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'February 1, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'July 31, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'July 31, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'February 1, 2020',\n", - " 'StudyFirstSubmitQCDate': 'February 3, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'February 5, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'February 18, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'February 20, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Beijing Tsinghua Chang Gung Hospital',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Institute for precision medicine of Tsinghua University',\n", - " 'CollaboratorClass': 'UNKNOWN'},\n", - " {'CollaboratorName': 'Institute for artificial intelligent of Tsinghua University',\n", - " 'CollaboratorClass': 'UNKNOWN'},\n", - " {'CollaboratorName': 'Chinese Medical Doctor Association',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'Institute for network behavior of Tsinghua University',\n", - " 'CollaboratorClass': 'UNKNOWN'},\n", - " {'CollaboratorName': 'school of clinical medicine of Tsinghua University',\n", - " 'CollaboratorClass': 'UNKNOWN'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'The \"COVID-19 infection self-test and alert system\" (hereinafter referred to as \"COVID-19 self-test applet\") jointly developed by Beijing Tsinghua Changgung Hospital, Institute for precision medicine, artificial intelligence of Tsinghua University was launched on February 1，2020. Residents , according to their actual healthy situation, after answering questions online, the system will conduct intelligent analysis, make disease risk assessment and give healthcare and medical guidance. Based on the Internet population survey, and referring to the diagnosis and screening standards of the National Health Commission of the People\\'s Republic of China, investigators carried out the mobile applet of Internet survey and registry study for the Internet accessible identifiable population, so as to screen the suspected population and guide the medical treatment.',\n", - " 'DetailedDescription': 'The \"COVID-19 infection self-test and alert system\" (hereinafter referred to as \"COVID-19 self-test applet\") jointly developed by Beijing Tsinghua Changgung Hospital, Institute for precision medicine, artificial intelligence of Tsinghua University was launched on February 1，2020. This survey was also advocated by Chinese Medical Doctor Association. Residents , or even oversea Chinese people，according to their actual healthy situation, after answering questions online, the system will conduct intelligent analysis, make disease risk assessment and give healthcare and medical guidance. Based on the Internet population survey, and referring to the diagnosis and screening standards of the National Health Commission of the People\\'s Republic of China, investigators carried out the mobile applet of Internet survey and registry study for the Internet accessible identifiable population, so as to screen the suspected population and guide the medical treatment.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Susceptibility to Viral and Mycobacterial Infection']},\n", - " 'KeywordList': {'Keyword': ['registry study',\n", - " 'novel coronavirus（COVID-19）',\n", - " 'mobile internet survey']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Other']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '300000',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", - " 'InterventionName': 'mobile internet survey on self-test',\n", - " 'InterventionDescription': '1. make a questionnaire, the content of which refers to the new coronavirus diagnosis and treatment guidelines released by the National Health Commission; 2. develop the mobile applet and carry out internet propagation; 3. background data could be identified according to computer technology, de duplication and de privacy; 4. once registered, the applet can automatically remind the self-test twice a day, and encourage to adhere to 14 days; 5. automatically compare with the standards and highly suspected population could be given medical guidance and encouraged to go to the fever clinic of the designated hospital for definite diagnosis.'}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'positive number diagnosed by national guideline in the evaluated population',\n", - " 'PrimaryOutcomeDescription': 'after the end of this study, investigators calculate and sum up the total evaluated population and positively diagnosed population, then check the ROC of this system, finally to calculate the sensitivity and accuracy of this self-test and self-alert system',\n", - " 'PrimaryOutcomeTimeFrame': '5 months'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'distribution map of evaluated people',\n", - " 'SecondaryOutcomeDescription': 'after the end of this study, investigators calculate the proportion and distribution of evaluated people with normal and abnormal scores',\n", - " 'SecondaryOutcomeTimeFrame': '5 month'},\n", - " {'SecondaryOutcomeMeasure': 'Effect of medical guidance by designated feedback questionnaire',\n", - " 'SecondaryOutcomeDescription': 'after the end of this study, investigators sent the feedback inform to every evaluated people and collect and analysis the response to find out whether this applet can help them in the following surveillance or medical treatment. And how it works.',\n", - " 'SecondaryOutcomeTimeFrame': '5 month'},\n", - " {'SecondaryOutcomeMeasure': 'mental scale of relief the mental anxiety and avoid unnecessary outpatient',\n", - " 'SecondaryOutcomeDescription': 'after the end of this study, investigators sent the designated mental scale including anxiety, and collect the response and draw the conclusion.',\n", - " 'SecondaryOutcomeTimeFrame': '5 month'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\npeople who lived in or out of China at present and threatened by the infection and spread of COVID-19\\n\\nwithout gender and age restriction\\npeople who have concerns of his health\\nvoluntary completion of the self-test and evaluation.\\n\\nExclusion Criteria:\\n\\npeople who are not internet accessible or can not use this Mobile Applet.\\npeople who can not recognize the questionnaire.',\n", - " 'Gender': 'All',\n", - " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'Most people including healthy or susceptible patients or diagnosed patients will be enrolled. People whoever worry about his heath status relating with infection of COVID-19 at present can register and answer the question and get a score for risk evaluation. If a high risk achieved, the applet will guide the interviewer for further medical diagnosis and treatment.',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Xiaobin Feng, M.D',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+86 13228683243',\n", - " 'CentralContactEMail': 'fengxiaobin200708@aliyun.com'},\n", - " {'CentralContactName': 'Bin Yang, Ph.D',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+86 13501102704',\n", - " 'CentralContactEMail': 'fxb19@mails.tsinghua.edu.cn'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Jiahong Dong, M.D',\n", - " 'OverallOfficialAffiliation': 'Beijing Tsinghua Changgung Hospital',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Beijing Tsinghua Changgung Hospital',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Beijing',\n", - " 'LocationState': 'Beijing',\n", - " 'LocationZip': '102218',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Xiaobin Feng, M.D',\n", - " 'LocationContactRole': 'Contact'},\n", - " {'LocationContactName': 'xiaobin feng, M.D',\n", - " 'LocationContactRole': 'Principal Investigator'},\n", - " {'LocationContactName': 'bin yang, Ph.D',\n", - " 'LocationContactRole': 'Principal Investigator'},\n", - " {'LocationContactName': 'jiahong dong, M.D',\n", - " 'LocationContactRole': 'Principal Investigator'},\n", - " {'LocationContactName': 'xiaojuan wang, Ph.D',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'chenquan li, D.E',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", - " 'ConditionMeshTerm': 'Infection'},\n", - " {'ConditionMeshId': 'D000003141',\n", - " 'ConditionMeshTerm': 'Communicable Diseases'},\n", - " {'ConditionMeshId': 'D000009164',\n", - " 'ConditionMeshTerm': 'Mycobacterium Infections'},\n", - " {'ConditionMeshId': 'D000004198',\n", - " 'ConditionMeshTerm': 'Disease Susceptibility'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000020969',\n", - " 'ConditionAncestorTerm': 'Disease Attributes'},\n", - " {'ConditionAncestorId': 'D000010335',\n", - " 'ConditionAncestorTerm': 'Pathologic Processes'},\n", - " {'ConditionAncestorId': 'D000000193',\n", - " 'ConditionAncestorTerm': 'Actinomycetales Infections'},\n", - " {'ConditionAncestorId': 'D000016908',\n", - " 'ConditionAncestorTerm': 'Gram-Positive Bacterial Infections'},\n", - " {'ConditionAncestorId': 'D000001424',\n", - " 'ConditionAncestorTerm': 'Bacterial Infections'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafAsFound': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafAsFound': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M5963',\n", - " 'ConditionBrowseLeafName': 'Disease Susceptibility',\n", - " 'ConditionBrowseLeafAsFound': 'Susceptibility',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M10702',\n", - " 'ConditionBrowseLeafName': 'Mycobacterium Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Mycobacterial Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M21284',\n", - " 'ConditionBrowseLeafName': 'Disease Attributes',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M3303',\n", - " 'ConditionBrowseLeafName': 'Bacterial Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M17835',\n", - " 'ConditionBrowseLeafName': 'Gram-Positive Bacterial Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'}]}}}}},\n", - " {'Rank': 52,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04333407',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '20HH5868'},\n", - " 'Organization': {'OrgFullName': 'Imperial College London',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial.',\n", - " 'OfficialTitle': 'Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial.',\n", - " 'Acronym': 'C-19-ACS'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 31, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 30, 2021',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'March 30, 2021',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'April 1, 2020',\n", - " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 3, 2020',\n", - " 'StudyFirstPostDateType': 'Estimate'},\n", - " 'LastUpdateSubmitDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", - " 'LastUpdatePostDateType': 'Estimate'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Imperial College London',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'The outbreak of a novel coronavirus (SARS-CoV-2) and associated COVID-19 disease in late December 2019 has led to a global pandemic. At the time of writing, there have been 150 000 confirmed cases and 3500 deaths. Apart from the morbidity and mortality directly related to COVID-19 cases, society has had to also cope with complex political and economic repercussions of this disease.\\n\\nAt present, and despite pressing need for therapeutic intervention, management of patients with COVID-19 is entirely supportive. Despite the majority of patients experiencing a mild respiratory illness a subgroup, and in particular those with pre-existing cardiovascular disease, will experience severe illness that requires invasive cardiorespiratory support in the intensive care unit.\\n\\nFurthermore, the severity of COVID-19 disease (as well as the likelihood of progressing to severe disease) appears to be in part driven by direct injury to the cardiovascular system. Analysis of data from two recent studies confirms a significantly higher likelihood of acute cardiac injury in patients who have to be admitted to intensive care for the management of COVID-19 disease.\\n\\nThe exact type of acute of cardiac injury that COVID-19 patients suffer remains unclear. There is however mounting evidence that heart attack like events are responsible. Tests ordinarily performed to definitely assess for heart attacks will not be possible in very sick COVID-19 patients. Randomising patients to cardioprotective medicines will help us understand the role of the cardiovascular system in COVID-19 disease. It will also help us determine if there is more we can do to treat these patients.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", - " 'KeywordList': {'Keyword': ['Coronavirus, SARS-CoV-2, COVID-19, Cardiovascular']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Not Applicable']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignInterventionModelDescription': 'Prospective Multicentre Randomised Controlled Trial',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '3170',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Active Arm',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Aspirin 75mg',\n", - " 'Drug: Clopidogrel 75mg',\n", - " 'Drug: Rivaroxaban 2.5 MG',\n", - " 'Drug: Atorvastatin 40mg',\n", - " 'Drug: Omeprazole 20mg']}},\n", - " {'ArmGroupLabel': 'Control Arm', 'ArmGroupType': 'No Intervention'}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Aspirin 75mg',\n", - " 'InterventionDescription': '• If patient not on aspirin, add aspirin 75mg once daily unless contraindicated.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Active Arm']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Clopidogrel 75mg',\n", - " 'InterventionDescription': '• If patient not on clopidogrel or equivalent, add clopidogrel 75mg once daily unless contraindicated',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Active Arm']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Rivaroxaban 2.5 MG',\n", - " 'InterventionDescription': 'If patient not on an anticoagulation, add rivaroxaban 2.5mg bd unless contraindicated\\nIf patient on DOAC then change to rivaroxaban 2.5mg unless contraindicated',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Active Arm']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Atorvastatin 40mg',\n", - " 'InterventionDescription': '• If patient not on a statin, add atorvastatin 40mg once daily unless contraindicated',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Active Arm']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Omeprazole 20mg',\n", - " 'InterventionDescription': '• If patient not on a proton pump inhibitor, add omeprazole 20mg once daily.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Active Arm']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Primary Efficacy Outcome',\n", - " 'PrimaryOutcomeDescription': 'All-cause mortality',\n", - " 'PrimaryOutcomeTimeFrame': 'at 30 days after admission'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Secondary Efficacy Outcome 1',\n", - " 'SecondaryOutcomeDescription': 'Absolute change in serum troponin from admission (or from suspicion/diagnosis of Covid-19 if already an inpatient) measurement to peak value (measured using high sensitivity troponin assay). (Phase I interim analysis)',\n", - " 'SecondaryOutcomeTimeFrame': 'within 7 days and within 30 days of admission'},\n", - " {'SecondaryOutcomeMeasure': 'Secondary Efficacy Outcome 2',\n", - " 'SecondaryOutcomeDescription': 'Discharge Rate: Proportion of patients discharged (or documented as medically fit for discharge)',\n", - " 'SecondaryOutcomeTimeFrame': 'at 7 days and 30 days after admission'},\n", - " {'SecondaryOutcomeMeasure': 'Secondary Efficacy Outcome 3',\n", - " 'SecondaryOutcomeDescription': 'Intubation Rate: Proportion of patients who have been intubated for mechanical ventilation',\n", - " 'SecondaryOutcomeTimeFrame': 'at 7 days and at 30 days after admission'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nConfirmed COVID-19 infection\\nAge =/>40 or diabetes or known coronary disease or hypertension\\nRequires hospital admission for further clinical management.\\n\\nExclusion Criteria:\\n\\nClear evidence of cardiac pathology needing ACS treatment.\\nMyocarditis with serum Troponin > 5000\\nBleeding risk suspected e.g. recent surgery, history of GI bleed, other abnormal blood results (Hb<10g/dl, Plts <100, any evidence of DIC)\\nStudy treatment may negatively impact standard best care (physician discretion).\\nUnrelated co-morbidity with life expectancy <3 months.\\nPregnancy.\\nAge <18 years and >85 years.',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '85 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Alena Marynina, BSc, MSc',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '07404750659',\n", - " 'CentralContactEMail': 'alena.marynina@nhs.net'},\n", - " {'CentralContactName': 'Clare Coyle, BMBCh, BA, MRCP',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '07985 352148',\n", - " 'CentralContactEMail': 'c.coyle@imperial.ac.uk'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Prapa Kanagaratnam, FRCP, PhD',\n", - " 'OverallOfficialAffiliation': 'Imperial College Healthcare NHS Trust',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No',\n", - " 'IPDSharingDescription': 'No individual participant data will be shared with other researchers or organisations. Anonymised data might be shared with other research organisations'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000001241',\n", - " 'InterventionMeshTerm': 'Aspirin'},\n", - " {'InterventionMeshId': 'D000009853',\n", - " 'InterventionMeshTerm': 'Omeprazole'},\n", - " {'InterventionMeshId': 'D000069552',\n", - " 'InterventionMeshTerm': 'Rivaroxaban'},\n", - " {'InterventionMeshId': 'D000077144',\n", - " 'InterventionMeshTerm': 'Clopidogrel'},\n", - " {'InterventionMeshId': 'D000069059',\n", - " 'InterventionMeshTerm': 'Atorvastatin'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000894',\n", - " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents, Non-Steroidal'},\n", - " {'InterventionAncestorId': 'D000018712',\n", - " 'InterventionAncestorTerm': 'Analgesics, Non-Narcotic'},\n", - " {'InterventionAncestorId': 'D000000700',\n", - " 'InterventionAncestorTerm': 'Analgesics'},\n", - " {'InterventionAncestorId': 'D000018689',\n", - " 'InterventionAncestorTerm': 'Sensory System Agents'},\n", - " {'InterventionAncestorId': 'D000018373',\n", - " 'InterventionAncestorTerm': 'Peripheral Nervous System Agents'},\n", - " {'InterventionAncestorId': 'D000045505',\n", - " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", - " {'InterventionAncestorId': 'D000000893',\n", - " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'},\n", - " {'InterventionAncestorId': 'D000005343',\n", - " 'InterventionAncestorTerm': 'Fibrinolytic Agents'},\n", - " {'InterventionAncestorId': 'D000050299',\n", - " 'InterventionAncestorTerm': 'Fibrin Modulating Agents'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000010975',\n", - " 'InterventionAncestorTerm': 'Platelet Aggregation Inhibitors'},\n", - " {'InterventionAncestorId': 'D000016861',\n", - " 'InterventionAncestorTerm': 'Cyclooxygenase Inhibitors'},\n", - " {'InterventionAncestorId': 'D000004791',\n", - " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", - " {'InterventionAncestorId': 'D000058633',\n", - " 'InterventionAncestorTerm': 'Antipyretics'},\n", - " {'InterventionAncestorId': 'D000000924',\n", - " 'InterventionAncestorTerm': 'Anticholesteremic Agents'},\n", - " {'InterventionAncestorId': 'D000000960',\n", - " 'InterventionAncestorTerm': 'Hypolipidemic Agents'},\n", - " {'InterventionAncestorId': 'D000000963',\n", - " 'InterventionAncestorTerm': 'Antimetabolites'},\n", - " {'InterventionAncestorId': 'D000057847',\n", - " 'InterventionAncestorTerm': 'Lipid Regulating Agents'},\n", - " {'InterventionAncestorId': 'D000019161',\n", - " 'InterventionAncestorTerm': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'},\n", - " {'InterventionAncestorId': 'D000058921',\n", - " 'InterventionAncestorTerm': 'Purinergic P2Y Receptor Antagonists'},\n", - " {'InterventionAncestorId': 'D000058919',\n", - " 'InterventionAncestorTerm': 'Purinergic P2 Receptor Antagonists'},\n", - " {'InterventionAncestorId': 'D000058914',\n", - " 'InterventionAncestorTerm': 'Purinergic Antagonists'},\n", - " {'InterventionAncestorId': 'D000058905',\n", - " 'InterventionAncestorTerm': 'Purinergic Agents'},\n", - " {'InterventionAncestorId': 'D000018377',\n", - " 'InterventionAncestorTerm': 'Neurotransmitter Agents'},\n", - " {'InterventionAncestorId': 'D000065427',\n", - " 'InterventionAncestorTerm': 'Factor Xa Inhibitors'},\n", - " {'InterventionAncestorId': 'D000000991',\n", - " 'InterventionAncestorTerm': 'Antithrombins'},\n", - " {'InterventionAncestorId': 'D000015842',\n", - " 'InterventionAncestorTerm': 'Serine Proteinase Inhibitors'},\n", - " {'InterventionAncestorId': 'D000011480',\n", - " 'InterventionAncestorTerm': 'Protease Inhibitors'},\n", - " {'InterventionAncestorId': 'D000000925',\n", - " 'InterventionAncestorTerm': 'Anticoagulants'},\n", - " {'InterventionAncestorId': 'D000000897',\n", - " 'InterventionAncestorTerm': 'Anti-Ulcer Agents'},\n", - " {'InterventionAncestorId': 'D000005765',\n", - " 'InterventionAncestorTerm': 'Gastrointestinal Agents'},\n", - " {'InterventionAncestorId': 'D000054328',\n", - " 'InterventionAncestorTerm': 'Proton Pump Inhibitors'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M3129',\n", - " 'InterventionBrowseLeafName': 'Aspirin',\n", - " 'InterventionBrowseLeafAsFound': 'Aspirin',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M11368',\n", - " 'InterventionBrowseLeafName': 'Omeprazole',\n", - " 'InterventionBrowseLeafAsFound': 'Omeprazole',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M463',\n", - " 'InterventionBrowseLeafName': 'Rivaroxaban',\n", - " 'InterventionBrowseLeafAsFound': 'Rivaroxaban',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M1669',\n", - " 'InterventionBrowseLeafName': 'Clopidogrel',\n", - " 'InterventionBrowseLeafAsFound': 'Clopidogrel',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M351',\n", - " 'InterventionBrowseLeafName': 'Atorvastatin',\n", - " 'InterventionBrowseLeafAsFound': 'Atorvastatin',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M19739',\n", - " 'InterventionBrowseLeafName': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M26217',\n", - " 'InterventionBrowseLeafName': 'Proton Pump Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2798',\n", - " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2799',\n", - " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents, Non-Steroidal',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2613',\n", - " 'InterventionBrowseLeafName': 'Analgesics',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19370',\n", - " 'InterventionBrowseLeafName': 'Analgesics, Non-Narcotic',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19188',\n", - " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M7056',\n", - " 'InterventionBrowseLeafName': 'Fibrinolytic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M12448',\n", - " 'InterventionBrowseLeafName': 'Platelet Aggregation Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M17792',\n", - " 'InterventionBrowseLeafName': 'Cyclooxygenase Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M27763',\n", - " 'InterventionBrowseLeafName': 'Antipyretics',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2824',\n", - " 'InterventionBrowseLeafName': 'Anticholesteremic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2859',\n", - " 'InterventionBrowseLeafName': 'Hypolipidemic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2862',\n", - " 'InterventionBrowseLeafName': 'Antimetabolites',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M27470',\n", - " 'InterventionBrowseLeafName': 'Lipid Regulating Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M27881',\n", - " 'InterventionBrowseLeafName': 'Purinergic P2Y Receptor Antagonists',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19088',\n", - " 'InterventionBrowseLeafName': 'Neurotransmitter Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M29100',\n", - " 'InterventionBrowseLeafName': 'Factor Xa Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2888',\n", - " 'InterventionBrowseLeafName': 'Antithrombins',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2887',\n", - " 'InterventionBrowseLeafName': 'Antithrombin III',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M12926',\n", - " 'InterventionBrowseLeafName': 'Protease Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M16974',\n", - " 'InterventionBrowseLeafName': 'Serine Proteinase Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M18192',\n", - " 'InterventionBrowseLeafName': 'HIV Protease Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2825',\n", - " 'InterventionBrowseLeafName': 'Anticoagulants',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2769',\n", - " 'InterventionBrowseLeafName': 'Antacids',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2800',\n", - " 'InterventionBrowseLeafName': 'Anti-Ulcer Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M7464',\n", - " 'InterventionBrowseLeafName': 'Gastrointestinal Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'T18',\n", - " 'InterventionBrowseLeafName': 'Serine',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Antipy',\n", - " 'InterventionBrowseBranchName': 'Antipyretics'},\n", - " {'InterventionBrowseBranchAbbrev': 'Infl',\n", - " 'InterventionBrowseBranchName': 'Anti-Inflammatory Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'FiAg',\n", - " 'InterventionBrowseBranchName': 'Fibrinolytic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'Analg',\n", - " 'InterventionBrowseBranchName': 'Analgesics'},\n", - " {'InterventionBrowseBranchAbbrev': 'PlAggInh',\n", - " 'InterventionBrowseBranchName': 'Platelet Aggregation Inhibitors'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", - " {'InterventionBrowseBranchAbbrev': 'Gast',\n", - " 'InterventionBrowseBranchName': 'Gastrointestinal Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'AnCoag',\n", - " 'InterventionBrowseBranchName': 'Anticoagulants'},\n", - " {'InterventionBrowseBranchAbbrev': 'Lipd',\n", - " 'InterventionBrowseBranchName': 'Lipid Regulating Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'AA',\n", - " 'InterventionBrowseBranchName': 'Amino Acids'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000054058',\n", - " 'ConditionMeshTerm': 'Acute Coronary Syndrome'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000017202',\n", - " 'ConditionAncestorTerm': 'Myocardial Ischemia'},\n", - " {'ConditionAncestorId': 'D000006331',\n", - " 'ConditionAncestorTerm': 'Heart Diseases'},\n", - " {'ConditionAncestorId': 'D000002318',\n", - " 'ConditionAncestorTerm': 'Cardiovascular Diseases'},\n", - " {'ConditionAncestorId': 'D000014652',\n", - " 'ConditionAncestorTerm': 'Vascular Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M26132',\n", - " 'ConditionBrowseLeafName': 'Acute Coronary Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Acute Coronary Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M5129',\n", - " 'ConditionBrowseLeafName': 'Coronary Artery Disease',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M18089',\n", - " 'ConditionBrowseLeafName': 'Myocardial Ischemia',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M9126',\n", - " 'ConditionBrowseLeafName': 'Ischemia',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8002',\n", - " 'ConditionBrowseLeafName': 'Heart Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M15983',\n", - " 'ConditionBrowseLeafName': 'Vascular Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC14',\n", - " 'ConditionBrowseBranchName': 'Heart and Blood Diseases'}]}}}}},\n", - " {'Rank': 53,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04328454',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'HBCBH-IEC-2020-101'},\n", - " 'Organization': {'OrgFullName': \"Shanghai 10th People's Hospital\",\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Clinical Characteristics and Prognostic Factors of Patients With COVID-19',\n", - " 'OfficialTitle': 'Clinical Characteristics and Prognostic Factors of Patients With COVID-19 in Chibi Hospital of Hubei Province'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'January 30, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 2, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'April 15, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 27, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 30, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 31, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 30, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 31, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Ming Li',\n", - " 'ResponsiblePartyInvestigatorTitle': \"Shanghai 10th People's Hospital\",\n", - " 'ResponsiblePartyInvestigatorAffiliation': \"Shanghai 10th People's Hospital\"},\n", - " 'LeadSponsor': {'LeadSponsorName': \"Shanghai 10th People's Hospital\",\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': \"Chibi People's Hospital, Hubei Province\",\n", - " 'CollaboratorClass': 'UNKNOWN'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.',\n", - " 'DetailedDescription': 'As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Retrospective']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '120',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'COVID-19 patients',\n", - " 'ArmGroupDescription': 'Hospitalized patients with COVID-19',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: retrospective analysis']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", - " 'InterventionName': 'retrospective analysis',\n", - " 'InterventionDescription': 'The investigators retrospectively analyzed the hospitalized patients with COVID-19',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['COVID-19 patients']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Time to negative conversion of severe acute respiratory syndrome coronavirus 2',\n", - " 'PrimaryOutcomeDescription': 'The primary outcome is the time to negative conversion of coronavirus',\n", - " 'PrimaryOutcomeTimeFrame': '1 month'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Length of stay in hospital',\n", - " 'SecondaryOutcomeDescription': 'The time of hospitalization',\n", - " 'SecondaryOutcomeTimeFrame': '1 month'},\n", - " {'SecondaryOutcomeMeasure': 'Survival',\n", - " 'SecondaryOutcomeDescription': 'The rate of survival within hospitalization of these patients will be tracked. The rate of survival within hospitalization of these patients will be tracked. The rate of survival within hospitalization of these patients will be tracked. The rate of survival within hospitalization of these patients will be tracked.',\n", - " 'SecondaryOutcomeTimeFrame': '1 month'},\n", - " {'SecondaryOutcomeMeasure': 'Intubation',\n", - " 'SecondaryOutcomeDescription': 'The rate of intubation within hospitalization of these patients will be tracked',\n", - " 'SecondaryOutcomeTimeFrame': '1 month'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAdult aged >=18years old; Diagnosed with CONVID19. Diagnostic criteria including: Laboratory (RT-PCR) confirmed SARS-Cov-2 infection; CT of the lung conformed to the manifestation of viral pneumonia.\\n\\nExclusion Criteria:\\n\\nNear-death state (expected survival time less than 24 hours); Malignant tumor; Pregnancy or puerperium women; Patients who refused to participant.',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'Patients with COVID-19',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'LocationList': {'Location': [{'LocationFacility': \"Shanghai 10th People's Hospital\",\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Shanghai',\n", - " 'LocationState': 'Shanghai',\n", - " 'LocationZip': '+86200072',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Ming Li, M.D.',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+8613524348108',\n", - " 'LocationContactEMail': 'mlid163@163.com'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 54,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04333550',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '1398.1224'},\n", - " 'Organization': {'OrgFullName': 'Kermanshah University of Medical Sciences',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Application of Desferal to Treat COVID-19',\n", - " 'OfficialTitle': 'Application of Iron Chelator (Desferal) to Reduce the Severity of COVID-19 Manifestations'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'September 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'March 2021',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'April 1, 2020',\n", - " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 3, 2020',\n", - " 'StudyFirstPostDateType': 'Estimate'},\n", - " 'LastUpdateSubmitDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", - " 'LastUpdatePostDateType': 'Estimate'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Dr. Yadollah Shakiba',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Dr. Yadollah Shakiba, MD, PhD',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Kermanshah University of Medical Sciences'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Kermanshah University of Medical Sciences',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'In this study, defined cases of COVID-19 with mild, moderate or severe pneumonia will be treated with standard treatment regimens in combination with IV injection of Deferoxamine. Improvement in clinical, laboratory and radiological manifestations will be evaluated in treated patient compared to control group.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", - " 'KeywordList': {'Keyword': ['COVID-19, Deferoxamine']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 1', 'Phase 2']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Double',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", - " 'Investigator']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '50',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Experimental: Desferal addition to standard treatment',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Deferoxamine']}},\n", - " {'ArmGroupLabel': 'Experimental: standard treatment',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Deferoxamine']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Deferoxamine',\n", - " 'InterventionDescription': 'Daily intravenous (IV) dose of Deferoxamine for 3 to 5 days',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Experimental: Desferal addition to standard treatment',\n", - " 'Experimental: standard treatment']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Mortality rate',\n", - " 'PrimaryOutcomeDescription': 'All cause of death',\n", - " 'PrimaryOutcomeTimeFrame': 'up to 20 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'change in patients clinical manifestation',\n", - " 'SecondaryOutcomeDescription': 'Mild, Moderate or Severe',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 20 days'},\n", - " {'SecondaryOutcomeMeasure': 'change in patients PaO2',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 20 days'},\n", - " {'SecondaryOutcomeMeasure': 'Length of hospitalization',\n", - " 'SecondaryOutcomeDescription': 'days',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 20 days'},\n", - " {'SecondaryOutcomeMeasure': 'C-reactive protein',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 20 days'},\n", - " {'SecondaryOutcomeMeasure': 'lymphocyte count',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 20 days'},\n", - " {'SecondaryOutcomeMeasure': 'length of intensive care unit stay',\n", - " 'SecondaryOutcomeTimeFrame': '1 to 20 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nMale or Female Age between 3 and 99 years, Patients with mild, moderate or severe COVID-19 pneumonia based on clinical evaluation\\n\\n,\\n\\nExclusion Criteria:\\n\\nPatients with previous history of allergy to Deferoxamin Pregnant patient Patients with kidney dysfunction (blood creatinine>2) co-existence of bacterial pneumonia consent denied',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '3 Years',\n", - " 'MaximumAge': '99 Years',\n", - " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Alireza Ghaffarieh, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+1-608-698-7334',\n", - " 'CentralContactEMail': 'alireza_ghaffarieh@meei.harvard.edu'},\n", - " {'CentralContactName': 'Yadollah Shakiba, MD, PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactEMail': 'yshakiba@gmail.com'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Alireza Ghaffarieh, MD',\n", - " 'OverallOfficialAffiliation': 'Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran',\n", - " 'OverallOfficialRole': 'Study Director'},\n", - " {'OverallOfficialName': 'Yadollah Shakiba, MD, PhD',\n", - " 'OverallOfficialAffiliation': 'Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran',\n", - " 'OverallOfficialRole': 'Study Chair'},\n", - " {'OverallOfficialName': 'Amir Kiani, PhD',\n", - " 'OverallOfficialAffiliation': 'Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Regenerative Medicine Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Kermanshah',\n", - " 'LocationZip': '083',\n", - " 'LocationCountry': 'Iran, Islamic Republic of',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Yadollah Shakiba, MD, PhD',\n", - " 'LocationContactRole': 'Contact'}]}}]}},\n", - " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '18552864',\n", - " 'ReferenceType': 'result',\n", - " 'ReferenceCitation': 'Drakesmith H, Prentice A. Viral infection and iron metabolism. Nat Rev Microbiol. 2008 Jul;6(7):541-52. doi: 10.1038/nrmicro1930. Review.'},\n", - " {'ReferencePMID': '25076907',\n", - " 'ReferenceType': 'result',\n", - " 'ReferenceCitation': 'Nairz M, Haschka D, Demetz E, Weiss G. Iron at the interface of immunity and infection. Front Pharmacol. 2014 Jul 16;5:152. doi: 10.3389/fphar.2014.00152. eCollection 2014. Review.'},\n", - " {'ReferencePMID': '10669330',\n", - " 'ReferenceType': 'result',\n", - " 'ReferenceCitation': 'Georgiou NA, van der Bruggen T, Oudshoorn M, Nottet HS, Marx JJ, van Asbeck BS. Inhibition of human immunodeficiency virus type 1 replication in human mononuclear blood cells by the iron chelators deferoxamine, deferiprone, and bleomycin. J Infect Dis. 2000 Feb;181(2):484-90.'},\n", - " {'ReferencePMID': '22187937',\n", - " 'ReferenceType': 'result',\n", - " 'ReferenceCitation': 'Vlahakos D, Arkadopoulos N, Kostopanagiotou G, Siasiakou S, Kaklamanis L, Degiannis D, Demonakou M, Smyrniotis V. Deferoxamine attenuates lipid peroxidation, blocks interleukin-6 production, ameliorates sepsis inflammatory response syndrome, and confers renoprotection after acute hepatic ischemia in pigs. Artif Organs. 2012 Apr;36(4):400-8. doi: 10.1111/j.1525-1594.2011.01385.x. Epub 2011 Dec 21.'},\n", - " {'ReferencePMID': '29619244',\n", - " 'ReferenceType': 'result',\n", - " 'ReferenceCitation': 'Wang H, Li Z, Niu J, Xu Y, Ma L, Lu A, Wang X, Qian Z, Huang Z, Jin X, Leng Q, Wang J, Zhong J, Sun B, Meng G. Antiviral effects of ferric ammonium citrate. Cell Discov. 2018 Mar 27;4:14. doi: 10.1038/s41421-018-0013-6. eCollection 2018.'},\n", - " {'ReferencePMID': '7811060',\n", - " 'ReferenceType': 'result',\n", - " 'ReferenceCitation': 'Cinatl J Jr, Cinatl J, Rabenau H, Gümbel HO, Kornhuber B, Doerr HW. In vitro inhibition of human cytomegalovirus replication by desferrioxamine. Antiviral Res. 1994 Sep;25(1):73-7.'},\n", - " {'ReferencePMID': '11886437',\n", - " 'ReferenceType': 'result',\n", - " 'ReferenceCitation': 'Visseren F, Verkerk MS, van der Bruggen T, Marx JJ, van Asbeck BS, Diepersloot RJ. Iron chelation and hydroxyl radical scavenging reduce the inflammatory response of endothelial cells after infection with Chlamydia pneumoniae or influenza A. Eur J Clin Invest. 2002 Mar;32 Suppl 1:84-90.'},\n", - " {'ReferencePMID': '8554902',\n", - " 'ReferenceType': 'result',\n", - " 'ReferenceCitation': 'Sappey C, Boelaert JR, Legrand-Poels S, Forceille C, Favier A, Piette J. Iron chelation decreases NF-kappa B and HIV type 1 activation due to oxidative stress. AIDS Res Hum Retroviruses. 1995 Sep;11(9):1049-61.'},\n", - " {'ReferencePMID': '25291189',\n", - " 'ReferenceType': 'result',\n", - " 'ReferenceCitation': 'Chang HC, Bayeva M, Taiwo B, Palella FJ Jr, Hope TJ, Ardehali H. Short communication: high cellular iron levels are associated with increased HIV infection and replication. AIDS Res Hum Retroviruses. 2015 Mar;31(3):305-12. doi: 10.1089/aid.2014.0169. Epub 2014 Oct 7.'},\n", - " {'ReferencePMID': '16787239',\n", - " 'ReferenceType': 'result',\n", - " 'ReferenceCitation': 'Meyer D. Iron chelation as therapy for HIV and Mycobacterium tuberculosis co-infection under conditions of iron overload. Curr Pharm Des. 2006;12(16):1943-7. Review.'},\n", - " {'ReferencePMID': '8665150',\n", - " 'ReferenceType': 'result',\n", - " 'ReferenceCitation': 'Cinatl J, Scholz M, Weber B, Cinatl J, Rabenau H, Markus BH, Encke A, Doerr HW. Effects of desferrioxamine on human cytomegalovirus replication and expression of HLA antigens and adhesion molecules in human vascular endothelial cells. Transpl Immunol. 1995 Dec;3(4):313-20.'},\n", - " {'ReferencePMID': '10051178',\n", - " 'ReferenceType': 'result',\n", - " 'ReferenceCitation': 'Mabeza GF, Loyevsky M, Gordeuk VR, Weiss G. Iron chelation therapy for malaria: a review. Pharmacol Ther. 1999 Jan;81(1):53-75. Review.'},\n", - " {'ReferencePMID': '8067783',\n", - " 'ReferenceType': 'result',\n", - " 'ReferenceCitation': 'Weinberg GA. Iron chelators as therapeutic agents against Pneumocystis carinii. Antimicrob Agents Chemother. 1994 May;38(5):997-1003.'},\n", - " {'ReferencePMID': '18369153',\n", - " 'ReferenceType': 'result',\n", - " 'ReferenceCitation': 'Paradkar PN, De Domenico I, Durchfort N, Zohn I, Kaplan J, Ward DM. Iron depletion limits intracellular bacterial growth in macrophages. Blood. 2008 Aug 1;112(3):866-74. doi: 10.1182/blood-2007-12-126854. Epub 2008 Mar 27.'},\n", - " {'ReferencePMID': '29719970',\n", - " 'ReferenceType': 'result',\n", - " 'ReferenceCitation': 'Giannakopoulou E, Pardali V, Zoidis G. Metal-chelating agents against viruses and parasites. Future Med Chem. 2018 Jun 1;10(11):1283-1285. doi: 10.4155/fmc-2018-0100. Epub 2018 May 3. Review.'},\n", - " {'ReferencePMID': '1406879',\n", - " 'ReferenceType': 'result',\n", - " 'ReferenceCitation': 'Gordeuk V, Thuma P, Brittenham G, McLaren C, Parry D, Backenstose A, Biemba G, Msiska R, Holmes L, McKinley E, et al. Effect of iron chelation therapy on recovery from deep coma in children with cerebral malaria. N Engl J Med. 1992 Nov 19;327(21):1473-7.'},\n", - " {'ReferencePMID': '28583206',\n", - " 'ReferenceType': 'result',\n", - " 'ReferenceCitation': 'Duchemin JB, Paradkar PN. Iron availability affects West Nile virus infection in its mosquito vector. Virol J. 2017 Jun 5;14(1):103. doi: 10.1186/s12985-017-0770-0.'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000003676',\n", - " 'InterventionMeshTerm': 'Deferoxamine'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000017262',\n", - " 'InterventionAncestorTerm': 'Siderophores'},\n", - " {'InterventionAncestorId': 'D000007502',\n", - " 'InterventionAncestorTerm': 'Iron Chelating Agents'},\n", - " {'InterventionAncestorId': 'D000002614',\n", - " 'InterventionAncestorTerm': 'Chelating Agents'},\n", - " {'InterventionAncestorId': 'D000064449',\n", - " 'InterventionAncestorTerm': 'Sequestering Agents'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M5461',\n", - " 'InterventionBrowseLeafName': 'Deferoxamine',\n", - " 'InterventionBrowseLeafAsFound': 'Deferoxamine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M9116',\n", - " 'InterventionBrowseLeafName': 'Iron',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M4443',\n", - " 'InterventionBrowseLeafName': 'Chelating Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M18141',\n", - " 'InterventionBrowseLeafName': 'Siderophores',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M9117',\n", - " 'InterventionBrowseLeafName': 'Iron Chelating Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", - " {'InterventionBrowseBranchAbbrev': 'Micro',\n", - " 'InterventionBrowseBranchName': 'Micronutrients'}]}}}}},\n", - " {'Rank': 55,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04318444',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'AAAS9676'},\n", - " 'Organization': {'OrgFullName': 'Columbia University',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Hydroxychloroquine Post Exposure Prophylaxis for Coronavirus Disease (COVID-19)',\n", - " 'OfficialTitle': 'Hydroxychloroquine Post Exposure Prophylaxis (PEP) for Household Contacts of COVID-19 Patients: A NYC Community-Based Randomized Clinical Trial'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 2021',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'March 2022',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 20, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 20, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 24, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 24, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 25, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Elizabeth Oelsner',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Assistant Professor',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Columbia University'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Columbia University',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'Yes',\n", - " 'IsFDARegulatedDevice': 'No',\n", - " 'IsUSExport': 'Yes'},\n", - " 'DescriptionModule': {'BriefSummary': 'The purpose of this study is to test the hypothesis that post-exposure prophylaxis with hydroxychloroquine will reduce the symptomatic secondary attack rate among household contacts of known or suspected COVID-19 patients.',\n", - " 'DetailedDescription': 'COVID-19 is a massive threat to public health worldwide. Current estimates suggest that the novel coronavirus (SARS-CoV-2) is both highly contagious (estimated reproductive rate, 2-3) and five to fifty-fold more lethal than seasonal influenza (estimated mortality rate, 0.5-5%). Interventions to decrease the incidence and severity of COVID-19 are emergently needed.\\n\\nHydroxychloroquine (brand name, Plaquenil), an inexpensive anti-malarial medication with immunomodulatory effects, is a promising therapy for COVID-19. Chloroquine, a related compound with a less favorable toxicity profile, has shown benefit in clinical studies conducted in approximately one-hundred SARS-CoV-2 infected patients. In vitro, hydroxychloroquine has been recently shown to have greater efficacy against SARS-CoV-2 versus chloroquine.\\n\\nCurrently, there is no established post-exposure prophylaxis for persons at high risk of developing COVID-19. Hydroxychloroquine (brand name, Plaquenil), is a medicine that has been found to be effective against the novel coronavirus in some recent experiments. Previously, hydroxychloquine has been safety used to prevent malaria or to treat autoimmune diseases.\\n\\nThis study will test if hydroxychloroquine may be used to prevent the development of COVID-19 symptoms in persons who live with an individual who has been diagnosed with COVID-19. If hydroxychloroquine is shown to reduce the risk of developing symptoms of COVID-19 among people at high risk of infection, this could help to reduce the morbidity and mortality of the COVID-19 epidemic.\\n\\nThis is a trial of hydroxychloroquine PEP among adult household contacts of COVID-19 patients in New York City (NYC). The trial will be initiated at NewYork-Presbyterian (NYP)/Columbia University Irving Medical Center (CUIMC).'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", - " 'Corona Virus Infection']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 2', 'Phase 3']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Prevention',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Quadruple',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", - " 'Care Provider',\n", - " 'Investigator',\n", - " 'Outcomes Assessor']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '1600',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Hydroxychloroquine',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Two tablets (400mg) twice daily on day 1; for days 2-5, they will be instructed to take one tablet (200mg) twice daily.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine']}},\n", - " {'ArmGroupLabel': 'Placebo',\n", - " 'ArmGroupType': 'Placebo Comparator',\n", - " 'ArmGroupDescription': 'Two tablets (400mg) twice daily on day 1; for days 2-5, they will be instructed to take one tablet (200mg) twice daily.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo oral tablet']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Hydroxychloroquine',\n", - " 'InterventionDescription': 'Two tablets (400mg) twice daily on day 1; for days 2-5, they will be instructed to take one tablet (200mg) twice daily.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Hydroxychloroquine']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Plaquenil']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Placebo oral tablet',\n", - " 'InterventionDescription': 'Two tablets (400mg) twice daily on day 1; for days 2-5, they will be instructed to take one tablet (200mg) twice daily.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Placebo']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Number of participants with symptomatic, lab-confirmed COVID-19.',\n", - " 'PrimaryOutcomeDescription': 'This is defined as either 1. COVID-19 infection confirmed within 14 days of enrollment, following self-report of COVID-19 symptoms to the research study; OR, 2. COVID-19 infection confirmed within 14 days of enrollment, with self-report of COVID-19 symptoms to a treating physician.',\n", - " 'PrimaryOutcomeTimeFrame': 'Date of enrollment to 14 days post-enrollment date'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nHousehold contact of index case: currently residing in the same household as an individual evaluated at NYP via outpatient, emergency department (ED), or inpatient services who (1) test positive for COVID-19, or (2) are defined as suspected cases, or persons under investigations (PUI), by the treating physician.\\nWilling to take study drug as directed for 5 days.\\n\\nExclusion Criteria:\\n\\nAge <18 years old\\nSuspected or confirmed current COVID-19, defined as: (1) temperature > 38 Celsius; (2) cough; (3) shortness of breath; (4) sore throat; or, if available (not required), (5) positive confirmatory testing for COVID-19\\nSuspected or confirmed convalescent COVID-19, defined as any of the above symptoms within the prior 4 weeks.\\nInability to take medications orally\\nInability to provide written consent\\nKnown sensitivity/allergy to hydroxychloroquine\\nCurrent use of hydroxychloroquine for another indication\\nPregnancy\\nPrior diagnosis of retinopathy\\nPrior diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency\\nMajor comorbidities increasing risk of study drug including: i. Hematologic malignancy, ii. Advanced (stage 4-5) chronic kidney disease or dialysis therapy, iii. Known history of ventricular arrhythmias, iv. Current use of drugs that prolong the QT interval',\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Elizabeth Oelsner, MD, MPH',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '212-305-9056',\n", - " 'CentralContactEMail': 'eco7@cumc.columbia.edu'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Elizabeth Oelsner, MD, MPH',\n", - " 'OverallOfficialAffiliation': 'Columbia University Irving Medical Center',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Columbia University Irving Medical Center',\n", - " 'LocationCity': 'New York',\n", - " 'LocationState': 'New York',\n", - " 'LocationZip': '10032',\n", - " 'LocationCountry': 'United States'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", - " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", - " 'InterventionAncestorTerm': 'Antimalarials'},\n", - " {'InterventionAncestorId': 'D000000981',\n", - " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", - " {'InterventionAncestorId': 'D000000977',\n", - " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", - " {'InterventionAncestorId': 'D000000890',\n", - " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", - " {'InterventionAncestorId': 'D000004791',\n", - " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", - " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M2861',\n", - " 'InterventionBrowseLeafName': 'Antimalarials',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2879',\n", - " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2875',\n", - " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2795',\n", - " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19188',\n", - " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", - " {'ConditionMeshId': 'D000045169',\n", - " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'},\n", - " {'ConditionMeshId': 'D000014777',\n", - " 'ConditionMeshTerm': 'Virus Diseases'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Corona Virus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Corona Virus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafAsFound': 'Virus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Corona Virus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 56,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04326920',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'SARPAC'},\n", - " 'Organization': {'OrgFullName': 'University Hospital, Ghent',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Sargramostim in Patients With Acute Hypoxic Respiratory Failure Due to COVID-19 (SARPAC)',\n", - " 'OfficialTitle': 'A Prospective, Randomized, Open-label, Interventional Study to Investigate the Efficacy of Sargramostim (Leukine®) in Improving Oxygenation and Short- and Long-term Outcome of COVID-19 (Corona Virus Disease) Patients With Acute Hypoxic Respiratory Failure.',\n", - " 'Acronym': 'SARPAC'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 24, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'October 31, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 24, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 27, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 30, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 31, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Bart N. Lambrecht',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Director, VIB-UGent Center for Inflammation Research',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'University Hospital, Ghent'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'University Hospital, Ghent',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Flanders Institute of Biotechnology',\n", - " 'CollaboratorClass': 'UNKNOWN'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'Yes',\n", - " 'IsFDARegulatedDevice': 'No',\n", - " 'IsUSExport': 'Yes'},\n", - " 'DescriptionModule': {'BriefSummary': 'Phase IV study to evaluate the effectiveness of additional inhaled sargramostim (GM-CSF) versus standard of care on blood oxygenation in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure.',\n", - " 'DetailedDescription': \"Leukine® is a yeast-derived recombinant humanized granulocyte-macrophage colony stimulating factor (rhuGM-CSF, sargramostim) and the only FDA approved GM-CSF. GMCSF, a pleiotropic cytokine, is an important leukocyte growth factor known to play a key role in hematopoiesis, effecting the growth and maturation of multiple cell lineages as well as the functional activities of these cells in antigen presentation and cell mediated immunity.\\n\\nLeukine inhalation or intravenous administration, as an adjuvant therapy, may confer benefit to patients with ARDS (Acute Respiratory Distress Syndrome) due to COVID-19 exposure, who are at significant risk of mortality. While there is no active IND (Investigational New Drug) for Leukine in the proposed patient population, Leukine is being studied in Fase II as an adjuvant therapy in the management of life-threatening infections to boost the hosts innate immune response to fight infection, reduce the risk of secondary infection, and in varied conditions as prevention of infection during critical illness. Inhaled Leukine has also been successfully used as primary therapy to improve oxygenation in patients with disordered gas exchange in the lungs. We propose that based on preclinical and clinical data, Leukine inhalation, as an adjuvant therapy, has an acceptable benefit-risk for use in patients with hypoxic respiratory failure and ARDS due to COVID-19 exposure, who are at significant risk of mortality.\\n\\nConfirmed COVID19 patients with hypoxic respiratory failure (saturation below 93% on minimal 2 l/min O2) will be randomized to receive sargramostim 125mcg twice daily for 5 days as a nebulized inhalation on top of standard of care, or to receive standard of care treatment. Upon progression to ARDS and initiation of invasive mechanical ventilator support within the 5 day period, in patients in the active group, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment. In the control group progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, the treating physician will have the option to initiate IV sargramostim 125mcg/m2 body surface area for 5 days. Safety data, including blood leukocyte counts, will be collected in all patients. Efficacy data will also be collected and will include arterial blood gases, oxygenation parameters, need for ventilation, lung compliance, organ function, radiographic changes, ferritin levels, etc. as well as occurrence of secondary bacterial infections.\"},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", - " 'KeywordList': {'Keyword': ['GM-CSF',\n", - " 'Acute Lung Injury',\n", - " 'Hypoxia',\n", - " 'Acute Respiratory Distress Syndrome',\n", - " 'Corona virus',\n", - " 'COVID-19',\n", - " 'SARS (Severe Acute Respiratory Syndrome)',\n", - " 'Alveolar Macrophage',\n", - " 'Acute Hypoxic respiratory failure']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 4']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '80',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Active sargramostim treatment group',\n", - " 'ArmGroupType': 'Active Comparator',\n", - " 'ArmGroupDescription': \"Inhaled sargramostim 125mcg twice daily for 5 days on top of standard of care. Upon progression to ARDS and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125mcg/m2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment\",\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Sargramostim']}},\n", - " {'ArmGroupLabel': 'Control group',\n", - " 'ArmGroupType': 'Placebo Comparator',\n", - " 'ArmGroupDescription': \"standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards, will have the option (clinician's decision) to initiate IV sargramostim 125mcg/m2 body surface area once daily for 5 days\",\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Sargramostim',\n", - " 'Other: Control']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Sargramostim',\n", - " 'InterventionDescription': 'Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Active sargramostim treatment group',\n", - " 'Control group']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['LEUKINE']}},\n", - " {'InterventionType': 'Other',\n", - " 'InterventionName': 'Control',\n", - " 'InterventionDescription': 'Standard of care',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Control group']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Improvement in oxygenation at a dose of 250 mcg daily during 5 days improves oxygenation in COVID-19 patients with acute hypoxic respiratory failure',\n", - " 'PrimaryOutcomeDescription': 'by mean change in PaO2/FiO2 (PaO2=Partial pressure of oxygen; FiO2= Fraction of inspired oxygen)',\n", - " 'PrimaryOutcomeTimeFrame': 'at end of 5 day treatment period'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Incidence of AE (Adverse Event)',\n", - " 'SecondaryOutcomeTimeFrame': 'at end of 5 day treatment period, 10 day period, 10-20 weeks'},\n", - " {'SecondaryOutcomeMeasure': 'Incidence of SAEs (Serious Adverse Event)',\n", - " 'SecondaryOutcomeTimeFrame': 'at end of 5 day treatment period, 10 day period, 10-20 weeks'},\n", - " {'SecondaryOutcomeMeasure': 'Clinical Status using 6-point ordinal scale',\n", - " 'SecondaryOutcomeTimeFrame': 'at end of 5 day treatment period, 10 day period, 10-20 weeks'},\n", - " {'SecondaryOutcomeMeasure': 'Clinical Status using Clincal sign score',\n", - " 'SecondaryOutcomeTimeFrame': 'at end of 5 day treatment period, 10 day period,10-20 weeks'},\n", - " {'SecondaryOutcomeMeasure': 'Clinical Status using SOFA score (Sequential Organ Failure Assessment score),',\n", - " 'SecondaryOutcomeTimeFrame': 'at end of 5 day treatment period, 10 day period, 10-20 weeks'},\n", - " {'SecondaryOutcomeMeasure': 'Clinical Status using NEWS2 score (National Early Warning Score)',\n", - " 'SecondaryOutcomeTimeFrame': 'at end of 5 day treatment period, 10 day period, 10-20 weeks'},\n", - " {'SecondaryOutcomeMeasure': 'incidence of severe or life-threatening bacterial, invasive fungal or opportunistic infection',\n", - " 'SecondaryOutcomeDescription': 'demonstrated by bacterial or fungal culture',\n", - " 'SecondaryOutcomeTimeFrame': 'during hospital admission (up to 28 days)'},\n", - " {'SecondaryOutcomeMeasure': 'number of patients requiring initiation of mechanical ventilation',\n", - " 'SecondaryOutcomeTimeFrame': 'during hospital admission (up to 28 days)'},\n", - " {'SecondaryOutcomeMeasure': 'Number of deaths due to any cause at 4 weeks',\n", - " 'SecondaryOutcomeTimeFrame': '4 weeks post inclusion'},\n", - " {'SecondaryOutcomeMeasure': 'Number of deaths due to any cause at 20 weeks',\n", - " 'SecondaryOutcomeTimeFrame': '20 weeks post inclusion'},\n", - " {'SecondaryOutcomeMeasure': 'number of patients developing features of secondary haemophagocytic lymphohistiocytosis',\n", - " 'SecondaryOutcomeDescription': 'defined by HS (Hemophagocytic Syndrome) score',\n", - " 'SecondaryOutcomeTimeFrame': 'at enrolment, end of 5 day treatment period, 10 day period, 10-20 weeks'},\n", - " {'SecondaryOutcomeMeasure': 'long term Clinical status defined by 6-point ordinal scale',\n", - " 'SecondaryOutcomeTimeFrame': '10-20 week'},\n", - " {'SecondaryOutcomeMeasure': 'long term Clinical status defined by chest X-ray',\n", - " 'SecondaryOutcomeTimeFrame': '10-20 weeks'},\n", - " {'SecondaryOutcomeMeasure': 'long term Clinical status defined lung function',\n", - " 'SecondaryOutcomeTimeFrame': '10-12 weeks'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nRecent (≤2weeks prior to randomization) PCR(Polymerase Chain Reaction) -Confirmed COVID-19 infection\\n\\nPresence of acute hypoxic respiratory failure defined as (either or both)\\n\\nsaturation below 93% on minimal 2 l/min O2\\nPaO2/FiO2 below 300\\nAdmitted to specialized COVID-19 ward\\nAge 18-80\\nMale or Female\\nWilling to provide informed consent\\n\\nExclusion Criteria:\\n\\nPatients with known history of serious allergic reactions, including anaphylaxis, to human granulocyte-macrophage colony stimulating factor such as sargramostim, yeast-derived products, or any component of the product.\\nmechanical ventilation before start of study\\npatients with peripheral white blood cell count above 25.000 per microliter and/or active myeloid malignancy\\npatients on high dose systemic steroids (> 20 mg methylprednisolone or equivalent)\\npatients on lithium carbonate therapy\\nPatients enrolled in another investigational drug study\\nPregnant or breastfeeding females (all female subjects regardless of childbearing potential status must have negative pregnancy test at screening)\\nPatients with serum ferritin >2000 mcg/ml (which will exclude ongoing HLH)',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '80 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Anja Delporte',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+32-9-3320228',\n", - " 'CentralContactEMail': 'anja.delporte@uzgent.be'},\n", - " {'CentralContactName': 'Bart Lambrecht, MD PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+32-9-3329110',\n", - " 'CentralContactEMail': 'bart.lambrecht@ugent.be'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Bart Lambrecht',\n", - " 'OverallOfficialAffiliation': 'University Hospital, Ghent',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'AZ Sint Jan Brugge',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Brugge',\n", - " 'LocationZip': '8000',\n", - " 'LocationCountry': 'Belgium',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Stefaan Vandecasteele, MD Phd',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+32-50 45 23 10',\n", - " 'LocationContactEMail': 'stefaan.vandecasteele@azsintjan.be'}]}},\n", - " {'LocationFacility': 'University Hospital Ghent',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Gent',\n", - " 'LocationZip': '9000',\n", - " 'LocationCountry': 'Belgium',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Anja Delporte',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+32-9-3320228',\n", - " 'LocationContactEMail': 'anja.delporte@uzgent.be'},\n", - " {'LocationContactName': 'Bart Lambrecht, MD PhD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+32-9-3329110',\n", - " 'LocationContactEMail': 'bart.lambrecht@ugent.be'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020',\n", - " 'RemovedCountryList': {'RemovedCountry': ['Italy']}},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'C000081222',\n", - " 'InterventionMeshTerm': 'Sargramostim'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000007155',\n", - " 'InterventionAncestorTerm': 'Immunologic Factors'},\n", - " {'InterventionAncestorId': 'D000045505',\n", - " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M267719',\n", - " 'InterventionBrowseLeafName': 'Sargramostim',\n", - " 'InterventionBrowseLeafAsFound': 'Sargramostim',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M8784',\n", - " 'InterventionBrowseLeafName': 'Immunologic Factors',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000012131',\n", - " 'ConditionMeshTerm': 'Respiratory Insufficiency'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000012120',\n", - " 'ConditionAncestorTerm': 'Respiration Disorders'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13547',\n", - " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Newborn',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13548',\n", - " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Adult',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M26731',\n", - " 'ConditionBrowseLeafName': 'Acute Lung Injury',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13551',\n", - " 'ConditionBrowseLeafName': 'Respiratory Insufficiency',\n", - " 'ConditionBrowseLeafAsFound': 'Respiratory Failure',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M26730',\n", - " 'ConditionBrowseLeafName': 'Lung Injury',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M2766',\n", - " 'ConditionBrowseLeafName': 'Hypoxia',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13102',\n", - " 'ConditionBrowseLeafName': 'Pulmonary Valve Insufficiency',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13540',\n", - " 'ConditionBrowseLeafName': 'Respiration Disorders',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T4953',\n", - " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Infant',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T191',\n", - " 'ConditionBrowseLeafName': 'Acute Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC16',\n", - " 'ConditionBrowseBranchName': 'Diseases and Abnormalities at or Before Birth'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC26',\n", - " 'ConditionBrowseBranchName': 'Wounds and Injuries'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC14',\n", - " 'ConditionBrowseBranchName': 'Heart and Blood Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 57,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04324866',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'Gisondi 4'},\n", - " 'Organization': {'OrgFullName': 'Universita di Verona',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Prevalence and Incidence of COVID-19 Infection in Patients With Chronic Plaque Psoriasis on Immunosuppressant Therapy',\n", - " 'OfficialTitle': 'Prevalence and Incidence of COVID-19 Infection in Patients With Chronic Plaque Psoriasis on Immunosuppressant Therapy'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'November 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'December 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 24, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 26, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 27, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 26, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 27, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Paolo Gisondi',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Associate Professor',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Universita di Verona'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Universita di Verona',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Azienda Ospedaliera Universitaria Integrata Verona',\n", - " 'CollaboratorClass': 'OTHER'}]}},\n", - " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'This study will assess the prevalence and incidence of COVID-19 infection in patients with chronic plaque psoriasis on immunosuppressant therapy.',\n", - " 'DetailedDescription': 'The ongoing COVID-19 pandemic has hit Northern Italy (including the Veneto region) particularly hard, causing several deaths and putting a huge strain on the Italian National Healthcare System. In the absence of specific treatments, preventing the infection from spreading remains the only effective measure. There is a lot of apprehension both from doctors (including dermatologists, rheumatologists and gastroenterologists) and their patients that immunosuppressive medications (biologics, methotrexate, ciclosporin and corticosteroids) might lead to an increased susceptibility to COVID-19 infection or negatively influence the course of the infection. However, there is currently a lack of scientific evidence to recommend whether immunosuppressive treatments should or should not be continued in patients who have no symptoms of COVID-19 infection. Besides, treatment discontinuation would cause flare-ups of diseases - such as plaque psoriasis, psoriatic arthritis and inflammatory bowel diseases - which are invalidating and have a relatively high prevalence in the Veneto population. In the Unit of Dermatology of the Azienda Ospedaliera Universitaria Intergrata di Verona alone, more than 2000 patients are currently being treated with immunosuppressive agents. As of now, there are no data available on the prevalence and incidence of COVID-19 infection in patients with immune-mediated diseases, nor can data from randomized clinical trials be extrapolated to the susceptibility to COVID-19 infection in patients on biologic drugs. This study aims to assess the prevalence and incidence of COVID-19 infection in patients with chronic plaque psoriasis on immunosuppressive therapy and to identify associated risk factors. Such data would prove invaluable for clinicians dealing with patients on immunosuppressive agents during the coronavirus outbreak.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus Infection']},\n", - " 'KeywordList': {'Keyword': ['psoriasis',\n", - " 'immunosuppressant therapy',\n", - " 'covid 19']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'BioSpec': {'BioSpecRetention': 'Samples Without DNA',\n", - " 'BioSpecDescription': 'Nasopharyngeal swabs'},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '300',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Group 1',\n", - " 'ArmGroupDescription': 'Patients with chronic plaque psoriasis on immunosuppressant therapy',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Diagnostic Test: Nasopharyngeal swab']}},\n", - " {'ArmGroupLabel': 'Group 2',\n", - " 'ArmGroupDescription': \"Psoriatic patients' partners\",\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Diagnostic Test: Nasopharyngeal swab']}},\n", - " {'ArmGroupLabel': 'Group 3',\n", - " 'ArmGroupDescription': 'Patients with atopic dermatitis treated with dupilumab',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Diagnostic Test: Nasopharyngeal swab']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Diagnostic Test',\n", - " 'InterventionName': 'Nasopharyngeal swab',\n", - " 'InterventionDescription': 'Nasopharyngeal swab for the molecular diagnosis of COVID-19 infection',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Group 1',\n", - " 'Group 2',\n", - " 'Group 3']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Point prevalence of COVID-19 infection',\n", - " 'PrimaryOutcomeTimeFrame': 'Baseline up to 6 months'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Incidence of COVID-19 infection',\n", - " 'SecondaryOutcomeTimeFrame': 'Baseline up to 6 months'},\n", - " {'SecondaryOutcomeMeasure': 'Percentage of subjects presenting fever or respiratory symptoms',\n", - " 'SecondaryOutcomeTimeFrame': 'Baseline up to 6 months'},\n", - " {'SecondaryOutcomeMeasure': 'Evaluate the relationship between COVID-19 infection and chronic pharmacological treatments',\n", - " 'SecondaryOutcomeTimeFrame': 'Baseline up to 6 months'},\n", - " {'SecondaryOutcomeMeasure': 'Evaluate the relationship between COVID-19 infection and comorbid medical conditions',\n", - " 'SecondaryOutcomeTimeFrame': 'Baseline up to 6 months'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Group 1\\n\\nInclusion Criteria:\\n\\nAged 18 to 75 years old\\nIndividuals with a clinical diagnosis of moderate-to-severe chronic plaque psoriasis confirmed by the Investigator\\nContinuous immunosuppressive therapy (etanercept, adalimumab, infliximab, ustekinumab, secukinumab, ixekizumab, brodalumab, guselkumab, apremilast, methotrexate, ciclsoporin, acitretin) for the past 3 months\\nIs willing and able to sign informed consent to participate\\n\\nExclusion Criteria:\\n\\nPatients unwilling to undergo noasopharyngeal swab\\nInability to give informed consent\\n\\nGroup 2\\n\\nInclusion Criteria:\\n\\nAged 18 to 75 years old\\nPartner of a patient with psoriasis enrolled in the study\\nIs willing and able to sign informed consent to participate\\n\\nExclusion Criteria:\\n\\nPersonal history of psoriasis\\nOngoing immunosuppressive therapy\\nPatients unwilling to undergo noasopharyngeal swab\\nInability to give informed consent\\n\\nGroup 3\\n\\nAged 18 to 75 years old\\nIndividuals with a clinical diagnosis of moderate-to-severe atopic dermatitis confirmed by the Investigator\\nContinuous therapy with dupilumab for the past 3 months\\nIs willing and able to sign informed consent to participate\\n\\nExclusion Criteria:\\n\\nPatients unwilling to undergo noasopharyngeal swab\\nInability to give informed consent',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '75 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'This study will enroll patients from the Unit of Dermatology of Azienda Ospedaliera Universitaria di Verona and their partners.',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Paolo Gisondi',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+39 0458122547',\n", - " 'CentralContactEMail': 'paolo.gisondi@univr.it'}]}}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000007166',\n", - " 'InterventionMeshTerm': 'Immunosuppressive Agents'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000007155',\n", - " 'InterventionAncestorTerm': 'Immunologic Factors'},\n", - " {'InterventionAncestorId': 'D000045505',\n", - " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8795',\n", - " 'InterventionBrowseLeafName': 'Immunosuppressive Agents',\n", - " 'InterventionBrowseLeafAsFound': 'Immunosuppressant',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M8784',\n", - " 'InterventionBrowseLeafName': 'Immunologic Factors',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", - " 'ConditionMeshTerm': 'Infection'},\n", - " {'ConditionMeshId': 'D000003141',\n", - " 'ConditionMeshTerm': 'Communicable Diseases'},\n", - " {'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", - " {'ConditionMeshId': 'D000045169',\n", - " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'},\n", - " {'ConditionMeshId': 'D000011565', 'ConditionMeshTerm': 'Psoriasis'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000017444',\n", - " 'ConditionAncestorTerm': 'Skin Diseases, Papulosquamous'},\n", - " {'ConditionAncestorId': 'D000012871',\n", - " 'ConditionAncestorTerm': 'Skin Diseases'},\n", - " {'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafAsFound': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafAsFound': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M13005',\n", - " 'ConditionBrowseLeafName': 'Psoriasis',\n", - " 'ConditionBrowseLeafAsFound': 'Psoriasis',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M14257',\n", - " 'ConditionBrowseLeafName': 'Skin Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M18296',\n", - " 'ConditionBrowseLeafName': 'Skin Diseases, Papulosquamous',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC17',\n", - " 'ConditionBrowseBranchName': 'Skin and Connective Tissue Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 58,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04275947',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'CAALC-008-CMHS'},\n", - " 'Organization': {'OrgFullName': 'Chinese Alliance Against Lung Cancer',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'The COVID-19 Mobile Health Study (CMHS)',\n", - " 'OfficialTitle': 'The COVID-19 Mobile Health Study, a Large-scale Clinical Observational Study Using nCapp',\n", - " 'Acronym': 'CMHS'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'February 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'February 14, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 30, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'May 31, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'February 17, 2020',\n", - " 'StudyFirstSubmitQCDate': 'February 17, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'February 19, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'February 17, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'February 19, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Bai Chunxue',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Chair',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Chinese Alliance Against Lung Cancer'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Chinese Alliance Against Lung Cancer',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Shanghai Respiratory Research Institution',\n", - " 'CollaboratorClass': 'UNKNOWN'}]}},\n", - " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'This study evaluates a brand-new cell phone-based auto-diagnosis system, which is based on the clinical guidelines, clinical experience, and statistic training model. We will achieve secure and 1st hand data from physicians in Wuhan, which including 150 cases in the training cohort and 300 cases in the validation cohort.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '450',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Training',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: nCapp, a cell phone-based auto-diagnosis system']}},\n", - " {'ArmGroupLabel': 'Validation',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: nCapp, a cell phone-based auto-diagnosis system']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", - " 'InterventionName': 'nCapp, a cell phone-based auto-diagnosis system',\n", - " 'InterventionDescription': 'Combined with 15 questions online, and a predicated formula to auto-diagnosis of the risk of COVID-19',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Training',\n", - " 'Validation']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Accuracy of nCapp COVID-19 risk diagnostic model',\n", - " 'PrimaryOutcomeDescription': 'Sensitivity, specificity and area under the ROC curve of nCapp model',\n", - " 'PrimaryOutcomeTimeFrame': '1 day'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nHigh risk of COVID-19\\nRT-PCR test result of SAR2-CoV-19\\n\\nExclusion Criteria:\\n\\nNot available for RT-PCR test result of SAR2-CoV-19',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '90 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': '-High risk of COVID-19',\n", - " 'SamplingMethod': 'Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Chunxue Bai',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+8618621170011\\u202c',\n", - " 'CentralContactEMail': 'bai.chunxue@zs-hospital.sh.cn'},\n", - " {'CentralContactName': 'Dawei Yang',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+8613564703813',\n", - " 'CentralContactEMail': 'yang.dawei@zs-hospital.sh.cn'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Chunxue Bai',\n", - " 'OverallOfficialAffiliation': 'Shanghai Respiratory Research Institution',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Renmin Hospital of Wuhan University',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Wuhan',\n", - " 'LocationState': 'Hubei',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Chunxue Bai',\n", - " 'LocationContactRole': 'Contact'},\n", - " {'LocationContactName': 'Xun Wang',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Jie Liu',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Chunlin Dong',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Yong Zhang',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Maosong Ye',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Chunxue Bai',\n", - " 'LocationContactRole': 'Principal Investigator'}]}}]}},\n", - " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '28940455',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Yang D, Zhang X, Powell CA, Ni J, Wang B, Zhang J, Zhang Y, Wang L, Xu Z, Zhang L, Wu G, Song Y, Tian W, Hu JA, Zhang Y, Hu J, Hong Q, Song Y, Zhou J, Bai C. Probability of cancer in high-risk patients predicted by the protein-based lung cancer biomarker panel in China: LCBP study. Cancer. 2018 Jan 15;124(2):262-270. doi: 10.1002/cncr.31020. Epub 2017 Sep 20.'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided',\n", - " 'IPDSharingDescription': 'The anonymous clinical data for training and validation the model'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'}}}},\n", - " {'Rank': 59,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04330144',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '3-2020-0036'},\n", - " 'Organization': {'OrgFullName': 'Gangnam Severance Hospital',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial)',\n", - " 'OfficialTitle': 'A Study of Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial)'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 30, 2021',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'March 30, 2022',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 30, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 31, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 31, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Young Goo Song',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Professor, Department of Internal Medicine,',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Gangnam Severance Hospital'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Gangnam Severance Hospital',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No',\n", - " 'IsUSExport': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'There is no known definite treatment after exposure to SARS-CoV-2, but the some animal and clinical trials confirmed the efficacy of hydroxychloroquine (HCQ) or chloroquine against SARS-CoV-2. Thus, in this study, we aim to evaluate the efficacy and safety of hydroxychloroquine as post exposure prophylaxis for SARS-CoV-2.\\n\\nPrimary end point: comparison the rate of COVID-19 between PEP with HCQ and control group.\\nSecondary end point: Comparison of the rate of COVID-19 according to the contact level (time, place, degree of wearing personal protective equipment).\\nSafety comparison: Safety verification by identifying major side effects in the HCQ group.\"'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Contact Person From COVID-19 Confirmed Patient']},\n", - " 'KeywordList': {'Keyword': ['Postexposure prophylaxis',\n", - " 'hydroxychloroquine',\n", - " 'SARS-CoV-2',\n", - " 'COVID-19']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 3']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Prevention',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Single',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Outcomes Assessor']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '2486',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'administration of hydroxychloroquine as PEP',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine as post exposure prophylaxis']}},\n", - " {'ArmGroupLabel': 'control with no PEP',\n", - " 'ArmGroupType': 'Active Comparator',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: Others(No intervention)']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Hydroxychloroquine as post exposure prophylaxis',\n", - " 'InterventionDescription': '1day: Hydroxychloroquine 800mg Qd po 2-5dy: Hydroxychloroquine 400mg Qd po',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['administration of hydroxychloroquine as PEP']}},\n", - " {'InterventionType': 'Other',\n", - " 'InterventionName': 'Others(No intervention)',\n", - " 'InterventionDescription': 'No treatment. Close monitoring and quarantine.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['control with no PEP']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'The rate of COVID-19',\n", - " 'PrimaryOutcomeDescription': 'After postexposure prophylaxis, the rate of COVID-19 conversion between two groups',\n", - " 'PrimaryOutcomeTimeFrame': 'PCR test of COVID-19 at 14 days after the contact from confirmed case'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nA contact person from confirmed case of SARS-CoV-2 infection\\nMedical staff exposed from confirmed case of SARS-CoV-2 infection in hospitals\\n\\nPersons exposed to SARS-CoV-2 in COVID-19 outbreak situation with certain workplaces, religious groups, and military, etc.\\n\\nSubjects of study include both symptomatic and asymptomatic contacts.\\n\\nExclusion Criteria:\\n\\nHypersensitivity to Chloroquine or Hydroxychloroquine\\nThose who are contraindicated in Hydroxychloroquine administration according to the permission requirements such as pregnant women, nursing mothers, visual disorders, macular disease, and porphyria, etc.\\nHuman immunodeficiency virus (HIV) infected person\\nPatients with autoimmune disease (Systemic lupus erythematosus, Mixed connective tissue disease)\\nPatients with autoimmune rheumatoid inflammatory disease (AIIRD; Autoimmune inflammatory rheumatic diseases - Ankylosing spondylitis, Rheumatic arthritis, Psoriatic arthritis)\\nArrhythmia, liver cirrhosis of Child Pugh C, chronic renal failure with eGFR≤30mL / min / 1.73m2\\nA person who is positive in the COVID-19 screening PCR test before starting PEP',\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '99 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Yong Goo Song, Professor',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '82-2-2019-3310',\n", - " 'CentralContactPhoneExt': '3310',\n", - " 'CentralContactEMail': 'imfell@yuhs.ac'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Yong Goo Song, Professor',\n", - " 'OverallOfficialAffiliation': 'Gangnam Severance Hospital',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]}}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", - " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", - " 'InterventionAncestorTerm': 'Antimalarials'},\n", - " {'InterventionAncestorId': 'D000000981',\n", - " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", - " {'InterventionAncestorId': 'D000000977',\n", - " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", - " {'InterventionAncestorId': 'D000000890',\n", - " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", - " {'InterventionAncestorId': 'D000004791',\n", - " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", - " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M2861',\n", - " 'InterventionBrowseLeafName': 'Antimalarials',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2879',\n", - " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2875',\n", - " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2795',\n", - " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19188',\n", - " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}}}}},\n", - " {'Rank': 60,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04327206',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '62586'},\n", - " 'Organization': {'OrgFullName': 'Murdoch Childrens Research Institute',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'BCG Vaccination to Protect Healthcare Workers Against COVID-19',\n", - " 'OfficialTitle': 'BCG Vaccination to Reduce the Impact of COVID-19 in Australian Healthcare Workers Following Coronavirus Exposure (BRACE) Trial',\n", - " 'Acronym': 'BRACE'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 30, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'October 30, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'March 30, 2022',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 25, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 27, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 31, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Murdoch Childrens Research Institute',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': \"Royal Children's Hospital\",\n", - " 'CollaboratorClass': 'OTHER'}]}},\n", - " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Open label, two-group, phase III randomised controlled trial in up to 4170 healthcare workers to determine if BCG vaccination reduces the incidence and severity of COVID-19 during the 2020 pandemic.',\n", - " 'DetailedDescription': 'Healthcare workers are at the frontline of the coronavirus disease (COVID-19) pandemic. Participants will be healthcare workers in Australian hospital sites. They will be randomised to receive a single dose of BCG vaccine, or no BCG vaccine. Participants will be followed-up for 12 months with regular mobile phone text messages (up to weekly) and surveys to identify and detail COVID-19 infection. Additional information on severe disease will be obtained from hospital medical records and government databases. Blood samples will be collected prior to randomisation and at 12 months to determine exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Where required, swab/blood samples will be taken at illness episodes to assess SARS-CoV-2 infection.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus Disease 2019 (COVID-19)',\n", - " 'Febrile Respiratory Illness',\n", - " 'Corona Virus Infection',\n", - " 'COVID-19']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 3']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignInterventionModelDescription': 'Phase III, two group, multicentre, open label randomised controlled trial',\n", - " 'DesignPrimaryPurpose': 'Prevention',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '4170',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'BCG vaccine',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Participants will receive a single dose of BCG vaccine (BCG-Denmark). The adult dose of BCG vaccine is 0.1 mL injected intradermally over the distal insertion of the deltoid muscle onto the humerus (approximately one third down the upper arm).',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: BCG Vaccine']}},\n", - " {'ArmGroupLabel': 'No BCG vaccine',\n", - " 'ArmGroupType': 'No Intervention',\n", - " 'ArmGroupDescription': 'Participants will not receive the BCG vaccine.'}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'BCG Vaccine',\n", - " 'InterventionDescription': 'Freeze-dried powder: Live attenuated strain of Mycobacterium bovis (BCG), Danish strain 1331.\\n\\nEach 0.1 ml vaccine contains between 200000 to 800000 colony forming units. Adult dose is 0.1 ml given by intradermal injection',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['BCG vaccine']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Bacille Calmette-Guerin Vaccine',\n", - " 'Bacillus Calmette-Guerin Vaccine',\n", - " 'Statens Serum Institute BCG vaccine',\n", - " 'Mycobacterium bovis BCG (Bacille Calmette Guérin), Danish Strain 1331',\n", - " 'BCG Denmark']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'COVID-19 disease incidence',\n", - " 'PrimaryOutcomeDescription': 'Number of participants with COVID-19 disease defined as\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus\\npositive SARS-Cov-2 test (PCR or serology)',\n", - " 'PrimaryOutcomeTimeFrame': 'Measured over the 6 months following randomisation'},\n", - " {'PrimaryOutcomeMeasure': 'Severe COVID-19 disease incidence',\n", - " 'PrimaryOutcomeDescription': 'Number of participants who were admitted to hospital or died (using self-reported questionnaire and/or medical/hospital records) in the context of a positive SARS-CoV-2 test',\n", - " 'PrimaryOutcomeTimeFrame': 'Measured over the 6 months following randomisation'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'COVID-19 incidence by 12 months',\n", - " 'SecondaryOutcomeDescription': 'Number of participants with COVID-19 disease defined as\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus\\npositive SARS-Cov-2 test (PCR or serology)',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Severe COVID-19 incidence by 12 months',\n", - " 'SecondaryOutcomeDescription': 'Number of participants with severe COVID-19 disease defined as hospitalisation or death in the context of a positive SARS-Cov-2 test (PCR or serology)',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Time to first symptom of COVID-19',\n", - " 'SecondaryOutcomeDescription': 'Time to first symptom of COVID-19 in a participant who subsequently meets the case definition:\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus\\npositive SARS-Cov-2 test (PCR or serology)',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Episodes of COVID-19',\n", - " 'SecondaryOutcomeDescription': 'Number of episodes of COVID-19 disease defined as\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus\\npositive SARS-Cov-2 test (PCR or serology)',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Asymptomatic SARS-CoV-2 infection',\n", - " 'SecondaryOutcomeDescription': 'Number of participants with asymptomatic SARS-CoV-2 infection defined as\\n\\nEvidence of SARS-CoV-2 infection (by PCR or seroconversion)\\nAbsence of respiratory illness (using self-reported questionnaire)\\nNo evidence of exposure prior to randomisation (inclusion serology negative)',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Work absenteeism due to COVID-19',\n", - " 'SecondaryOutcomeDescription': 'Number of days (using self-reported questionnaire) unable to work (excludes quarantine/workplace restrictions) due to COVID-19 disease defined as\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus\\npositive SARS-Cov-2 test (PCR or serology)',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Bed confinement due to COVID-19',\n", - " 'SecondaryOutcomeDescription': 'Number of days confined to bed (using self-reported questionnaire) due to COVID-19 disease defined as\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus\\npositive SARS-Cov-2 test (PCR or serology)',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Symptom duration of COVID-19',\n", - " 'SecondaryOutcomeDescription': 'Number of days with symptoms in any episode of illness that meets the case definition for COVID-19 disease:\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus\\npositive SARS-Cov-2 test (PCR or serology)',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'SARS-CoV-2 pneumonia',\n", - " 'SecondaryOutcomeDescription': 'Number of pneumonia cases (abnormal chest X-ray) (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Oxygen therapy with SARS-CoV-2',\n", - " 'SecondaryOutcomeDescription': 'Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Critical care admissions with SARS-CoV-2',\n", - " 'SecondaryOutcomeDescription': 'Number of admission to critical care (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Critical care admission duration with SARS-CoV-2',\n", - " 'SecondaryOutcomeDescription': 'Number of days admitted to critical care (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Mechanical ventilation with SARS-CoV-2',\n", - " 'SecondaryOutcomeDescription': 'Number of participants needing mechanical ventilation (using self-reported questionnaire and/or medical/hospital records) and a positive SARS-CoV-2 test',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Mechanical ventilation duration with SARS-CoV-2',\n", - " 'SecondaryOutcomeDescription': 'Number of days that participants needed mechanical ventilation (using self-reported questionnaire and/or medical/hospital records) and a positive SARS-CoV-2 test',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Hospitalisation duration with COVID-19',\n", - " 'SecondaryOutcomeDescription': 'Number of days of hospitalisation due to COVID-19 (using self-reported questionnaire and/or medical/hospital records).',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Mortality with SARS-CoV-2',\n", - " 'SecondaryOutcomeDescription': 'Number of deaths (from death registry) associated with a positive SARS-CoV-2 test',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Febrile respiratory illness',\n", - " 'SecondaryOutcomeDescription': 'Number of participants with febrile respiratory illness defined as\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Episodes of febrile respiratory illness',\n", - " 'SecondaryOutcomeDescription': 'Number of episodes of febrile respiratory illness, defined as\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Work absenteeism due to febrile respiratory illness',\n", - " 'SecondaryOutcomeDescription': 'Number of days (using self-reported questionnaire) unable to work (excludes quarantine/workplace restrictions) due to febrile respiratory illness defined as\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Bed confinement due to febrile respiratory illness',\n", - " 'SecondaryOutcomeDescription': 'Number of days confined to bed (using self-reported questionnaire) due to febrile respiratory illness defined as\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Symptom duration of febrile respiratory illness',\n", - " 'SecondaryOutcomeDescription': 'Number of days with symptoms in any episode of illness that meets the case definition for febrile respiratory illness:\\n\\nfever (using self-reported questionnaire), plus\\nat least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire)',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Pneumonia',\n", - " 'SecondaryOutcomeDescription': 'Number of pneumonia cases (abnormal chest X-ray) (using self-reported questionnaire and/or medical/hospital records)',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Oxygen therapy',\n", - " 'SecondaryOutcomeDescription': 'Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records)',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Critical care admissions',\n", - " 'SecondaryOutcomeDescription': 'Number of admission to critical care (using self-reported questionnaire and/or medical/hospital records)',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Mechanical ventilation',\n", - " 'SecondaryOutcomeDescription': 'Number of participants needing mechanical ventilation (using self-reported questionnaire and/or medical/hospital records)',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Mortality',\n", - " 'SecondaryOutcomeDescription': 'Number of deaths (from death registry)',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Hospitalisation duration with febrile respiratory illness',\n", - " 'SecondaryOutcomeDescription': 'Number of days of hospitalisation due to febrile respiratory illness (using self-reported questionnaire and/or medical/hospital records)',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Unplanned work absenteeism',\n", - " 'SecondaryOutcomeDescription': 'Number of days of unplanned absenteeism for any reason (using self-reported questionnaire)',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Hospitalisation cost to treat COVID-19',\n", - " 'SecondaryOutcomeDescription': 'Cost of hospitalisation due to COVID-19 reported in Australian dollars (using hospital administrative linked costing records held by individual hospitals and state government routine costing data collections to provide an estimate of the cost to hospitals for each episode of COVID-19 care)',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 12 months following randomisation'},\n", - " {'SecondaryOutcomeMeasure': 'Local and systemic adverse events to BCG vaccination in healthcare workers',\n", - " 'SecondaryOutcomeDescription': 'Type and severity of local and systemic adverse events will be collected in self-reported questionnaire and graded using toxicity grading scale.',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured over the 3 months following randomisation'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\nOver 18 years of age\\nEmployed by one of the hospitals involved in the study\\nProvide a signed and dated informed consent form\\nPre-randomisation blood collected\\n\\nExclusion Criteria:\\n\\nHas any BCG vaccine contraindication\\nFever or generalised skin infection (where feasible, randomisation can be delayed until cleared)\\nWeakened resistance toward infections due to a disease in/of the immune system\\nReceiving medical treatment that affects the immune response or other immunosuppressive therapy in the last year. These therapies include systemic corticosteroids (more than or equal to 20 mg for more than or equal to 2 weeks), non-biological immunosuppressant (also known as 'DMARDS'), biological agents (such as monoclonal antibodies against tumour necrosis factor (TNF)-alpha).\\nHas a congenital cellular immunodeficiency, including specific deficiencies of the interferon-gamma pathway\\nHas a malignancy involving bone marrow or lymphoid systems\\nHas any serious underlying illness (such as malignancy). Please note: People with cardiovascular disease, hypertension, diabetes, and/or chronic respiratory disease are eligible if not immunocompromised\\nKnown or suspected HIV infection, even if asymptomatic or has normal immune function. This is because of the risk of disseminated BCG infection\\nHas active skin disease such as eczema, dermatitis or psoriasis at or near the site of vaccination. A different site (other than left arm) can be chosen if necessary\\nPregnant or breastfeeding Although there is no evidence that BCG vaccination is harmful during pregnancy or breastfeeding, it is a contra-indication to BCG vaccination. Therefore, we will exclude women who think they could be pregnant.\\nAnother live vaccine administered in the month prior to randomisation\\nRequire another live vaccine to be administered within the month following BCG randomisation If the other live vaccine can be given on the same day, this exclusion criteria does not apply\\nKnown anaphylactic reaction to any of the ingredient present in the BCG vaccine\\nBCG vaccine given within the last year\\nHas previously had a SARS-CoV-2 positive test result\\nAlready part of this trial, recruited at a different hospital\",\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Prof Nigel Curtis, MBBS PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '93456366',\n", - " 'CentralContactEMail': 'nigel.curtis@rch.org.au'},\n", - " {'CentralContactName': 'Kaya Gardiner',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '99366461',\n", - " 'CentralContactEMail': 'kaya.gardiner@mcri.edu.au'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Prof Nigel Curtis',\n", - " 'OverallOfficialAffiliation': \"Murdoch Children's Research Institute\",\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': \"Royal Children's Hospital\",\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Melbourne',\n", - " 'LocationState': 'Victoria',\n", - " 'LocationZip': '3108',\n", - " 'LocationCountry': 'Australia',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Prof Nigel Curtis, MBBS PhD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '9345 6366',\n", - " 'LocationContactEMail': 'nigel.curtis@mcri.edu.au'},\n", - " {'LocationContactName': 'Kaya Gardiner',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '9936 6042',\n", - " 'LocationContactEMail': 'kaya.gardiner@mcri.edu.au'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", - " 'IPDSharingDescription': \"Beginning 6 months following analysis and article publications, the following may be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions, under a collaborator agreement, for accessing:\\n\\nIndividual participant data that underlie the results reported in our articles after de-identification (text, tables, figures and appendices)\\nStudy protocol, Statistical Analysis Plan, Participant Informed Consent Form (PICF)\",\n", - " 'IPDSharingInfoTypeList': {'IPDSharingInfoType': ['Study Protocol',\n", - " 'Statistical Analysis Plan (SAP)',\n", - " 'Informed Consent Form (ICF)']},\n", - " 'IPDSharingTimeFrame': 'Beginning 6 months following analysis and article publications, for long-term use',\n", - " 'IPDSharingAccessCriteria': \"Researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions, under a collaborator agreement\"}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000014612',\n", - " 'InterventionMeshTerm': 'Vaccines'},\n", - " {'InterventionMeshId': 'D000001500',\n", - " 'InterventionMeshTerm': 'BCG Vaccine'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000007155',\n", - " 'InterventionAncestorTerm': 'Immunologic Factors'},\n", - " {'InterventionAncestorId': 'D000045505',\n", - " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", - " {'InterventionAncestorId': 'D000000276',\n", - " 'InterventionAncestorTerm': 'Adjuvants, Immunologic'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M15943',\n", - " 'InterventionBrowseLeafName': 'Vaccines',\n", - " 'InterventionBrowseLeafAsFound': 'Vaccine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M3374',\n", - " 'InterventionBrowseLeafName': 'BCG Vaccine',\n", - " 'InterventionBrowseLeafAsFound': 'BCG vaccine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M8784',\n", - " 'InterventionBrowseLeafName': 'Immunologic Factors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2209',\n", - " 'InterventionBrowseLeafName': 'Adjuvants, Immunologic',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", - " {'ConditionMeshId': 'D000045169',\n", - " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'},\n", - " {'ConditionMeshId': 'D000014777',\n", - " 'ConditionMeshTerm': 'Virus Diseases'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Corona Virus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Corona Virus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafAsFound': 'Virus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M7047',\n", - " 'ConditionBrowseLeafName': 'Fever',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Corona Virus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 61,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04330690',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '2114'},\n", - " 'Organization': {'OrgFullName': 'Sunnybrook Health Sciences Centre',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Treatments for COVID-19: Canadian Arm of the SOLIDARITY Trial',\n", - " 'OfficialTitle': 'A Multi-centre, Adaptive, Randomized, Open-label, Controlled Clinical Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Patients',\n", - " 'Acronym': 'CATCO'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Active, not recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 18, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 18, 2022',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'May 18, 2022',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 23, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 31, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 31, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Sunnybrook Health Sciences Centre',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'AbbVie',\n", - " 'CollaboratorClass': 'INDUSTRY'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'This study is an adaptive, randomized, open-label, controlled clinical trial.\\n\\nSubjects will be randomized to receive either standard-of-care products or the study medication plus standard of care, while being hospitalized for COVID-19.\\n\\nLopinavir/ritonavir will be administered 400 mg/100 mg orally (or weight based dose adjustment for children) for a 14-day course, or until discharge from hospital, whichever occurs first',\n", - " 'DetailedDescription': 'This study is an adaptive, randomized, open-label, controlled clinical trial.\\n\\nSubjects will be randomized to receive either standard-of-care products (control) or the study medication plus standard of care while being hospitalized for lab confirmed COVID-19. Randomization will be stratified by i) site; and ii) severity of illness (see section 5); iii) age < 55\\n\\nLopinavir/ritonavir will be administered orally for a 14-day course, or until discharge from hospital; subjects who can swallow will be given 2 tablets (200 mg/50mg) twice daily; for those who cannot swallow, 5 mL oral suspension (400 mg.100 mg/5 mL) will be given twice daily. Children will receive 10 mg/kg of lopinavir/ritonavir, via tablet or suspension, twice daily, capped at the maximum adult dose.\\n\\nSubjects will be assessed daily while hospitalized, including Oropharyngeal (OP) swabbing on days 1, 3, 5, 8, 11, 15, and 29. Discharged subjects will be telephoned at Days 15, 29, and 60. Hospitalized subjects will require blood sampling on days 1, 5 and 11'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 2']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignInterventionModelDescription': '2-arms in a 1:1 ratio randomization to either the control arm, consisting of standard of care supportive treatment for COVID-19, or the investigational product, lopinavir/ritonavir plus standard of care. Lopinavir/ritonavir will be the first agent tested. Additional arms will be added as data emerges.\\n\\nThis study is intended to allow for multiple adaptations, including: i) the primary endpoint at the first interim analysis, based on performance characteristics, both in its characteristics and its timepoint, with adapted sample size calculations performed for the new primary endpoints; ii) Intervention arm, with emerging data from both internal and external to the trial, with arms being dropped or added based on pre-specified stopping rules in conjunction with the DSMB.',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)',\n", - " 'DesignMaskingDescription': 'Endpoint assessment'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '440',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Control',\n", - " 'ArmGroupType': 'No Intervention',\n", - " 'ArmGroupDescription': 'This arm will receive standard of care using supportive care guidelines for COVID-19. This is expected the vary regionally and may change throughout the trial based on new and emerging data on best care guidelines for patients.'},\n", - " {'ArmGroupLabel': 'lopinavir/ritonavir plus standard of care',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Lopinavir/ritonavir will be administered 400 mg/100 mg orally (or weight based dose adjustment for children) for a 14-day course, or until discharge from hospital, whichever occurs first plus expected standard of care.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Lopinavir/ritonavir']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Lopinavir/ritonavir',\n", - " 'InterventionDescription': 'Lopinavir/ritonavir will be administered 400 mg/100 mg orally (or weight based dose adjustment for children) for a 14-day course, or until discharge from hospital, whichever occurs first',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['lopinavir/ritonavir plus standard of care']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Efficacy of Intervention',\n", - " 'PrimaryOutcomeDescription': 'The overall objective of the study is to evaluate the clinical efficacy and safety of lopinavir/ritonavir relative to the control arm in participants hospitalized with COVID-19, specifically looking at the subjects clinical status at day 29 as measured on a 10-point ordinal scale through a proportional odds model.\\n\\nThe scale is as below 0: Uninfected, no viral RNA\\n\\nAsymptomatic, viral RNA detected\\nSymptomatic, independent\\nSymptomatic, Assistance Needed\\nHospitalized: no oxygen therapy\\nHospitalized, on oxygen\\nHospitalized, Oxygen by NIV or high-flow\\nMechanical ventilation, p/f>150 or s/f >200\\nMechanical ventilation, p/f<150 or s/f<200 OR vasopressors\\nmechanical ventilation, p/f<150 AND vasopressors, dialysis, or ECMO\\ndeath',\n", - " 'PrimaryOutcomeTimeFrame': '29 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Time to improvement of one catergory from admission',\n", - " 'SecondaryOutcomeDescription': 'Measure with Ordinal Scale the time it takes for subject improvement',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 60 days'},\n", - " {'SecondaryOutcomeMeasure': 'Subject clinical status',\n", - " 'SecondaryOutcomeDescription': 'Subject clinical status at days 3, 5, 8, 11, 15, 29, 60 measured using an ordinal scale',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 60 days'},\n", - " {'SecondaryOutcomeMeasure': 'Change in Subject clinical status',\n", - " 'SecondaryOutcomeDescription': 'Mean change in the ranking from baseline to days 3, 5, 8, 11, 15, 29, 60 using an ordinal scale',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 60 days'},\n", - " {'SecondaryOutcomeMeasure': 'Oxygen free days',\n", - " 'SecondaryOutcomeDescription': 'the number of oxygen free days exprienced',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 29 days'},\n", - " {'SecondaryOutcomeMeasure': 'Incidence of oxygen use',\n", - " 'SecondaryOutcomeDescription': 'if the subject required oxygen during hospitalization',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 29 days'},\n", - " {'SecondaryOutcomeMeasure': 'Duration of oxygen use',\n", - " 'SecondaryOutcomeDescription': 'if the subject required oxygen, for how long was it required',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 29 days'},\n", - " {'SecondaryOutcomeMeasure': 'Incidence of new mechanical ventilation',\n", - " 'SecondaryOutcomeDescription': 'if the subject required mechanical ventilation during hospitalization',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 29 days'},\n", - " {'SecondaryOutcomeMeasure': 'Duration of mechanical ventilation',\n", - " 'SecondaryOutcomeDescription': 'if the subject required mechanical ventilation, for how long was it required',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 29 days'},\n", - " {'SecondaryOutcomeMeasure': 'Duration of hospitalization',\n", - " 'SecondaryOutcomeDescription': 'the length of hospitalization required',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 29 days'},\n", - " {'SecondaryOutcomeMeasure': 'Mortality',\n", - " 'SecondaryOutcomeDescription': 'Mortality rates calculated at day 15, 29, and 60.',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 60 days'},\n", - " {'SecondaryOutcomeMeasure': 'Cumulative Incidence of Grade 3 and 4 Adverse Events (AEs) and Serious Adverse Events (SAEs)',\n", - " 'SecondaryOutcomeDescription': 'The safety of the intervention will be evaluated during the trial period as compared to the control arm as assessed by the cumulative incidence of Grade 3 and 4 AEs and SAEs using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Paediatric Adverse Events, version 2.1 (July 2017).',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 30 days after last dose of drug adminstration'}]},\n", - " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'Time to viral clearance of lopinavir/ritonavir as compared to the control arm',\n", - " 'OtherOutcomeDescription': 'To evaluate the virologic efficacy of lopinavir/ritonavir as compared to the control arm as assessed by the percent of subjects with SARS-CoV-2 detectable in OP sample at days 3, 5, 8, 11, 15, and 29',\n", - " 'OtherOutcomeTimeFrame': '29 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\n> 6 months of age\\nHas laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen prior to randomization.\\nHospitalized at a participating centre\\n\\nExclusion Criteria:\\n\\nAnticipated transfer to another hospital, within 72 hours, which is not a study site\\nKnown allergy to study medication or its components (non-medicinal ingredients)\\n\\nCurrently taking any of the following medications:\\n\\nalfuzosin (e.g., Xatral®)\\namiodarone (eg Cordarone™)\\napalutamide (e.g. Erleada™)\\nastemizole*, terfenadine*\\ncisapride*\\ncolchicine, when used in patients with renal and/or hepatic impairment\\ndronedarone (e.g., Multaq®)\\ndisulfiram (for those who may need to take the oral solution)\\nelbasvir/grazoprevir (e.g., ZepatierTM) - used to treat hepatitis C virus (HCV)\\nergotamine*, dihydroergotamine\\nergonovine, methylergonovine* (used after labour and delivery), such as Cafergot®, Migranal®, D.H.E. 45®*, Methergine®*, and others\\nfusidic acid (e.g., Fucidin®), systemic\\nlurasidone (e.g., Latuda®), pimozide (e.g., Orap®*)\\nmetronidazole (for those who may need to take the oral solution)\\nneratinib (e.g., Nerlynx®) - used for breast cancer\\nsildenafil (e.g., Revatio®)\\ntriazolam, oral midazolam\\nrifampin, also known as Rimactane®*, Rifadin®, Rifater®*, or Rifamate®*.\\nSt. John's Wort\\nVenetoclax\\nlovastatin (e.g., Mevacor®*), lomitapide (e.g., JuxtapidTM) or simvastatin (e.g., Zocor®)\\nPDE5 inhibitors vardenafil (e.g., Levitra® or Revatio).\\nsalmeterol, also known as Advair® and Serevent®.\\nKnown HIV infection\",\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '6 Months',\n", - " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'LocationList': {'Location': [{'LocationFacility': 'Sunnybrook Health Sciences Centre',\n", - " 'LocationCity': 'Toronto',\n", - " 'LocationState': 'Ontario',\n", - " 'LocationZip': 'M4N3M5',\n", - " 'LocationCountry': 'Canada'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", - " 'IPDSharingDescription': 'As per World Health Organization policies on data sharing in a Public Health Emergency, any clinical trial outcome data will be shared at the earliest possible opportunity. In addition, given the nature of this protocol, being performed across regions, the DSMB may access other regions trials, and possibly recommend alterations in study design based on accumulating data, through a centralized data repository being built under the auspices of the World Health Organization.\\n\\nData Sharing for Secondary Research Data from this study may be used for secondary research. All of the individual subject data collected during the trial will be made available after de-identification through expert determination. The SAP and Analytic Code will also be made available. This data will be available immediately following publication, with no end date, as part of data sharing requirements from journals and funding agencies.',\n", - " 'IPDSharingInfoTypeList': {'IPDSharingInfoType': ['Study Protocol',\n", - " 'Statistical Analysis Plan (SAP)',\n", - " 'Clinical Study Report (CSR)']},\n", - " 'IPDSharingTimeFrame': 'Unknown and variable'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000019438',\n", - " 'InterventionMeshTerm': 'Ritonavir'},\n", - " {'InterventionMeshId': 'D000061466',\n", - " 'InterventionMeshTerm': 'Lopinavir'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000017320',\n", - " 'InterventionAncestorTerm': 'HIV Protease Inhibitors'},\n", - " {'InterventionAncestorId': 'D000011480',\n", - " 'InterventionAncestorTerm': 'Protease Inhibitors'},\n", - " {'InterventionAncestorId': 'D000004791',\n", - " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000019380',\n", - " 'InterventionAncestorTerm': 'Anti-HIV Agents'},\n", - " {'InterventionAncestorId': 'D000044966',\n", - " 'InterventionAncestorTerm': 'Anti-Retroviral Agents'},\n", - " {'InterventionAncestorId': 'D000000998',\n", - " 'InterventionAncestorTerm': 'Antiviral Agents'},\n", - " {'InterventionAncestorId': 'D000000890',\n", - " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", - " {'InterventionAncestorId': 'D000065692',\n", - " 'InterventionAncestorTerm': 'Cytochrome P-450 CYP3A Inhibitors'},\n", - " {'InterventionAncestorId': 'D000065607',\n", - " 'InterventionAncestorTerm': 'Cytochrome P-450 Enzyme Inhibitors'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M4846',\n", - " 'InterventionBrowseLeafName': 'Coal Tar',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19978',\n", - " 'InterventionBrowseLeafName': 'Ritonavir',\n", - " 'InterventionBrowseLeafAsFound': 'Ritonavir',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M28424',\n", - " 'InterventionBrowseLeafName': 'Lopinavir',\n", - " 'InterventionBrowseLeafAsFound': 'Lopinavir',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M18192',\n", - " 'InterventionBrowseLeafName': 'HIV Protease Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M12926',\n", - " 'InterventionBrowseLeafName': 'Protease Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19934',\n", - " 'InterventionBrowseLeafName': 'Anti-HIV Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M24015',\n", - " 'InterventionBrowseLeafName': 'Anti-Retroviral Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2895',\n", - " 'InterventionBrowseLeafName': 'Antiviral Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2795',\n", - " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M29151',\n", - " 'InterventionBrowseLeafName': 'Cytochrome P-450 CYP3A Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M29124',\n", - " 'InterventionBrowseLeafName': 'Cytochrome P-450 Enzyme Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Derm',\n", - " 'InterventionBrowseBranchName': 'Dermatologic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", - " {'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'}]}}}}},\n", - " {'Rank': 62,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04329832',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '1051355'},\n", - " 'Organization': {'OrgFullName': 'Intermountain Health Care, Inc.',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19',\n", - " 'OfficialTitle': 'Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19 (HAHPS): A Prospective Pragmatic Trial',\n", - " 'Acronym': 'HAHPS'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'December 31, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2021',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 30, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 30, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 30, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Samuel Brown',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Director, Critical Care Research',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Intermountain Health Care, Inc.'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Intermountain Health Care, Inc.',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'University of Utah',\n", - " 'CollaboratorClass': 'OTHER'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'Yes',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'This study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating hospitalized patients with suspected or confirmed COVID-19.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", - " 'KeywordList': {'Keyword': ['SARS-CoV-2',\n", - " 'Hydroxychloroquine',\n", - " 'Azithromycin']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 2']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '300',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Hydroxychloroquine',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine']}},\n", - " {'ArmGroupLabel': 'Azithromycin',\n", - " 'ArmGroupType': 'Active Comparator',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Azithromycin']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Hydroxychloroquine',\n", - " 'InterventionDescription': 'Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 4 days (dose reductions for weight < 45 kg or GFR (glomerular filtration rate)<50ml/min).',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Hydroxychloroquine']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Azithromycin',\n", - " 'InterventionDescription': 'Patients in the azithromycin arm will receive azithromycin 500 mg on day 1 plus 250 mg daily on days 2-5 (may be administered intravenously per clinician preference). If the patient has already received azithromycin prior to randomization, the prior doses will count toward the 5-day total.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Azithromycin']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'COVID Ordinal Outcomes Scale at 14 days',\n", - " 'PrimaryOutcomeDescription': 'Per https://www.who.int/blueprint/priority-diseases/key-action/COVID-19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf, this scale reflects a range from uninfected to dead, where 0 is \"no clinical or virological evidence of infection\", 1 is \"no limitation of activities\", 2 is \"limitation of activities\", 3 is \"hospitalized, no oxygen therapy\", 4 is \"oxygen by mask or nasal prongs\", 5 is \"non-invasive ventilation or high-flow oxygen\", 6 is \"intubation and mechanical ventilation\", 7 is \"ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)\", and 8 is \"death\".',\n", - " 'PrimaryOutcomeTimeFrame': 'Assessed once on day 14 after enrollment (enrollment is day 0)'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Hospital-free days at 28 days (number of days patient not in hospital)',\n", - " 'SecondaryOutcomeDescription': 'Calculated as a worst-rank ordinal (death is counted as -1 days).',\n", - " 'SecondaryOutcomeTimeFrame': 'Admission (day 1) to 28 days after admission (day 28)'},\n", - " {'SecondaryOutcomeMeasure': 'Ventilator-free days at 28 days (number of days patient not on a ventilator)',\n", - " 'SecondaryOutcomeDescription': 'Calculated as a worst-rank ordinal (death is counted as -1 days).',\n", - " 'SecondaryOutcomeTimeFrame': 'Admission (day 1) to 28 days after admission (day 28)'},\n", - " {'SecondaryOutcomeMeasure': 'ICU-free days at 28 days (number of days patient not in an ICU)',\n", - " 'SecondaryOutcomeDescription': 'Calculated as a worst-rank ordinal (death is counted as -1 days).',\n", - " 'SecondaryOutcomeTimeFrame': 'Admission (day 1) to 28 days after admission (day 28)'},\n", - " {'SecondaryOutcomeMeasure': 'Time to a 1-point decrease in the WHO ordinal recovery score',\n", - " 'SecondaryOutcomeTimeFrame': 'Admission (day 1) to 14 days after admission (day 14)'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAdult (age ≥ 18 years)\\n\\nConfirmed OR suspected COVID-19,\\n\\nConfirmed: Positive assay for COVID-19 within the last 10 days\\nSuspected: Pending assay for COVID-19 WITH high clinical suspicion\\nScheduled for admission or already admitted to an inpatient bed\\nPatients must be enrolled within 48 hours of hospital admission\\n\\nExclusion Criteria:\\n\\nAllergy to hydroxychloroquine or azithromycin\\nHistory of bone marrow transplant\\nKnown G6PD deficiency\\nChronic hemodialysis or Glomerular Filtration Rate < 20ml/min\\nPsoriasis\\nPorphyria\\nConcomitant use of digitalis, flecainide, amiodarone, procainamide, or propafenone\\nKnown history of long QT syndrome\\nCurrent known QTc>500 msec\\nPregnant or nursing\\nPrisoner\\nWeight < 35kg\\nSevere liver disease\\nSeizure disorder',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Valerie T Aston, MBA',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '8015074606',\n", - " 'CentralContactEMail': 'Valerie.Aston@imail.org'},\n", - " {'CentralContactName': 'David P Tomer, MS',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '801-507-4694',\n", - " 'CentralContactEMail': 'David.Tomer@imail.org'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Samuel M Brown, MD MS',\n", - " 'OverallOfficialAffiliation': 'Intermountain Health Care, Inc.',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Intermountain Medical Center',\n", - " 'LocationCity': 'Murray',\n", - " 'LocationState': 'Utah',\n", - " 'LocationZip': '84107',\n", - " 'LocationCountry': 'United States',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Valerie T Aston, MD MS',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '801-507-4606',\n", - " 'LocationContactEMail': 'Valerie.Aston@imail.org'},\n", - " {'LocationContactName': 'Samuel M Brown, MD MS',\n", - " 'LocationContactRole': 'Principal Investigator'}]}},\n", - " {'LocationFacility': 'University of Utah',\n", - " 'LocationCity': 'Salt Lake City',\n", - " 'LocationState': 'Utah',\n", - " 'LocationZip': '84112',\n", - " 'LocationCountry': 'United States',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Estelle Harris, MD',\n", - " 'LocationContactRole': 'Contact'},\n", - " {'LocationContactName': 'Estelle Harris, MD',\n", - " 'LocationContactRole': 'Principal Investigator'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No',\n", - " 'IPDSharingDescription': 'In order to protect patient privacy and comply with relevant regulations, identified data are unavailable. Requests for deidentified data from qualified researchers with appropriate ethics board approvals and relevant data use agreements will be processed by the Intermountain Office of Research, officeofresearch@imail.org.'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", - " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", - " 'InterventionAncestorTerm': 'Antimalarials'},\n", - " {'InterventionAncestorId': 'D000000981',\n", - " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", - " {'InterventionAncestorId': 'D000000977',\n", - " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", - " {'InterventionAncestorId': 'D000000890',\n", - " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", - " {'InterventionAncestorId': 'D000004791',\n", - " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", - " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M18715',\n", - " 'InterventionBrowseLeafName': 'Azithromycin',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2861',\n", - " 'InterventionBrowseLeafName': 'Antimalarials',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2879',\n", - " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2875',\n", - " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2795',\n", - " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19188',\n", - " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}}}}},\n", - " {'Rank': 63,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04324996',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'ChongqingPublicHMC'},\n", - " 'Organization': {'OrgFullName': 'Chongqing Public Health Medical Center',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'A Phase I/II Study of Universal Off-the-shelf NKG2D-ACE2 CAR-NK Cells for Therapy of COVID-19',\n", - " 'OfficialTitle': 'A Phase I/II Study of Universal Off-the-shelf NKG2D-ACE2 CAR-NK Cells Secreting IL15 Superagonist and GM-CSF-neutralizing scFv for Therapy of COVID-19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 21, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 31, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'September 30, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 25, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 25, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 27, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 25, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 27, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Chongqing Public Health Medical Center',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Chongqing Sidemu Biotechnology Technology Co.,Ltd.',\n", - " 'CollaboratorClass': 'UNKNOWN'}]}},\n", - " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'SARS-CoV-2 infection mainly leads to interstitial pneumonia. The patients with low immunity have more serious conditions. At present, there is no specific drug/therapy available for COVID-19. NK cells are the major cells of the natural immune system, which are essential for innate immunity and adaptive immunity, and are indispensable in the defense of virus infection. NKG2D is an activating receptor of NK cells, which can recognize and thus clear virus infected cells. NK cells modified by CAR play a role in targeted cell therapy, and have benn demonstrated very safe without severe side effects such as cytokine releasing syndromes. The survival time of NK cells will be very short if there is no IL-15-sustained support after adoptive transfer into the body. In comparison with natural IL-15 in vivo, IL-15 superagonist (sIL-15/IL-15Rɑ chimeric protein) has increased the activity by nearly 20 times and as well as improved pharmacokinetic characteristics with longer persistence and enhanced target cytotoxicity. CAR-T cell-mediated cytokine release syndrome (CRS) and neurotoxicity have been shown to be abrogated through GM-CSF neutralization. ACE2 is the receptor of SARS-CoV-2 and binds to S protein of the virus envelope. We have constructed and prepared the universal off-the-shelf IL15 superagonist- and GM-CSF neutralizing scFv-secreting NKG2D-ACE2 CAR-NK derived from cord blood. By targeting the S protein of SARS-CoV-2 and NKG2DL on the surface of infected cells with ACE2 and NKG2D, respectively, and with the strong synergistic effect of IL15 superagonist and CRS prevention through GM-CSF neutralizing scFv, we hope that the SARS-CoV-2 virus particles and their infected cells can be safely and effectively removed, thus providing a safe and effective cell therapy for COVID-19. In addition, ACE2 CAR-NK cells can competitively inhibit SARS-CoV-2 infection of type II alveolar epithelial cells and other important organ or tissue cells through ACE2 so as to make SARS-CoV-2 abortive infection (i.e., no production of infectious virus particles).\\n\\nThis project is an open, randomized, parallel, multicenter phase I/II clinical trial. The NKG2D-ACE2 CAR-NK cells secreting super IL15 superagonist and GM-CSF neutralizing scFv are going to be give by intravenous infusion (108 cells per kilogram of body weight, once a week) for the treatment of 30 patients with each common, severe and critical type COVID-19, respectively.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", - " 'KeywordList': {'Keyword': ['NKG2D-ACE2 CAR-NK',\n", - " 'IL15 superagonist',\n", - " 'GM-CSF-neutralizing scFv',\n", - " 'COVID-19']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 1', 'Phase 2']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Quadruple',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", - " 'Care Provider',\n", - " 'Investigator',\n", - " 'Outcomes Assessor']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '90',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'NK cells',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'The NK cells are going to be give by intravenous infusion (10E8 cells per kilogram of body weight, once a week) .',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: NK cells,IL15-NK cells,NKG2D CAR-NK cells,ACE2 CAR-NK cells,NKG2D-ACE2 CAR-NK cells']}},\n", - " {'ArmGroupLabel': 'IL15-NK cells',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'The NK cells secreting super IL15 superagonist are going to be give by intravenous infusion (10E8 cells per kilogram of body weight, once a week) .',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: NK cells,IL15-NK cells,NKG2D CAR-NK cells,ACE2 CAR-NK cells,NKG2D-ACE2 CAR-NK cells']}},\n", - " {'ArmGroupLabel': 'NKG2D CAR-NK cells',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'The NKG2D CAR-NK cells are going to be give by intravenous infusion (10E8 cells per kilogram of body weight, once a week).',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: NK cells,IL15-NK cells,NKG2D CAR-NK cells,ACE2 CAR-NK cells,NKG2D-ACE2 CAR-NK cells']}},\n", - " {'ArmGroupLabel': 'ACE2 CAR-NK cells',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'The ACE2 CAR-NK cells are going to be give by intravenous infusion (10E8 cells per kilogram of body weight, once a week).',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: NK cells,IL15-NK cells,NKG2D CAR-NK cells,ACE2 CAR-NK cells,NKG2D-ACE2 CAR-NK cells']}},\n", - " {'ArmGroupLabel': 'NKG2D-ACE2 CAR-NK cells',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'The NKG2D-ACE2 CAR-NK cells secreting IL15 superagonist and GM-CSF-neutralizing scFv are going to be give by intravenous infusion (10E8 cells per kilogram of body weight, once a week).',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: NK cells,IL15-NK cells,NKG2D CAR-NK cells,ACE2 CAR-NK cells,NKG2D-ACE2 CAR-NK cells']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Biological',\n", - " 'InterventionName': 'NK cells,IL15-NK cells,NKG2D CAR-NK cells,ACE2 CAR-NK cells,NKG2D-ACE2 CAR-NK cells',\n", - " 'InterventionDescription': 'The CAR-NK cells are universal off the shelf NK cells enriched from umbilical cord blood and engineered genetically.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['ACE2 CAR-NK cells',\n", - " 'IL15-NK cells',\n", - " 'NK cells',\n", - " 'NKG2D CAR-NK cells',\n", - " 'NKG2D-ACE2 CAR-NK cells']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Clinical response',\n", - " 'PrimaryOutcomeDescription': 'the efficacy of NKG2D-ACE2 CAR-NK cells in treating severe and critical 2019 new coronavirus (COVID-19) pneumonia',\n", - " 'PrimaryOutcomeTimeFrame': 'Up to 28 days'},\n", - " {'PrimaryOutcomeMeasure': 'Side effects in the treatment group',\n", - " 'PrimaryOutcomeDescription': 'the safety and tolerability of NKG2D-ACE2 CAR-NK cells in patients with severe and critical 2019 new coronavirus (COVID-19) pneumonia',\n", - " 'PrimaryOutcomeTimeFrame': 'Up to 28 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nSign written informed consent;\\nAge ≥18 years;\\nConforms to the NCP Critical and Critical Diagnostic Standards, namely \"Pneumonitis Diagnosis and Treatment Scheme for New Coronavirus Infection (Trial Version 6)\". Comprehensive judgment based on epidemiological history, clinical manifestations and etiological examination;\\nThe course of disease is within 14 days after the onset of illness;\\nWilling to collect nasopharyngeal or oropharyngeal swabs before administration.\\n\\nExclusion Criteria:\\n\\nPatients participating in clinical trials of other drugs;\\npregnant or lactating women;\\nALT / AST> 5 times ULN, or neutrophils <0.5 * 109 / L, or platelets less than 50 * 109 / L;\\nExpected survival time is less than 1 week;\\nA clear diagnosis of rheumatism-related diseases;\\nLong-term oral anti-rejection drugs or immunomodulatory drugs;\\nPatients hypersensitive to NK cells and their preservation solution.',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Min Liu, A.B',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '13668072999',\n", - " 'CentralContactEMail': 'gwzxliumin@foxmail.com'},\n", - " {'CentralContactName': 'Jimin Gao, PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '0577-86699341',\n", - " 'CentralContactEMail': 'jimingao64@163.com'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Min Liu, A.B',\n", - " 'OverallOfficialAffiliation': 'Chongqing Public Health Center',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Chongqing Public Health Medical Center',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Chongqing',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Min Liu, A.B',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '13668072999',\n", - " 'LocationContactEMail': 'gwzxliumin@foxmail.com'}]}}]}},\n", - " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '32015507',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3.'},\n", - " {'ReferencePMID': '32015508',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Wu F, Zhao S, Yu B, Chen YM, Wang W, Song ZG, Hu Y, Tao ZW, Tian JH, Pei YY, Yuan ML, Zhang YL, Dai FH, Liu Y, Wang QM, Zheng JJ, Xu L, Holmes EC, Zhang YZ. A new coronavirus associated with human respiratory disease in China. Nature. 2020 Mar;579(7798):265-269. doi: 10.1038/s41586-020-2008-3. Epub 2020 Feb 3.'},\n", - " {'ReferencePMID': '16988814',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Kuba K, Imai Y, Rao S, Jiang C, Penninger JM. Lessons from SARS: control of acute lung failure by the SARS receptor ACE2. J Mol Med (Berl). 2006 Oct;84(10):814-20. Epub 2006 Sep 19. Review.'},\n", - " {'ReferencePMID': '31978945',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.'},\n", - " {'ReferencePMID': '32007143',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.'},\n", - " {'ReferencePMID': '31995857',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Li M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JTK, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Jan 29. doi: 10.1056/NEJMoa2001316. [Epub ahead of print]'},\n", - " {'ReferencePMID': '31867006',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Minetto P, Guolo F, Pesce S, Greppi M, Obino V, Ferretti E, Sivori S, Genova C, Lemoli RM, Marcenaro E. Harnessing NK Cells for Cancer Treatment. Front Immunol. 2019 Dec 6;10:2836. doi: 10.3389/fimmu.2019.02836. eCollection 2019. Review.'},\n", - " {'ReferencePMID': '31720075',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Liu H, Wang S, Xin J, Wang J, Yao C, Zhang Z. Role of NKG2D and its ligands in cancer immunotherapy. Am J Cancer Res. 2019 Oct 1;9(10):2064-2078. eCollection 2019. Review.'},\n", - " {'ReferencePMID': '31790761',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Wang W, Jiang J, Wu C. CAR-NK for tumor immunotherapy: Clinical transformation and future prospects. Cancer Lett. 2020 Mar 1;472:175-180. doi: 10.1016/j.canlet.2019.11.033. Epub 2019 Nov 29.'},\n", - " {'ReferencePMID': '28386260',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Sarvaria A, Jawdat D, Madrigal JA, Saudemont A. Umbilical Cord Blood Natural Killer Cells, Their Characteristics, and Potential Clinical Applications. Front Immunol. 2017 Mar 23;8:329. doi: 10.3389/fimmu.2017.00329. eCollection 2017. Review.'},\n", - " {'ReferencePMID': '16284400',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Mortier E, Quéméner A, Vusio P, Lorenzen I, Boublik Y, Grötzinger J, Plet A, Jacques Y. Soluble interleukin-15 receptor alpha (IL-15R alpha)-sushi as a selective and potent agonist of IL-15 action through IL-15R beta/gamma. Hyperagonist IL-15 x IL-15R alpha fusion proteins. J Biol Chem. 2006 Jan 20;281(3):1612-9. Epub 2005 Nov 11.'},\n", - " {'ReferencePMID': '32023374',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Liu E, Marin D, Banerjee P, Macapinlac HA, Thompson P, Basar R, Nassif Kerbauy L, Overman B, Thall P, Kaplan M, Nandivada V, Kaur I, Nunez Cortes A, Cao K, Daher M, Hosing C, Cohen EN, Kebriaei P, Mehta R, Neelapu S, Nieto Y, Wang M, Wierda W, Keating M, Champlin R, Shpall EJ, Rezvani K. Use of CAR-Transduced Natural Killer Cells in CD19-Positive Lymphoid Tumors. N Engl J Med. 2020 Feb 6;382(6):545-553. doi: 10.1056/NEJMoa1910607.'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'C000081222',\n", - " 'InterventionMeshTerm': 'Sargramostim'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000007155',\n", - " 'InterventionAncestorTerm': 'Immunologic Factors'},\n", - " {'InterventionAncestorId': 'D000045505',\n", - " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M267719',\n", - " 'InterventionBrowseLeafName': 'Sargramostim',\n", - " 'InterventionBrowseLeafAsFound': 'GM-CSF',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M8784',\n", - " 'InterventionBrowseLeafName': 'Immunologic Factors',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}}}}},\n", - " {'Rank': 64,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04327570',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'COntAGIouS'},\n", - " 'Organization': {'OrgFullName': 'Universitaire Ziekenhuizen Leuven',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'In-depth Immunological Investigation of COVID-19.',\n", - " 'OfficialTitle': 'In-depth Characterisation of the Dynamic Host Immune Response to Coronavirus SARS-CoV-2',\n", - " 'Acronym': 'COntAGIouS'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 27, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'September 30, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'September 30, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 26, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 26, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 31, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 26, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 31, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Universitaire Ziekenhuizen Leuven',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'The COntAGIouS trial (COvid-19 Advanced Genetic and Immunologic Sampling; an in-depth characterization of the dynamic host immune response to coronavirus SARS-CoV-2) proposes a transdisciplinary approach to identify host factors resulting in hyper-susceptibility to SARS-CoV-2 infection, which is urgently needed for directed medical interventions.',\n", - " 'DetailedDescription': \"The overall aim of this prospective study is to provide an in-depth characterization of clinical and immunological features of patients hospitalized in UZ Leuven because of SARS-CoV-2 infection. For this purpose, clinical data and blood, nasopharyngeal/rectal swab, and if safe, bronchoalveolar lavage (BAL) fluid and lung tissue samples will be collected from PCR- or CT-confirmed COVID-19 patients, with varying degrees of disease severity. Assessed characteristics will be compared between severe and non-severe COVID-19 patients, and between COVID-19 positive and negative ('control') patients.\"},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus Infections']},\n", - " 'KeywordList': {'Keyword': ['COVID-19']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'Yes',\n", - " 'TargetDuration': '6 Months',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Other']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'BioSpec': {'BioSpecRetention': 'Samples With DNA',\n", - " 'BioSpecDescription': 'Blood, plasma, PBMC, BAL, lung tissue'},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '100',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'ICU-hospitalised COVID-19 patients',\n", - " 'ArmGroupDescription': \"COVID-19 positive patients hospitalised in intensive care ('severe disease').\",\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: Patient sampling']}},\n", - " {'ArmGroupLabel': 'ward-hospitalised COVID-19 patients',\n", - " 'ArmGroupDescription': \"COVID-19 positive patients requiring hospitalisation,not on intensive care department ('non-severe').\",\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: Patient sampling']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", - " 'InterventionName': 'Patient sampling',\n", - " 'InterventionDescription': 'Blood draw, NP/rectal swab, bronchoscopy if clinically indicated, lung tissue if applicable',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['ICU-hospitalised COVID-19 patients',\n", - " 'ward-hospitalised COVID-19 patients']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Clinical Features',\n", - " 'PrimaryOutcomeDescription': 'Description of clinical, laboratory and radiological features of illness and complications.',\n", - " 'PrimaryOutcomeTimeFrame': '6 months'},\n", - " {'PrimaryOutcomeMeasure': 'Immune host response at systemic level',\n", - " 'PrimaryOutcomeDescription': 'Evaluation of dynamic host immune response at systemic level (immune signalling molecules in plasma, peripheral blood mononuclear cell isolation for advanced immunophenotyping and transcriptomics). Real-time analysis using CyTOF will be performed as screening, in combination with in-depth immunophenotyping.',\n", - " 'PrimaryOutcomeTimeFrame': '6 months'},\n", - " {'PrimaryOutcomeMeasure': 'Immune host response at local level',\n", - " 'PrimaryOutcomeDescription': 'Evaluation of dynamic host immune response at systemic level (immune signalling molecules in plasma, peripheral blood mononuclear cell isolation for advanced immunophenotyping and transcriptomics).',\n", - " 'PrimaryOutcomeTimeFrame': '6 months'},\n", - " {'PrimaryOutcomeMeasure': 'Host genetic variation',\n", - " 'PrimaryOutcomeDescription': 'Identification of host genetic variants that are associated with severity of disease.',\n", - " 'PrimaryOutcomeTimeFrame': '6 months'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Comparison severe and non-severe COVID-19 hospitalised patients',\n", - " 'SecondaryOutcomeDescription': 'Differences in baseline factors',\n", - " 'SecondaryOutcomeTimeFrame': '6 months'},\n", - " {'SecondaryOutcomeMeasure': 'Comparison severe and non-severe COVID-19 hospitalised patients',\n", - " 'SecondaryOutcomeDescription': 'Differences in immune characteristics',\n", - " 'SecondaryOutcomeTimeFrame': '6 months'},\n", - " {'SecondaryOutcomeMeasure': 'Correlation of findings with outcome',\n", - " 'SecondaryOutcomeDescription': 'Correlation of findings with outcome, aiming to identify early biomarkers of severe disease and putative targets for immunomodulatory therapy',\n", - " 'SecondaryOutcomeTimeFrame': '6 months'},\n", - " {'SecondaryOutcomeMeasure': 'Correlation of immune profiling - microbiome',\n", - " 'SecondaryOutcomeDescription': 'Correlation of immune profiling with microbiome analysis of patients',\n", - " 'SecondaryOutcomeTimeFrame': '6 months'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nPatients >/= 18 years old AND\\nHospitalised with PCR-confirmed and/or CT-confirmed SARS-CoV-2 disease\\n\\nExclusion Criteria:\\n\\nAge < 18 years old\\nNo informed consent\\nPatients on cyclosporine/tacrolimus/sirolimus/everolimus therapy*',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'All non-immunosuppressed* consecutive patients (>18 years old) that are admitted to UZ Leuven from March 2020 until September 2020 with PCR-confirmed and/or CT-confirmed SARS-CoV-2 disease are eligible for inclusion.',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Joost Wauters, MD PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '003216344275',\n", - " 'CentralContactEMail': 'joost.wauters@uzleuven.com'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Joost Wauters, MD PhD',\n", - " 'OverallOfficialAffiliation': 'UZ Leuven',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", - " {'ConditionMeshId': 'D000045169',\n", - " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 65,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04332016',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'CHUBX 2020/11'},\n", - " 'Organization': {'OrgFullName': 'University Hospital, Bordeaux',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'COVID-19 Biological Samples Collection',\n", - " 'OfficialTitle': 'Biological Samples Collection From Patients and Caregivers Treated at Bordeaux University Hospital for Asymptomatic and Symptomatic Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) Infection (COVID-19).',\n", - " 'Acronym': 'COLCOV19-BX'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 2, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 2023',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'March 2023',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 30, 2020',\n", - " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 2, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'April 2, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", - " 'LastUpdatePostDateType': 'Estimate'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'University Hospital, Bordeaux',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'The coronavirus disease 2019 (COVID-19) outbreak is now considered as a public health emergency of international concern by the World Health Organization.\\n\\nIn the context of the health emergency, research on the pathogen (the SARS-CoV-2 coronavirus), the disease and the therapeutic care is being organized. Research projects require the use of biological samples. This study aims at setting up a collection of biological samples intended for application projects in any discipline.\\n\\nThe main objective of the study is to collect, process and store biological samples from patients and caregivers infected with SARS-CoV-2 (COVID-19) at the biological ressources center of the Bordeaux University Hospital.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Infection Viral']},\n", - " 'KeywordList': {'Keyword': ['COVID-19',\n", - " 'SARS-CoV-2',\n", - " 'coronavirus',\n", - " 'biological samples']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Case-Only']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'BioSpec': {'BioSpecRetention': 'Samples With DNA',\n", - " 'BioSpecDescription': 'Whole Blood Sample Upper respiratory sampling Urine and stool collection Post mortem biopsies'},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '2000',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'COVID-19 infected patients',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: biological samples collection']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", - " 'InterventionName': 'biological samples collection',\n", - " 'InterventionDescription': 'collection of whole blood samples, urine and stool samples, upper respiratory samples, post-mortem biopsies',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['COVID-19 infected patients']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'COVID-19 desease description',\n", - " 'PrimaryOutcomeDescription': 'From blood samples: protein levels, whole genome sequence, transcriptomic analysis data.\\n\\nFrom upper respiratory samples: protein levels, virus transcriptomic analysis data.\\n\\nFrom stool: microbiota analysis data.\\n\\nFrom urine: protein level.',\n", - " 'PrimaryOutcomeTimeFrame': 'Inclusion visit (Day 1)'},\n", - " {'PrimaryOutcomeMeasure': 'COVID-19 desease description',\n", - " 'PrimaryOutcomeDescription': 'From blood samples: protein levels.',\n", - " 'PrimaryOutcomeTimeFrame': 'Day 30 to 90'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nPatients / caregivers treated at Bordeaux University Hospital for asymptomatic or symptomatic infection by SARS -CoV-2\\nmen and women, adults and minors as well as pregnant or breastfeeding women\\npatients who died following infection with SARS-CoV-2 (specific criterion for post-mortem biopsies)\\nBe affiliated with or beneficiary of a social security scheme\\nFree and informed consent obtained and signed by the patient\\n\\nExclusion Criteria:\\n\\nUnder guardianship or curatorship',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MaximumAge': '100 Years',\n", - " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'Patients / caregivers treated at Bordeaux University Hospital for asymptomatic or symptomatic infection by SARS -CoV-2.',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Isabelle PELLEGRIN',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '05 57 82 11 50',\n", - " 'CentralContactEMail': 'isabelle.pellegrin@chu-bordeaux.fr'},\n", - " {'CentralContactName': 'Aurélie POUZET',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '05 57 82 17 31',\n", - " 'CentralContactEMail': 'aurelie.pouzet@chu-bordeaux.fr'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Centre Hospitalier Universitaire de Bordeaux',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Bordeaux',\n", - " 'LocationZip': '33076',\n", - " 'LocationCountry': 'France',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Isabelle PELLEGRIN',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '05 57 82 11 50',\n", - " 'LocationContactEMail': 'isabelle.pellegrin@chu-bordeaux.fr'},\n", - " {'LocationContactName': 'Aurélie POUZET',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '05 57 82 17 31',\n", - " 'LocationContactEMail': 'aurelie.pouzet@chu-bordeaux.fr'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", - " 'ConditionMeshTerm': 'Infection'},\n", - " {'ConditionMeshId': 'D000014777',\n", - " 'ConditionMeshTerm': 'Virus Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafAsFound': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafAsFound': 'Infection Viral',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 66,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04321421',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'IRCCSSanMatteoH'},\n", - " 'Organization': {'OrgFullName': 'Foundation IRCCS San Matteo Hospital',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Hyperimmune Plasma for Critical Patients With COVID-19',\n", - " 'OfficialTitle': 'Plasma From Donors Recovered From New Coronavirus 2019 As Therapy For Critical Patients With Covid-19',\n", - " 'Acronym': 'COV19-PLASMA'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Active, not recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 17, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 31, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'May 31, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 23, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 23, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 25, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 23, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 25, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Cesare Perotti',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Medical Doctor',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Foundation IRCCS San Matteo Hospital'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Foundation IRCCS San Matteo Hospital',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'OSPEDALE CARLO POMA ASST MANTOVA',\n", - " 'CollaboratorClass': 'UNKNOWN'},\n", - " {'CollaboratorName': 'OSPEDALE MAGGIORE LODI',\n", - " 'CollaboratorClass': 'UNKNOWN'},\n", - " {'CollaboratorName': 'OSPEDALE ASST CREMONA',\n", - " 'CollaboratorClass': 'UNKNOWN'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has become pandemic. To date, no specific treatment has been proven to be effective. Promising results were obtained in China using Hyperimmune plasma from patients recovered from the disease.We plan to treat critical Covid-19 patients with hyperimmune plasma.',\n", - " 'DetailedDescription': 'Apheresis from recovered donors will be performed with a cell separator device , with 500-600 mL of plasma obtained from each donor. Donors are males, age 18 yrs or more, evaluated for transmissible diseases according to the italian law. Adjunctive tests will be for hepatitis A virus, hepatatis E virusand Parvovirus B-19. All donors will be tested for the Covid-19 neutralizing title. Each plasma bag obtained from plasmapheresis will be immediately divided in two units and frozen according to the national standards and stored separately.\\n\\nBased on experience published in literature 250-300 mL of convalescent plasma will be used to treat each of the recruited patients at most 3 times over 5 days.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", - " 'KeywordList': {'Keyword': ['hyperimmune plasma', 'COVID-19']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Not Applicable']},\n", - " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", - " 'DesignInterventionModelDescription': 'Longitudinal assessment of COVID-19 patients treated with hyperimmune plasma',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '49',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'treated',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'treated with hyperimmune plasma',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: hyperimmune plasma']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", - " 'InterventionName': 'hyperimmune plasma',\n", - " 'InterventionDescription': 'administration of hyperimmune plasma at day 1 and based on clinical response on day 3 and 5',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['treated']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'death',\n", - " 'PrimaryOutcomeDescription': 'death from any cause',\n", - " 'PrimaryOutcomeTimeFrame': 'within 7 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'time to extubation',\n", - " 'SecondaryOutcomeDescription': 'days since intubation',\n", - " 'SecondaryOutcomeTimeFrame': 'within 7 days'},\n", - " {'SecondaryOutcomeMeasure': 'length of intensive care unit stay',\n", - " 'SecondaryOutcomeDescription': 'days from entry to exit from ICU',\n", - " 'SecondaryOutcomeTimeFrame': 'within 7 days'},\n", - " {'SecondaryOutcomeMeasure': 'time to CPAP weaning',\n", - " 'SecondaryOutcomeDescription': 'days since CPAP initiation',\n", - " 'SecondaryOutcomeTimeFrame': 'within 7 days'},\n", - " {'SecondaryOutcomeMeasure': 'viral load',\n", - " 'SecondaryOutcomeDescription': 'naso-pharyngeal swab, sputum and BAL',\n", - " 'SecondaryOutcomeTimeFrame': 'at days 1, 3 and 7'},\n", - " {'SecondaryOutcomeMeasure': 'immune response',\n", - " 'SecondaryOutcomeDescription': 'neutralizing title',\n", - " 'SecondaryOutcomeTimeFrame': 'at days 1, 3 and 7'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nage >=18 yrs\\npositive for reverse transcription polymerase chain reaction (RT-PCR) severe acute respiratory syndrome (SARS)-CoV-2\\nAcute respiratory distress syndrome (ARDS) moderate to severe, according to Berlin definition, lasting less than10 days\\nPolymerase chain reaction (PCR) increased by 3.5 with respect to baseline or >18 mg/dl\\nneed for mechanical ventilation or continuous positive airway pressure (CPAP)\\nsigned informed consent unless unfeasible for the critical condition\\n\\nExclusion Criteria:\\n\\nModerate to severe ARDS lasting more than 10 days\\nproven hypersensitivity or allergic reaction to hemoderivatives or immunoglobulins\\nconsent denied',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Cesare Perotti, MD',\n", - " 'OverallOfficialAffiliation': 'Foundation IRCCS San Matteo Hospital',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Catherine Klersy',\n", - " 'LocationCity': 'Pavia',\n", - " 'LocationState': 'PV',\n", - " 'LocationZip': '27100',\n", - " 'LocationCountry': 'Italy'}]}},\n", - " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '32113510',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Chen L, Xiong J, Bao L, Shi Y. Convalescent plasma as a potential therapy for COVID-19. Lancet Infect Dis. 2020 Feb 27. pii: S1473-3099(20)30141-9. doi: 10.1016/S1473-3099(20)30141-9. [Epub ahead of print]'},\n", - " {'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'WHO. Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected. 2020. https://www.who. int/docs/default-source/coronaviruse/clinical-management-of-novel-cov. pdf (accessed Feb 20, 2020).'},\n", - " {'ReferencePMID': '16172857',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Lai ST. Treatment of severe acute respiratory syndrome. Eur J Clin Microbiol Infect Dis. 2005 Sep;24(9):583-91. Review.'},\n", - " {'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'WHO. Use of convalescent whole blood or plasma collected from patients recovered from Ebola virus disease for transfusion, as an empirical treatment during outbreaks. 2014. http://apps.who.int/iris/rest/ bitstreams/604045/retrieve (accessed Feb 20, 2020).'},\n", - " {'ReferencePMID': '26618098',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Arabi Y, Balkhy H, Hajeer AH, Bouchama A, Hayden FG, Al-Omari A, Al-Hameed FM, Taha Y, Shindo N, Whitehead J, Merson L, AlJohani S, Al-Khairy K, Carson G, Luke TC, Hensley L, Al-Dawood A, Al-Qahtani S, Modjarrad K, Sadat M, Rohde G, Leport C, Fowler R. Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol. Springerplus. 2015 Nov 19;4:709. doi: 10.1186/s40064-015-1490-9. eCollection 2015.'},\n", - " {'ReferencePMID': '21248066',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19.'},\n", - " {'ReferencePMID': '32004427',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H, Spitters C, Ericson K, Wilkerson S, Tural A, Diaz G, Cohn A, Fox L, Patel A, Gerber SI, Kim L, Tong S, Lu X, Lindstrom S, Pallansch MA, Weldon WC, Biggs HM, Uyeki TM, Pillai SK; Washington State 2019-nCoV Case Investigation Team. First Case of 2019 Novel Coronavirus in the United States. N Engl J Med. 2020 Mar 5;382(10):929-936. doi: 10.1056/NEJMoa2001191. Epub 2020 Jan 31.'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided',\n", - " 'IPDSharingDescription': 'will be decided'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", - " {'Rank': 67,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04305574',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '2020-CERC-001'},\n", - " 'Organization': {'OrgFullName': 'Yale-NUS College',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Social Media Use During COVID-19',\n", - " 'OfficialTitle': 'Getting it Right: Towards Responsible Social Media Use During a Pandemic'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 8, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 31, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'May 31, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 8, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 11, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 12, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 16, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 17, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor-Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Jean Liu',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Assistant Professor',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Yale-NUS College'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Jean Liu',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'The investigators plan to conduct a cross-sectional survey to examine how social media use during COVID-19 relates to: (1) information management, (2) assessment of the situation, and (3) affect.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus',\n", - " 'Depression',\n", - " 'Anxiety',\n", - " 'Stress']},\n", - " 'KeywordList': {'Keyword': ['COVID-19',\n", - " 'Social media',\n", - " 'Communication']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Cross-Sectional']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '5000',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Community sample',\n", - " 'ArmGroupDescription': 'We plan to recruit a representative sample of the Singapore population.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Behavioral: Use of social media during COVID-19']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Behavioral',\n", - " 'InterventionName': 'Use of social media during COVID-19',\n", - " 'InterventionDescription': \"Participants' self-reported use of social media to receive and share news about COVID-19\",\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Community sample']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Assessment of COVID-19 situation',\n", - " 'PrimaryOutcomeDescription': '3 items on fear of the situation, confidence the government can manage the situation, and assessed chance of being infected (each rated using 4-point scales: min = 1, max = 4; higher scores indicate increased confidence / likelihood / fear)',\n", - " 'PrimaryOutcomeTimeFrame': 'Single measurement (upon study enrolment)'},\n", - " {'PrimaryOutcomeMeasure': 'Depression, Anxiety and Stress Scale',\n", - " 'PrimaryOutcomeDescription': '21-item validated scale assessing symptoms of depression, anxiety, and stress (DASS-21): Min score = 0, Max score = 21; higher score indicates a worse outcome',\n", - " 'PrimaryOutcomeTimeFrame': 'Single measurement (upon study enrolment)'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Familiarity and trust in COVID-related rumours',\n", - " 'SecondaryOutcomeDescription': \"Participants' self-report of their familiarity (yes/no) and belief of specific (yes/no), and whether they shared these on social media (yes/no)\",\n", - " 'SecondaryOutcomeTimeFrame': 'Single measurement (upon study enrolment)'},\n", - " {'SecondaryOutcomeMeasure': 'Availability heuristic',\n", - " 'SecondaryOutcomeDescription': \"Participants' assessment of how many cases there have been in COVID-19 and SARS\",\n", - " 'SecondaryOutcomeTimeFrame': 'Single measurement (upon study enrolment)'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAt least 21 years\\nHas stayed in Singapore for at least 2 years\\n\\nExclusion Criteria:\\n\\nBelow 21 years\\nHas stayed in Singapore for less than 2 years',\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '21 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'Representative sample of the Singapore population',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Jean Liu, PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '66013694',\n", - " 'CentralContactEMail': 'jeanliu@yale-nus.edu.sg'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Jean Liu, PhD',\n", - " 'OverallOfficialAffiliation': 'Yale-NUS College',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Yale-NUS College',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Singapore',\n", - " 'LocationZip': '138527',\n", - " 'LocationCountry': 'Singapore',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Jean Liu, PhD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactEMail': 'jeanliu@yale-nus.edu.sg'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No',\n", - " 'IPDSharingDescription': 'Due to stipulations by the Institutional Review Board, data cannot be shared.'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", - " {'ConditionMeshId': 'D000003863',\n", - " 'ConditionMeshTerm': 'Depression'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000001526',\n", - " 'ConditionAncestorTerm': 'Behavioral Symptoms'},\n", - " {'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M5641',\n", - " 'ConditionBrowseLeafName': 'Depression',\n", - " 'ConditionBrowseLeafAsFound': 'Depression',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M5644',\n", - " 'ConditionBrowseLeafName': 'Depressive Disorder',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M2905',\n", - " 'ConditionBrowseLeafName': 'Anxiety Disorders',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M3399',\n", - " 'ConditionBrowseLeafName': 'Behavioral Symptoms',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BXM',\n", - " 'ConditionBrowseBranchName': 'Behaviors and Mental Disorders'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 68,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04331795',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'IRB20-0515'},\n", - " 'Organization': {'OrgFullName': 'University of Chicago',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Tocilizumab to Prevent Clinical Decompensation in Hospitalized, Non-critically Ill Patients With COVID-19 Pneumonitis',\n", - " 'OfficialTitle': 'Early Institution of Tocilizumab Titration in Non-Critical Hospitalized COVID-19 Pneumonitis',\n", - " 'Acronym': 'COVIDOSE'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 3, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'July 1, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'December 1, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'April 1, 2020',\n", - " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 2, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'University of Chicago',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'IsFDARegulatedDrug': 'Yes',\n", - " 'IsFDARegulatedDevice': 'No',\n", - " 'IsUSExport': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Coronavirus disease-2019 (COVID-19) has a quoted inpatient mortality as high as 25%. This high mortality may be driven by hyperinflammation resembling cytokine release syndrome (CRS), offering the hope that therapies targeting the interleukin-6 (IL-6) axis therapies commonly used to treat CRS can be used to reduce COVID-19 mortality. Retrospective analysis of severe to critical COVID-19 patients receiving tocilizumab demonstrated that the majority of patients had rapid resolution (i.e., within 24-72 hours following administration) of both clinical and biochemical signs (fever and CRP, respectively) of hyperinflammation with only a single tocilizumab dose.\\n\\nHypotheses:\\n\\nTocilizumab is effective in decreasing signs, symptoms, and laboratory evidence of COVID-19 pneumonitis in hospitalized, non-critically ill patients with clinical risk factors for clinical decompensation, intensive care utilization, and death.\\nLow-dose tocilizumab is effective in decreasing signs, symptoms, and laboratory evidence of COVID-19 pneumonitis in hospitalized, non-critically ill patients with and without clinical risk factors for clinical decompensation, intensive care utilization, and death.\\n\\nObjectives:\\n\\nTo establish proof of concept that tocilizumab is effective in decreasing signs, symptoms, and laboratory evidence of COVID-19 pneumonitis in hospitalized, non-critically ill patients with clinical risk factors for clinical decompensation, intensive care utilization, and death, as determined by the clinical outcome of resolution of fever and the biochemical outcome measures of time to CRP normalization for the individual patient and the rate of patients whose CRP normalize.\\nTo establish proof of concept that low-dose tocilizumab is effective in decreasing signs, symptoms, and laboratory evidence of COVID-19 pneumonitis in hospitalized, non-critically ill patients without clinical risk factors for clinical decompensation, intensive care utilization, and death, as determined by the clinical outcome of resolution of fever and the biochemical outcome measures of time to CRP normalization for the individual patient and the rate of patients whose CRP normalize.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 2']},\n", - " 'DesignInfo': {'DesignAllocation': 'Non-Randomized',\n", - " 'DesignInterventionModel': 'Single Group Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '50',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Group A',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Hospitalized, non-critically ill patients with COVID-19 pneumonitis with risk factors for decompensation',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Tocilizumab']}},\n", - " {'ArmGroupLabel': 'Group B',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Hospitalized, non-critically ill patients with COVID-19 pneumonitis without risk factors for decompensation',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Tocilizumab']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Tocilizumab',\n", - " 'InterventionDescription': 'Group A: Tocilizumab (beginning dose 200mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.\\n\\nSecond dose is provisioned if evidence of clinical worsening or lack of C-reactive protein response.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Group A']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Tocilizumab',\n", - " 'InterventionDescription': 'Group B: Low-dose tocilizumab (beginning dose 80mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.\\n\\nSecond dose is provisioned if evidence of clinical worsening or lack of C-reactive protein response.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Group B']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Clinical response',\n", - " 'PrimaryOutcomeDescription': 'Tmax Response: Resolution of fever (from Tmax > 38C in 24H period to Tmax < 38C in following 24H period, with Tmax measured by commonly accepted clinical methods [forehead, tympanic, oral, axillary, rectal]). Maximum temperature within 24-hour period of time (0:00-23:59) on the day prior to, day of, and every 24 hours after tocilizumab administration. The primary endpoint is absence of Tmax greater than or equal to 38ºC in the 24-hour period following tocilizumab administration.',\n", - " 'PrimaryOutcomeTimeFrame': 'Assessed for the 24 hour period after tocilizumab administration'},\n", - " {'PrimaryOutcomeMeasure': 'Biochemical response',\n", - " 'PrimaryOutcomeDescription': 'CRP normalization rate: Calculated as the ratio of the number of patients who achieve normal CRP value following tocilizumab administration and total number of patients who receive tocilizumab.\\n\\nTime to CRP normalization: Calculated as the number of hours between tocilizumab administration and first normal CRP value.',\n", - " 'PrimaryOutcomeTimeFrame': \"Assessed every 24 hours during patient's hospitalization, up to 4 weeks after tocilizumab administration\"}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Overall survival',\n", - " 'SecondaryOutcomeDescription': '28-Day Overall Survival is defined as the status of the patient at the end of 28 days, beginning from the time of the first dose of tocilizumab.',\n", - " 'SecondaryOutcomeTimeFrame': '28 days'},\n", - " {'SecondaryOutcomeMeasure': 'Survival to hospital discharge',\n", - " 'SecondaryOutcomeDescription': 'This will be defined as the percentage of patients who are discharged in stable condition compared to the percentage of patients who die in the hospital. Patients who are discharged to hospice will be excluded from this calculation.',\n", - " 'SecondaryOutcomeTimeFrame': 'Hospitalization, up to 4 weeks after tocilizumab administration'},\n", - " {'SecondaryOutcomeMeasure': 'Progression of COVID-19 pneumonitis',\n", - " 'SecondaryOutcomeDescription': \"This will be a binary outcome defined by worsening COVID-19 pneumonitis resulting in transition from clinical Group A or Group B COVID-19 pneumonitis to critical COVID-19 pneumonitis during the course of the patient's COVID-19 infection. This diagnosis will be determined by treating physicians on the basis of worsening pulmonary infiltrates on chest imaging as well as clinical deterioration marked by persistent fever, rising supplemental oxygen requirement, declining PaO2/FiO2 ratio, and the need for intensive care such as mechanical ventilation or vasopressor/inotrope medication(s).\",\n", - " 'SecondaryOutcomeTimeFrame': 'Hospitalization, up to 4 weeks after tocilizumab administration'},\n", - " {'SecondaryOutcomeMeasure': 'Rate of non-elective mechanical ventilation',\n", - " 'SecondaryOutcomeDescription': \"This will be a binary outcome defined as worsening COVID-19 disease resulting in the use of non-invasive (BiPap, heated high-flow nasal cannula) or invasive positive pressure ventilation during the course of the patient's COVID-19 infection. For patients admitted to the hospital using non-invasive mechanical ventilation, the utilization of mechanical ventilation will count toward this metric, as well. Calculated as the ratio of the number of patients who require non-invasive or invasive positive pressure ventilation during hospitalization and total number of patients who receive tocilizumab.\",\n", - " 'SecondaryOutcomeTimeFrame': 'Hospitalization, up to 4 weeks after tocilizumab administration'},\n", - " {'SecondaryOutcomeMeasure': 'Duration of mechanical ventilation',\n", - " 'SecondaryOutcomeDescription': 'This will be a continuous outcome defined by the amount of time between initiation and cessation of mechanical ventilation (invasive and non-invasive).',\n", - " 'SecondaryOutcomeTimeFrame': 'Hospitalization, up to 4 weeks after tocilizumab administration'},\n", - " {'SecondaryOutcomeMeasure': 'Time to mechanical ventilation',\n", - " 'SecondaryOutcomeDescription': 'This will be a continuous outcome defined by the amount of time between tocilizumab dose administration and the initiation of mechanical ventilation. This will be treated as a time-to-event with possible censoring.',\n", - " 'SecondaryOutcomeTimeFrame': 'Assessed over hospitalization, up to 4 weeks after tocilizumab administration'},\n", - " {'SecondaryOutcomeMeasure': 'Rate of vasopressor/inotrope utilization',\n", - " 'SecondaryOutcomeDescription': \"This will be a binary outcome defined as utilization of any vasopressor or inotropic medication during the course of the patient's COVID-19 infection. Calculated as the ratio of the number of patients who require vasopressor or inotrope medication during hospitalization and total number of patients who receive tocilizumab.\",\n", - " 'SecondaryOutcomeTimeFrame': 'Hospitalization, up to 4 weeks after tocilizumab administration'},\n", - " {'SecondaryOutcomeMeasure': 'Duration of vasopressor/inotrope utilization',\n", - " 'SecondaryOutcomeDescription': 'This will be a continuous outcome defined by the amount of time between initiation of first and cessation of last vasopressor or inotrope medication(s).',\n", - " 'SecondaryOutcomeTimeFrame': 'Hospitalization, up to 4 weeks after tocilizumab administration'},\n", - " {'SecondaryOutcomeMeasure': 'Time to vasopressor or inotropic utilization',\n", - " 'SecondaryOutcomeDescription': 'This will be a continuous outcome defined by the amount of time between first tocilizumab dose administration and the initiation of vasopressor or inotropic medication(s). This will be treated as a time-to-event with possible censoring.',\n", - " 'SecondaryOutcomeTimeFrame': 'Assessed over hospitalization, up to 4 weeks after tocilizumab administration'},\n", - " {'SecondaryOutcomeMeasure': 'Number of ICU days',\n", - " 'SecondaryOutcomeDescription': 'Number of ICU days is defined as the time period when a patient is admitted to the ICU (defined as the timestamp on the first vital signs collected in an ICU) until they are transferred from the ICU to a non-ICU setting such as a general acute care bed (defined as the timestamp on the first vital signs collected outside an ICU, excepting any \"off the floor\" vital signs charted from operating rooms or procedure or imaging suites). Death in the ICU will be a competing risk.',\n", - " 'SecondaryOutcomeTimeFrame': 'Hospitalization, up to 4 weeks after tocilizumab administration'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\nAdults ≥ 18 years of age\\nApproval from the patient's primary service\\nAdmitted as an inpatient to University of Chicago Medicine\\nFever, documented in electronic medical record and defined as: T ≥ 38*C by any conventional clinical method (forehead, tympanic, oral, axillary, rectal)\\nPositive test for active SARS-CoV-2 infection\\nRadiographic evidence of infiltrates on chest radiograph (CXR) or computed tomography (CT)\\n\\nExclusion Criteria:\\n\\nConcurrent use of invasive mechanical ventilation (patients receiving non-invasive mechanical ventilation [CPAP, BiPap, HHFNC] are eligible)\\nConcurrent use of vasopressor or inotropic medications\\nPrevious receipt of tocilizumab or another anti-IL6R or IL-6 inhibitor.\\nKnown history of hypersensitivity to tocilizumab.\\nPatients who are actively being considered for a study of an antiviral agent that would potentially exclude concurrent enrollment on this study.\\nPatients actively receiving an investigational antiviral agent in the context of a clinical research study.\\nDiagnosis of end-stage liver disease or listed for liver transplant.\\nElevation of AST or ALT in excess of 5 times the upper limit of normal.\\nNeutropenia (Absolute neutrophil count < 500/uL).\\nThrombocytopenia (Platelets < 50,000/uL).\\nOn active therapy with a biologic immunosuppressive agent.\\nHistory of bone marrow transplantation or solid organ transplant.\\nKnown history of Hepatitis B or Hepatitis C.\\nKnown history of mycobacterium tuberculosis infection at risk for reactivation.\\nKnown history of gastrointestinal perforation or active diverticulitis.\\nMulti-organ failure as determined by primary treating team\\nAny other documented serious, active infection besides COVID-19.\\nPregnant patients\\nPatients who are unable to discontinue scheduled antipyretic medications, either as monotherapy (e.g., acetaminophen or ibuprofen [aspirin is acceptable]) or as part of combination therapy (e.g., hydrocodone/acetaminophen, aspirin/acetaminophen/caffeine [Excedrin®])\\nCRP < 40 mg/L (or ug/mL)\\n\\nPatients will be assigned to Group A if:\\n\\n● C-reactive protein (CRP) ≥ 75 ug/mL\\n\\nAND\\n\\nAny one of the following criteria are met:\\n\\nPrevious ICU admission\\nPrevious non-elective intubation\\nAdmission for heart failure exacerbation within the past 12 months\\nHistory of percutaneous coronary intervention (PCI)\\nHistory of coronary artery bypass graft (CABG) surgery\\nDiagnosis of pulmonary hypertension\\nBaseline requirement for supplemental O2\\nDiagnosis of interstitial lung disease (ILD)\\nAdmission for chronic obstructive pulmonary disease (COPD) exacerbation within the past 12 months\\nAsthma with use of daily inhaled corticosteroid\\nHistory of pneumonectomy or lobectomy\\nHistory of radiation therapy to the lung\\nHistory of HIV\\nCancer of any stage and receiving active treatment (excluding hormonal therapy)\\nAny history of diagnosed immunodeficiency\\nEnd-stage renal disease (ESRD) requiring peritoneal or hemodialysis\\n\\nAll other eligible patients assigned to Group B\",\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Pankti Reid, MD, MPH',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '7737021220',\n", - " 'CentralContactEMail': 'pankti.reid@uchospitals.edu'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Pankti Reid, MD, MPH',\n", - " 'OverallOfficialAffiliation': 'University of Chicago, Department of Medicine, Section of Rheumatology',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'University of Chicago Medicine',\n", - " 'LocationCity': 'Chicago',\n", - " 'LocationState': 'Illinois',\n", - " 'LocationZip': '60637',\n", - " 'LocationCountry': 'United States',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Pankti Reid, MD, MPH',\n", - " 'LocationContactRole': 'Contact'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000011014',\n", - " 'ConditionMeshTerm': 'Pneumonia'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000008171',\n", - " 'ConditionAncestorTerm': 'Lung Diseases'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M12487',\n", - " 'ConditionBrowseLeafName': 'Pneumonia',\n", - " 'ConditionBrowseLeafAsFound': 'Pneumonitis',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M9751',\n", - " 'ConditionBrowseLeafName': 'Lung Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'}]}}}}},\n", - " {'Rank': 69,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04316884',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'EPN 2017/043 Covid19'},\n", - " 'Organization': {'OrgFullName': 'Uppsala University',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Mechanisms for Organ Dysfunction in Covid-19',\n", - " 'OfficialTitle': 'Uppsala Intensive Care Study of Mechanisms for Organ Dysfunction in Covid-19',\n", - " 'Acronym': 'UMODCOVID19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 12, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'December 31, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2021',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 13, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 18, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 20, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 18, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 20, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Uppsala University',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'The study aims to investigate organ dysfunction and biomarkers in patients with suspected or verified COVID-19 during intensive care at Uppsala University Hospital.',\n", - " 'DetailedDescription': 'Consenting patients with suspected or verified SARS-COV-2 infection, COVID-19, will undergo daily blood, urine and sputum sampling during their stay in intensive care. Data on organ dysfunction will be collected through the electronic patient journal and electronic patient data management system. The collected samples will be analysed for a panel of potential biomarkers that will be correlated to organ dysfunction and clinical outcome.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", - " 'Organ Dysfunction Syndrome Sepsis',\n", - " 'Organ Dysfunction Syndrome, Multiple',\n", - " 'Septic Shock',\n", - " 'Acute Kidney Injury',\n", - " 'Acute Respiratory Distress Syndrome']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'BioSpec': {'BioSpecRetention': 'Samples With DNA',\n", - " 'BioSpecDescription': 'Plasma, Urine and Sputum'},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '100',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'COVID-19',\n", - " 'ArmGroupDescription': 'Patients with suspected or verified COVID-19 admitted to intensive care at Uppsala University Hospital'}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Acute Kidney Injury',\n", - " 'PrimaryOutcomeDescription': 'KDIGO AKI score',\n", - " 'PrimaryOutcomeTimeFrame': 'During Intensive Care, an estimated average of 10 days.'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'ARDS',\n", - " 'SecondaryOutcomeDescription': 'Acute Respiratory Distress Syndrome yes/no',\n", - " 'SecondaryOutcomeTimeFrame': 'During intensive care, an estimated average of 10 days.'},\n", - " {'SecondaryOutcomeMeasure': '30 day mortality',\n", - " 'SecondaryOutcomeDescription': 'Death within 30 days of ICU admission',\n", - " 'SecondaryOutcomeTimeFrame': '30 days'},\n", - " {'SecondaryOutcomeMeasure': '1 year mortality',\n", - " 'SecondaryOutcomeDescription': 'Death within 1 year of ICU admission',\n", - " 'SecondaryOutcomeTimeFrame': '1 year'},\n", - " {'SecondaryOutcomeMeasure': 'Chronic Kidney Disease',\n", - " 'SecondaryOutcomeDescription': 'Development of Chronic Kidney Disease',\n", - " 'SecondaryOutcomeTimeFrame': '60 days and 1 year after ICU admission'},\n", - " {'SecondaryOutcomeMeasure': 'SOFA-score',\n", - " 'SecondaryOutcomeDescription': 'Sequential Organ Failure Score as a continuous variable',\n", - " 'SecondaryOutcomeTimeFrame': 'During Intensive Care, an estimated average of 10 days.'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAdmitted to intensive care\\nsuspected or verified COVID-19\\n\\nExclusion Criteria:\\n\\nPregnancy or breastfeeding\\nPreexisting end-stage kidney failure or dialysis\\nUnder-age',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'All patients requiring intensive care with suspected or verified COVID19',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Robert Frithiof, MD. PhD.',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '0736563473',\n", - " 'CentralContactEMail': 'robert.frithiof@surgsci.uu.se'},\n", - " {'CentralContactName': 'Sara Bülow Anderberg, MD.',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '0730247414',\n", - " 'CentralContactEMail': 'sarabulow@gmail.com'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Robert Frithiof, MD. PhD',\n", - " 'OverallOfficialAffiliation': 'Uppsala University Hospital',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Uppsala University Hospital',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Uppsala',\n", - " 'LocationZip': '75185',\n", - " 'LocationCountry': 'Sweden',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Robert Frithiof, MD. PhD.',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '073-6563473',\n", - " 'LocationContactEMail': 'robert.frithiof@surgsci.uu.se'},\n", - " {'LocationContactName': 'Sara Bülow Anderberg, MD.',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '073-0247414',\n", - " 'LocationContactEMail': 'sarabulow@gmail.com'},\n", - " {'LocationContactName': 'Robert Frithiof, MD. PhD.',\n", - " 'LocationContactRole': 'Principal Investigator'},\n", - " {'LocationContactName': 'Sara Bülow Anderberg, MD.',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Michael Hultström, MD. PhD.',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Miklos Lipcsey, MD. PhD.',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided',\n", - " 'IPDSharingDescription': 'IPD may be made available upon reasonable request.'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000012127',\n", - " 'ConditionMeshTerm': 'Respiratory Distress Syndrome, Newborn'},\n", - " {'ConditionMeshId': 'D000012128',\n", - " 'ConditionMeshTerm': 'Respiratory Distress Syndrome, Adult'},\n", - " {'ConditionMeshId': 'D000055371',\n", - " 'ConditionMeshTerm': 'Acute Lung Injury'},\n", - " {'ConditionMeshId': 'D000058186',\n", - " 'ConditionMeshTerm': 'Acute Kidney Injury'},\n", - " {'ConditionMeshId': 'D000013577', 'ConditionMeshTerm': 'Syndrome'},\n", - " {'ConditionMeshId': 'D000018746',\n", - " 'ConditionMeshTerm': 'Systemic Inflammatory Response Syndrome'},\n", - " {'ConditionMeshId': 'D000009102',\n", - " 'ConditionMeshTerm': 'Multiple Organ Failure'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000004194',\n", - " 'ConditionAncestorTerm': 'Disease'},\n", - " {'ConditionAncestorId': 'D000010335',\n", - " 'ConditionAncestorTerm': 'Pathologic Processes'},\n", - " {'ConditionAncestorId': 'D000051437',\n", - " 'ConditionAncestorTerm': 'Renal Insufficiency'},\n", - " {'ConditionAncestorId': 'D000007674',\n", - " 'ConditionAncestorTerm': 'Kidney Diseases'},\n", - " {'ConditionAncestorId': 'D000014570',\n", - " 'ConditionAncestorTerm': 'Urologic Diseases'},\n", - " {'ConditionAncestorId': 'D000007249',\n", - " 'ConditionAncestorTerm': 'Inflammation'},\n", - " {'ConditionAncestorId': 'D000012769',\n", - " 'ConditionAncestorTerm': 'Shock'},\n", - " {'ConditionAncestorId': 'D000008171',\n", - " 'ConditionAncestorTerm': 'Lung Diseases'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", - " {'ConditionAncestorId': 'D000012120',\n", - " 'ConditionAncestorTerm': 'Respiration Disorders'},\n", - " {'ConditionAncestorId': 'D000007235',\n", - " 'ConditionAncestorTerm': 'Infant, Premature, Diseases'},\n", - " {'ConditionAncestorId': 'D000007232',\n", - " 'ConditionAncestorTerm': 'Infant, Newborn, Diseases'},\n", - " {'ConditionAncestorId': 'D000055370',\n", - " 'ConditionAncestorTerm': 'Lung Injury'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M13547',\n", - " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Newborn',\n", - " 'ConditionBrowseLeafAsFound': 'Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M13548',\n", - " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Adult',\n", - " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M26731',\n", - " 'ConditionBrowseLeafName': 'Acute Lung Injury',\n", - " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M14160',\n", - " 'ConditionBrowseLeafName': 'Shock',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M19448',\n", - " 'ConditionBrowseLeafName': 'Sepsis',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M15452',\n", - " 'ConditionBrowseLeafName': 'Toxemia',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M27585',\n", - " 'ConditionBrowseLeafName': 'Acute Kidney Injury',\n", - " 'ConditionBrowseLeafAsFound': 'Acute Kidney Injury',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M14163',\n", - " 'ConditionBrowseLeafName': 'Shock, Septic',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M19402',\n", - " 'ConditionBrowseLeafName': 'Systemic Inflammatory Response Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Organ Dysfunction Syndrome Sepsis',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M26730',\n", - " 'ConditionBrowseLeafName': 'Lung Injury',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M10642',\n", - " 'ConditionBrowseLeafName': 'Multiple Organ Failure',\n", - " 'ConditionBrowseLeafAsFound': 'Organ Dysfunction Syndrome, Multiple',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M25305',\n", - " 'ConditionBrowseLeafName': 'Renal Insufficiency',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M9281',\n", - " 'ConditionBrowseLeafName': 'Kidney Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M15902',\n", - " 'ConditionBrowseLeafName': 'Urologic Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8876',\n", - " 'ConditionBrowseLeafName': 'Inflammation',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M9751',\n", - " 'ConditionBrowseLeafName': 'Lung Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13540',\n", - " 'ConditionBrowseLeafName': 'Respiration Disorders',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M24456',\n", - " 'ConditionBrowseLeafName': 'Premature Birth',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8862',\n", - " 'ConditionBrowseLeafName': 'Infant, Premature, Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8859',\n", - " 'ConditionBrowseLeafName': 'Infant, Newborn, Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T4953',\n", - " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Infant',\n", - " 'ConditionBrowseLeafAsFound': 'Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'T191',\n", - " 'ConditionBrowseLeafName': 'Acute Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC16',\n", - " 'ConditionBrowseBranchName': 'Diseases and Abnormalities at or Before Birth'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BXS',\n", - " 'ConditionBrowseBranchName': 'Urinary Tract, Sexual Organs, and Pregnancy Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC26',\n", - " 'ConditionBrowseBranchName': 'Wounds and Injuries'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 70,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04333693',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'RIV-2020-1'},\n", - " 'Organization': {'OrgFullName': 'Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery',\n", - " 'OrgClass': 'NETWORK'},\n", - " 'BriefTitle': 'Outcomes of Vascular Surgery in COVID-19 Infection: National Cohort Study',\n", - " 'OfficialTitle': 'Outcomes of Vascular Surgery in COVID-19 Infection: National Cohort Study (Covid-VAS)',\n", - " 'Acronym': 'Covid-VAS'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'October 1, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'November 1, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 31, 2020',\n", - " 'StudyFirstSubmitQCDate': 'April 2, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 3, 2020',\n", - " 'StudyFirstPostDateType': 'Estimate'},\n", - " 'LastUpdateSubmitDate': 'April 2, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", - " 'LastUpdatePostDateType': 'Estimate'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery',\n", - " 'LeadSponsorClass': 'NETWORK'}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'There is an urgent need to understand the outcomes of COVID-19 infected patients who undergo surgery, specially vascular surgery. Capturing real-world data and sharing Spanish national experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, improving their clinical care.\\n\\nThe global community has recognised that rapid dissemination and completion of studies in COVID-19 infected patients is a high priority, so we encourage all stakeholders (local investigators, ethics committees, IRBs) to work as quickly as possible to approve this project.\\n\\nThis investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk. This study does not collect any patient identifiable information (including no dates) and data will not be analysed at hospital-level.',\n", - " 'DetailedDescription': 'To determine 30-day mortality in patients with COVID-19 infection who undergo vascular surgery.\\n\\nThis will inform future risk stratification, decision making, and patient consent.\\n\\nInclusion criteria\\n\\nThe inclusion criteria are:\\n\\n• Adults (age ≥18 years) undergoing ANY type of vascular surgery in an operating theatre, this includes open surgery, endovascular surgery or hybrid procedures.\\n\\nAND\\n\\n• Either before or after surgery: (i) lab test confirmed COVID-19 infection or (ii) clinical diagnosis of COVID-19 infection (no test performed).\\n\\nTherefore this study should capture:\\n\\nemergency surgery patients with clinical diagnosis or lab confirmation of COVID-19 infection before surgery.\\nemergency surgery patients with clinical diagnosis or lab confirmation of COVID-19 infection after surgery.\\nelective surgery patients with clinical diagnosis or lab confirmation of COVID-19 infection after surgery. Patients who meet the inclusion criteria should be included regardless of surgical indication (aneurysm, limb or visceral ischemia, carotid stenosis, vascular trauma), anaesthetic type (local, regional, general), procedure type, or surgical approach (open surgery, endovascular surgery, hybrid procedure).\\n\\nAt most sites it is anticipated that the number of eligible patients is likely to be low. If possible all consecutive patients fulfilling inclusion criteria should be entered.\\n\\nStudy period Overall we plan to close data entry in September 2020 when the global pandemic is likely to be over, however individual centres may select their own study windows, depending on the timing of COVID-19 epidemic in their community.\\n\\nPatient enrolment Ideally patients should be identified prospectively. However, given the rapid progression of the global pandemic, there may be no further new cases of COVID-19 infection in some hospitals that treated large numbers of COVID-19 earlier in the pandemic. It is important to capture the experience of these centres, therefore retrospective patient identification and data entry is permitted.\\n\\nPrimary outcome\\n\\n30-day mortality Secondary outcome\\n7-day mortality\\n30-day reoperation\\nPostoperative ICU admission\\nPostoperative respiratory failure\\nPostoperative acute respiratory distress syndrome (ARDS)\\nPostoperative sepsis\\n\\nData collection Data will be collected and stored online through a secure server running the Spanish Society for Angiology and Vascular Surgery (SEACV) web application. This secure server allows collaborators to enter and store data in a secure system. A designated collaborator at each participating site will be provided with a project server login details, allowing them to securely submit data on to the system. Only anonymised data will be uploaded to the database. No patient identifiable data will be collected. Data collected will be on comorbidities, physiological state, treatment/operation, and outcome. No dates (e.g. date of surgery) will be collected. qSOFA and CURB-65 will be calculated based on the individual data points entered.\\n\\nLocal approvals The principal investigator at each participating site is responsible for obtaining necessary local approvals (e.g. research ethics committee or institutional review board approvals).The first approval will be on the Valladolid East Ethics Committee for Clinical Investigation.\\n\\nCollaborators will be required to confirm that a local approval is in place at the time of uploading each patient record to the study database.\\n\\nWhere an audit approval is needed, this can be either registered as service evaluation, or to benchmark against an auditable standard (e.g. overall mortality after emergency surgery should be <15%).\\n\\nPrior to formal local study approval, collaborators may prospectively collect data, but this should not be uploaded to the database until approval is confirmed.\\n\\nAnalysis A detailed statistical analysis plan will be written. Analyses will be overseen by the independent data monitoring committee (DMC). Reports will include description of the primary and secondary outcomes in the cohort. Multivariable modelling will be undertaken to CovidVAS protocol identify risk factors for 30-days mortality. Analyses will be stratified according to whether or not diagnosis of COVID-19 was confirmed by a lab test. Interim analyses will be performed as guided by the independent DMC. The first analysis will be performed once 50 patients have been entered on to the database, and the frequency of subsequent analyses will be agreed with the DMC. The decision to submit data for publication will be agreed by the steering committee with the DMC. Hospital-level data will not be released or published.\\n\\nAuthorship Collaborators from each site who contribute patients will be recognised on any resulting publications as PubMed-citable co-authors.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Vascular Surgical Procedures',\n", - " 'COVID-19',\n", - " 'Postoperative Complications']},\n", - " 'KeywordList': {'Keyword': ['Vascular surgical procedures',\n", - " 'Endovascular procedures',\n", - " 'COVID-19',\n", - " 'Postoperative complications',\n", - " 'Prognosis']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'Yes',\n", - " 'TargetDuration': '6 Months',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '50',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Cases',\n", - " 'ArmGroupDescription': 'Adults (age>18years) undergoing any type of vascular surgery (open surgery, endovascular surgery or hybrid procedure) in an operating theatre and either before or after surgery: lab test confirmed COVID-19 or clinical diagnosis of COVI-19 infection (no test performed)',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Procedure: Vascular surgery']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Procedure',\n", - " 'InterventionName': 'Vascular surgery',\n", - " 'InterventionDescription': 'Open vascular, endovascular or hybrid procedures',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Cases']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': '30-days mortality',\n", - " 'PrimaryOutcomeDescription': '30-days mortality after vascular surgery in patients with COVID-19 infection',\n", - " 'PrimaryOutcomeTimeFrame': '30-days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': '7-days mortality',\n", - " 'SecondaryOutcomeDescription': '7-days mortality after vascular surgery in patients with COVID-19 infection',\n", - " 'SecondaryOutcomeTimeFrame': '7-days'},\n", - " {'SecondaryOutcomeMeasure': '30-days reoperation',\n", - " 'SecondaryOutcomeDescription': '30-days reoperation after vascular surgery in patients with COVID-19 infection',\n", - " 'SecondaryOutcomeTimeFrame': '30-days'},\n", - " {'SecondaryOutcomeMeasure': 'Postoperative ICU admission',\n", - " 'SecondaryOutcomeDescription': 'Postoperative ICU admission after vascular surgery in patients with COVID-19 infection',\n", - " 'SecondaryOutcomeTimeFrame': '30-days'},\n", - " {'SecondaryOutcomeMeasure': 'Postoperative respiratory failure',\n", - " 'SecondaryOutcomeDescription': 'Postoperative respiratory failure after vascular surgery in patients with COVID-19 infection',\n", - " 'SecondaryOutcomeTimeFrame': '30-days'},\n", - " {'SecondaryOutcomeMeasure': 'Postoperative acute respiratory distress syndrome (ARDS)',\n", - " 'SecondaryOutcomeDescription': 'Postoperative acute respiratory distress syndrome (ARDS) after vascular surgery in patients with COVID-19 infection',\n", - " 'SecondaryOutcomeTimeFrame': '30-days'},\n", - " {'SecondaryOutcomeMeasure': 'Postoperative sepsis',\n", - " 'SecondaryOutcomeDescription': 'Postoperative sepsis after vascular surgery in patients with COVID-19 infection',\n", - " 'SecondaryOutcomeTimeFrame': '30-days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAdults (age ≥18 years) undergoing ANY type of vascular surgery in an operating theatre, this includes obstetrics. AND\\nEither before or after surgery: (i) lab test confirmed COVID-19 infection or (ii) clinical diagnosis of COVID-19 infection (no test performed).\\n\\nTherefore this study should capture:\\n\\nemergency surgery patients with clinical diagnosis or lab confirmation of COVID-19 infection before surgery.\\nemergency surgery patients with clinical diagnosis or lab confirmation of COVID-19 infection after surgery.\\nelective surgery patients with clinical diagnosis or lab confirmation of COVID-19 infection after surgery.\\n\\nExclusion Criteria:\\n\\nNot informed consent signed.',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'Patients with COVID-19 infection who undergo vascular surgery.',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Enrique M San Norberto, MD, PhD, MsC',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '0034686754618',\n", - " 'CentralContactEMail': 'esannorberto@hotmail.com'},\n", - " {'CentralContactName': 'Investigator Council',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '0034910569145',\n", - " 'CentralContactEMail': 'secretaria@seacv.es'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Spanish Society for Angiology and Vascular Surgery',\n", - " 'LocationCity': 'Madrid',\n", - " 'LocationZip': '28006',\n", - " 'LocationCountry': 'Spain',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Enrique M San Norberto, MD, PhD, MsC',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '0034686754618',\n", - " 'LocationContactEMail': 'esannorberto@hotmail.com'},\n", - " {'LocationContactName': 'Investigator Council',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '0034910569145',\n", - " 'LocationContactEMail': 'secretaria@seacv.es'},\n", - " {'LocationContactName': 'Enrique M San Norberto, MD, PhD, MsC',\n", - " 'LocationContactRole': 'Principal Investigator'},\n", - " {'LocationContactName': 'Joaquin de Haro, MD, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Carlos Vaquero, MD, PhD, Prof',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Luis Riera, MD, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Alvaro Torres, MD, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Raul Lara, MD, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Jorge Cuenca, MD, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Jorge Fernández-Noya, MD, PdD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Sergi Bellmunt, MD, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}}]}},\n", - " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '32222820',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Zoia C, Bongetta D, Veiceschi P, Cenzato M, Di Meco F, Locatelli D, Boeris D, Fontanella MM. Neurosurgery during the COVID-19 pandemic: update from Lombardy, northern Italy. Acta Neurochir (Wien). 2020 Mar 28. doi: 10.1007/s00701-020-04305-w. [Epub ahead of print]'},\n", - " {'ReferencePMID': '32221117',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Aminian A, Safari S, Razeghian-Jahromi A, Ghorbani M, Delaney CP. COVID-19 Outbreak and Surgical Practice: Unexpected Fatality in Perioperative Period. Ann Surg. 2020 Mar 26. doi: 10.1097/SLA.0000000000003925. [Epub ahead of print]'},\n", - " {'ReferencePMID': '32202401',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Ficarra V, Novara G, Abrate A, Bartoletti R, Crestani A, De Nunzio C, Giannarini G, Gregori A, Liguori G, Mirone V, Pavan N, Scarpa RM, Simonato A, Trombetta C, Tubaro A, Porpiglia F; Members of the Research Urology Network (RUN). Urology practice during COVID-19 pandemic. Minerva Urol Nefrol. 2020 Mar 23. doi: 10.23736/S0393-2249.20.03846-1. [Epub ahead of print]'},\n", - " {'ReferencePMID': '32188602',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Iacobucci G. Covid-19: all non-urgent elective surgery is suspended for at least three months in England. BMJ. 2020 Mar 18;368:m1106. doi: 10.1136/bmj.m1106.'},\n", - " {'ReferencePMID': '32109013',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMoa2002032. [Epub ahead of print]'}]},\n", - " 'SeeAlsoLinkList': {'SeeAlsoLink': [{'SeeAlsoLinkLabel': 'Spanish Society for Angiology and Vascular Surgery',\n", - " 'SeeAlsoLinkURL': 'http://www.seacv.es'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided',\n", - " 'IPDSharingDescription': 'No sharing plan available nowadays.'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000011183',\n", - " 'ConditionMeshTerm': 'Postoperative Complications'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000010335',\n", - " 'ConditionAncestorTerm': 'Pathologic Processes'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M12648',\n", - " 'ConditionBrowseLeafName': 'Postoperative Complications',\n", - " 'ConditionBrowseLeafAsFound': 'Postoperative Complications',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'}]}}}}},\n", - " {'Rank': 71,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04324606',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'COV001'},\n", - " 'Organization': {'OrgFullName': 'University of Oxford',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'A Study of a Candidate COVID-19 Vaccine (COV001)',\n", - " 'OfficialTitle': 'A Phase I/II Study to Determine Efficacy, Safety and Immunogenicity of the Candidate Coronavirus Disease (COVID-19) Vaccine ChAdOx1 nCoV-19 in UK Healthy Adult Volunteers'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 2021',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'May 2021',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 20, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 26, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 27, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 26, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 27, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'University of Oxford',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'A phase I/II single-blinded, randomised, placebo controlled, multi-centre study to determine efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in UK healthy adult volunteers aged 18-55 years. The vaccine will be administered intramuscularly (IM).',\n", - " 'DetailedDescription': 'There will be 5 study groups and it is anticipated that a total of 510 volunteers will be enrolled. Volunteers will participate in the study for approximately 6 months, with the option to come for an additional follow up visit at Day 364.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus']},\n", - " 'KeywordList': {'Keyword': ['COVID-19, Vaccine']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 1', 'Phase 2']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Sequential Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Single',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '510',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Group 1a',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19. Volunteers will be blinded and will not know if they have received the IMP or the placebo.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: ChAdOx1 nCoV-19']}},\n", - " {'ArmGroupLabel': 'Group 1b',\n", - " 'ArmGroupType': 'Placebo Comparator',\n", - " 'ArmGroupDescription': 'Volunteers will receive a single injection of saline intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: Saline Placebo']}},\n", - " {'ArmGroupLabel': 'Group 2a',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19. Volunteers will be blinded and will not know if they have received the IMP or the placebo.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: ChAdOx1 nCoV-19']}},\n", - " {'ArmGroupLabel': 'Group 2b',\n", - " 'ArmGroupType': 'Placebo Comparator',\n", - " 'ArmGroupDescription': 'Volunteers will receive a single injection of saline intramuscularly. Volunteers will be blinded and will not know if they have received the IMP or the placebo.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: Saline Placebo']}},\n", - " {'ArmGroupLabel': 'Group 3',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Volunteers will receive two doses of 5x10^10vp ChAdOx1 nCoV-19 at week 0 and week 4.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: ChAdOx1 nCoV-19']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Biological',\n", - " 'InterventionName': 'ChAdOx1 nCoV-19',\n", - " 'InterventionDescription': '5x10^10vp of ChAdOx1 nCoV-19',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Group 1a',\n", - " 'Group 2a',\n", - " 'Group 3']}},\n", - " {'InterventionType': 'Other',\n", - " 'InterventionName': 'Saline Placebo',\n", - " 'InterventionDescription': 'Saline injection delivered intramuscularly',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Group 1b',\n", - " 'Group 2b']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19: Number of virologically confirmed (PCR positive) symptomatic cases',\n", - " 'PrimaryOutcomeDescription': 'Number of virologically confirmed (PCR positive) symptomatic cases of COVID-19',\n", - " 'PrimaryOutcomeTimeFrame': '6 months'},\n", - " {'PrimaryOutcomeMeasure': 'Assess the safety of the candidate vaccine ChAdOx1 nCoV: Occurrence of serious adverse events (SAEs)',\n", - " 'PrimaryOutcomeDescription': 'Occurrence of serious adverse events (SAEs) throughout the study duration',\n", - " 'PrimaryOutcomeTimeFrame': '6 months'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited local reactogenicity signs and symptoms',\n", - " 'SecondaryOutcomeDescription': 'Occurrence of solicited local reactogenicity signs and symptoms for 7 days following vaccination',\n", - " 'SecondaryOutcomeTimeFrame': '7 days following vaccination'},\n", - " {'SecondaryOutcomeMeasure': 'Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited systemic reactogenicity signs and symptoms',\n", - " 'SecondaryOutcomeDescription': 'Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following vaccination',\n", - " 'SecondaryOutcomeTimeFrame': '7 days following vaccination'},\n", - " {'SecondaryOutcomeMeasure': 'Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of unsolicited adverse events (AEs)',\n", - " 'SecondaryOutcomeDescription': 'Occurrence of unsolicited adverse events (AEs) for 28 days following vaccination',\n", - " 'SecondaryOutcomeTimeFrame': '28 days following vaccination'},\n", - " {'SecondaryOutcomeMeasure': 'Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV through standard blood tests',\n", - " 'SecondaryOutcomeDescription': 'Change from baseline for safety laboratory measures (haematology and biochemistry blood results)',\n", - " 'SecondaryOutcomeTimeFrame': '6 months'},\n", - " {'SecondaryOutcomeMeasure': 'Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV by measuring the number of disease enhancement episodes',\n", - " 'SecondaryOutcomeDescription': 'Occurrence of disease enhancement episodes',\n", - " 'SecondaryOutcomeTimeFrame': '6 months'},\n", - " {'SecondaryOutcomeMeasure': 'Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19',\n", - " 'SecondaryOutcomeDescription': 'Number of deaths associated with COVID-19',\n", - " 'SecondaryOutcomeTimeFrame': '6 months'},\n", - " {'SecondaryOutcomeMeasure': 'Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19',\n", - " 'SecondaryOutcomeDescription': 'Number of hospital admissions associated with COVID-19',\n", - " 'SecondaryOutcomeTimeFrame': '6 months'},\n", - " {'SecondaryOutcomeMeasure': 'Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19',\n", - " 'SecondaryOutcomeDescription': 'Number of intensive care unit admissions associated with COVID-19',\n", - " 'SecondaryOutcomeTimeFrame': '6 months'},\n", - " {'SecondaryOutcomeMeasure': 'Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates',\n", - " 'SecondaryOutcomeDescription': 'Proportion of people who become seropositive for non-Spike SARS-CoV-2 antigens during the study',\n", - " 'SecondaryOutcomeTimeFrame': '6 months'},\n", - " {'SecondaryOutcomeMeasure': 'Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays',\n", - " 'SecondaryOutcomeDescription': 'Interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) responses to SARS-CoV-2 spike protein',\n", - " 'SecondaryOutcomeTimeFrame': '6 months'},\n", - " {'SecondaryOutcomeMeasure': 'Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19',\n", - " 'SecondaryOutcomeDescription': 'Enzyme-linked immunosorbent assay (ELISA) to quantify antibodies against SARS-CoV-2 spike protein (seroconversion rates)',\n", - " 'SecondaryOutcomeTimeFrame': '6 months'}]},\n", - " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through Virus neutralising antibody assays',\n", - " 'OtherOutcomeDescription': 'Virus neutralising antibody (NAb) assays against live and/or pseudotype SARS-CoV-2 virus',\n", - " 'OtherOutcomeTimeFrame': '6 months'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\nHealthy adults aged 18-55 years.\\nAble and willing (in the Investigator's opinion) to comply with all study requirements.\\nWilling to allow the investigators to discuss the volunteer's medical history with their General Practitioner and access all medical records when relevant to study procedures.\\nFor females only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination.\\nAgreement to refrain from blood donation during the course of the study.\\nProvide written informed consent.\\n\\nExclusion Criteria:\\n\\nPrior receipt of any vaccines (licensed or investigational) ≤30 days before enrolment\\nPlanned receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination .\\nPrior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines).\\nAdministration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.\\nAny confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and chronic use (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed).\\nHistory of allergic disease or reactions likely to be exacerbated by any component of the vaccine.\\nAny history of hereditary angioedema or idiopathic angioedema.\\nAny history of anaphylaxis in relation to vaccination.\\nPregnancy, lactation or willingness/intention to become pregnant during the study.\\nHistory of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).\\nHistory of serious psychiatric condition likely to affect participation in the study.\\nBleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.\\nAny other serious chronic illness requiring hospital specialist supervision.\\nSuspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week.\\nSuspected or known injecting drug abuse in the 5 years preceding enrolment.\\nAny clinically significant abnormal finding on screening biochemistry, haematology blood tests or urinalysis.\\nAny other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.\\nHistory of laboratory confirmed COVID-19.\\nNew onset of fever and a cough or shortness of breath in the 30 days preceding screening and/or enrolment\\n\\nRe-Vaccination Exclusion Criteria\\n\\nAnaphylactic reaction following administration of vaccine\\nPregnancy\",\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '55 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Volunteer Recruitment Co-ordinator',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '01865 611424',\n", - " 'CentralContactEMail': 'vaccinetrials@ndm.ox.ac.uk'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Andrew Pollard, Prof',\n", - " 'OverallOfficialAffiliation': 'University of Oxford',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'NIHR WTCRF, University Hospital Southampton NHS Foundation Trust',\n", - " 'LocationCity': 'Southampton',\n", - " 'LocationState': 'Hampshire',\n", - " 'LocationZip': 'SO16 6YD',\n", - " 'LocationCountry': 'United Kingdom'},\n", - " {'LocationFacility': 'Imperial College Healthcare NHS Trust',\n", - " 'LocationCity': 'London',\n", - " 'LocationZip': 'W2 1NY',\n", - " 'LocationCountry': 'United Kingdom'},\n", - " {'LocationFacility': 'CCVTM, University of Oxford, Churchill Hospital',\n", - " 'LocationCity': 'Oxford',\n", - " 'LocationZip': 'OX3 7LE',\n", - " 'LocationCountry': 'United Kingdom'},\n", - " {'LocationFacility': 'John Radcliffe Hospital',\n", - " 'LocationCity': 'Oxford',\n", - " 'LocationZip': 'OX3 9DU',\n", - " 'LocationCountry': 'United Kingdom'}]}}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000014612',\n", - " 'InterventionMeshTerm': 'Vaccines'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000007155',\n", - " 'InterventionAncestorTerm': 'Immunologic Factors'},\n", - " {'InterventionAncestorId': 'D000045505',\n", - " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M15943',\n", - " 'InterventionBrowseLeafName': 'Vaccines',\n", - " 'InterventionBrowseLeafAsFound': 'Vaccine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M8784',\n", - " 'InterventionBrowseLeafName': 'Immunologic Factors',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 72,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04313946',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '0110'},\n", - " 'Organization': {'OrgFullName': 'Grigore T. Popa University of Medicine and Pharmacy',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Artificial Intelligence Algorithms for Discriminating Between COVID-19 and Influenza Pneumonitis Using Chest X-Rays',\n", - " 'OfficialTitle': 'The Benefits of Artificial Intelligence Algorithms (CNNs) for Discriminating Between COVID-19 and Influenza Pneumonitis in an Emergency Department Using Chest X-Ray Examinations',\n", - " 'Acronym': 'AI-COVID-Xr'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 18, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'August 16, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'August 18, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 17, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 17, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 18, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor-Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Professor Adrian Covic',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Clinical Professor',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Grigore T. Popa University of Medicine and Pharmacy'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Professor Adrian Covic',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Falcon Trading Iasi',\n", - " 'CollaboratorClass': 'UNKNOWN'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'This project aims to use artificial intelligence (image discrimination) algorithms, specifically convolutional neural networks (CNNs) for scanning chest radiographs in the emergency department (triage) in patients with suspected respiratory symptoms (fever, cough, myalgia) of coronavirus infection COVID 19. The objective is to create and validate a software solution that discriminates on the basis of the chest x-ray between Covid-19 pneumonitis and influenza',\n", - " 'DetailedDescription': 'This project aims to use artificial intelligence (image discrimination) algorithms;\\n\\nspecifically convolutional neural networks (CNNs) for scanning chest radiographs in the emergency department (triage) in patients with suspected respiratory symptoms (fever, cough, myalgia) of coronavirus infection COVID 19;\\nthe objective is to create and validate a software solution that discriminates on the basis of the chest x-ray between Covid-19 pneumonitis and influenza;\\nthis software will be trained by introducing X-Rays from patients with/without COVID-19 pneumonitis and/or flu pneumonitis;\\nthe same AI algorithm will run on future X-Ray scans for predicting possible COVID-19 pneumonitis'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", - " 'Pneumonia, Viral',\n", - " 'Influenza With Pneumonia',\n", - " 'Flu Symptom',\n", - " 'Flu Like Illness',\n", - " 'Pneumonia, Interstitial',\n", - " 'Pneumonia, Ventilator-Associated',\n", - " 'Pneumonia Atypical']},\n", - " 'KeywordList': {'Keyword': ['Artificial Intelligence',\n", - " 'CNNs',\n", - " 'COVID-19',\n", - " 'chest X-Ray',\n", - " 'Emergency Department',\n", - " 'Triage',\n", - " 'Flu']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Ecologic or Community']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '200',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Symptomatic Patients',\n", - " 'ArmGroupDescription': 'Our goal is to identify an artificial intelligence algorithm that can be run on lung radiographs in patients with influenza / respiratory viral symptoms who come to the emergency department / triage. This algorithm aims to identify the radiographs of patients with COVID-19 and those with influenza pneumonitis, with accuracy verified by COVID-19 tests.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Diagnostic Test: Scanning Chest X-rays and performing AI algorithms on images']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Diagnostic Test',\n", - " 'InterventionName': 'Scanning Chest X-rays and performing AI algorithms on images',\n", - " 'InterventionDescription': 'Chest X-Rays; AI CNNs; Results',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Symptomatic Patients']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'COVID-19 positive X-Rays',\n", - " 'PrimaryOutcomeDescription': 'Number of participants with pneumonitis on Chest X-Ray and COVID 19 positive',\n", - " 'PrimaryOutcomeTimeFrame': '6 months'},\n", - " {'PrimaryOutcomeMeasure': 'COVID-19 negative X-Rays',\n", - " 'PrimaryOutcomeDescription': 'Number of participants with pneumonitis on Chest X-Ray and COVID 19 negative',\n", - " 'PrimaryOutcomeTimeFrame': '6 months'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nflu-like symptoms: myalgia, cough, fever, sputum\\nChest X-Rays\\nCOVID-19 biological tests\\n\\nExclusion Criteria:\\n\\npatient refusal\\nuncertain radiographs\\nuncertain tests results',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'All patients with influenza symptoms that arrive at emergency department with cough, fever, myalgia - which are suspected of COVID-19 infection',\n", - " 'SamplingMethod': 'Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Alexandru Burlacu, MD, PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '0040744488580',\n", - " 'CentralContactEMail': 'alexandru.burlacu@umfiasi.ro'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Alexandru Burlacu, Lecturer',\n", - " 'OverallOfficialAffiliation': 'University of Medicine and Pharmacy Gr T Popa - Iasi',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Radu Dabija, Lecturer',\n", - " 'OverallOfficialAffiliation': 'University of Medicine and Pharmacy Gr T Popa - Iasi',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'U.O. Multidisciplinare di Patologia Mammaria e Ricerca Traslazionale; Dipartimento Universitario Clinico di Scienze Mediche, Chirurgiche e della Salute Università degli Studi di Trieste',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Cremona',\n", - " 'LocationZip': '26100',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Daniele Generali, MD, PhD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+390372408042',\n", - " 'LocationContactEMail': 'dgenerali@units.it'},\n", - " {'LocationContactName': 'Daniele Generali, MD, PhD',\n", - " 'LocationContactRole': 'Principal Investigator'}]}},\n", - " {'LocationFacility': 'University of Medicine and Pharmacy Gr T Popa',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Iaşi',\n", - " 'LocationZip': '700503',\n", - " 'LocationCountry': 'Romania',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Alexandru Burlacu, MD, PhD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '0040744488580',\n", - " 'LocationContactEMail': 'alexandru.burlacu@umfiasi.ro'},\n", - " {'LocationContactName': 'Alexandru Burlacu, MD, PhD',\n", - " 'LocationContactRole': 'Principal Investigator'}]}},\n", - " {'LocationFacility': 'Department of Cardiology at Chelsea and Westminster NHS hospital',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'London',\n", - " 'LocationCountry': 'United Kingdom',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Emmanuel Ako, MD, PhD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+447932970131',\n", - " 'LocationContactEMail': 'e.ako@ucl.ac.uk'},\n", - " {'LocationContactName': 'Emmanuel Ako, MD, PhD',\n", - " 'LocationContactRole': 'Principal Investigator'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", - " 'IPDSharingDescription': 'Yes, we would be happy to share the algorithm code and the results with any scientist interested (without any financial interests)',\n", - " 'IPDSharingInfoTypeList': {'IPDSharingInfoType': ['Study Protocol',\n", - " 'Informed Consent Form (ICF)',\n", - " 'Analytic Code']}}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000053717',\n", - " 'ConditionMeshTerm': 'Pneumonia, Ventilator-Associated'},\n", - " {'ConditionMeshId': 'D000007251',\n", - " 'ConditionMeshTerm': 'Influenza, Human'},\n", - " {'ConditionMeshId': 'D000011024',\n", - " 'ConditionMeshTerm': 'Pneumonia, Viral'},\n", - " {'ConditionMeshId': 'D000011014', 'ConditionMeshTerm': 'Pneumonia'},\n", - " {'ConditionMeshId': 'D000017563',\n", - " 'ConditionMeshTerm': 'Lung Diseases, Interstitial'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000009976',\n", - " 'ConditionAncestorTerm': 'Orthomyxoviridae Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", - " {'ConditionAncestorId': 'D000008171',\n", - " 'ConditionAncestorTerm': 'Lung Diseases'},\n", - " {'ConditionAncestorId': 'D000003428',\n", - " 'ConditionAncestorTerm': 'Cross Infection'},\n", - " {'ConditionAncestorId': 'D000007239',\n", - " 'ConditionAncestorTerm': 'Infection'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M12487',\n", - " 'ConditionBrowseLeafName': 'Pneumonia',\n", - " 'ConditionBrowseLeafAsFound': 'Pneumonia',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M6379',\n", - " 'ConditionBrowseLeafName': 'Emergencies',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M12497',\n", - " 'ConditionBrowseLeafName': 'Pneumonia, Viral',\n", - " 'ConditionBrowseLeafAsFound': 'Pneumonia, Viral',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M8878',\n", - " 'ConditionBrowseLeafName': 'Influenza, Human',\n", - " 'ConditionBrowseLeafAsFound': 'Influenza',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M26032',\n", - " 'ConditionBrowseLeafName': 'Pneumonia, Ventilator-Associated',\n", - " 'ConditionBrowseLeafAsFound': 'Pneumonia, Ventilator-Associated',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M9751',\n", - " 'ConditionBrowseLeafName': 'Lung Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M18396',\n", - " 'ConditionBrowseLeafName': 'Lung Diseases, Interstitial',\n", - " 'ConditionBrowseLeafAsFound': 'Pneumonia, Interstitial',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M11485',\n", - " 'ConditionBrowseLeafName': 'Orthomyxoviridae Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M5225',\n", - " 'ConditionBrowseLeafName': 'Cross Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'}]}}}}},\n", - " {'Rank': 73,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04306497',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'JSZYJ202001'},\n", - " 'Organization': {'OrgFullName': 'Jiangsu Famous Medical Technology Co., Ltd.',\n", - " 'OrgClass': 'INDUSTRY'},\n", - " 'BriefTitle': 'Clinical Trial on Regularity of TCM Syndrome and Differentiation Treatment of COVID-19.',\n", - " 'OfficialTitle': 'Clinical Trial on Regularity of TCM Syndrome and Differentiation Treatment of COVID-19 in Jiangsu Province',\n", - " 'Acronym': 'CTOROTSADTOC'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'January 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 2, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'May 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 1, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 10, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 13, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 14, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 17, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Jiangsu Famous Medical Technology Co., Ltd.',\n", - " 'LeadSponsorClass': 'INDUSTRY'}},\n", - " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Evaluation of the efficacy and safety of TCM differential treatment of COVID-19 in Jiangsu Province based on a prospective multicenter cohort study.',\n", - " 'DetailedDescription': \"In order to further observe the efficacy and safety of this project under natural intervention. A prospective multicenter cohort study was designed, focusing on the common type with the largest number of confirmed cases, to evaluate the intervention effect of this project in relieving the disease and preventing disease progression, in order to provide more sufficient clinical evidence for the further improvement and application of this project.\\n\\nAccording to the actual situation of receiving treatment, according to whether or not exposed to this study to observe the treatment of TCM, COVID-19 (common type) will be divided into two cohorts: control group (western medicine cohort) and exposure group (integrated traditional Chinese and western medicine cohort). The choice of treatment for patients is entirely determined by clinicians according to the patient's condition, and patients are free to choose after fully understanding different schemes). western medicine cohort:Routine treatment + one or both of the following antiviral drugs.Cohort of integrated TCM and western medicine: routine treatment + one or two of the following antiviral drugs + the following TCM regimens.The sample size is tentatively set at 340.\"},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", - " 'KeywordList': {'Keyword': ['COVID-19',\n", - " 'Syndrome investigation',\n", - " 'differentiation treatment',\n", - " 'multicenter cohort study']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '340',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Cohort of western medicine',\n", - " 'ArmGroupDescription': \"Routine treatment：\\n\\n① support treatment:maintain water and electrolyte balance .\\n\\n②oxygen therapy: give nasal catheters to inhale oxygen.\\n\\n③ basic treatment of traditional Chinese and western medicine: antiviral drugs and proprietary Chinese medicines with similar composition or function to the observed scheme of differentiation and treatment of traditional Chinese medicine are not included in the scope of such drugs.\\n\\nAntiviral drugs ：Clinicians can judge according to the patient's condition according to the latest version of the diagnosis and treatment plan for COvID-19 issued by the General Office of the National Health Commission / the Office of the State Administration of traditional Chinese Medicine (currently the latest version is the sixth trial edition). Select any of the recommended antiviral drugs(for example:IFN-α、lopinavir-ritonavir、Ribavirin、Chloroquine Phosphate、Arbidol)or a combination of two antiviral drugs.\",\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: TCM prescriptions']}},\n", - " {'ArmGroupLabel': 'Cohort of integrated TCM and western medicine',\n", - " 'ArmGroupDescription': 'routine treatment + Antiviral drugs + the following TCM regimens. 1.TCM regimens:① Early stage: Dampness trapped in exterior and interior. Recommended prescription: Huoxiang 15g, Suye15g, Cangzhu15g, Houpo10g, Qianhu15g, Chaihu15g, Huangqin10g, Qinghao20g, Xingren10g, JInyinhua15g, Lianqiao15g.\\n\\nTake decocted or granule, one dose a day.\\n\\n② Middle stage: Dampness-toxicity blocking lung Recommended prescription: Zhimahuang9g, Xingren10g, Sangbaipi30g, Tinglizi20g, Dongguazi20g, Fabanxia10g, Houpo10g, Suzi15g, Baijiezi10g, Gualoupi15g, Xuanfuhua9g, Xiangfu10g, Yujin10g, Taoren10g, Huangqi20g.\\n\\nTake decocted or granule, one dose a day.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: TCM prescriptions']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'TCM prescriptions',\n", - " 'InterventionDescription': 'TCM prescriptions1:Take decocted or granule, one dose a day; TCM prescriptions2:Take decocted or granule, one dose a day.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Cohort of integrated TCM and western medicine',\n", - " 'Cohort of western medicine']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'The relief / disappearance rate of main symptoms',\n", - " 'PrimaryOutcomeDescription': 'disappearance of fever, cough and shortness of breath/ the rate of complete relief /.',\n", - " 'PrimaryOutcomeTimeFrame': '9day'},\n", - " {'PrimaryOutcomeMeasure': 'Chest CT absorption',\n", - " 'PrimaryOutcomeDescription': 'with reference to the \"pneumonia chest X-ray absorption Evaluation scale\" developed by Renyi Yin et al, the final absorption judgment will be used to evaluate the chest CT absorption of patients with pneumonia, which is divided into four levels according to the degree of absorption: complete absorption, majority absorption, partial absorption and no absorption.',\n", - " 'PrimaryOutcomeTimeFrame': '9day'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Virus antigen negative conversion rate',\n", - " 'SecondaryOutcomeDescription': 'detection negative rat of nasopharyngeal swab, conjunctival sac secretion virus nucleic acid e',\n", - " 'SecondaryOutcomeTimeFrame': '9day'},\n", - " {'SecondaryOutcomeMeasure': 'Clinical effective time: the average effective time',\n", - " 'SecondaryOutcomeDescription': 'the average time it takes for the clinical curative effect to reach the effective standard. Median response time: the average time it takes for 50% of patients to reach the effective standard.',\n", - " 'SecondaryOutcomeTimeFrame': '9day'},\n", - " {'SecondaryOutcomeMeasure': 'The number of severe and critical conversion cases',\n", - " 'SecondaryOutcomeDescription': 'the number of severe and critical cases occurred after the start of intervention.',\n", - " 'SecondaryOutcomeTimeFrame': '9day'},\n", - " {'SecondaryOutcomeMeasure': 'Incidence of complications',\n", - " 'SecondaryOutcomeDescription': 'defined as complications during isolation and hospitalization due to pneumonia infected by novel coronavirus, including bacterial infection, aggravation of underlying diseases, etc',\n", - " 'SecondaryOutcomeTimeFrame': '9day'},\n", - " {'SecondaryOutcomeMeasure': 'Traditional Chinese Medicine Syndrome Score',\n", - " 'SecondaryOutcomeDescription': 'According to the Traditional Chinese Medicine symptom score scale, the change of symptom score before and after treatment was observed.The highest score was 92 points, and the lowest was 23 points. The higher the score, the more severe the symptoms.',\n", - " 'SecondaryOutcomeTimeFrame': '9day'}]},\n", - " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'CRP changes',\n", - " 'OtherOutcomeDescription': 'Changes in c-reactive protein.',\n", - " 'OtherOutcomeTimeFrame': '9day'},\n", - " {'OtherOutcomeMeasure': 'ESR changes',\n", - " 'OtherOutcomeDescription': 'Changes in erythrocyte sedimentation rate.',\n", - " 'OtherOutcomeTimeFrame': '9day'},\n", - " {'OtherOutcomeMeasure': 'PCTchanges',\n", - " 'OtherOutcomeDescription': 'Changes in procalcitonin.',\n", - " 'OtherOutcomeTimeFrame': '9day'},\n", - " {'OtherOutcomeMeasure': 'The index of T cell subsets changed',\n", - " 'OtherOutcomeDescription': 'Changes of CD4+ and CD8+',\n", - " 'OtherOutcomeTimeFrame': '9day'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nIt conforms to the diagnostic criteria of confirmed cases of COVID-19;\\nAge from 18-75, regardless gender.\\nThe patient informed consent and sign the informed consent form (if the subject has no capacity, limited capacity and limited expression of personal will, he or she should obtain the consent of his guardian and sign the informed consent at the same time).\\n\\nExclusion Criteria:\\n\\nWomen during pregnancy or lactation;\\nAllergic constitution, such as those who have a history of allergy to two or more drugs or food, or who are known to be allergic to drug ingredients observed in this study.\\nSevere complications such as multiple organ failure and shock occurred.\\nComplicated with severe primary diseases such as heart, brain, liver, kidney and so on.\\nPatients have mental illness.\\nPatients who participated in or is currently participating in other clinical trials within the first month of this study.',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '75 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'It conforms to the diagnostic criteria of confirmed cases of COVID-19.',\n", - " 'SamplingMethod': 'Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Haibo Cheng, phD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '13815857118',\n", - " 'CentralContactEMail': '363994906@qq.com'},\n", - " {'CentralContactName': 'Zhe Feng, phD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '13584046875',\n", - " 'CentralContactEMail': '794200027@qq.com'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': \"Huai'an fourth people's Hospital\",\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Huaian',\n", - " 'LocationState': 'Jiangsu',\n", - " 'LocationZip': '210029',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Lei Cui, phD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '13951266803',\n", - " 'LocationContactEMail': 'houy@famousmed.net'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided',\n", - " 'IPDSharingDescription': 'All researchers in this study'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M4562',\n", - " 'InterventionBrowseLeafName': 'Chloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M151035',\n", - " 'InterventionBrowseLeafName': 'Chloroquine diphosphate',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19978',\n", - " 'InterventionBrowseLeafName': 'Ritonavir',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M28424',\n", - " 'InterventionBrowseLeafName': 'Lopinavir',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2895',\n", - " 'InterventionBrowseLeafName': 'Antiviral Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M17826',\n", - " 'InterventionBrowseLeafName': 'Interferon-alpha',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M3435',\n", - " 'InterventionBrowseLeafName': 'Benzocaine',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M13666',\n", - " 'InterventionBrowseLeafName': 'Ribavirin',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'T433',\n", - " 'InterventionBrowseLeafName': 'Tannic Acid',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'T309',\n", - " 'InterventionBrowseLeafName': 'Sweet Wormwood',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", - " {'InterventionBrowseBranchAbbrev': 'Infl',\n", - " 'InterventionBrowseBranchName': 'Anti-Inflammatory Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'Analg',\n", - " 'InterventionBrowseBranchName': 'Analgesics'},\n", - " {'InterventionBrowseBranchAbbrev': 'CNSDep',\n", - " 'InterventionBrowseBranchName': 'Central Nervous System Depressants'},\n", - " {'InterventionBrowseBranchAbbrev': 'Ot',\n", - " 'InterventionBrowseBranchName': 'Other Dietary Supplements'},\n", - " {'InterventionBrowseBranchAbbrev': 'HB',\n", - " 'InterventionBrowseBranchName': 'Herbal and Botanical'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000013577',\n", - " 'ConditionMeshTerm': 'Syndrome'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000004194',\n", - " 'ConditionAncestorTerm': 'Disease'},\n", - " {'ConditionAncestorId': 'D000010335',\n", - " 'ConditionAncestorTerm': 'Pathologic Processes'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", - " {'Rank': 74,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04329923',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '842838'},\n", - " 'Organization': {'OrgFullName': 'University of Pennsylvania',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'The PATCH Trial (Prevention And Treatment of COVID-19 With Hydroxychloroquine)',\n", - " 'OfficialTitle': 'The PATCH Trial (Prevention And Treatment of COVID-19 With Hydroxychloroquine)',\n", - " 'Acronym': 'PATCH'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 6, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 1, 2021',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'December 1, 2021',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 30, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 30, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 30, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor-Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Ravi Amaravadi, MD',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Associate Professor',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'University of Pennsylvania'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Ravi Amaravadi, MD',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'Yes',\n", - " 'IsFDARegulatedDevice': 'No',\n", - " 'IsUSExport': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'The PATCH trial (Prevention And Treatment of COVID-19 with Hydroxychloroquine) is funded investigator-initiated trial that includes 3 cohorts. Cohort 1: a double-blind placebo controlled trial of high dose HCQ as a treatment for home bound COVID-19 positive patients; Cohort 2: a randomized study testing different doses of HCQ in hospitalized patients; Cohort 3: a double blind placebo controlled trial of low dose HCQ as a preventative medicine in health care workers.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 2']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignInterventionModelDescription': 'There are 3 cohorts. All partcipants in of each the cohorts are randomized to one of two arms',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Triple',\n", - " 'DesignMaskingDescription': 'Cohorts 1 and 3 are double-blind placebo control cohorts. Cohort 2 is an open label randomized study',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", - " 'Care Provider',\n", - " 'Investigator']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '400',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Cohort 1 HCQ',\n", - " 'ArmGroupType': 'Active Comparator',\n", - " 'ArmGroupDescription': 'COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with hydroxychloroquine 400 mg twice a day for up to 14 days',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine Sulfate 400 mg twice a day']}},\n", - " {'ArmGroupLabel': 'Cohort 1 Placebo',\n", - " 'ArmGroupType': 'Placebo Comparator',\n", - " 'ArmGroupDescription': 'COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with placebo twice a day for up to 14 days',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo oral tablet']}},\n", - " {'ArmGroupLabel': 'Cohort 2 HCQ high dose',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Hospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg twice a day for up to 14 days',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine Sulfate 600 mg twice a day']}},\n", - " {'ArmGroupLabel': 'Cohort 2 HCQ low dose',\n", - " 'ArmGroupType': 'Active Comparator',\n", - " 'ArmGroupDescription': 'Hospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg once a day for up to 7 days',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine Sulfate 600 mg once a day']}},\n", - " {'ArmGroupLabel': 'Cohort 3 HCQ',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Health care workers at high risk of contracting COVID-19 randomized to this arm will be treated with hydroxychloroquine 600 mg once a day for 2 months',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine Sulfate 600 mg once a day']}},\n", - " {'ArmGroupLabel': 'Cohort 3 Placebo',\n", - " 'ArmGroupType': 'Placebo Comparator',\n", - " 'ArmGroupDescription': 'Health care workers at high risk of contracting COVID-19 randomized to this arm will be treated with placebo for 2 months',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo oral tablet']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Hydroxychloroquine Sulfate 400 mg twice a day',\n", - " 'InterventionDescription': 'Antimalarial compound',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Cohort 1 HCQ']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Plaquenil']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Hydroxychloroquine Sulfate 600 mg twice a day',\n", - " 'InterventionDescription': 'Antimalarial compound',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Cohort 2 HCQ high dose']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Plaquenil']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Hydroxychloroquine Sulfate 600 mg once a day',\n", - " 'InterventionDescription': 'Antimalarial compound',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Cohort 2 HCQ low dose',\n", - " 'Cohort 3 HCQ']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Plaqeunil']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Placebo oral tablet',\n", - " 'InterventionDescription': 'Placebo',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Cohort 1 Placebo',\n", - " 'Cohort 3 Placebo']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Placebo']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Median release from quarantine time',\n", - " 'PrimaryOutcomeDescription': 'Cohort 1 (home quarantined COVID-19 patients): Median time to release from quarantine by meeting the following criteria: 1) No fever for 72 hours 2) improvement in other symptoms and 3) 7 days have elapsed since the beginning of symptom onset.',\n", - " 'PrimaryOutcomeTimeFrame': '14 days or less'},\n", - " {'PrimaryOutcomeMeasure': 'Rate of hospital discharge',\n", - " 'PrimaryOutcomeDescription': 'Cohort 2 (hospitalized COVID-19 patients): Rate of participants discharged at or before 14 days',\n", - " 'PrimaryOutcomeTimeFrame': '14 days'},\n", - " {'PrimaryOutcomeMeasure': 'Rate of infection',\n", - " 'PrimaryOutcomeDescription': 'Cohort 3 Physicians and nurse prophylaxis: Rate of COVID-19 infection at 2 months',\n", - " 'PrimaryOutcomeTimeFrame': '2 months'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Rate of housemate infection',\n", - " 'SecondaryOutcomeDescription': 'Cohort 1 rate of participant-reported secondary infection of housemates',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Rate of hospitalization',\n", - " 'SecondaryOutcomeDescription': 'Cohort 1 rate of hospitalization',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Cohort 1 adverse event rate',\n", - " 'SecondaryOutcomeDescription': 'Cohort 1 rate of treatment related adverse events',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Time to condition appropriate for discharge',\n", - " 'SecondaryOutcomeDescription': 'Cohort 2 Time to condition appropriate for discharge. The primary care team indicates the patients has improved to the point of being discharged.',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Rate of ICU admission',\n", - " 'SecondaryOutcomeDescription': 'Cohort 2 rate of ICU admission from a floor bed in the hospital',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Time to PCR negativity',\n", - " 'SecondaryOutcomeDescription': 'Cohort 2 the number of days between hospital admission and a negative PCR test for SARS-CoV-2.',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Cohort 2 adverse events',\n", - " 'SecondaryOutcomeDescription': 'Cohort 2 rate of treatment related adverse events',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Scheduled shifts missed',\n", - " 'SecondaryOutcomeDescription': 'Cohort 3 number of scheduled shifts at the hospital that are missed.',\n", - " 'SecondaryOutcomeTimeFrame': '2 months'},\n", - " {'SecondaryOutcomeMeasure': 'Cohort 3 adverse events',\n", - " 'SecondaryOutcomeDescription': 'Cohort 3 rate of treatment related adverse events',\n", - " 'SecondaryOutcomeTimeFrame': '2 months'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAge ≥ 18 years old (Sub-studies 2 and 3)\\nCompetent and capable to provide informed consent\\nHave access to a smart device such as a cell phone, tablet, laptop computer with necessary data/internet accessibility\\nSubjects meeting the following criteria by Sub-Study\\n\\nCohort 1:\\n\\nAge ≥40 years since the risk of prolonged disease that progresses to severe COVID-19 disease increases with age.\\nPCR-positive for the SARS-CoV2 virus\\nAt least one symptom of COVID-19 (T> 100.5º F, cough, headache, fatigue, shortness of breath, diarrhea, smell disturbance)\\n≤4 days since the first symptoms of COVID-19 and date of testing\\nNot requiring hospitalization and is sent home for quarantine.\\nMust live within 30 miles of HUP or Penn Presbytarian Medical Center to facilitate drop-off of medication\\nMust own a working computer, or smartphone and have internet access\\nMust be willing to fill out a daily symptom diary\\nMust be available for a daily phone call,\\nMust take their own temperature twice a day\\nMust be willing to report the observed symptoms and development of COVID-19 in the co-inhabitants of the residence at which the quarantine will be served.\\n\\nCohort 2 Hospitalized non-ICU patients.\\n\\nPCR-positive for SARS-CoV-2\\nPatients admitted to a floorbed at Hospital of the University of Pennsylvania or Penn Presbytarian.\\nOne or more of the following risk factors for progression to severe disease including: immunocompromising conditions, structural lung disease, hypertension, coronary artery disease, diabetes, age > 60, ferritin > 850, CRP > 6, D-dimer > 1000\\n\\nCohort 3 Health Care Worker Prevention\\n\\nEmergency Medicine or Infectious Disease Team physician or nurse at HUP or PPMC\\n≥20 hours per week of clinical work scheduled in the coming 2 months during the COVID-19 pandemic\\nWilling to report compliance with HCQ in the form of a diary\\nPatients must be able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.\\n\\nExclusion Criteria:\\n\\n<18 years of age\\nPrisoners or other detained persons\\nAllergy to hydroxychloroquine\\nPregnant or lactating or positive pregnancy test during pre-medication examination\\nReceiving any treatment drug for 2019-ncov within 14 days prior to screening evaluation (off label, compassionate use or trial related).\\nKnown history of retinal disease including but not limited to age related macular degeneration.\\nHistory of interstitial lung disease or chronic pneumonitis unrelated COVID-19.\\nDue to risk of disease exacerbation patients with porphyria or psoriasis are ineligible unless the disease is well controlled and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations.\\nPatients with serious intercurrent illness that requires active infusional therapy, intense monitoring, or frequent dose adjustments for medication including but not limited to infectious disease, cancer, autoimmune disease, cardiovascular disease.\\nPatients who have undergone major abdominal, thoracic, spine or CNS surgery in the last 2 months, or plan to undergo surgery during study participation.\\nPatients receiving cytochrome P450 enzyme-inducing anticonvulsant drugs (i.e. phenytoin, carbamazepine, Phenobarbital, primidone or oxcarbazepine) within 4 weeks of the start of the study treatment\\nHistory or evidence of increased cardiovascular risk including any of the following:\\nLeft ventricular ejection fraction (LVEF) < institutional lower limit of normal. Baseline echocardiogram is not required.\\nA QT interval corrected for heart rate using the Frederica formula > 500 msec (Sub-study 2)\\nCurrent clinically significant uncontrolled arrhythmias. Exception: Subjects with controlled atrial fibrillation\\nHistory of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to enrollment\\nCurrent ≥ Class II congestive heart failure as defined by New York Heart Association',\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Ravi Amaravadi, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '2157965159',\n", - " 'CentralContactEMail': 'ravi.amaravadi@pennmedicine.upenn.edu'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Ravi Amaravadi',\n", - " 'OverallOfficialAffiliation': 'University of Pennsylvania',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'University of Pennsylvania',\n", - " 'LocationCity': 'Philadelphia',\n", - " 'LocationState': 'Pennsylvania',\n", - " 'LocationZip': '19104',\n", - " 'LocationCountry': 'United States',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Ravi Amaravadi, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '215-796-5159',\n", - " 'LocationContactEMail': 'ravi.amaravadi@pennmedicine.upenn.edu'},\n", - " {'LocationContactName': 'Ravi Amaravadi, MD',\n", - " 'LocationContactRole': 'Principal Investigator'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Yes',\n", - " 'IPDSharingDescription': 'We will publish our results in a peer-reviewed journal and make available de-identified data for additional analysis',\n", - " 'IPDSharingInfoTypeList': {'IPDSharingInfoType': ['Study Protocol',\n", - " 'Statistical Analysis Plan (SAP)',\n", - " 'Informed Consent Form (ICF)',\n", - " 'Clinical Study Report (CSR)',\n", - " 'Analytic Code']},\n", - " 'IPDSharingTimeFrame': 'One year after study completion',\n", - " 'IPDSharingAccessCriteria': 'Open access'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", - " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", - " 'InterventionAncestorTerm': 'Antimalarials'},\n", - " {'InterventionAncestorId': 'D000000981',\n", - " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", - " {'InterventionAncestorId': 'D000000977',\n", - " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", - " {'InterventionAncestorId': 'D000000890',\n", - " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", - " {'InterventionAncestorId': 'D000004791',\n", - " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", - " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M2861',\n", - " 'InterventionBrowseLeafName': 'Antimalarials',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2879',\n", - " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2875',\n", - " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2795',\n", - " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19188',\n", - " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}}}}},\n", - " {'Rank': 75,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04285801',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '2020.059'},\n", - " 'Organization': {'OrgFullName': 'Chinese University of Hong Kong',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Critically Ill Patients With COVID-19 in Hong Kong: a Multicentre Observational Cohort Study',\n", - " 'OfficialTitle': 'Critically Ill Patients With COVID-19 in Hong Kong: a Multicentre Observational Cohort Study'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Completed',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'February 14, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'February 25, 2020',\n", - " 'PrimaryCompletionDateType': 'Actual'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'February 25, 2020',\n", - " 'CompletionDateType': 'Actual'},\n", - " 'StudyFirstSubmitDate': 'February 24, 2020',\n", - " 'StudyFirstSubmitQCDate': 'February 24, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'February 26, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 8, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 10, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Lowell Ling',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Clinical Lecturer',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Chinese University of Hong Kong'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Chinese University of Hong Kong',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'The purpose of this case series is to describe the characteristics, organ dysfunction and support and 2 week outcomes of critically ill patients with nCov infection.',\n", - " 'DetailedDescription': 'The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China 1. It has manifest into a global health crisis with escalating confirmed cases and spread across 15 countries. Whilst it is currently an epidemic in China, The World Health Organization (WHO) Global Level risk assessment is set at high 2.\\n\\nSequencing showed that 2019-nCov is similar to bat severe acute syndrome (SARS)-related coronaviruses found in Chinese horseshoe bats 3. This is compatible with the initial epidemiological link with a local wet market which sells bats. Furthermore, data sharing and sequencing data has facilitated development of accurate diagnostic tests.\\n\\nIn contrast, our current understanding of the epidemiological and clinical features of 2019-nCov is limited. In a case series of 41 hospitalized patients with confirmed infection, at least 30% of these patients required critical care admission. These patients developed severe respiratory failure and 10% required mechanical ventilation and 5% needed extracorporeal membrane oxygenation support. More worryingly 2019-nCov infection was associated with 15% mortality. Although these figures are likely overestimates due to unreported mild cases, there is currently no effective treatment. The optimal supportive care for patients with severe 2019-nCov infection is a research priority.\\n\\nThe spread of the 2019-nCov epidemic to Hong Kong has started. Patients have been admitted to the Intensive Care Unit for multiorgan dysfunction. Currently there are no published data focused specifically on critically ill patients with nCov infection. The purpose of this case series is to describe the characteristics, organ dysfunction and support and 2 week outcomes of critically ill patients with nCov infection.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Case-Only']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Retrospective']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '8', 'EnrollmentType': 'Actual'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'COVID-19 infection',\n", - " 'ArmGroupDescription': 'critically ill patients with COVID-19 infection'}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': '28 day mortality',\n", - " 'PrimaryOutcomeDescription': 'survival or death at 28 days',\n", - " 'PrimaryOutcomeTimeFrame': '28 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'vasopressor days',\n", - " 'SecondaryOutcomeDescription': 'days on vasopressor',\n", - " 'SecondaryOutcomeTimeFrame': '28 days'},\n", - " {'SecondaryOutcomeMeasure': 'days on mechanical ventilation',\n", - " 'SecondaryOutcomeDescription': 'days on mechanical ventilation during ICU stay',\n", - " 'SecondaryOutcomeTimeFrame': '28 days'},\n", - " {'SecondaryOutcomeMeasure': 'sequential organ function assessment score',\n", - " 'SecondaryOutcomeDescription': 'daily sequential organ function assessment score (0 minimum to 24 maximum), higher scores worse organ function',\n", - " 'SecondaryOutcomeTimeFrame': 'daily for first 5 days'},\n", - " {'SecondaryOutcomeMeasure': 'ECMO use',\n", - " 'SecondaryOutcomeDescription': 'Percentage of patients requiring ECMO during ICU stay.',\n", - " 'SecondaryOutcomeTimeFrame': '28 days'},\n", - " {'SecondaryOutcomeMeasure': 'percentage nitric oxide use',\n", - " 'SecondaryOutcomeDescription': 'percentage of patients requiring nitric oxide during ICU stay.',\n", - " 'SecondaryOutcomeTimeFrame': '28 days'},\n", - " {'SecondaryOutcomeMeasure': 'percentage free from oxygen supplement',\n", - " 'SecondaryOutcomeDescription': 'percentage not requiring oxygen therapy',\n", - " 'SecondaryOutcomeTimeFrame': '28 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nadmission to ICU\\nadult (≥18 years old)\\nconfirmed case of 2019-nCov infection by 2019-nCov RNA by reverse transcription polymerase chain reaction , isolation in cell culture of 2019-nCov from a clinical specimen or serum antibody to 2019-nCov\\n\\nExclusion Criteria:\\n\\n- none',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'All critically ill patients with confirmed COVID-19 infection in Hong Kong',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'LocationList': {'Location': [{'LocationFacility': 'Pamela Youde Nethersole Eastern Hospital',\n", - " 'LocationCity': 'Hong Kong',\n", - " 'LocationCountry': 'Hong Kong'},\n", - " {'LocationFacility': 'Prince of Wales Hospital',\n", - " 'LocationCity': 'Hong Kong',\n", - " 'LocationCountry': 'Hong Kong'},\n", - " {'LocationFacility': 'Princess Margaret Hospital',\n", - " 'LocationCity': 'Hong Kong',\n", - " 'LocationCountry': 'Hong Kong'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000016638',\n", - " 'ConditionMeshTerm': 'Critical Illness'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000020969',\n", - " 'ConditionAncestorTerm': 'Disease Attributes'},\n", - " {'ConditionAncestorId': 'D000010335',\n", - " 'ConditionAncestorTerm': 'Pathologic Processes'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M17593',\n", - " 'ConditionBrowseLeafName': 'Critical Illness',\n", - " 'ConditionBrowseLeafAsFound': 'Critically Ill',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M21284',\n", - " 'ConditionBrowseLeafName': 'Disease Attributes',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", - " {'Rank': 76,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04291053',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'TJ-IRB20200205'},\n", - " 'Organization': {'OrgFullName': 'Tongji Hospital', 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'The Efficacy and Safety of Huai er in the Adjuvant Treatment of COVID-19',\n", - " 'OfficialTitle': 'The Efficacy and Safety of Huai er in the Adjuvant Treatment of COVID-19: a Prospective, Multicenter, Randomized, Parallel Controlled Clinical Study'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'August 1, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'September 1, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'February 27, 2020',\n", - " 'StudyFirstSubmitQCDate': 'February 27, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 2, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 14, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 17, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Chen Xiaoping',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Tongji Hospital'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Tongji Hospital',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'In December 2019,a new type of pneumonia caused by the coronavirus (COVID-2019) broke out in Wuhan ,China, and spreads quickly to other Chinese cities and 28 countries. More than 70000 people were infected and over 2000 people died all over the world.There is no specific drug treatment for this disease. This study is planned to observe the efficacy and safety of Huaier granule in the adjuvant treatment COVID-19.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", - " 'KeywordList': {'Keyword': ['COVID-19', 'Huaier granule']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 2', 'Phase 3']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '550',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'experimental group',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Standard therapy+Huaier granule Huaier granule 20g, po, tid for 2 weeks( or until discharge)',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Huaier Granule']}},\n", - " {'ArmGroupLabel': 'control group',\n", - " 'ArmGroupType': 'No Intervention',\n", - " 'ArmGroupDescription': 'standard therapy'}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Huaier Granule',\n", - " 'InterventionDescription': 'standard treatment + Huaier Granule 20g po tid for 2weeks',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['experimental group']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Mortality rate',\n", - " 'PrimaryOutcomeDescription': 'All cause mortality',\n", - " 'PrimaryOutcomeTimeFrame': 'up to 28 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Clinical status assessed according to the official guideline',\n", - " 'SecondaryOutcomeDescription': '1.mild type：no No symptoms, Imaging examination showed no signs of pneumonia; 2,moderate type: with fever or respiratory symptoms,Imaging examination showed signs of pneumonia, SpO2＞93% without oxygen inhalation ; severe type:Match any of the following：a. R≥30bpm；b.Pulse Oxygen Saturation(SpO2)≤93% without oxygen inhalation，c. PaO2/FiO2(fraction of inspired oxygen )≤300mmHg ；4. Critically type：match any of the follow: a. need mechanical ventilation; b. shock; c. (multiple organ dysfunction syndrome) MODS',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", - " {'SecondaryOutcomeMeasure': 'The differences in oxygen intake methods',\n", - " 'SecondaryOutcomeDescription': 'Pulse Oxygen Saturation(SpO2)＞93%，1. No need for supplemental oxygenation; 2. nasal catheter oxygen inhalation（oxygen concentration%,The oxygen flow rate：L/min）；3. Mask oxygen inhalation（oxygen concentration%,The oxygen flow rate：L/min）；4. Noninvasive ventilator oxygen supply（Ventilation mode,oxygen concentration%,The oxygen flow rate：L/min,）；5. Invasive ventilator oxygen supply（Ventilation mode,oxygen concentration%,The oxygen flow rate：L/min,）.',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", - " {'SecondaryOutcomeMeasure': 'Duration (days) of supplemental oxygenation',\n", - " 'SecondaryOutcomeDescription': 'days',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", - " {'SecondaryOutcomeMeasure': 'Duration (days) of mechanical ventilation',\n", - " 'SecondaryOutcomeDescription': 'days',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", - " {'SecondaryOutcomeMeasure': 'The mean PaO2/FiO2',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", - " {'SecondaryOutcomeMeasure': 'Length of hospital stay (days)',\n", - " 'SecondaryOutcomeDescription': 'days',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", - " {'SecondaryOutcomeMeasure': 'Length of ICU stay (days)',\n", - " 'SecondaryOutcomeDescription': 'days',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", - " {'SecondaryOutcomeMeasure': 'Pulmonary function',\n", - " 'SecondaryOutcomeDescription': 'forced expiratory volume at one second ,maximum voluntary ventilation at 1month，2month，3month after discharge',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 3 months after discharge'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAged between 18 and 75 years, extremes included, male or female\\nPatients diagnosed with mild or common type COVID-19, according to the official guideline \"Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)\"\\npatients can generally tolerable for treatment recommended by the official guideline \"Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)\"\\nPatients have not been accompanied by serious physical diseases of heart, lung, brain, etc.,Eastern Cooperative Oncology Group score standard:0-1\\nAbility to understand and the willingness to sign a written informed consent document.\\n\\nExclusion Criteria:\\n\\nFemale subjects who are pregnant or breastfeeding.\\npatients who are allergic to this medicine\\npatients meet the contraindications of Huaier granule\\nPatients with diabetes\\nPatients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.\\npatients can\\'t take drugs orally',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '75 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Lin Chen',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+8613517260864',\n", - " 'CentralContactEMail': 'chenlin_tj@126.com'}]}}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'}}}},\n", - " {'Rank': 77,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04312997',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'PUL-042-502'},\n", - " 'Organization': {'OrgFullName': 'Pulmotect, Inc.',\n", - " 'OrgClass': 'INDUSTRY'},\n", - " 'BriefTitle': 'The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection',\n", - " 'OfficialTitle': 'A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'September 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'October 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 16, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 16, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 18, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 22, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 24, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Pulmotect, Inc.',\n", - " 'LeadSponsorClass': 'INDUSTRY'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'Yes',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Adults who have tested positive for SARS-CoV-2 infection and are under observation or admitted to a controlled facility (such as a hospital) will receive PUL-042 Inhalation Solution or placebo up to 3 times over a one week period in addition to their normal care. Subjects will be be followed and assessed for their clinical status over a 14 day period with follow up at 28 days to see if PUL-042 Inhalation Solution improves the clinical outcome'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 2']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Quadruple',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", - " 'Care Provider',\n", - " 'Investigator',\n", - " 'Outcomes Assessor']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '100',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'PUL-042 Inhalation Solution',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'PUL-042 Inhalation Solution given by nebulization on study days 1, 3 and 6',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: PUL-042 Inhalation Solution']}},\n", - " {'ArmGroupLabel': 'Sterile normal saline for inhalation',\n", - " 'ArmGroupType': 'Placebo Comparator',\n", - " 'ArmGroupDescription': 'Sterile normal saline for Inhalation given by nebulization on study days 1, 3 and 6',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'PUL-042 Inhalation Solution',\n", - " 'InterventionDescription': '20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042) given by nebulization on study days 1, 3 and 6',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['PUL-042 Inhalation Solution']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Placebo',\n", - " 'InterventionDescription': 'Sterile normal saline for inhalation',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Sterile normal saline for inhalation']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Severity of COVID-19',\n", - " 'PrimaryOutcomeDescription': 'Ordinal Scale for Clinical Improvement (score 1-8)',\n", - " 'PrimaryOutcomeTimeFrame': '14 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'All cause mortality',\n", - " 'SecondaryOutcomeDescription': 'Death',\n", - " 'SecondaryOutcomeTimeFrame': '28 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\n1. Subjects must have a documented positive test for the COVID-19 virus within 72 hours of the administration of study drug\\n2. Subjects who have no requirement for oxygen (Ordinal Scale for Clinical Improvement score of 3 or less)\\n3. Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient)\\n4. Subjects must be receiving standard of care (SOC) for COVID-19\\n5. Subject's spirometry (forced expiratory volume in one second [FEV1] and forced vital capacity [FVC]) must be ≥70% of predicted value\\n6. If female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception must be: practicing two effective methods of birth control (acceptable methods include intrauterine device, spermicide, barrier, male partner surgical sterilization, and hormonal contraception) during the study and through 30 days after completion of the study. Abstinence is not classified as an effective method of birth control.\\n7. If female, must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study. A pregnancy test must be negative at the Screening Visit, prior to dosing on Day 1.\\n8. If male, must be surgically sterile or willing to practice two effective methods of birth control (acceptable methods include barrier, spermicide, or female partner surgical sterilization) during the study and through 30 days after completion of the study. Abstinence is not classified as an effective method of birth control.\\n9. Must have the ability to understand and give informed consent.\\n\\nExclusion Criteria:\\n\\n1. No documented infection with SARS-CoV-2\\n2. Patients who are symptomatic and require oxygen (Ordinal Scale for Clinical Improvement score >3) at the time of screening\\n3. Known history of chronic pulmonary disease (e.g., asthma [including atopic asthma, exercise-induced asthma, or asthma triggered by respiratory infection], chronic pulmonary disease, pulmonary fibrosis, COPD), pulmonary hypertension, or heart failure.\\n4. Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints.\\n5. Previous exposure to PUL-042 Inhalation Solution\",\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Colin Broom, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '713-579-9226',\n", - " 'CentralContactEMail': 'clinicaltrials@pulmotect.com'},\n", - " {'CentralContactName': 'Brenton Scott, Ph D',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '713-579-9226',\n", - " 'CentralContactEMail': 'clinicaltrials@pulmotect.com'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Colin Broom, MD',\n", - " 'OverallOfficialAffiliation': 'Pulmotect, Inc.',\n", - " 'OverallOfficialRole': 'Study Director'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Houston Methodist Hospital',\n", - " 'LocationCity': 'Houston',\n", - " 'LocationState': 'Texas',\n", - " 'LocationZip': '77030',\n", - " 'LocationCountry': 'United States'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'C000627946',\n", - " 'InterventionMeshTerm': 'PUL-042'},\n", - " {'InterventionMeshId': 'D000019999',\n", - " 'InterventionMeshTerm': 'Pharmaceutical Solutions'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000019141',\n", - " 'InterventionAncestorTerm': 'Respiratory System Agents'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M20444',\n", - " 'InterventionBrowseLeafName': 'Pharmaceutical Solutions',\n", - " 'InterventionBrowseLeafAsFound': 'Solution',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M266568',\n", - " 'InterventionBrowseLeafName': 'PUL-042',\n", - " 'InterventionBrowseLeafAsFound': 'PUL-042',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M19721',\n", - " 'InterventionBrowseLeafName': 'Respiratory System Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", - " {'InterventionBrowseBranchAbbrev': 'Resp',\n", - " 'InterventionBrowseBranchName': 'Respiratory System Agents'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", - " 'ConditionMeshTerm': 'Infection'},\n", - " {'ConditionMeshId': 'D000053120',\n", - " 'ConditionMeshTerm': 'Respiratory Aspiration'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000012120',\n", - " 'ConditionAncestorTerm': 'Respiration Disorders'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", - " {'ConditionAncestorId': 'D000010335',\n", - " 'ConditionAncestorTerm': 'Pathologic Processes'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafAsFound': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M25724',\n", - " 'ConditionBrowseLeafName': 'Respiratory Aspiration',\n", - " 'ConditionBrowseLeafAsFound': 'Inhalation',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M13540',\n", - " 'ConditionBrowseLeafName': 'Respiration Disorders',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'}]}}}}},\n", - " {'Rank': 78,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04273581',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '20200214-COVID-19-S-T'},\n", - " 'Organization': {'OrgFullName': 'First Affiliated Hospital of Wenzhou Medical University',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'The Efficacy and Safety of Thalidomide Combined With Low-dose Hormones in the Treatment of Severe COVID-19',\n", - " 'OfficialTitle': 'The Efficacy and Safety of Thalidomide Combined With Low-dose Hormones in the Treatment of Severe New Coronavirus (COVID-19) Pneumonia: a Prospective, Multicenter, Randomized, Double-blind, Placebo, Parallel Controlled Clinical Study'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'February 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'February 18, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 30, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'May 30, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'February 14, 2020',\n", - " 'StudyFirstSubmitQCDate': 'February 14, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'February 18, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'February 19, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'February 21, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'First Affiliated Hospital of Wenzhou Medical University',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Second Affiliated Hospital of Wenzhou Medical University',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'Wenzhou Central Hospital',\n", - " 'CollaboratorClass': 'OTHER'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Patients with severe COVID-19 have rapid disease progression and high mortality. There is currently no effective treatment method, which may be related to the excessive immune response caused by cytokine storm. This study will evaluate thalidomide combined with low-dose hormone adjuvant therapy for severe COVID-19 Patient effectiveness and safety.',\n", - " 'DetailedDescription': 'Thalidomide has been clinically reported, and combined with antiviral drugs and other conventional treatments have achieved good results in the treatment of severe H1N1, especially after the death of a young severe patient. After the addition of thalidomide, the reported 35 patients did not Deaths. Subsequent basic research at Fudan University confirmed that thalidomide can treat H1N1 lung injury. And think that the combination with antiviral drugs may be a better alternative strategy for H1N1 before the vaccine is successfully developed.\\n\\nIn view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Patients with severe COVID-19 have rapid disease progression and high mortality. There is currently no effective treatment method, which may be related to the excessive immune response caused by cytokine storm.It has been reported that the combined use of thalidomide and dexamethasone can effectively inhibit NK / T-cell lymphoma combined with ECSIT V140A mutation of hematophilic syndrome. The AIDS immune reconstitution syndrome (IRIS) is also an abnormal inflammatory response in nature. It has been reported that thalidomide as an immunomodulatory agent for the treatment of IRIS is effective. This study will evaluate thalidomide combined with low-dose hormone adjuvant therapy for severe COVID-19 Patient effectiveness and safety.\\n\\nAlthough the death rate of COVID-19 infected persons is not high, their rapid infectiousness and the lack of effective antiviral treatment currently have become the focus of the national and international epidemic. Thalidomide has been available for more than sixty years, and has been widely used in clinical applications. It has been proved to be safe and effective in IPF, severe H1N1 influenza lung injury and paraquat poisoning lung injury, and the mechanism of anti-inflammatory and anti-fibrosis is relatively clear. As the current research on COVID-19 at home and abroad mainly focuses on the exploration of antiviral efficacy, this study intends to find another way to start with host treatment in the case that antiviral is difficult to overcome in the short term, in order to control or relieve lung inflammation caused by the virus To improve lung function.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19 Thalidomide']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 2']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Quadruple',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", - " 'Care Provider',\n", - " 'Investigator',\n", - " 'Outcomes Assessor']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '40',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Control group',\n", - " 'ArmGroupType': 'Placebo Comparator',\n", - " 'ArmGroupDescription': 'α-interferon： nebulized inhalation, 5 million U or equivalent dose added 2ml of sterile water for injection, 2 times a day, for 7 days； Abidol, 200mg / time, 3 times a day, for 7 days; Methylprednisolone： 40mg, q12h， for 5 days. placebo：100mg/d，qn，for 14 days.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: placebo']}},\n", - " {'ArmGroupLabel': 'Thalidomide group',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'α-interferon： nebulized inhalation, 5 million U or equivalent dose added 2ml of sterile water for injection, 2 times a day, for 7 days； Abidol, 200mg / time, 3 times a day, for 7 days; Methylprednisolone： 40mg, q12h， for 5 days. thalidomide：100mg/d，qn，for 14 days.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Thalidomide']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'placebo',\n", - " 'InterventionDescription': '100mg/d，qn，for 14 days.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Control group']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Thalidomide',\n", - " 'InterventionDescription': '100mg/d，qn，for 14 days.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Thalidomide group']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['fanyingting']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Time to Clinical Improvement (TTCI)',\n", - " 'PrimaryOutcomeDescription': 'TTCI is defined as the time (in days) from initiation of study treatment (active or placebo) until a decline of two categories from admission status on a six-category ordinal scale of clinical status which ranges from 1 (discharged) to 6 (death). Six-category ordinal scale: 6. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy; 3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC); 2. Hospitalization, not requiring supplemental oxygen; 1. Hospital discharge. Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula.',\n", - " 'PrimaryOutcomeTimeFrame': 'up to 28 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Clinical status',\n", - " 'SecondaryOutcomeDescription': 'Clinical status, assessed by the ordinal scale at fixed time points',\n", - " 'SecondaryOutcomeTimeFrame': 'days 7, 14, 21, and 28'},\n", - " {'SecondaryOutcomeMeasure': 'Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", - " {'SecondaryOutcomeMeasure': 'All cause mortality',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", - " {'SecondaryOutcomeMeasure': 'Duration (days) of mechanical ventilation',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", - " {'SecondaryOutcomeMeasure': 'Duration (days) of extracorporeal membrane oxygenation',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", - " {'SecondaryOutcomeMeasure': 'Duration (days) of supplemental oxygenation',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", - " {'SecondaryOutcomeMeasure': 'Length of hospital stay (days)',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", - " {'SecondaryOutcomeMeasure': 'Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", - " {'SecondaryOutcomeMeasure': 'Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve.',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", - " {'SecondaryOutcomeMeasure': 'Frequency of serious adverse drug events',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", - " {'SecondaryOutcomeMeasure': 'Serum TNF-α, IL-1β, IL-2, IL-6, IL-7, IL-10, GSCF, IP10#MCP1, MIP1α and other cytokine expression levels before and after treatment',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 28 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAge ≥18 years;\\nThe laboratory (RT-PCR) confirmed the diagnosis of severe patients infected with CoVID-19 (refer to the fifth edition of the Chinese diagnosis and treatment guideline for trial); the diagnosis of new coronavirus pneumonia was confirmed, and any of the following: 1) Respiratory distress, breathing ≥30 beats / min; 2) In the resting state, the oxygen saturation is ≤93%; 3) Arterial blood oxygen partial pressure / oxygen concentration ≤300mmHg\\nThe diagnosis is less than or equal to 12 days;\\n\\nExclusion Criteria:\\n\\nSevere liver disease (such as Child Pugh score ≥ C, AST> 5 times the upper limit); severe renal dysfunction (the glomerulus is 30ml / min / 1.73m2 or less)\\nPregnancy or breastfeeding or positive pregnancy test;\\nIn the 30 days before the screening assessment, have taken any experimental treatment drugs for CoVID-19 (including off-label, informed consent use or trial-related);\\nThose with a history of thromboembolism, except for those caused by PICC.',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Jinglin Xia, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '0577-55578166',\n", - " 'CentralContactEMail': 'xiajinglin@fudan.edu.cn'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Jinglin Xia, MD',\n", - " 'OverallOfficialAffiliation': 'First Affiliated Hospital of Wenzhou Medical University',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]}},\n", - " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '32029004',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Jin YH, Cai L, Cheng ZS, Cheng H, Deng T, Fan YP, Fang C, Huang D, Huang LQ, Huang Q, Han Y, Hu B, Hu F, Li BH, Li YR, Liang K, Lin LK, Luo LS, Ma J, Ma LL, Peng ZY, Pan YB, Pan ZY, Ren XQ, Sun HM, Wang Y, Wang YY, Weng H, Wei CJ, Wu DF, Xia J, Xiong Y, Xu HB, Yao XM, Yuan YF, Ye TS, Zhang XC, Zhang YW, Zhang YG, Zhang HM, Zhao Y, Zhao MJ, Zi H, Zeng XT, Wang YY, Wang XH; , for the Zhongnan Hospital of Wuhan University Novel Coronavirus Management and Research Team, Evidence-Based Medicine Chapter of China International Exchange and Promotive Association for Medical and Health Care (CPAM). A rapid advice guideline for the diagnosis and treatment of 2019 novel coronavirus (2019-nCoV) infected pneumonia (standard version). Mil Med Res. 2020 Feb 6;7(1):4. doi: 10.1186/s40779-020-0233-6.'},\n", - " {'ReferencePMID': '32043983',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Russell CD, Millar JE, Baillie JK. Clinical evidence does not support corticosteroid treatment for 2019-nCoV lung injury. Lancet. 2020 Feb 15;395(10223):473-475. doi: 10.1016/S0140-6736(20)30317-2. Epub 2020 Feb 7.'},\n", - " {'ReferencePMID': '15057291',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Bartlett JB, Dredge K, Dalgleish AG. The evolution of thalidomide and its IMiD derivatives as anticancer agents. Nat Rev Cancer. 2004 Apr;4(4):314-22. doi: 10.1038/nrc1323. Review.'},\n", - " {'ReferencePMID': '19604271',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Zhao L, Xiao K, Wang H, Wang Z, Sun L, Zhang F, Zhang X, Tang F, He W. Thalidomide has a therapeutic effect on interstitial lung fibrosis: evidence from in vitro and in vivo studies. Clin Exp Immunol. 2009 Aug;157(2):310-5. doi: 10.1111/j.1365-2249.2009.03962.x.'},\n", - " {'ReferencePMID': '32031570',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Feb 7. doi: 10.1001/jama.2020.1585. [Epub ahead of print]'},\n", - " {'ReferencePMID': '29291352',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Wen H, Ma H, Cai Q, Lin S, Lei X, He B, Wu S, Wang Z, Gao Y, Liu W, Liu W, Tao Q, Long Z, Yan M, Li D, Kelley KW, Yang Y, Huang H, Liu Q. Recurrent ECSIT mutation encoding V140A triggers hyperinflammation and promotes hemophagocytic syndrome in extranodal NK/T cell lymphoma. Nat Med. 2018 Feb;24(2):154-164. doi: 10.1038/nm.4456. Epub 2018 Jan 1.'},\n", - " {'ReferencePMID': '24912813',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Zhu H, Shi X, Ju D, Huang H, Wei W, Dong X. Anti-inflammatory effect of thalidomide on H1N1 influenza virus-induced pulmonary injury in mice. Inflammation. 2014 Dec;37(6):2091-8. doi: 10.1007/s10753-014-9943-9.'},\n", - " {'ReferencePMID': '31533530',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Kwon HY, Han YJ, Im JH, Baek JH, Lee JS. Two cases of immune reconstitution inflammatory syndrome in HIV patients treated with thalidomide. Int J STD AIDS. 2019 Oct;30(11):1131-1135. doi: 10.1177/0956462419847297. Epub 2019 Sep 19.'}]},\n", - " 'SeeAlsoLinkList': {'SeeAlsoLink': [{'SeeAlsoLinkLabel': 'Clinical characteristics of 2019 novel coronavirus infection in China by Nan-Shan Zhong',\n", - " 'SeeAlsoLinkURL': 'http://doi.org/10.1101/2020.02.06.20020974'}]}}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000013792',\n", - " 'InterventionMeshTerm': 'Thalidomide'},\n", - " {'InterventionMeshId': 'D000006728',\n", - " 'InterventionMeshTerm': 'Hormones'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000006730',\n", - " 'InterventionAncestorTerm': 'Hormones, Hormone Substitutes, and Hormone Antagonists'},\n", - " {'InterventionAncestorId': 'D000045505',\n", - " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", - " {'InterventionAncestorId': 'D000007166',\n", - " 'InterventionAncestorTerm': 'Immunosuppressive Agents'},\n", - 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" 'InterventionBrowseLeafName': 'Prednisolone hemisuccinate',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M243004',\n", - " 'InterventionBrowseLeafName': 'Prednisolone phosphate',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M8990',\n", - " 'InterventionBrowseLeafName': 'Interferons',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M15142',\n", - " 'InterventionBrowseLeafName': 'Thalidomide',\n", - " 'InterventionBrowseLeafAsFound': 'Thalidomide',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M8371',\n", - " 'InterventionBrowseLeafName': 'Hormone Antagonists',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M8795',\n", - " 'InterventionBrowseLeafName': 'Immunosuppressive Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M8784',\n", - " 'InterventionBrowseLeafName': 'Immunologic Factors',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2803',\n", - " 'InterventionBrowseLeafName': 'Anti-Bacterial Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2795',\n", - " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M20902',\n", - " 'InterventionBrowseLeafName': 'Angiogenesis Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", - " {'InterventionBrowseBranchAbbrev': 'Infl',\n", - " 'InterventionBrowseBranchName': 'Anti-Inflammatory Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'AnEm',\n", - " 'InterventionBrowseBranchName': 'Antiemetics'},\n", - " {'InterventionBrowseBranchAbbrev': 'NeuroAg',\n", - " 'InterventionBrowseBranchName': 'Neuroprotective Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'Gast',\n", - " 'InterventionBrowseBranchName': 'Gastrointestinal Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ANeo',\n", - " 'InterventionBrowseBranchName': 'Antineoplastic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'}]}},\n", - " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M12487',\n", - " 'ConditionBrowseLeafName': 'Pneumonia',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'}]}}}}},\n", - " {'Rank': 79,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04317092',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'TOCIVID-19'},\n", - " 'SecondaryIdInfoList': {'SecondaryIdInfo': [{'SecondaryId': '2020-001110-38',\n", - " 'SecondaryIdType': 'EudraCT Number'}]},\n", - " 'Organization': {'OrgFullName': 'National Cancer Institute, Naples',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Tocilizumab in COVID-19 Pneumonia (TOCIVID-19)',\n", - " 'OfficialTitle': 'Multicenter Study on the Efficacy and Tolerability of Tocilizumab in the Treatment of Patients With COVID-19 Pneumonia',\n", - " 'Acronym': 'TOCIVID-19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 19, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'December 19, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'December 19, 2022',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 19, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 19, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 20, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 19, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 20, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'National Cancer Institute, Naples',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'This study project includes a single-arm phase 2 study and a parallel observational cohort study, enrolling patients with COVID-19 pneumonia.',\n", - " 'DetailedDescription': 'Phase 2 study: this is a multicenter, single-arm, open-label, phase 2 study. All the patients enrolled are treated with tocilizumab. One-month mortality rate is the primary endpoint.\\n\\nObservational cohort study: patients who are not eligible for the phase 2 study because: (a) emergency conditions or infrastructural or operational limits prevented registration before the administration of the experimental drug or (b) they had been intubated more than 48 hours before registration. The same information planned for the phase 2 cohort is in principle required also for the observational cohort study. The sample size of the observational study is not defined a priori and the cohort will close at the end of the overall project.\\n\\nIn both study groups (phase 2 and observational study), participants will receive two doses of Tocilizumab 8 mg/kg (up to a maximum of 800mg per dose), with an interval of 12 hours.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19 Pneumonia']},\n", - " 'KeywordList': {'Keyword': ['COVID-19', 'pneumonia', 'tocilizumab']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 2']},\n", - " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", - " 'DesignInterventionModelDescription': 'This is a multicenter, single-arm, open-label, phase 2 study. All the patients enrolled are treated with tocilizumab',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '330',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'tocilizumab treatment',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'All the patients enrolled are treated with tocilizumab.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Tocilizumab Injection']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Tocilizumab Injection',\n", - " 'InterventionDescription': 'Tocilizumab 8 mg/kg (up to a maximum of 800mg per dose), with an interval of 12 hours.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['tocilizumab treatment']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'One-month mortality rate',\n", - " 'PrimaryOutcomeDescription': '1-month mortality is defined as the ratio of patients who will alive after 1month from study start out of those registered at baseline',\n", - " 'PrimaryOutcomeTimeFrame': 'up to 1 month'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Interleukin-6 level',\n", - " 'SecondaryOutcomeDescription': 'IL-6 levels will be assessed using commercial ELISA method.',\n", - " 'SecondaryOutcomeTimeFrame': 'baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month'},\n", - " {'SecondaryOutcomeMeasure': 'Lymphocyte count',\n", - " 'SecondaryOutcomeDescription': 'Lymphocyte count assessed by routinely used determination of blood count',\n", - " 'SecondaryOutcomeTimeFrame': 'baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month'},\n", - " {'SecondaryOutcomeMeasure': 'CRP (C-reactive protein) level',\n", - " 'SecondaryOutcomeDescription': 'CRP is assessed by routinely used determination of CRP',\n", - " 'SecondaryOutcomeTimeFrame': 'baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month'},\n", - " {'SecondaryOutcomeMeasure': 'PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio)',\n", - " 'SecondaryOutcomeDescription': 'calculated from arterial blood gas analyses (values from 300 to 100)',\n", - " 'SecondaryOutcomeTimeFrame': 'baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month'},\n", - " {'SecondaryOutcomeMeasure': 'Change of the SOFA (Sequential Organ Failure Assessment)',\n", - " 'SecondaryOutcomeDescription': 'It evaluates 6 variables, each representing an organ system (one for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems), and scored from 0 (normal) to 4 (high degree of dysfunction/failure). Thus, the maximum score may range from 0 to 24.',\n", - " 'SecondaryOutcomeTimeFrame': 'baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month'},\n", - " {'SecondaryOutcomeMeasure': 'Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) version 5.0',\n", - " 'SecondaryOutcomeDescription': 'graded according to CTCAE citeria (v5.0)',\n", - " 'SecondaryOutcomeTimeFrame': 'during treatment and up to 30 days after the last treatment dose'},\n", - " {'SecondaryOutcomeMeasure': 'Radiological response',\n", - " 'SecondaryOutcomeDescription': 'Thoracic CT scan or Chest XR',\n", - " 'SecondaryOutcomeTimeFrame': 'at baseline (optional), after seven days and if clinically indicated (up to 1 month)'},\n", - " {'SecondaryOutcomeMeasure': 'Duration of hospitalization',\n", - " 'SecondaryOutcomeDescription': 'Days of hospitalization',\n", - " 'SecondaryOutcomeTimeFrame': \"from baseline up to patient's discharge (up to 1 month)\"},\n", - " {'SecondaryOutcomeMeasure': 'Remission of respiratory symptoms',\n", - " 'SecondaryOutcomeDescription': 'time to invasive mechanical ventilation (if not previously initiated) calculated from baseline to intubation',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 1 month'},\n", - " {'SecondaryOutcomeMeasure': 'Remission of respiratory symptoms',\n", - " 'SecondaryOutcomeDescription': 'time to definitive extubation calculated from intubation (any time occurred) to extubation in days',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 1 month'},\n", - " {'SecondaryOutcomeMeasure': 'Remission of respiratory symptoms',\n", - " 'SecondaryOutcomeDescription': 'time to independence from non-invasive mechanical ventilation calculated in days',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 1 month'},\n", - " {'SecondaryOutcomeMeasure': 'Remission of respiratory symptoms',\n", - " 'SecondaryOutcomeDescription': 'time to independence from oxygen therapy in days',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 1 month'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAny gender\\nNo age limit\\nInformed consent for participation in the study\\nVirological diagnosis of Sars-CoV2 infection (PCR)\\nHospitalized due to clinical/instrumental diagnosis of pneumonia\\nOxygen saturation at rest in ambient air ≤93% (valid for not intubated patients and for both phase 2 and observational cohort)\\nIntubated less than 24 hours before registration (eligible for phase 2 only - criterium #6 does not apply in this case)\\nIntubated more than 24 hours before registration (eligible for observational cohort only - criterium #6 does not apply in this case)\\nPatients already treated with tocilizumab before registration are eligible for observational cohort only if one criterium among #6, #7, #8 is valid\\n\\nExclusion Criteria:\\n\\nKnown hypersensitivity to tocilizumab or its excipients\\nPatient being treated with immunomodulators or anti-rejection drugs\\nKnown active infections or other clinical condition that controindicate tocilizumab and cannot be treated or solved according to the judgement of the clinician\\nALT / AST> 5 times the upper limit of the normality\\nNeutrophils <500 / mmc\\nPlatelets <50.000 / mmc\\nBowel diverticulitis or perforation',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Francesco Perrone, MD, PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+390815903571',\n", - " 'CentralContactEMail': 'f.perrone@istitutotumori.na.it'},\n", - " {'CentralContactName': 'Maria Carmela Piccirillo, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+390815903615',\n", - " 'CentralContactEMail': 'm.piccirillo@istitutotumori.na.it'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Francesco Perrone, MD, PhD',\n", - " 'OverallOfficialAffiliation': 'Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Azienda Ospedaliera \"SS. Antonio e Biagio e C. Arrigo\" (Dipartimento Internistico SSD Reumatologia)',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Alessandria',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Stobbione Paolo, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '0131/206860',\n", - " 'LocationContactEMail': 'pstobbione@ospedale.al.it'},\n", - " {'LocationContactName': 'Stobbione Paolo, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'Ospedale di Busto Arsizio ASST Valle Olona (U.O.C. Malattie Infettive)',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Busto Arsizio',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Fabio Franzetti, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '0331/699270',\n", - " 'LocationContactEMail': 'fabio.franzetti@asst-valleolona.it'},\n", - " {'LocationContactName': 'Fabio Franzetti, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': \"A.O.U. Policlinico V. Emanuele (U.O. di Malattie infettive, U.O. di Anestesia e Rianimazione, U.O. di Medicina d'Urgenza)\",\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Catania',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Arturo Montineri, MD',\n", - " 'LocationContactRole': 'Contact'},\n", - " {'LocationContactName': 'Arturo Montineri, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Salvo Nicosia, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Giuseppe Carpinteri, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'AOE Cannizzaro di Catania (U.O. di Malattie Infettive, U.O. di Anestesia e Rianimazione, U.O.',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Catania',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Carmelo Iacobello, MD',\n", - " 'LocationContactRole': 'Contact'},\n", - " {'LocationContactName': 'Carmelo Iacobello, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Maria Concetta Monea, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'Ospedale Annunziata Azienda Ospedaliera di Cosenza (U.O.C. Malattie Infettive)',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Cosenza',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Antonio Mastroianni, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '0984-681833',\n", - " 'LocationContactEMail': 'antoniomastroianni@yahoo.it'},\n", - " {'LocationContactName': 'Antonio Mastroianni, MD',\n", - " 'LocationContactRole': 'Contact'}]}},\n", - " {'LocationFacility': 'ASST OVEST MILANESE presidi Legnano - Magenta',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Magenta',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Paola Faggioli, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '0331449175-919',\n", - " 'LocationContactEMail': 'paola.faggioli@sst-ovestmi.it'},\n", - " {'LocationContactName': 'Paola Faggioli, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'Azienda Ospedaliero-Universitaria di Modena',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Modena',\n", - " 'LocationZip': '42100',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Carlo Salvarani, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+39 0522 296684',\n", - " 'LocationContactEMail': 'salvarani.carlo@ausl.re.it'},\n", - " {'LocationContactName': 'Carlo Salvarani, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'A.O.U. di Modena (Dipartimento Chirurgie Generali e Specialità Chirurgiche - Struttura Complessa di Anestesia e Rianimazione I)',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Modena',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Massimo Girardis, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '0594225868',\n", - " 'LocationContactEMail': 'ricercainnovazione@aou.mo.it'},\n", - " {'LocationContactName': 'Massimo Girardis, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'A.O.U. di Modena (Dipartimento Chirurgie Generali e Specialità Chirurgiche - Struttura Complessa di Anestesia e Rianimazione II)',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Modena',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Elisabetta Bertelli, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '0594225868',\n", - " 'LocationContactEMail': 'ricercainnovazione@aou.mo.it'},\n", - " {'LocationContactName': 'Elisabetta Bertelli, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'A.O.U. di Modena (Dipartimento Medicine Specialistiche - Struttura Complessa Malattie Infettive)',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Modena',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Cristina Mussini, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '0594223673',\n", - " 'LocationContactEMail': 'nb.protocolli@unimore.it'},\n", - " {'LocationContactName': 'Cristina Mussini, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': \"Dipartimento Medicine Specialistiche - Struttura Complessa Malattie dell'Apparato Respiratorio\",\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Modena',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Enrico Clini, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '0594225868',\n", - " 'LocationContactEMail': 'ricercainnovazione@aou.mo.it'},\n", - " {'LocationContactName': 'Enrico Clini, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'A.O.R.N. Ospedale dei Colli Monaldi-Cotugno-CTO (U.O.C. Oncologia)',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Naples',\n", - " 'LocationZip': '80131',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Vincenzo Montesarchio, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+39 0817065268',\n", - " 'LocationContactEMail': 'vincenzo.montesarchio@ospedaledeicolli.it'},\n", - " {'LocationContactName': 'Vincenzo Montesarchio, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'National Cancer Institute',\n", - " 'LocationStatus': 'Not yet recruiting',\n", - " 'LocationCity': 'Naples',\n", - " 'LocationZip': '80131',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Paolo Ascierto, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+39 0815903431',\n", - " 'LocationContactEMail': 'p.ascierto@istitutotumori.na.it'},\n", - " {'LocationContactName': 'Paolo Ascierto, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'A.O.R.N. Ospedale dei Colli Monaldi-Cotugno-CTO (U.O.C. Anestesia Rianimazione e terapia intensiva)',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Naples',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Fiorentino Fragranza, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+39 08170672571',\n", - " 'LocationContactEMail': 'fiorentino.fragranza@ospedaledeicolli.it'},\n", - " {'LocationContactName': 'Fiorentino Fragranza, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'A.O.R.N. Ospedale dei Colli Monaldi-Cotugno-CTO (U.O.C. Malattie Infettive ad indirizzo respiratorio)',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Naples',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Roberto Parrella, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+39 0817067584',\n", - " 'LocationContactEMail': 'roberto.parrella@ospedaledeicolli.it'},\n", - " {'LocationContactName': 'Roberto Parrella, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': \"A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore di Pesaro (UOC Pronto Soccorso e Medicina d'Urgenza)\",\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Pesaro',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Giancarlo Titolo, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '328 4157022',\n", - " 'LocationContactEMail': 'giancarlo.titolo@ospedalimarchenord.it'},\n", - " {'LocationContactName': 'Giancarlo Titolo, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': \"Denominazione: UOC di Medicina e Chirurgia d'Accettazione e d'Urgenza dell'Ospedale Santa Maria delle Grazie di Pozzuoli\",\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Pozzuoli',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Fabio Giuliano Numis, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactEMail': 'fabiogiuliano.numis@aslnapoli2nord.it'},\n", - " {'LocationContactName': 'Fabio Giuliano Numis, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'Ospedale Santa Maria delle Croci, AUSL della Romagna (U.O. Anestesia e Rianimazione)',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Ravenna',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Maurizio Fusari, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '0544285918',\n", - " 'LocationContactEMail': 'maurizio.fusari@auslromagna.it'},\n", - " {'LocationContactName': 'Maurizio Fusari, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'Grande Ospedale Metropolitano, Reggio Calabria',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Reggio Calabria',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Demetrio Labate, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '340 0940460',\n", - " 'LocationContactEMail': 'labatedemtrio84@gmail.com'},\n", - " {'LocationContactName': 'Demetrio Labate',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'Ospedale Infermi, AUSL della Romagna (U.O. Malattie Infettive)',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Rimini',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Francesco Cristini, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '0541705506 - 0541705315',\n", - " 'LocationContactEMail': 'francesco.cristini@auslromagna.it'},\n", - " {'LocationContactName': 'Francesco Cristini, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'Policlinico Gemelli (U.O.C. Dipartimento Scienze di Laboratorio e Infettivologiche)',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Rome',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Roberto Cauda, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '06 3015 4945',\n", - " 'LocationContactEMail': 'roberto.cauda@policlinicogemelli.it'},\n", - " {'LocationContactName': 'Roberto Cauda, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'ASST Sette Laghi (Dipartimento di Medicina Interna)',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Varese',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Francesco Dentali, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '0332/393056',\n", - " 'LocationContactEMail': 'francesco.dentali@asst-settelaghi.it'},\n", - " {'LocationContactName': 'Francesco Dentali, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'ASST Sette Laghi (Dipartimento Emergenze ed Urgenze)',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Varese',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Walter Ageno, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '0332/393056',\n", - " 'LocationContactEMail': 'walter.ageno@asst-settelaghi.it'},\n", - " {'LocationContactName': 'Walter Ageno, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'ASST Sette Laghi (U.O.C. 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Malattie Infettive e Tropicali)',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Varese',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Paolo Grossi, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '0332/393056',\n", - " 'LocationContactEMail': 'paolo.grossi@asst-settelaghi.it'},\n", - " {'LocationContactName': 'Paolo Grossi, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'A.O.U. Integrata di Verona (Dip. Malattie Infettive)',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Verona',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Evelina Tacconelli, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '045 8128243 - 8128244',\n", - " 'LocationContactEMail': 'evelina.tacconelli@univr.it'},\n", - " {'LocationContactName': 'Evelina Tacconelli, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'Ospedale Magalini (U.O. Malattie Infettive)',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Villafranca Di Verona',\n", - " 'LocationCountry': 'Italy',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Maria Danzi, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '331/6237628',\n", - " 'LocationContactEMail': 'maria.danzi@aulss9.veneto.it'},\n", - " {'LocationContactName': 'Maria Danzi, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}}]}},\n", - " 'ReferencesModule': {'SeeAlsoLinkList': {'SeeAlsoLink': [{'SeeAlsoLinkLabel': 'sponsor web-site for study conduction',\n", - " 'SeeAlsoLinkURL': 'http://usc-intnapoli.net'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000011014',\n", - " 'ConditionMeshTerm': 'Pneumonia'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000008171',\n", - " 'ConditionAncestorTerm': 'Lung Diseases'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M12487',\n", - " 'ConditionBrowseLeafName': 'Pneumonia',\n", - " 'ConditionBrowseLeafAsFound': 'Pneumonia',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M9751',\n", - " 'ConditionBrowseLeafName': 'Lung Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'}]}}}}},\n", - " {'Rank': 80,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04323644',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'CS-20200324'},\n", - " 'Organization': {'OrgFullName': 'University of Birmingham',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Outcomes of Surgery in COVID-19 Infection: International Cohort Study (CovidSurg)',\n", - " 'OfficialTitle': 'Outcomes of Surgery in COVID-19 Infection: International Cohort Study (CovidSurg)',\n", - " 'Acronym': 'CovidSurg'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 31, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'September 30, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'September 30, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 25, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 25, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 26, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 25, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 26, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'University of Birmingham',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'CovidSurg will capture real-world international data, to determine 30-day mortality in patients with COVID-19 infection who undergo surgery. This shared international experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, ultimately improving their clinical care.',\n", - " 'DetailedDescription': 'There is an urgent need to understand the outcomes of COVID-19 infected patients who undergo surgery. Capturing real-world data and sharing international experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, improving their clinical care.\\n\\nThe primary aim of the study is to determine 30-day mortality in patients with COVID-19 infection who undergo surgery. In doing so, this will inform future risk stratification, decision making, and patient consent.\\n\\nCovidSurg is an investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk. This study does not collect any patient identifiable information (including no dates) and data will not be analysed at hospital-level.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", - " 'Coronavirus',\n", - " 'Surgery']},\n", - " 'KeywordList': {'Keyword': ['COVID-19', 'Coronavirus', 'Surgery']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Other']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '1000',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Cohort 1',\n", - " 'ArmGroupDescription': 'Patients with COVID-19 infection undergoing surgery',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Procedure: Surgery']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Procedure',\n", - " 'InterventionName': 'Surgery',\n", - " 'InterventionDescription': 'Emergency or elective surgery',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Cohort 1']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': '30-day mortality',\n", - " 'PrimaryOutcomeDescription': 'Death up to 30-days post surgery',\n", - " 'PrimaryOutcomeTimeFrame': '30 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': '7-day mortality',\n", - " 'SecondaryOutcomeDescription': 'Death up to 7-days post surgery',\n", - " 'SecondaryOutcomeTimeFrame': '7 days post surgery'},\n", - " {'SecondaryOutcomeMeasure': '30-day reoperation',\n", - " 'SecondaryOutcomeDescription': 'Reoperation up to 30-days post surgery',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 30-days post surgery'},\n", - " {'SecondaryOutcomeMeasure': 'Postoperative ICU admission',\n", - " 'SecondaryOutcomeDescription': 'Admission to ICU post surgery',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 30 days post surgery'},\n", - " {'SecondaryOutcomeMeasure': 'Postoperative respiratory failure',\n", - " 'SecondaryOutcomeDescription': 'Respiratory failure post surgery',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 30 days post surgery'},\n", - " {'SecondaryOutcomeMeasure': 'Postoperative acute respiratory distress syndrome (ARDS)',\n", - " 'SecondaryOutcomeDescription': 'Acute respiratory distress syndrome post surgery',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 30 days post surgery'},\n", - " {'SecondaryOutcomeMeasure': 'Postoperative sepsis',\n", - " 'SecondaryOutcomeDescription': 'Sepsis post surgery',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 30 days post surgery'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nPatients undergoing ANY type of surgery in an operating theatre, this includes obstetrics\\n\\nAND\\n\\n- The patient had COVID-19 infection either at the time of surgery or within 30 days of surgery, based on\\n\\n(i) positive COVID-19 lab test or computed tomography (CT) chest scan\\n\\nOR\\n\\n(ii) clinical diagnosis (no COVID-19 lab test or CT chest performed)\\n\\nExclusion Criteria:\\n\\nIf COVID-19 infection is diagnosed >30 days after discharge, the patient should not be included.',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'Patients with COVID-19 infection who undergo surgery',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Aneel Bhangu',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+44 1216272949',\n", - " 'CentralContactEMail': 'A.A.Bhangu@bham.ac.uk'},\n", - " {'CentralContactName': 'Dmitri Nepogodiev',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+44 1216272949',\n", - " 'CentralContactEMail': 'D.Nepogodiev@bham.ac.uk'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No',\n", - " 'IPDSharingDescription': 'No individual participant data will be available to other researchers'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - 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" {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 81,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04331886',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'TARGET-COVID-19'},\n", - " 'Organization': {'OrgFullName': 'Target PharmaSolutions, Inc.',\n", - " 'OrgClass': 'INDUSTRY'},\n", - " 'BriefTitle': 'An Observational Study of Patients With Coronavirus Disease 2019',\n", - " 'OfficialTitle': 'An Observational Study of Patients With Coronavirus Disease 2019',\n", - " 'Acronym': 'COVID-19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 2021',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'March 2021',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 31, 2020',\n", - " 'StudyFirstSubmitQCDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 2, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 2, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Target PharmaSolutions, Inc.',\n", - " 'LeadSponsorClass': 'INDUSTRY'}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'This is an observational study of patients with COVID-19 designed to specifically address important clinical questions that remain incompletely answered for coronavirus disease 2019.',\n", - " 'DetailedDescription': \"Data from up to 5,000 adult patients in the US will be captured from eligible patients enrolled following admission to the hospital. Participants will have de-identified medical records collected from hospital admission to discharge, including but not limited to critical care monitoring, details on mechanical ventilation, laboratory data, imaging reports, medications, and all procedures. Diagnosis and patient management will follow each hospital's standard of care and no specific treatments, procedures or laboratory tests will be dictated by enrollment in TARGET-COVID-19.\"},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", - " 'Coronavirus']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Other']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '5000',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Natural history of COVID-19: Characteristics of COVID-19',\n", - " 'PrimaryOutcomeTimeFrame': '12 months'},\n", - " {'PrimaryOutcomeMeasure': 'Natural history of COVID-19: Participant demographics',\n", - " 'PrimaryOutcomeTimeFrame': '12 months'},\n", - " {'PrimaryOutcomeMeasure': 'Natural history of COVID-19: Treatment use',\n", - " 'PrimaryOutcomeTimeFrame': '12 months'},\n", - " {'PrimaryOutcomeMeasure': 'Time point of clinical response',\n", - " 'PrimaryOutcomeTimeFrame': '12 months'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAdults (age ≥18 years) who are or have been hospitalized and diagnosed with Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection.\\nSARS-CoV-2 confirmed diagnosis (e.g. polymerase chain reaction [PCR] or other clinically utilized test).\\n\\nExclusion Criteria:\\n\\nN/A',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'Adults and children who are or have been hospitalized for diagnosed or suspected Coronavirus (SARS-CoV-2) infection',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Chuck Moser',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '984-234-0268',\n", - " 'CentralContactEMail': 'cmoser@targetpharmasolutions.com'}]}}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 82,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04287686',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'GIRH-APN01'},\n", - " 'Organization': {'OrgFullName': 'The First Affiliated Hospital of Guangzhou Medical University',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19',\n", - " 'OfficialTitle': 'A Randomized, Open Label, Controlled Clinical Study to Evaluate the Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) in Adult Patients With COVID-19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Withdrawn',\n", - " 'WhyStopped': 'Without CDE Approval',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'February 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'April 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'February 21, 2020',\n", - " 'StudyFirstSubmitQCDate': 'February 25, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'February 27, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 15, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 17, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Yimin LI',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Director Physician',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'The First Affiliated Hospital of Guangzhou Medical University'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'The First Affiliated Hospital of Guangzhou Medical University',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'This is an open label, randomized, controlled, pilot clinical study in patients with COVID-19, to obtain preliminary biologic, physiologic, and clinical data in patients with COVID-19 treated with rhACE2 or control patients, to help determine whether a subsequent Phase 2B trial is warranted.',\n", - " 'DetailedDescription': 'This is a small pilot study investigating whether there is any efficacy signal that warrants a larger Phase 2B trial, or any harm that suggests that such a trial should not be done. It is not expected to produce statistically significant results in the major endpoints. The investigators will examine all of the biologic, physiological, and clinical data to determine whether a Phase 2B trial is warranted.\\n\\nPrimary efficacy analysis will be carried only on patients receiving at least 4 doses of active drug. Safety analysis will be carried out on all patients receiving at least one dose of active drug.\\n\\nIt is planned to enroll more than or equal to 24 subjects with COVID-19. It is expected to have at least 12 evaluable patients in each group.\\n\\nExperimental group: 0.4 mg/kg rhACE2 IV BID and standard of care Control group: standard of care\\n\\nIntervention duration: up to 7 days of therapy\\n\\nNo planned interim analysis.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", - " 'KeywordList': {'Keyword': ['SARS-CoV-2',\n", - " 'Renin-angiotensin-system (RAS)']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Not Applicable']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignInterventionModelDescription': '2-arm pilot study',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '0', 'EnrollmentType': 'Actual'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'rhACE2 group',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': '0.4 mg/kg IV BID for 7 days (unblinded) + standard of care',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Recombinant human angiotensin-converting enzyme 2 (rhACE2)']}},\n", - " {'ArmGroupLabel': 'Control group',\n", - " 'ArmGroupType': 'No Intervention',\n", - " 'ArmGroupDescription': 'Standard of care; no placebo'}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Recombinant human angiotensin-converting enzyme 2 (rhACE2)',\n", - " 'InterventionDescription': 'In this study, the experimental group will receive 0.4 mg/kg rhACE2 IV BID for 7 days.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['rhACE2 group']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Time course of body temperature (fever)',\n", - " 'PrimaryOutcomeDescription': 'Compare the time course of body temperature (fever) between two groups over time.',\n", - " 'PrimaryOutcomeTimeFrame': '14 days'},\n", - " {'PrimaryOutcomeMeasure': 'Viral load over time',\n", - " 'PrimaryOutcomeDescription': 'Compare viral load between two groups over time.',\n", - " 'PrimaryOutcomeTimeFrame': '14 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'P/F ratio over time',\n", - " 'SecondaryOutcomeDescription': 'PaO2/FiO2 ratio',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Sequential organ failure assessment score(SOFA score) over time',\n", - " 'SecondaryOutcomeDescription': 'SOFA, including assessment of respiratory, blood, liver, circulatory, nerve, kidney, from 0 to 4 scores in each systems, the higher scores mean a worse outcome.',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Pulmonary Severity Index (PSI)',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Image examination of chest over time',\n", - " 'SecondaryOutcomeDescription': \"Based on radiologist's assessment of inflammatory exudative disease, category as follows: significant improvement, partial improvement, no improvement, increase of partial exudation, significant increase in exudation, unable to judge.\",\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Proportion of subjects who progressed to critical illness or death',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Time from first dose to conversion to normal or mild pneumonia',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'T-lymphocyte counts over time',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'C-reactive protein levels over time',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Angiotensin II (Ang II) changes over time',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Angiotensin 1-7 (Ang 1-7) changes over time',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Angiotensin 1-5 (Ang 1-5) changes over time',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Renin changes over time',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Aldosterone changes over time',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Angiotensin-converting enzyme (ACE) changes over time',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Angiotensin-converting enzyme 2 (ACE2) changes over time',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Interleukin 6 (IL-6) changes over time',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Interleukin 8 (IL-8) changes over time',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Plasminogen activator inhibitor type-1 (PAI-1) changes over time',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Von willebrand factor (vWF) changes over time',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Tumor necrosis factor-α (TNF-α) changes over time',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Soluble receptor for advanced glycation end products (sRAGE) changes over time',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Surfactant protein-D (SP-D) changes over time',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Angiopoietin-2 changes over time',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Frequency of adverse events and severe adverse events',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nLaboratory diagnosis:\\n\\nRespiratory specimen is positive for SARS-CoV-2 nucleic acid by RT-PCR; OR,\\nThe viral gene sequencing of the respiratory specimen is highly homologous to known novel coronavirus.\\n\\nFever:\\n\\nAxillary temperature >37.3℃\\n\\nRespiratory variables (meets one of the following criteria):\\n\\nRespiratory rate: RR ≥25 breaths/min\\nOxygen saturation ≤93% at rest on room air\\nPaO2/FiO2 ≤300 mmHg（1 mmHg=0.133 KPa）\\nPulmonary imaging showed that the lesions progressed more than 50% within 24-48 hours, and the patients were managed as severe\\nHBsAg negative, or HBV DNA ≤10^4 copy/ml if HBsAg positive; anti-HCV negative; HIV negative two weeks prior to signed Informed Consent Form (ICF)\\nAppropriate ethics approval and\\nICF\\n\\nExclusion Criteria:\\n\\nAge <18 years; Age >80 years\\nPregnant or breast feeding woman or with positive pregnancy test result\\nP/F <100 mmHg\\nMoribund condition (death likely in days) or not expected to survive for >7 days\\nRefusal by attending MD\\nNot hemodynamically stable in the preceding 4 hours (MAP ≤65 mmHg, or SAP <90 mmHg, DAP <60 mmHg, vasoactive agents are required)\\nPatient on invasive mechanical ventilation or ECMO\\nPatient in other therapeutic clinical trial within 30 days before ICF\\nReceive any other ACE inhibitors (ACEI), angiotensin-receptor blockers (ARB) treatment within 7 days before ICF\\nChronic immunosuppression: current autoimmune diseases or patients who received immunotherapy within 30 days before ICF\\nHematologic malignancy (lymphoma, leukemia, multiple myeloma)\\nOther patient characteristics (not thought to be related to underlying COVID-19) that portend a very poor prognosis (e.g, severe liver failure, and ect)\\nKnown allergy to study drug or its ingredients related to renin-angiotensin system (RAS), or frequent and/or severe allergic reactions with multiple medications\\nOther uncontrolled diseases, as judged by investigators\\nBody weight ≥85 kg',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '80 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Yimin Li, PhD, MD',\n", - " 'OverallOfficialAffiliation': 'The First Affiliated Hospital of Guangzhou Medical University',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'GCP Office of The First Affiliated Hospital of Guangzhou Medical University',\n", - " 'LocationCity': 'Guangzhou',\n", - " 'LocationState': 'Guangdong',\n", - " 'LocationZip': '510120',\n", - " 'LocationCountry': 'China'}]}}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'}}}},\n", - " {'Rank': 83,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04329650',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'SILCOR-COVID-19'},\n", - " 'Organization': {'OrgFullName': 'Fundacion Clinic per a la Recerca Biomédica',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Efficacy and Safety of Siltuximab vs. Corticosteroids in Hospitalized Patients With COVID19 Pneumonia',\n", - " 'OfficialTitle': 'Phase 2, Randomized, Open-label Study to Compare Efficacy and Safety of Siltuximab vs. Corticosteroids in Hospitalized Patients With COVID19 Pneumonia'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 20, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'May 20, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 31, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 31, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 31, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor-Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Judit Pich Martínez',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Clinical Research Manager',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Fundacion Clinic per a la Recerca Biomédica'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Judit Pich Martínez',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'In our center up to 25% of the hospitalized patients with COVID-19 progress and need an intensive care unit. It is urgent to find measures that can avoid this progression to severe stages of the disease. We hypothesize that the use of anti-inflammatory drugs used at the time they start hyperinflammation episodes could improve symptoms and prognosis of patients and prevent their progression sufficiently to avoid their need for be admitted to an Intensive Care Unit.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 2']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '100',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Siltuximab 11mg/Kg',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Siltuximab']}},\n", - " {'ArmGroupLabel': 'Methylprednisolone 250mg/24h',\n", - " 'ArmGroupType': 'Active Comparator',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Methylprednisolone']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Siltuximab',\n", - " 'InterventionDescription': 'A single-dose of 11mg/Kg of siltuximab will be administered by intravenous infusion.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Siltuximab 11mg/Kg']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Methylprednisolone',\n", - " 'InterventionDescription': 'A dose of 250mg/24 hours of methylprednisolone during 3 days followed by 30mg/24 hours during 3 days will be administered by intravenous infusion.\\n\\nIf the patient is taken lopinavir/ritonavir, the dose will be 125 mg/ 24 hours during 3 days followed by 15mg/24 hours during 3 days.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Methylprednisolone 250mg/24h']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Proportion of patients requiring ICU admission at any time within the study period.',\n", - " 'PrimaryOutcomeTimeFrame': '29 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Days of stay in the ICU during the study period.',\n", - " 'SecondaryOutcomeTimeFrame': '29 days'},\n", - " {'SecondaryOutcomeMeasure': 'Days until resolution of fever defined as body temperature (axillary ≤ 36.6 ° C, oral ≤ 37.2 ° C, or rectal or tympanic ≤ 37.8 ° C) for at least 48 hours, without administration of antipyretics or until hospital discharge.',\n", - " 'SecondaryOutcomeTimeFrame': '29 days'},\n", - " {'SecondaryOutcomeMeasure': 'Proportion of patients with a worsening requirement of supplemental oxygen at 29 days. days.',\n", - " 'SecondaryOutcomeTimeFrame': '29 days'},\n", - " {'SecondaryOutcomeMeasure': 'Days with hypoxemia (SpO2 <93% in ambient air or requiring oxygen supplemental or mechanical ventilation support) at 29 days.',\n", - " 'SecondaryOutcomeTimeFrame': '29 days'},\n", - " {'SecondaryOutcomeMeasure': 'Proportion of patients using mechanical ventilation at 29 days.',\n", - " 'SecondaryOutcomeTimeFrame': '29 days'},\n", - " {'SecondaryOutcomeMeasure': 'Days with use of mechanical ventilation at 29 days.',\n", - " 'SecondaryOutcomeTimeFrame': '29 days'},\n", - " {'SecondaryOutcomeMeasure': 'Days until the start of use of mechanical ventilation, non-invasive ventilation or use of high flow nasal cannula (if the patient have not previously required these interventions at the inclusion of the study) at 29 days.',\n", - " 'SecondaryOutcomeTimeFrame': '29 days'},\n", - " {'SecondaryOutcomeMeasure': 'Days of hospitalization among survivors at 29 days.',\n", - " 'SecondaryOutcomeTimeFrame': '29 days'},\n", - " {'SecondaryOutcomeMeasure': 'Mortality rate from any cause at 29 days.',\n", - " 'SecondaryOutcomeTimeFrame': '29 days'},\n", - " {'SecondaryOutcomeMeasure': 'Proportion of patients with serious adverse events at 29 days.',\n", - " 'SecondaryOutcomeTimeFrame': '29 days'},\n", - " {'SecondaryOutcomeMeasure': 'Proportion of patients with invasive bacterial or fungal infections clinically significant or opportunistic with grade 4 neutropenia (count neutrophil absolute <500 / mm3) at 29 days.',\n", - " 'SecondaryOutcomeTimeFrame': '29 days'},\n", - " {'SecondaryOutcomeMeasure': 'Proportion of patients with invasive bacterial or fungal infections clinically significant or opportunistic at 29 days.',\n", - " 'SecondaryOutcomeTimeFrame': '29 days'},\n", - " {'SecondaryOutcomeMeasure': 'Proportion of patients with grade 2 or higher adverse reactions related to the infusion of the sudy treatments at 29 days.',\n", - " 'SecondaryOutcomeTimeFrame': '29 days'},\n", - " {'SecondaryOutcomeMeasure': 'Proportion of patients with hypersensitivity reactions of grade 2 or higher related to the administration of the study treatments at 29 days.',\n", - " 'SecondaryOutcomeTimeFrame': '29 days'},\n", - " {'SecondaryOutcomeMeasure': 'Proportion of patients with gastrointestinal perforation at 29 days.',\n", - " 'SecondaryOutcomeTimeFrame': '29 days'},\n", - " {'SecondaryOutcomeMeasure': 'Proportion of patients with secondary severe infections confirmed by laboratory or worsening of existing infections at 29 days.',\n", - " 'SecondaryOutcomeTimeFrame': '29 days'},\n", - " {'SecondaryOutcomeMeasure': 'Changes from baseline in plasma leukocyte levels at days 1, 3, 5, 7 and 9.',\n", - " 'SecondaryOutcomeTimeFrame': 'Days 1, 3, 5, 7 and 9'},\n", - " {'SecondaryOutcomeMeasure': 'Changes from baseline in plasma hemoglobin levels at days 1, 3, 5, 7 and 9.',\n", - " 'SecondaryOutcomeTimeFrame': 'Days 1, 3, 5, 7 and 9'},\n", - " {'SecondaryOutcomeMeasure': 'Changes from baseline in plasma platelet at days 1, 3, 5, 7 and 9.',\n", - " 'SecondaryOutcomeTimeFrame': 'Days 1, 3, 5, 7 and 9'},\n", - " {'SecondaryOutcomeMeasure': 'Changes from baseline in plasma creatinine levels at days 1, 3, 5, 7 and 9.',\n", - " 'SecondaryOutcomeTimeFrame': 'Days 1, 3, 5, 7 and 9'},\n", - " {'SecondaryOutcomeMeasure': 'Changes from baseline in plasma total bilirubin levels at days 1, 3, 5, 7 and 9.',\n", - " 'SecondaryOutcomeTimeFrame': 'Days 1, 3, 5, 7 and 9'},\n", - " {'SecondaryOutcomeMeasure': 'Proportion of patients with ALT≥ 3 times ULN (for patients with initial values normal) or> 3 times ULN AND at least 2 times more than the initial value (for patients with abnormal initial values) at days 1, 3, 5, 7 and 9.',\n", - " 'SecondaryOutcomeTimeFrame': 'Days 1, 3, 5, 7 and 9'},\n", - " {'SecondaryOutcomeMeasure': 'Changes from baseline in plasma biomarkers (PCR, lymphocytes, ferritin, d-dimer and LDH) at days 1, 3, 5, 7 and 9.',\n", - " 'SecondaryOutcomeTimeFrame': 'Days 1, 3, 5, 7 and 9'},\n", - " {'SecondaryOutcomeMeasure': 'Changes from baseline in chest Rx at days 1, 3 and 5.',\n", - " 'SecondaryOutcomeTimeFrame': 'Days 1, 3 and 5'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\nAge ≥ 18 years old.\\n\\nHospitalized patient (or documentation of a hospitalization plan if the patient is in an emergency department) with illness of more than 5 days of duration with evidence of pneumonia by chest radiography / tomography computed chest and meets at least one of the following requirements:\\n\\nNon-critical patient with pneumonia in radiological progression and / or\\nPatient with progressive respiratory failure at the last 24-48 hours.\\nLaboratory confirmed SARS-CoV-2 infection (by PCR) or other commercialized analysis or public health in any sample collected 4 days before the randomization or COVID-19 criteria following the defined diagnostic criteria at that time in the center.\\nPatient with a maximum O2 support of 35%\\nBe willing and able to comply with the study related procedures / evaluations.\\nWomen of childbearing potential * should have a negative serum pregnancy test before enrollment in the study and must commit to using methods highly effective contraceptives (intrauterine device, bilateral tubal occlusion, vasectomized couple and sexual abstinence).\\nWritten informed consent. In case of inability of the patient to sign the informed consent, a verbal informed consent from the legal representative or family witness (or failing this, an impartial witness outside the investigator team) will be obtained by phone.\\n\\nWhen circumstances so allow, participants should sign the consent form. The confirmation of the verbal informed consent will be documented in a document as evidence that verbal consent has been obtained.\\n\\nExclusion Criteria:\\n\\nPatient who, in the investigator's opinion, is unlikely to survive> 48 hours after the inclusion in the study.\\n\\nPresence of any of the following abnormal analytical values at the time of the inclusion in the study:\\n\\nabsolute neutrophil count less than 2000 / mm3;\\nAST or ALT> 5 times the upper limit of normality;\\nplatelets <50,000 per mm3.\\nIn active treatment with immunosuppressants or previous prolonged treatment (more 3 months) of oral corticosteroids for a disease not related to COVID-19 at a dose greater than 10 mg of prednisone or equivalent per day.\\nKnown active tuberculosis or known history of tuberculosis uncompleted treatment.\\nPatients with active systemic bacterial and / or fungal infections.\\nParticipants who, at the investigator's discretion, are not eligible to participate, regardless of the reason, including medical or clinical conditions, or participants potentially at risk of not following study procedures.\\nPatients who do not have entry criteria in the Intensive Care Unit.\\nPregnancy or lactation.\\nKnown hypersensitivity to siltuximab or to any of its excipients (histidine, histidine hydrochloride, polysorbate 80 and sucrose).\",\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Felipe García, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+34932275400',\n", - " 'CentralContactPhoneExt': '2884',\n", - " 'CentralContactEMail': 'fgarcia@clinic.cat'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Felipe García, MD',\n", - " 'OverallOfficialAffiliation': 'Hospital Clínic de Barcelona',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Hospital Clínic de Barcelona',\n", - " 'LocationCity': 'Barcelona',\n", - " 'LocationZip': '08036',\n", - " 'LocationCountry': 'Spain',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Felipe García, MD',\n", - " 'LocationContactRole': 'Contact'},\n", - 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" 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04330495',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'EnCOVID-HidroxiCLOROQUINA'},\n", - " 'Organization': {'OrgFullName': 'Instituto de Investigación Marqués de Valdecilla',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Randomized, Controlled, Double-blind Clinical Trial Comparing the Efficacy and Safety of Chemoprophylaxis With Hydroxychloroquine in Patients Under Biological Treatment and / or JAK Inhibitors in the Prevention of SARS-CoV-2 Infection',\n", - " 'OfficialTitle': 'Randomized, Controlled, Double-blind Clinical Trial Comparing the Efficacy and Safety of Chemoprophylaxis With Hydroxychloroquine in Patients Under Biological Treatment and / or JAK Inhibitors in the Prevention of SARS-CoV-2 Infection'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 6, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'November 6, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'November 6, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 31, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 31, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 1, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 31, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Instituto de Investigación Marqués de Valdecilla',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'The investigators plan to evaluate a strategy of chemoprophylaxis with hydroxyloquine (HCQ) against COVID-19 infection in patients diagnosed with an immunomediated inflammatory disease who are following a treatment with biological agents and / or Jak inhibitors. The strategy will be carried out through a randomised double blind, placebo-controlled clinical trial and will assess comparative rates of infection (prevalence, incidence), severity including mortality, impact on clínical course of the primary diseases and toxicity. Such evaluation will require prospective surveillance to assess the different end-points.\\n\\nDrug interventions in this protocol will follow the Spanish law about off-label use of medicines.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID 19',\n", - " 'Immunomediated Inflammatory Disease in Treatment With Biological Agents and / or Jak Inhibitors']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 4']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignInterventionModelDescription': 'Randomized, controlled, double-blind clinical trial',\n", - " 'DesignPrimaryPurpose': 'Prevention',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Double',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", - " 'Investigator']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '800',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Testing and prophylaxis of SARS-CoV-2',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Chemoprophylaxis with hydroxychloroquine at a dose of 200 mg twice a day for 6 months.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Experimental group']}},\n", - " {'ArmGroupLabel': 'placebo',\n", - " 'ArmGroupType': 'Active Comparator',\n", - " 'ArmGroupDescription': 'Testing of SARS-CoV-2 and prescription of placebo (Hydroxychloroquine placebo) twice daily for 6 months',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Control group']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Experimental group',\n", - " 'InterventionDescription': 'Chemoprophylaxis with hydroxychloroquine at a dose of 200 mg twice a day for 6 months.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Testing and prophylaxis of SARS-CoV-2']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Control group',\n", - " 'InterventionDescription': 'Testing of SARS-CoV-2 and prescription of placebo (Hydroxychloroquine placebo) twice daily for 6 months',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['placebo']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Incidence rate of new COVID-19 cases in both arms',\n", - " 'PrimaryOutcomeDescription': 'number of new cases divided by number of persons-time at risk',\n", - " 'PrimaryOutcomeTimeFrame': 'From day 14 after start of treatment up to the end of follow-up: week 27'},\n", - " {'PrimaryOutcomeMeasure': 'Prevalence of COVID-19 cases in both arms',\n", - " 'PrimaryOutcomeDescription': 'percentage of cases of COVID 19',\n", - " 'PrimaryOutcomeTimeFrame': '27 weeks after the beginning of the study'},\n", - " {'PrimaryOutcomeMeasure': 'Mortality rate secondary to COVID-19 cases in both groups',\n", - " 'PrimaryOutcomeDescription': 'Case fatality rate (CFR): the proportion of diagnosed cases of COVID 19 that lead to death',\n", - " 'PrimaryOutcomeTimeFrame': '27 weeks after the beginning of the study'},\n", - " {'PrimaryOutcomeMeasure': 'Intensive Care Unit (CU) admission rate secondary to COVID-19 cases in both groups',\n", - " 'PrimaryOutcomeDescription': 'percentage of patients who need admission in an ICU due to COVID 19 infection',\n", - " 'PrimaryOutcomeTimeFrame': '27 weeks after the beginning of the study'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Adverse events',\n", - " 'SecondaryOutcomeDescription': 'Presence and type of adverse events at this point.',\n", - " 'SecondaryOutcomeTimeFrame': '12 weeks after the start of treatment'},\n", - " {'SecondaryOutcomeMeasure': 'Adverse events',\n", - " 'SecondaryOutcomeDescription': 'Proportion of participants that drop out of study',\n", - " 'SecondaryOutcomeTimeFrame': '27 weeks after the beginning of the study'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nPatients who meet the requirements of the New Coronavirus Infection Diagnosis (Acute respiratory infection symptoms or acute cough alone and positive PCR)\\nAged ≥18 and < 75 years male or female;\\nIn women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study.\\nWilling to take study medication\\nWilling to comply with all study procedures,\\nDiagnosis of IBD disease, rheumatoid arthritis, seronegative spondyloarthritis or psoriasis for more than 6 months.\\nBe on stable treatment with biological agents, for a minimum period of 6 months, including treatment with Infliximab, etanercept, adalimumab, certolizumab, golimumab, rituximab, abatacept, tocilizumab, sarilumab, secukinumab, vedolizumab, natalizumab, ustekinumab, tofacit\\nAble to provide oral and written informed consent\\n\\nExclusion Criteria\\n\\nPrevious infection with SARS-CoV-2.\\nCurrent treatment with hydroxychloroquine / chloroquine.\\nPrevious or current treatment with tamoxifen or raloxifene.\\nPrevious eye disease, especially maculopathy.\\nKnown heart failure grade III-IV of the classification of the New York Heart Association).\\nAny type of cancer (except basal cell) in the last 5 years.\\nPregnancy.\\nRefusal to give informed consent.\\nEvidence of any other unstable or clinically significant unstable, clinically significant, immunological, endocrine, hematologic, gastrointestinal, neurological, neoplastic, or psychiatric illness.\\nInstability or mental incompetence, so that the validity of the informed consent or the ability to complete the study is uncertain.\\nPositive antibodies to the human immunodeficiency virus.\\nData on decompensated liver disease:\\n\\nto. Aspartate aminotransferase (AST) and / or ALT> 10 x upper limit of normal (LSN).\\n\\nb. Total bilirubin> 25 μmol / l (1.5 mg / dl). c. International normalized index> 1.4. d. Platelet count <100,000 / mm3. 17. Serum creatinine levels> 135 μmol / l (> 1.53 mg / dl) in men and> 110 μmol / l (> 24 mg / dl) in women.\\n\\n18.Significant kidney disease, including nephrotic syndrome, chronic kidney disease (patients with markers of liver injury or estimated glomerular filtration rate [eGFR] of less than 60 ml / min / 1.73 m2). If an abnormal value is obtained at the first screening visit, the measurement of eGFR may be repeated before randomization within the following time frame: minimum 4 weeks after the initial test and maximum 2 weeks before the planned randomization. Repeated abnormal eGFR (less than 60 ml / min / 1.73 m2) leads to exclusion from the study.Pregnant or lactating women; 19. Inability to consent and/or comply with study protocol; 20. Individuals with known hypersensitivity to the study drugs. 21. Any contraindications as per the Data Sheet of or Hydroxychloroquine.',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '75 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Javier Crespo, MDPhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '942202520',\n", - " 'CentralContactEMail': 'javiercrespo1991@gmail.com'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", - " 'InterventionMeshTerm': 'Hydroxychloroquine'},\n", - " {'InterventionMeshId': 'D000075242',\n", - " 'InterventionMeshTerm': 'Janus Kinase Inhibitors'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", - " 'InterventionAncestorTerm': 'Antimalarials'},\n", - " {'InterventionAncestorId': 'D000000981',\n", - " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", - " {'InterventionAncestorId': 'D000000977',\n", - " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", - " {'InterventionAncestorId': 'D000000890',\n", - " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", - " {'InterventionAncestorId': 'D000004791',\n", - " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'},\n", - " {'InterventionAncestorId': 'D000047428',\n", - " 'InterventionAncestorTerm': 'Protein Kinase Inhibitors'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", - " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M1474',\n", - " 'InterventionBrowseLeafName': 'Janus Kinase Inhibitors',\n", - " 'InterventionBrowseLeafAsFound': 'JAK inhibitor',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M2861',\n", - " 'InterventionBrowseLeafName': 'Antimalarials',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2879',\n", - " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2875',\n", - " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2795',\n", - " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19188',\n", - " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M24407',\n", - " 'InterventionBrowseLeafName': 'Protein Kinase Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", - " 'ConditionMeshTerm': 'Infection'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafAsFound': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", - " {'Rank': 85,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04280913',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'GZHZ-COVID19'},\n", - " 'Organization': {'OrgFullName': 'Guangzhou Institute of Respiratory Disease',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Clinical Outcomes of Patients With COVID19',\n", - " 'OfficialTitle': 'Clinical Outcomes of Hospitalized Patients With Coronavirus Disease 2019'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Withdrawn',\n", - " 'WhyStopped': 'The research project was changed.',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'February 22, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'March 31, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'March 31, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'February 20, 2020',\n", - " 'StudyFirstSubmitQCDate': 'February 20, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'February 21, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 17, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 19, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'LuQian Zhou',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Guangzhou Institute of Respiratory Disease'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Guangzhou Institute of Respiratory Disease',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Huizhou Municipal Central Hospital',\n", - " 'CollaboratorClass': 'OTHER'}]}},\n", - " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus Disease 2019']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Retrospective']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '0', 'EnrollmentType': 'Actual'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'COVID-19 patients',\n", - " 'ArmGroupDescription': 'Hospitalized patients with COVID-19',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: retrospective analysis']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Other',\n", - " 'InterventionName': 'retrospective analysis',\n", - " 'InterventionDescription': 'The investigators retrospectively analyzed the hospitalized patients with COVID-19.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['COVID-19 patients']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Time to negative conversion of severe acute respiratory syndrome coronavirus 2',\n", - " 'PrimaryOutcomeDescription': 'The primary outcome is the time to negative conversion of coronavirus',\n", - " 'PrimaryOutcomeTimeFrame': '1 month'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Length of stay in hospital',\n", - " 'SecondaryOutcomeDescription': 'The time of hospitalization.',\n", - " 'SecondaryOutcomeTimeFrame': '1 month'},\n", - " {'SecondaryOutcomeMeasure': 'Survival',\n", - " 'SecondaryOutcomeDescription': 'The rate of survival within hospitalization of these patients will be tracked.',\n", - " 'SecondaryOutcomeTimeFrame': '1 month'},\n", - " {'SecondaryOutcomeMeasure': 'Intubation',\n", - " 'SecondaryOutcomeDescription': 'The rate of intubation within hospitalization of these patients will be tracked.',\n", - " 'SecondaryOutcomeTimeFrame': '1 month'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nHospitalized patients with COVID19\\n\\nExclusion Criteria:\\n\\nSuspected patients with COVID19, not confirmed by the laboratory\\nPatients who are refused to receive medical treatments',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'This is a retrospective study of hospitalized patients with COVID19.',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Luqian Zhou, MD',\n", - " 'OverallOfficialAffiliation': 'The First Affiliated Hospital of Guangzhou Medical University',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'HuiZhou Municipal Central Hospital',\n", - " 'LocationCity': 'Huizhou',\n", - " 'LocationState': 'Guangdong',\n", - " 'LocationZip': '516001',\n", - " 'LocationCountry': 'China'}]}}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 86,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04273529',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '20200214-COVID-19-M-T'},\n", - " 'Organization': {'OrgFullName': 'First Affiliated Hospital of Wenzhou Medical University',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'The Efficacy and Safety of Thalidomide in the Adjuvant Treatment of Moderate New Coronavirus (COVID-19) Pneumonia',\n", - " 'OfficialTitle': 'The Efficacy and Safety of Thalidomide in the Adjuvant Treatment of Moderate New Coronavirus (COVID-19) Pneumonia: a Prospective, Multicenter, Randomized, Double-blind, Placebo, Parallel Controlled Clinical Study'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'February 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'February 20, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 30, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'June 30, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'February 14, 2020',\n", - " 'StudyFirstSubmitQCDate': 'February 14, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'February 18, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'February 19, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'February 21, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'First Affiliated Hospital of Wenzhou Medical University',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Second Affiliated Hospital of Wenzhou Medical University',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'Wenzhou Central Hospital',\n", - " 'CollaboratorClass': 'OTHER'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No',\n", - " 'IsUSExport': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a real-time reverse transcription PCR (real time RT-PCR) diagnostic assay.\\n\\nIn view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Thalidomide has anti-inflammatory, anti-fibrotic, anti-angiogenesis, and immune regulation effects. This study is the first Prospective, Multicenter, Randomized, Double-blind, Placebo, Parallel Controlled Clinical Study at home and abroad to use immunomodulators to treat patients with COVID-19 infection.',\n", - " 'DetailedDescription': 'The new coronavirus (COVID-19) [1] belongs to the new beta coronavirus. Current research shows that it has 85% homology with bat SARS-like coronavirus (bat-SL-CoVZC45), but its genetic characteristics are similar to SARSr-CoV. There is a clear difference from MERSr-COV. Since December 2019, Wuhan City, Hubei Province has successively found multiple cases of patients with pneumonia infected by a new type of coronavirus. With the spread of the epidemic, as of 12:00 on February 12, 2020, a total of 44726 confirmed cases nationwide (Hubei Province) 33,366 cases, accounting for 74.6%), with 1,114 deaths (1068 cases in Hubei Province), and a mortality rate of 2.49% (3.20% in Hubei Province).\\n\\nIn view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Thalidomide has anti-inflammatory, anti-fibrotic, anti-angiogenesis, and immune regulation effects. In the early clinical practice of treating severe A H1N1, it was clinically concerned, and combined with hormones and conventional treatment, and achieved good results.\\n\\nAlthough the death rate of COVID-19 infected persons is not high, their rapid infectiousness and the lack of effective antiviral treatment currently have become the focus of the national and international epidemic. Thalidomide has been available for more than sixty years, and has been widely used in clinical applications. It has been proved to be safe and effective in IPF, severe H1N1 influenza lung injury and paraquat poisoning lung injury, and the mechanism of anti-inflammatory and anti-fibrosis is relatively clear. As the current research on COVID-19 at home and abroad mainly focuses on the exploration of antiviral efficacy, this study intends to find another way to start with host treatment in the case that antiviral is difficult to overcome in the short term, in order to control or relieve lung inflammation caused by the virus To improve lung function. This study is the first study at home and abroad to use immunomodulators to treat patients with COVID-19 infection. It is hoped that the patients can get out of the bitter sea as soon as possible and provide effective solutions for the country and society.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19 Thalidomide']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 2']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Quadruple',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", - " 'Care Provider',\n", - " 'Investigator',\n", - " 'Outcomes Assessor']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '100',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Control group',\n", - " 'ArmGroupType': 'Placebo Comparator',\n", - " 'ArmGroupDescription': 'placebo',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: placebo']}},\n", - " {'ArmGroupLabel': 'Thalidomide group',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'thalidomide',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: thalidomide']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'thalidomide',\n", - " 'InterventionDescription': '100mg，po，qn，for 14 days.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Thalidomide group']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['fanyingting']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'placebo',\n", - " 'InterventionDescription': '100mg，po，qn，for 14 days.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Control group']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Time to Clinical recoveryTime to Clinical Recovery (TTCR)',\n", - " 'PrimaryOutcomeDescription': 'TTCR is defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours. Normalisation and alleviation criteria:\\n\\nFever - ≤36.6°C or -axilla, ≤37.2 °C oral or ≤37.8°C rectal or tympanic, Respiratory rate - ≤24/minute on room air, Oxygen saturation - >94% on room air, Cough - mild or absent on a patient reported scale of severe, moderate, mild, absent.',\n", - " 'PrimaryOutcomeTimeFrame': 'up to 28 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'All cause mortality',\n", - " 'SecondaryOutcomeDescription': 'baseline SpO2 during screening, PaO2/FiO2 ＜300mmHg or a respiratory rate ≥ 24 breaths per min without supplemental oxygen',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", - " {'SecondaryOutcomeMeasure': 'Frequency of respiratory progression',\n", - " 'SecondaryOutcomeDescription': 'Defined as SPO2≤ 94% on room air or PaO2/FiO2 <300mmHg and requirement for supplemental oxygen or more advanced ventilator support.',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 28 days'},\n", - " {'SecondaryOutcomeMeasure': 'Time to defervescence',\n", - " 'SecondaryOutcomeDescription': 'in those with fever at enrolment',\n", - " 'SecondaryOutcomeTimeFrame': 'up to 28 days'}]},\n", - " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'Time to cough reported as mild or absent',\n", - " 'OtherOutcomeDescription': 'in those with cough at enrolment rated severe or moderate',\n", - " 'OtherOutcomeTimeFrame': 'up to 28 days'},\n", - " {'OtherOutcomeMeasure': 'Respiratory improvement time',\n", - " 'OtherOutcomeDescription': 'patients with moderate / severe dyspnea when enrolled',\n", - " 'OtherOutcomeTimeFrame': 'up to 28 days'},\n", - " {'OtherOutcomeMeasure': 'Frequency of requirement for supplemental oxygen or non-invasive ventilation',\n", - " 'OtherOutcomeTimeFrame': 'up to 28 days'},\n", - " {'OtherOutcomeMeasure': 'Time to 2019-nCoV RT-PCR negative in upper respiratory tract specimen',\n", - " 'OtherOutcomeTimeFrame': 'up to 28 days'},\n", - " {'OtherOutcomeMeasure': 'Change (reduction) in 2019-nCoV viral load in upper respiratory tract specimen as assessed by area under viral load curve',\n", - " 'OtherOutcomeTimeFrame': 'up to 28 days'},\n", - " {'OtherOutcomeMeasure': 'Frequency of requirement for mechanical ventilation',\n", - " 'OtherOutcomeTimeFrame': 'up to 28 days'},\n", - " {'OtherOutcomeMeasure': 'Frequency of serious adverse events',\n", - " 'OtherOutcomeTimeFrame': 'up to 28 days'},\n", - " {'OtherOutcomeMeasure': 'Serum TNF-α, IL-1β, IL-2, IL-6, IL-7, IL-10, GSCF, IP10，MCP1, MIP1α and other cytokine expression levels before and after treatment',\n", - " 'OtherOutcomeTimeFrame': 'up to 28 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAge ≥18 years;\\nLaboratory (RT-PCR) diagnosis of common patients infected with COVID-19 (refer to the fifth edition of the Chinese Guidelines for Diagnosis and Treatment);\\nchest imaging confirmed lung damage;\\nThe diagnosis is less than or equal to 8 days;\\n\\nExclusion Criteria:\\n\\nSevere liver disease (such as Child Pugh score ≥ C, AST> 5 times the upper limit); severe renal dysfunction (the glomerulus is 30ml / min / 1.73m2 or less)\\nPositive pregnancy or breastfeeding or pregnancy test;\\nIn the 30 days before the screening assessment, have taken any experimental treatment drugs for COVID-19 (including off-label, informed consent use or trial-related);\\nThose with a history of thromboembolism, except for those caused by PICC.',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Jinglin Xia, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '0577-55578166',\n", - " 'CentralContactEMail': 'xiajinglin@fudan.edu.cn'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Jinglin Xia, MD',\n", - " 'OverallOfficialAffiliation': 'First Affiliated Hospital of Wenzhou Medical University',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]}},\n", - " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '19604271',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Zhao L, Xiao K, Wang H, Wang Z, Sun L, Zhang F, Zhang X, Tang F, He W. Thalidomide has a therapeutic effect on interstitial lung fibrosis: evidence from in vitro and in vivo studies. Clin Exp Immunol. 2009 Aug;157(2):310-5. doi: 10.1111/j.1365-2249.2009.03962.x.'},\n", - " {'ReferencePMID': '32043983',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Russell CD, Millar JE, Baillie JK. Clinical evidence does not support corticosteroid treatment for 2019-nCoV lung injury. Lancet. 2020 Feb 15;395(10223):473-475. doi: 10.1016/S0140-6736(20)30317-2. Epub 2020 Feb 7.'},\n", - " {'ReferencePMID': '32029004',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Jin YH, Cai L, Cheng ZS, Cheng H, Deng T, Fan YP, Fang C, Huang D, Huang LQ, Huang Q, Han Y, Hu B, Hu F, Li BH, Li YR, Liang K, Lin LK, Luo LS, Ma J, Ma LL, Peng ZY, Pan YB, Pan ZY, Ren XQ, Sun HM, Wang Y, Wang YY, Weng H, Wei CJ, Wu DF, Xia J, Xiong Y, Xu HB, Yao XM, Yuan YF, Ye TS, Zhang XC, Zhang YW, Zhang YG, Zhang HM, Zhao Y, Zhao MJ, Zi H, Zeng XT, Wang YY, Wang XH; , for the Zhongnan Hospital of Wuhan University Novel Coronavirus Management and Research Team, Evidence-Based Medicine Chapter of China International Exchange and Promotive Association for Medical and Health Care (CPAM). A rapid advice guideline for the diagnosis and treatment of 2019 novel coronavirus (2019-nCoV) infected pneumonia (standard version). Mil Med Res. 2020 Feb 6;7(1):4. doi: 10.1186/s40779-020-0233-6.'},\n", - " {'ReferencePMID': '32031570',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Feb 7. doi: 10.1001/jama.2020.1585. [Epub ahead of print]'},\n", - " {'ReferencePMID': '29291352',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Wen H, Ma H, Cai Q, Lin S, Lei X, He B, Wu S, Wang Z, Gao Y, Liu W, Liu W, Tao Q, Long Z, Yan M, Li D, Kelley KW, Yang Y, Huang H, Liu Q. Recurrent ECSIT mutation encoding V140A triggers hyperinflammation and promotes hemophagocytic syndrome in extranodal NK/T cell lymphoma. Nat Med. 2018 Feb;24(2):154-164. doi: 10.1038/nm.4456. Epub 2018 Jan 1.'},\n", - " {'ReferencePMID': '31533530',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Kwon HY, Han YJ, Im JH, Baek JH, Lee JS. Two cases of immune reconstitution inflammatory syndrome in HIV patients treated with thalidomide. Int J STD AIDS. 2019 Oct;30(11):1131-1135. doi: 10.1177/0956462419847297. Epub 2019 Sep 19.'},\n", - " {'ReferencePMID': '24912813',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Zhu H, Shi X, Ju D, Huang H, Wei W, Dong X. Anti-inflammatory effect of thalidomide on H1N1 influenza virus-induced pulmonary injury in mice. Inflammation. 2014 Dec;37(6):2091-8. doi: 10.1007/s10753-014-9943-9.'},\n", - " {'ReferencePMID': '15057291',\n", - " 'ReferenceType': 'result',\n", - " 'ReferenceCitation': 'Bartlett JB, Dredge K, Dalgleish AG. The evolution of thalidomide and its IMiD derivatives as anticancer agents. Nat Rev Cancer. 2004 Apr;4(4):314-22. doi: 10.1038/nrc1323. Review.'}]}}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000013792',\n", - " 'InterventionMeshTerm': 'Thalidomide'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000007166',\n", - " 'InterventionAncestorTerm': 'Immunosuppressive Agents'},\n", - " {'InterventionAncestorId': 'D000007155',\n", - " 'InterventionAncestorTerm': 'Immunologic Factors'},\n", - " {'InterventionAncestorId': 'D000045505',\n", - " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", - " {'InterventionAncestorId': 'D000007917',\n", - " 'InterventionAncestorTerm': 'Leprostatic Agents'},\n", - " {'InterventionAncestorId': 'D000000900',\n", - " 'InterventionAncestorTerm': 'Anti-Bacterial Agents'},\n", - " {'InterventionAncestorId': 'D000000890',\n", - " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", - 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" 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000011014',\n", - " 'ConditionMeshTerm': 'Pneumonia'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000008171',\n", - " 'ConditionAncestorTerm': 'Lung Diseases'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M12487',\n", - " 'ConditionBrowseLeafName': 'Pneumonia',\n", - " 'ConditionBrowseLeafAsFound': 'Pneumonia',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M9751',\n", - " 'ConditionBrowseLeafName': 'Lung Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'}]}}}}},\n", - " {'Rank': 87,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04315896',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'HidroxycloroquinaCOVID19'},\n", - " 'Organization': {'OrgFullName': 'National Institute of Respiratory Diseases, Mexico',\n", - " 'OrgClass': 'OTHER_GOV'},\n", - " 'BriefTitle': 'Hydroxychloroquine Treatment for Severe COVID-19 Pulmonary Infection (HYDRA Trial)',\n", - " 'OfficialTitle': 'Hydroxychloroquine Treatment for Severe COVID-19 Respiratory Disease: Randomised Clinical Trial (HYDRA Trial)',\n", - " 'Acronym': 'HYDRA'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 23, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'October 31, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'March 22, 2021',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 18, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 18, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 20, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 18, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 20, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'National Institute of Respiratory Diseases, Mexico',\n", - " 'LeadSponsorClass': 'OTHER_GOV'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Sanofi',\n", - " 'CollaboratorClass': 'INDUSTRY'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No',\n", - " 'IsUSExport': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Double blinded randomized clinical trial designed to evaluate the security and efficacy of hydroxychloroquine as treatment for COVID-19 severe respiratory disease. The investigators hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause hospital mortality in patients with severe respiratory COVID-19 disease.',\n", - " 'DetailedDescription': \"Since hydroxychloroquine is a low cost and safe anti-malaria drug that has proven effects against COVID-19 in vitro. The investigators aim to study the security and efficacy of this drug in trough a double blinded randomized clinical trial. Recruited patients with severe respiratory disease from COVID-19 will be randomized to an intervention group (400mg per day dose of hydroxychloroquine) and placebo. The investigators' main outcome will be all cause hospital mortality. The investigators hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause hospital mortality in patients with severe respiratory COVID-19 disease. Results will be compared in an intention to treat analysis. All clinical, analysis and data team members will be blinded to treatment assignment.\"},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", - " 'Severe Acute Respiratory Syndrome']},\n", - " 'KeywordList': {'Keyword': ['COVID-19',\n", - " 'Severe acute respiratory syndrome']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 3']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignInterventionModelDescription': 'Double blinded, randomized controlled trial',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Quadruple',\n", - " 'DesignMaskingDescription': 'Clinical practitioners and data analysts will remain blinded all through the study. Blinding will end in case the attending physician considers the patient should abandon the study or some of the exclusion/elimination criteria apply.',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", - " 'Care Provider',\n", - " 'Investigator',\n", - " 'Outcomes Assessor']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '500',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'treatment',\n", - " 'ArmGroupType': 'Active Comparator',\n", - " 'ArmGroupDescription': 'Hydroxychloroquine tablet 200mg every 12 hours for 10 days.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine']}},\n", - " {'ArmGroupLabel': 'placebo',\n", - " 'ArmGroupType': 'Placebo Comparator',\n", - " 'ArmGroupDescription': 'identical placebo, one tablet every 12 hours for 10 days',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo oral tablet']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Hydroxychloroquine',\n", - " 'InterventionDescription': 'hydroxychloroquine 400mg day for 10 days',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['treatment']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Placebo oral tablet',\n", - " 'InterventionDescription': 'Placebo oral tablet',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['placebo']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'All-cause hospital mortality',\n", - " 'PrimaryOutcomeDescription': 'incidence of all-cause mortality',\n", - " 'PrimaryOutcomeTimeFrame': 'From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Length of hospital stay',\n", - " 'SecondaryOutcomeDescription': 'Days from ER admission to hospital discharge',\n", - " 'SecondaryOutcomeTimeFrame': 'From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days'},\n", - " {'SecondaryOutcomeMeasure': 'Need of mechanical ventilation',\n", - " 'SecondaryOutcomeDescription': 'need of invasive or non invasive mechanical ventilation',\n", - " 'SecondaryOutcomeTimeFrame': 'From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days'},\n", - " {'SecondaryOutcomeMeasure': 'Ventilator free days',\n", - " 'SecondaryOutcomeDescription': '28 minus days without invasive ventilation support in patients with invasive mechanical ventilation at randomization',\n", - " 'SecondaryOutcomeTimeFrame': 'From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days'},\n", - " {'SecondaryOutcomeMeasure': 'Grade 3-4 adverse reaction',\n", - " 'SecondaryOutcomeDescription': 'Adverse Reactions',\n", - " 'SecondaryOutcomeTimeFrame': 'From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to120 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nSigned informed consent\\nnegative pregnancy test in women\\nCOVID-19 confirmed by rtPCR in any respiratory sample.\\n\\nSevere COVID-19 disease defined as any from the following:\\n\\nPulse oximetry less than 91% or a 3% drop from base pulse oximetry or need to increase supplementary oxygen in chronic hypoxia\\nNeed for mechanical ventilation (invasive or non invasive )\\nSepsis/septic shock.\\n\\nExclusion Criteria:\\n\\nhistory of anaphylactic shock to hydroxychloroquine.\\nHistory of previous administration of chloroquine or hydroxychloroquine (within 1 month)\\ndecision of attending physician by any reason.\\nHistory of chronic hepatic disease (Child-Pugh B or C)\\nHistory of Chronic renal disease (GFR less than 30)',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'MaximumAge': '80 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Carmen Hernandez-Cárdenas, MD. MSc',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '54871700',\n", - " 'CentralContactPhoneExt': '5213',\n", - " 'CentralContactEMail': 'cmhcar@hotmail.com'},\n", - " {'CentralContactName': 'Rogelio Perez-Padilla, MD. PhD.',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '54871700',\n", - " 'CentralContactEMail': 'perezpad@gmail.com'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Carmen Hernandez-Cárdenas, MD. MSc.',\n", - " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Luis-Felipe Jurado-Camacho, MD',\n", - " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", - " 'OverallOfficialRole': 'Study Director'},\n", - " {'OverallOfficialName': 'Ireri Thirion-Romero, MD. MSc',\n", - " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", - " 'OverallOfficialRole': 'Study Chair'},\n", - " {'OverallOfficialName': 'Sebastian Rodriguez-Llamazares, MD.MPH',\n", - " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", - " 'OverallOfficialRole': 'Study Chair'},\n", - " {'OverallOfficialName': 'Rogelio Perez-Padilla, MD. PhD',\n", - " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", - " 'OverallOfficialRole': 'Study Director'},\n", - " {'OverallOfficialName': 'Cristobal Guadarrama, MD MSc',\n", - " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", - " 'OverallOfficialRole': 'Study Chair'},\n", - " {'OverallOfficialName': 'Joel Vasquez-Pérez, MD',\n", - " 'OverallOfficialAffiliation': 'National Institute of Respiratory Diseases - México',\n", - " 'OverallOfficialRole': 'Study Chair'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided',\n", - " 'IPDSharingDescription': 'As requested by other investigators.'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", - " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", - " 'InterventionAncestorTerm': 'Antimalarials'},\n", - " {'InterventionAncestorId': 'D000000981',\n", - " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", - " {'InterventionAncestorId': 'D000000977',\n", - " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", - " {'InterventionAncestorId': 'D000000890',\n", - " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", - " {'InterventionAncestorId': 'D000004791',\n", - " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", - " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - 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" 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13540',\n", - " 'ConditionBrowseLeafName': 'Respiration Disorders',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 88,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04324190',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'IPUB_2020_01'},\n", - " 'Organization': {'OrgFullName': 'International Psychoanalytic University Berlin',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'DIgital Online SuPport for COVID-19 StrEss',\n", - " 'OfficialTitle': 'Online Support for Psychosocial Stress in the Context of the COVID-19 Pandemic',\n", - " 'Acronym': 'DISPOSE'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'June 2021',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'December 2021',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 26, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 26, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 27, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 26, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 27, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor-Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Gunther Meinlschmidt',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Prof. Dr.',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'International Psychoanalytic University Berlin'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Gunther Meinlschmidt',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Selfapy GmbH',\n", - " 'CollaboratorClass': 'UNKNOWN'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'The COVID-19 pandemic leads to a greatly increased risk of substantial psychological stress worldwide. We intend to evaluate an online support program aiming at reducing stress in the context of the COVID-19 pandemic. The program consists of twelve modules that participants undergo, covering a broad range of topics related to stress in the context of the COVID-19 pandemic. It has been developed together with and is provided by Selfapy GmbH, Berlin. The aim of this randomised clinical trial with observational components is to estimate the effects of the intervention as a whole, as well as individual modules and selected chapters. Further, follow-up assessments as well as information on risks and the long-term course of COVID pandemic-related stress may help to elucidate COVID-19 pandemic stress across time and what we can do to prevent long-term negative consequences.',\n", - " 'DetailedDescription': 'The overall aim of this randomised trial with observational component is to estimate the effects of a guided digital online support program to increase mental health and reduce psychosocial stress in the context of the COVID-19 pandemic. More specifically, the main hypothesis is to estimate whether the improvement in mental health is stronger during the first two weeks of applying the online support program as compared to a two weeks waiting condition (with provision of WHO information on \\'coping with stress during the 2019-nCoV\\' outbreak only). Furthermore, our aim is to estimate changes in the outcomes along taking part in the program.\\n\\nAdditional research questions are:\\n\\nto compare the intervention effects across modules and chapters of the online support program, including between module comparison with an unspecific, control (comparator) module: \"general information on the corona virus\" and its unspecific chapters;\\nto estimate the effects of selected modules on additional outcomes (e.g. physical activity, and schooling related factors);\\nto describe the magnitude and course of psychosocial stress, mental health and related factors in the context of the COVID-19 pandemic;\\nto estimate and predict which subjects profit most from specific parts of the program.\\n\\nFollow-up assessment shall allow estimating whether the program prevents the development of detrimental mental health conditions, e.g. depression, anxiety, etc.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19',\n", - " 'Psychosocial Stress',\n", - " 'Mental Health']},\n", - " 'KeywordList': {'Keyword': ['COVID-19',\n", - " 'SARS-CoV-2',\n", - " 'psychosocial stress',\n", - " 'online support',\n", - " 'guided',\n", - " 'mental health',\n", - " 'anxiety',\n", - " 'depression',\n", - " 'somatic symptom disorder']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Not Applicable']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Sequential Assignment',\n", - " 'DesignInterventionModelDescription': 'Randomized controlled trial with a waiting comparator condition (provision of WHO recommendations, comparable to treatment as usual, TAU), consisting of a two weeks waiting period during which general WHO recommendations how to handle stress in the context of the COVID-19 pandemic will be provided. All subjects in the waiting condition will undergo the intervention following the waiting period. Main assessments will be conducted before the waiting period, before beginning of the intervention, two weeks after beginning of the intervention (+2 weeks), +4 weeks, +12 weeks, and follow ups at +6 months and +12 months.',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Single',\n", - " 'DesignMaskingDescription': 'Care providers (providing guidance) are not informed about wether participants have been assigned to the online support program condition or the comparator condition, consisting of a waiting period followed by the online support program.',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Care Provider']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '600',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Online support program',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Guided Online support program, consisting of 12 modules (structured in chapters) aiming at reduce stress related to the COVID-19 pandemic.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Behavioral: Guided online support program']}},\n", - " {'ArmGroupLabel': 'waiting period (WHO recommendation)',\n", - " 'ArmGroupType': 'Active Comparator',\n", - " 'ArmGroupDescription': 'Waiting period (2 weeks duration) during which subjects are provided with the WHO recommendations \"Coping with stress during the 2019 nCoV outbreak\". Following the 2 weeks waiting period, subjects are provided with the guided online support program outlined in the arm \\'online support program\\'',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Behavioral: Guided online support program',\n", - " 'Behavioral: WHO recommendations (waiting condition)']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Behavioral',\n", - " 'InterventionName': 'Guided online support program',\n", - " 'InterventionDescription': 'Guided online support program consisting of several modules; Module \"General information ...\" is an unspecific control module (providing general information on hygiene etc. with no expected effect on outcomes)',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Online support program',\n", - " 'waiting period (WHO recommendation)']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['online intervention',\n", - " 'guided online support']}},\n", - " {'InterventionType': 'Behavioral',\n", - " 'InterventionName': 'WHO recommendations (waiting condition)',\n", - " 'InterventionDescription': 'During the waiting period, a german translation of the WHO recommendations \"Coping with stress during the 2019-nCoV outbreak\" is provided',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['waiting period (WHO recommendation)']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Change in Short-Form-36 (SF-36) Health Survey - Mental Health Component Summary score',\n", - " 'PrimaryOutcomeDescription': 'The SF-36 is a widely used patient-reported outcome assessment tool to measure health-related quality of life and has high acceptability. The SF-36 is a standardised questionnaire with good psychometric properties.',\n", - " 'PrimaryOutcomeTimeFrame': 'Change from T1 (baseline before online support - day 1) to T2 (T1 + 2 weeks) in arm 1, versus change from T0 (baseline before waiting) to T1 (baseline before online support) in arm 2'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Chronic stress items (9 items)',\n", - " 'SecondaryOutcomeDescription': 'Assessing chronic stress (Petrowski et al., 2019)',\n", - " 'SecondaryOutcomeTimeFrame': 'baseline before waiting (T0, arm 2 only); baseline before online support (day 1, T1), T1+2 weeks, T1+4weeks, T1+12weeks, follow ups: T1+ 6 months; T1+12 months'},\n", - " {'SecondaryOutcomeMeasure': 'Generalized Anxiety Disorder Scale (GAD-7)',\n", - " 'SecondaryOutcomeDescription': 'Assessing anxiety symptoms (Löwe et al., 2008)',\n", - " 'SecondaryOutcomeTimeFrame': 'baseline before waiting (T0, arm 2 only); baseline before online support (day 1, T1), T1+2 weeks, T1+4weeks, T1+12weeks, follow ups: T1+ 6 months; T1+12 months'},\n", - " {'SecondaryOutcomeMeasure': 'Patient Health Questionnaire (PHQ8)',\n", - " 'SecondaryOutcomeDescription': 'Assessing depressive symptoms (Kroenke et al., 2001)',\n", - " 'SecondaryOutcomeTimeFrame': 'baseline before waiting (T0, arm 2 only); baseline before online support (day 1, T1), T1+2 weeks, T1+4weeks, T1+12weeks, follow ups: T1+ 6 months; T1+12 months'},\n", - " {'SecondaryOutcomeMeasure': 'Somatic Symptom Disorder (SSD-12)',\n", - " 'SecondaryOutcomeDescription': 'Assessing depressive symptoms (Toussaint et al., 2019)',\n", - " 'SecondaryOutcomeTimeFrame': 'baseline before waiting (T0, arm 2 only); baseline before online support (day 1, T1), T1+2 weeks, T1+4weeks, T1+12weeks, follow ups: T1+ 6 months; T1+12 months'},\n", - " {'SecondaryOutcomeMeasure': 'Somatic Symptom Scale (SSS-8)',\n", - " 'SecondaryOutcomeDescription': 'Assessing somatic symptoms (Gierk et al., 2015)',\n", - " 'SecondaryOutcomeTimeFrame': 'baseline before waiting (T0, arm 2 only); baseline before online support (day 1, T1), T1+2 weeks, T1+4weeks, T1+12weeks, follow ups: T1+ 6 months; T1+12 months'},\n", - " {'SecondaryOutcomeMeasure': 'Screening Tool for Psychological Distress (STOP-D) - selected items',\n", - " 'SecondaryOutcomeDescription': 'stress, anxiety, depression, social support - single item assessments to be applied repeatedly along the online support intervention (Young, Ignaszewski, Fofonoff, Kaan; 2007)',\n", - " 'SecondaryOutcomeTimeFrame': 'baseline before waiting (T0, arm 2 only); baseline before online support (day 1, T1), T1+2 weeks, T1+4weeks, T1+12weeks, follow ups: T1+ 6 months; T1+12 months'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion criteria:\\n\\nSufficient German language skills to participate in the assessments.\\nProviding informed consent for participation',\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Gunther Meinlschmidt, Prof. Dr.',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+49 30 300117',\n", - " 'CentralContactPhoneExt': '710',\n", - " 'CentralContactEMail': 'gunther.meinlschmidt@ipu-berlin.de'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Selfapy GmbH',\n", - " 'LocationCity': 'Berlin',\n", - " 'LocationZip': '10435',\n", - " 'LocationCountry': 'Germany',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Kati Bermbach',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+49 (0) 30 - 3982031',\n", - " 'LocationContactPhoneExt': '20',\n", - " 'LocationContactEMail': 'contact@selfapy.com'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M5641',\n", - " 'ConditionBrowseLeafName': 'Depression',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M5644',\n", - " 'ConditionBrowseLeafName': 'Depressive Disorder',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M2905',\n", - " 'ConditionBrowseLeafName': 'Anxiety Disorders',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M885',\n", - " 'ConditionBrowseLeafName': 'Medically Unexplained Symptoms',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BXM',\n", - " 'ConditionBrowseBranchName': 'Behaviors and Mental Disorders'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'}]}}}}},\n", - " {'Rank': 89,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04317040',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'CD24Fc-007'},\n", - " 'Organization': {'OrgFullName': 'OncoImmune, Inc.',\n", - " 'OrgClass': 'INDUSTRY'},\n", - " 'BriefTitle': 'CD24Fc as a Non-antiviral Immunomodulator in COVID-19 Treatment',\n", - " 'OfficialTitle': 'A Randomized, Double-blind, Placebo-controlled, Multi-site, Phase III Study to Evaluate the Safety and Efficacy of CD24Fc in COVID-19 Treatment',\n", - " 'Acronym': 'SAC-COVID'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'May 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 2021',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'May 2022',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 19, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 19, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 20, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 19, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 23, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'OncoImmune, Inc.',\n", - " 'LeadSponsorClass': 'INDUSTRY'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'Yes',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'The study is designed as a randomized, placebo-controlled, double blind, multicenter, Phase III trial to compare two COVID-19 treatment regimens in hospitalized adult subjects who are diagnosed with severe COVID 19 and absolute lymphocyte counts ≤ 800/mm^3 in peripheral blood.\\n\\nArm A: CD24Fc/Best Available Treatment; Arm B: placebo/ Best Available Treatment. CD24Fc will be administered as single dose of 480 mg via IV infusion on Day 1. Total of 230 subjects will be enrolled and randomized in 1:1 ratio to receive CD24Fc or placebo. Serum cytokine IL-6 level will be used as stratification factor in randomization. All subjects will be treated with the best available treatment. The follow up period is 15 days.',\n", - " 'DetailedDescription': 'As the newest global medical emergency, the COVID-19 (diagnosed SARS-CoV2 infection with lung involvement) exhibits features that are unlikely ameliorated by antivirals-based approaches alone. First, although the new coronavirus (SARS-CoV-2) infect lung and intestine, many patients suddenly take a turn for the worse even when the viral replication appears to be under control. Second, patients with serious or critical clinical symptoms show remarked T cell lymphopenia that are more severe and more acute than human immunodeficiency virus (HIV) infection. Functional exhaustion of T cells is suggested by high expression of T-cell exhaustion markers, which again appears more acute than in HIV patients. Third, multiple cytokines are elevated among patients with severe clinical symptoms, which potentially explains the multiple organ failure associated with COVID-19. For these reasons, treatment of COVID-19 likely requires a combination of both antivirals and non-antivirals-based approaches.\\n\\nCD24Fc is a biological immunomodulator in Phase II/III clinical trial stage. CD24Fc comprises the nonpolymorphic regions of CD24 attached to the Fc region of human IgG1. We have shown that CD24 is an innate checkpoint against the inflammatory response to tissue injuries or danger-associated molecular patterns (DAMPs). Preclinical and clinical studies have demonstrated that CD24Fc effectively address the major challenges associated with COVID-19. First, a Phase I clinical trial on healthy volunteers not only demonstrated safety of CD24Fc, but also demonstrated its biological activity in suppressing expression of multiple inflammatory cytokines. Second, in Phase II clinical trial in leukemia patients undergoing hematopoietic stem cell transplantation (HCT), three doses of CD24Fc effectively eliminated severe (Grade 3-4) acute graft vs host diseases (GVHD), which is caused by over reacting immune system and transplanted T cells attacking recipient target tissues. Third, in preclinical models of HIV/SIV infections, we have shown that CD24Fc ameliorated production of multiple inflammatory cytokines, reversed the loss of T lymphocytes as well as functional T cell exhaustion and reduced the leukocyte infiltration of multiple organs. It is particularly noteworthy that CD24Fc reduced the rate of pneumonia in SIV-infected Chinese rhesus monkey from 83% to 33%. Therefore, CD24Fc maybe a prime candidate for non-antiviral biological modifier for COVID-19 therapy. The phase III trial will involve 230 patients randomized into blinded placebo and CD24Fc arms, with time to clinical improvement from severe to mild symptom as the primary endpoint.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Severe Coronavirus Disease (COVID-19)']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 3']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Quadruple',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", - " 'Care Provider',\n", - " 'Investigator',\n", - " 'Outcomes Assessor']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '230',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'CD24Fc Treatment',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Single dose at Day 1, CD24Fc, 480mg, diluted to 100ml with normal saline, IV infusion in 60 minutes.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: CD24Fc']}},\n", - " {'ArmGroupLabel': 'Placebo',\n", - " 'ArmGroupType': 'Placebo Comparator',\n", - " 'ArmGroupDescription': 'Single dose at Day 1, normal saline solution 100ml, IV infusion in 60 minutes.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'CD24Fc',\n", - " 'InterventionDescription': 'CD24Fc is given on Day 1.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['CD24Fc Treatment']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Human CD24 and human IgG Fc Fusion Protein']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Placebo',\n", - " 'InterventionDescription': 'Placebo is given on Day 1.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Placebo']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Saline']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Improvement of COVID-19 disease status',\n", - " 'PrimaryOutcomeDescription': 'Time to improve in clinical status: the time (days) required from the start of treatment to the improvement of clinical status \"severe\" to \"moderate/mild\"; or improvement from \"scale 3 or 4\" to \"scale 5 or higher\" based on NIAID ordinal scales.',\n", - " 'PrimaryOutcomeTimeFrame': '14 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Conversion rate of clinical status at Day 8',\n", - " 'SecondaryOutcomeDescription': 'Conversion rate of clinical status on days 8 (proportion of subjects who changed from \"severe\" to \"moderate or mild\", or the improvement from \"scale 3 or 4\" to \"scale 5 or higher\" on NIAID ordinal scale)',\n", - " 'SecondaryOutcomeTimeFrame': '7 days'},\n", - " {'SecondaryOutcomeMeasure': 'Conversion rate of clinical status at Day 15',\n", - " 'SecondaryOutcomeDescription': 'Conversion rate of clinical status on days 15 (proportion of subjects who changed from \"severe\" to \"moderate or mild\", or the improvement from \"scale 3 or 4\" to \"scale 5 or higher\" on NIAID ordinal scale)',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Hospital discharge time',\n", - " 'SecondaryOutcomeDescription': 'The discharge time or NEWS2 (National Early Warning Score 2) of ≤2 is maintained for 24 hours',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'All cause of death',\n", - " 'SecondaryOutcomeDescription': 'All cause of death',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Duration of mechanical ventilation',\n", - " 'SecondaryOutcomeDescription': 'Duration of mechanical ventilation (IMV, NIV) (days)',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Duration of pressors',\n", - " 'SecondaryOutcomeDescription': 'Duration of pressors (days)',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Duration of ECMO',\n", - " 'SecondaryOutcomeDescription': 'Duration of extracorporeal membrane oxygenation (days)',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Duration of oxygen therapy',\n", - " 'SecondaryOutcomeDescription': 'Duration of oxygen therapy (oxygen inhalation by nasal cannula or mask) (days)',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Length of hospital stay',\n", - " 'SecondaryOutcomeDescription': 'Length of hospital stay (days)',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Absolute lymphocyte count',\n", - " 'SecondaryOutcomeDescription': 'Changes of absolute lymphocyte count in peripheral blood',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nShould be at least 18 years of age,\\nMale or female,\\nDiagnosed with COVID-19 and confirmed SARS-coV-2 viral infection.\\nAble to sign the consent form.\\nSevere COVID-19 (Appendix A), or NIAID 7-point ordinal score 3 to 4 (requiring non-invasive ventilation or oxygen, a SpO2 /= 24 breaths/min), Appendix B).\\nThe absolute lymphocyte count is ≤ 0.8 × 10^9 / L (8x10^5 / mL, 800 / mm3).\\n\\nExclusion Criteria:\\n\\nPatients with COVID 19 in critical condition or ARDS (Appendix A) or NIAID 7-point ordinal score 2 (Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)).\\nPatients with bacterial / fungal infections.\\nPatients who are pregnant, breastfeeding, or have a positive pregnancy test result before enrollment.\\nSevere liver damage (Child-Pugh score ≥ C, AST> 5 times the upper limit).\\nPatients with known severe renal impairment (creatinine clearance ≤ 30 mL / min) or patients receiving continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.\\nWill be transferred to a non-study site hospital within 72 hours.\\nThe investigator believes that participating in the trial is not in the best interests of the patient, or the investigator considers unsuitable for enrollment (such as unpredictable risks or subject compliance issues).',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Pan Zheng, MD, PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '(202) 7516823',\n", - " 'CentralContactEMail': 'pzheng@oncoimmune.com'},\n", - " {'CentralContactName': 'Martin Devenport, PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '(410) 2070582',\n", - " 'CentralContactEMail': 'mdevenport@oncoimmune.com'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Shyamasundaran Kottilil',\n", - " 'OverallOfficialAffiliation': 'Institute of Human Virology, University of Maryland Baltimore',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Institute of Human Virology, University of Maryland Baltimore',\n", - " 'LocationCity': 'Baltimore',\n", - " 'LocationState': 'Maryland',\n", - " 'LocationZip': '21201',\n", - " 'LocationCountry': 'United States'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M20444',\n", - " 'InterventionBrowseLeafName': 'Pharmaceutical Solutions',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2209',\n", - " 'InterventionBrowseLeafName': 'Adjuvants, Immunologic',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 90,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04327349',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'IR.MAZUMS.REC.1399.7330'},\n", - " 'SecondaryIdInfoList': {'SecondaryIdInfo': [{'SecondaryId': 'IRCT20181104041551N1',\n", - " 'SecondaryIdType': 'Registry Identifier',\n", - " 'SecondaryIdDomain': 'Iranian Registry of Clinical Trials (IRCT)'}]},\n", - " 'Organization': {'OrgFullName': 'Mazandaran University of Medical Sciences',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial',\n", - " 'OfficialTitle': 'Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Enrolling by invitation',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 28, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 20, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'September 30, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 24, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 30, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 31, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 30, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 31, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Amir Shamshirian',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Mazandaran University of Medical Sciences'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Mazandaran University of Medical Sciences',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Coronavirus disease 2019 (COVID-19) was recognized as a pandemic on March 11, 2020 by the World Health Organization. The virus that causes COVID-19 (SARS-CoV-2) is easily transmitted through person to person and there is still no specific approach against the disease and mortality rate in severe cases is also significant. Therefore, finding effective treatment for the mortality of these patients is very important. In this study the investigators aim to determine the effect of Convalescent Plasma on COVID-19 patients Outcome through a Clinical Trial'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus Infections']},\n", - " 'KeywordList': {'Keyword': ['Coronavirus',\n", - " 'COVID-19',\n", - " 'SARS-CoV-2',\n", - " 'Severe acute respiratory syndrome coronavirus 2']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Not Applicable']},\n", - " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '30',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'COVID-19 Patients',\n", - " 'ArmGroupType': 'Other',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: Convalescent Plasma']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Biological',\n", - " 'InterventionName': 'Convalescent Plasma',\n", - " 'InterventionDescription': 'Intervention to evaluate convalescent plasma transfer to COVID-19 patients admitted to ICU',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['COVID-19 Patients']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Mortality changes in day 10',\n", - " 'PrimaryOutcomeDescription': 'Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.',\n", - " 'PrimaryOutcomeTimeFrame': '10 days after plasma transmission'},\n", - " {'PrimaryOutcomeMeasure': 'Mortality changes in day 30',\n", - " 'PrimaryOutcomeDescription': 'Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.',\n", - " 'PrimaryOutcomeTimeFrame': '30 days after plasma transmission'},\n", - " {'PrimaryOutcomeMeasure': 'Changes of C-reactive protein',\n", - " 'PrimaryOutcomeDescription': 'Measurement of CRP',\n", - " 'PrimaryOutcomeTimeFrame': 'Day 1'},\n", - " {'PrimaryOutcomeMeasure': 'Changes of C-reactive protein',\n", - " 'PrimaryOutcomeDescription': 'Measurement of CRP',\n", - " 'PrimaryOutcomeTimeFrame': 'Day 3'},\n", - " {'PrimaryOutcomeMeasure': 'Changes of C-reactive protein',\n", - " 'PrimaryOutcomeDescription': 'Measurement of CRP',\n", - " 'PrimaryOutcomeTimeFrame': 'Day 7'},\n", - " {'PrimaryOutcomeMeasure': 'Changes of Interleukin 6',\n", - " 'PrimaryOutcomeDescription': 'Measurement of IL-6',\n", - " 'PrimaryOutcomeTimeFrame': 'Day 1'},\n", - " {'PrimaryOutcomeMeasure': 'Changes of Interleukin 6',\n", - " 'PrimaryOutcomeDescription': 'Measurement of IL-6',\n", - " 'PrimaryOutcomeTimeFrame': 'Day 3'},\n", - " {'PrimaryOutcomeMeasure': 'Changes of Interleukin 6',\n", - " 'PrimaryOutcomeDescription': 'Measurement of IL-6',\n", - " 'PrimaryOutcomeTimeFrame': 'Day 7'},\n", - " {'PrimaryOutcomeMeasure': 'Changes of tumor necrosis factor-α',\n", - " 'PrimaryOutcomeDescription': 'Measurement of TNF-α',\n", - " 'PrimaryOutcomeTimeFrame': 'Day 1'},\n", - " {'PrimaryOutcomeMeasure': 'Changes of tumor necrosis factor-α',\n", - " 'PrimaryOutcomeDescription': 'Measurement of TNF-α',\n", - " 'PrimaryOutcomeTimeFrame': 'Day 3'},\n", - " {'PrimaryOutcomeMeasure': 'Changes of tumor necrosis factor-α',\n", - " 'PrimaryOutcomeDescription': 'Measurement of TNF-α',\n", - " 'PrimaryOutcomeTimeFrame': 'Day 7'},\n", - " {'PrimaryOutcomeMeasure': 'Changes of PaO2/FiO2 Ratio',\n", - " 'PrimaryOutcomeDescription': 'Partial pressure of arterial oxygen/Percentage of inspired oxygen',\n", - " 'PrimaryOutcomeTimeFrame': 'Day 1'},\n", - " {'PrimaryOutcomeMeasure': 'Changes of PaO2/FiO2 Ratio',\n", - " 'PrimaryOutcomeDescription': 'Partial pressure of arterial oxygen/Percentage of inspired oxygen',\n", - " 'PrimaryOutcomeTimeFrame': 'Day 3'},\n", - " {'PrimaryOutcomeMeasure': 'Changes of PaO2/FiO2 Ratio',\n", - " 'PrimaryOutcomeDescription': 'Partial pressure of arterial oxygen/Percentage of inspired oxygen',\n", - " 'PrimaryOutcomeTimeFrame': 'Day 7'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Changes of CD3',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of CD3',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of CD3',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of CD4',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of CD4',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of CD4',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of CD8',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of CD8',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of CD8',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of CD4/CD8 ratio',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of CD4/CD8 ratio',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of CD4/CD8 ratio',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of lymphocyte count',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of lymphocyte count',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of lymphocyte count',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of leukocyte count',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of leukocyte count',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of leukocyte count',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of alanine transaminase (ALT)',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of alanine transaminase (ALT)',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of alanine transaminase (ALT)',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of aspartate transaminase (AST)',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of aspartate transaminase (AST)',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of aspartate transaminase (AST)',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of alkaline phosphatase (ALP)',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of alkaline phosphatase (ALP)',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of alkaline phosphatase (ALP)',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of lactate dehydrogenase (LDH)',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of lactate dehydrogenase (LDH)',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of lactate dehydrogenase (LDH)',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of creatine phosphokinase (CPK)',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of creatine phosphokinase (CPK)',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of creatine phosphokinase (CPK)',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of Creatine kinase-MB (CK-MB)',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of Creatine kinase-MB (CK-MB)',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of Creatine kinase-MB (CK-MB)',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of Specific IgG',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 1'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of Specific IgG',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 3'},\n", - " {'SecondaryOutcomeMeasure': 'Changes of Specific IgG',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 7'},\n", - " {'SecondaryOutcomeMeasure': 'Radiological findings',\n", - " 'SecondaryOutcomeDescription': 'Computed tomography Scan and Chest X-Ray',\n", - " 'SecondaryOutcomeTimeFrame': 'Within 2 hours after admission'},\n", - " {'SecondaryOutcomeMeasure': 'Radiological findings',\n", - " 'SecondaryOutcomeDescription': 'Computed tomography Scan and Chest X-Ray',\n", - " 'SecondaryOutcomeTimeFrame': 'Day 14'},\n", - " {'SecondaryOutcomeMeasure': 'Number of days ventilated',\n", - " 'SecondaryOutcomeTimeFrame': 'Through study completion, an average of 2 weeks'},\n", - " {'SecondaryOutcomeMeasure': 'Length of hospitalization',\n", - " 'SecondaryOutcomeTimeFrame': 'Through study completion, an average of 2 weeks'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': \"Inclusion Criteria:\\n\\nRecipient:\\n\\nCOVID-19 Patients\\nConsent to attend the study\\nAge 30 to 70 years\\nDon't be intubated\\nPaO2 / FiO2 is above 200 or Spo2 is greater than 85%.\\n\\nDonator:\\n\\nComplete recovery from severe COVID-19 disease and hospital discharge\\nConsent to donate blood to the infected person\\nAge 30 to 60 years\\nHas normal CBC test results\\nNegative COVID-19 RT-PCR test\\n\\nExclusion Criteria:\\n\\nRecipient:\\n\\nA history of hypersensitivity to blood transfusions or its products\\nHistory of IgA deficiency\\nHeart failure or any other factor that prevents the transmission of of 500 ml plasma\\nEntering the intubation stage\\n\\nDonator:\\n\\nPatients infected with blood-borne viral / infectious diseases\\nUnderlying heart disease, low or high blood pressure, diabetes, epilepsy, and anything that may prohibit blood donation.\\nUse of banned drugs for blood donation (eg, ethertinate, acitretin, aliotretinoin, isotretinoin, antiandrogens, NSAIDs, etc.)\\nUse of different drugs\\nOther prohibited donations based on blood transfusion standards\",\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '30 Years',\n", - " 'MaximumAge': '70 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Majid Saeedi, Ph.D.',\n", - " 'OverallOfficialAffiliation': 'Vice-Chancellor for Research, Mazandaran University of Medical Sciences',\n", - " 'OverallOfficialRole': 'Study Chair'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Imam Khomeini Hospital, Mazandaran University of Medical Sciences',\n", - " 'LocationCity': 'Sari',\n", - " 'LocationState': 'Mazandaran',\n", - " 'LocationZip': '4816633131',\n", - " 'LocationCountry': 'Iran, Islamic Republic of'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", - " {'ConditionMeshId': 'D000045169',\n", - " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 91,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04308668',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'STUDY00009267'},\n", - " 'Organization': {'OrgFullName': 'University of Minnesota',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2',\n", - " 'OfficialTitle': 'Post-exposure Prophylaxis and Preemptive Therapy for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial',\n", - " 'Acronym': 'COVID-19 PEP'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 17, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 21, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'May 12, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 11, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 11, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 16, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'April 1, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", - " 'LastUpdatePostDateType': 'Estimate'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'University of Minnesota',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'University of Manitoba',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'University of Alberta',\n", - " 'CollaboratorClass': 'OTHER'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'Yes',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Study Objective:\\n\\nTo test if post-exposure prophylaxis with hydroxychloroquine can prevent symptomatic COVID-19 disease after known exposure to the SARS-CoV-2 coronavirus.\\nTo test if preemptive therapy with hydroxychloroquine early in the sypmptomatic COVID-19 disease course can prevent progression of persons with known symptomatic COVID19 disease, decrease hospitalization.',\n", - " 'DetailedDescription': 'Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging viral infection causing COVID19. The current strategy uses a public health model of identifying infected cases, isolation, and quarantine to stop transmission. Once exposed, observation is standard-of-care. Therapy is generally not given to persons who are not hospitalized.\\n\\nHydroxychloroquine may have antiviral effects against SARS-COV2 which may prevent COVID-19 disease or early preemptive therapy may decrease disease severity. This trial will use a modification of standard malaria dosing of hydroxychloroquine to provide post-exposure prophylaxis to prevent disease or preemptive therapy for those with early symptoms. People around the the United States and Canada can participate to help answer this critically important question. No in-person visits are needed.\\n\\nThis trial is targeting 5 groups of people NATIONWIDE to participate:\\n\\nIf you are symptomatic with a positive COVID-19 test within the first 4 days of symptoms and are not hospitalized; OR\\nIf you live with someone who has been diagnosed with COVID-19, with your last exposure within the last 4 days, and do not have any symptoms; OR\\nIf you live with someone who has been diagnosed with COVID-19, and your symptoms started within the last 4 days; OR\\nIf you are a healthcare worker or first responder with known exposure to someone with lab-confirmed COVID-19 within the last 4 days and do not have symptoms; OR\\nIf you are a healthcare worker or first responder and have compatible symptoms starting within the last 4 days;\\n\\nYou may participate if you live anywhere in the United States (including territories) or in the Canadian Provinces of Quebec, Manitoba, or Alberta.\\n\\nFor information on how to participate in the research trial, go to covidpep.umn.edu or email covid19@umn.edu for instructions. Please check your spam folder if you email.\\n\\nIn Canada, for trial information, please go to: www.covid-19research.ca'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Corona Virus Infection',\n", - " 'Acute Respiratory Distress Syndrome',\n", - " 'SARS-CoV Infection',\n", - " 'Coronavirus',\n", - " 'Coronavirus Infections']},\n", - " 'KeywordList': {'Keyword': ['COVID-19',\n", - " 'Corona Virus',\n", - " 'SARS-COV-2',\n", - " 'Coronavirus']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 3']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignInterventionModelDescription': 'Asymptomatic participants are randomized and analyzed separate from symptomatic participants.',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Quadruple',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant',\n", - " 'Care Provider',\n", - " 'Investigator',\n", - " 'Outcomes Assessor']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '3000',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Treatment',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Participants in this arm will receive the study drug.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Hydroxychloroquine']}},\n", - " {'ArmGroupLabel': 'Placebo',\n", - " 'ArmGroupType': 'Placebo Comparator',\n", - " 'ArmGroupDescription': 'Participants in this arm will receive a placebo treatment.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Other: Placebo']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Hydroxychloroquine',\n", - " 'InterventionDescription': '200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Treatment']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Plaquenil']}},\n", - " {'InterventionType': 'Other',\n", - " 'InterventionName': 'Placebo',\n", - " 'InterventionDescription': '4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Placebo']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Incidence of COVID19 Disease among those who are asymptomatic at trial entry',\n", - " 'PrimaryOutcomeDescription': 'Number of participants at 14 days post enrollment with active COVID19 disease.',\n", - " 'PrimaryOutcomeTimeFrame': '14 days'},\n", - " {'PrimaryOutcomeMeasure': 'Ordinal Scale of COVID19 Disease Severity at 14 days among those who are symptomatic at trial entry',\n", - " 'PrimaryOutcomeDescription': 'Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the percent of participants who fall into each category per arm.',\n", - " 'PrimaryOutcomeTimeFrame': '14 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Incidence of Hospitalization',\n", - " 'SecondaryOutcomeDescription': 'Outcome reported as the number of participants in each arm who require hospitalization for COVID19-related disease.',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Incidence of Death',\n", - " 'SecondaryOutcomeDescription': 'Outcome reported as the number of participants in each arm who expire due to COVID-19-related disease.',\n", - " 'SecondaryOutcomeTimeFrame': '90 days'},\n", - " {'SecondaryOutcomeMeasure': 'Incidence of Confirmed SARS-CoV-2 Detection',\n", - " 'SecondaryOutcomeDescription': 'Outcome reported as the number of participants in each arm who have confirmed SARS-CoV-2 infection.',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Incidence of Symptoms Compatible with COVID19 (possible disease)',\n", - " 'SecondaryOutcomeDescription': 'Outcome reported as the number of participants in each arm who self-report symptoms compatible with COVID19 infection.',\n", - " 'SecondaryOutcomeTimeFrame': '90 days'},\n", - " {'SecondaryOutcomeMeasure': 'Incidence of All-Cause Study Medicine Discontinuation or Withdrawal',\n", - " 'SecondaryOutcomeDescription': 'Outcome reported as the number of participants in each arm who discontinue or withdraw medication use for any reason.',\n", - " 'SecondaryOutcomeTimeFrame': '14 days'},\n", - " {'SecondaryOutcomeMeasure': 'Overall symptom severity at 5 and 14 day',\n", - " 'SecondaryOutcomeDescription': 'Visual Analog Scale 0-10 score of rating overall symptom severity (0 = no symptoms; 10 = most severe)',\n", - " 'SecondaryOutcomeTimeFrame': '5 and 14 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nProvision of informed consent\\nExposure to a COVID19 case within 4 days as either a healthcare worker or household contact, OR\\nSymptomatic COVID19 case with confirmed diagnosis within 4 days of symptom onset OR symptomatic healthcare worker with known COVID19 contact and within 4 days of symptom onset;\\n\\nExclusion Criteria:\\n\\nCurrent hospitalization\\nAllergy to hydroxychloroquine\\nRetinal eye disease\\nKnown glucose-6 phosphate dehydrogenase (G-6-PD) deficiency\\nKnown chronic kidney disease, stage 4 or 5 or receiving dialysis\\nWeight < 40 kg\\nKnown Porphyria\\nCurrent use of: hydroxychloroquine or cardiac medicines of: flecainide, Tambocor; amiodarone, Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or Procan, Procanbid, propafenone, Rythmal)',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'David Boulware (Please email), MD, MPH',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '6126249996',\n", - " 'CentralContactEMail': 'covid19@umn.edu'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'David Boulware, MD, MPH',\n", - " 'OverallOfficialAffiliation': 'University of Minnesota',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Nationwide Enrollment via Internet, please email: covid19@umn.edu',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Minneapolis',\n", - " 'LocationState': 'Minnesota',\n", - " 'LocationZip': '55455',\n", - " 'LocationCountry': 'United States',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'David Boulware',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactEMail': 'covid19@umn.edu'}]}},\n", - " {'LocationFacility': 'University of Minnesota',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Minneapolis',\n", - " 'LocationState': 'Minnesota',\n", - " 'LocationZip': '55455',\n", - " 'LocationCountry': 'United States',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'David R Boulware, MD, MPH',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactEMail': 'covid19@umn.edu'},\n", - " {'LocationContactName': 'Matt Pullen, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Sarah Lofgren, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Caleb Skipper, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Radha Rajasingham, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Mahsa Abassi, DO, MPH',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Ananta Bangdiwala, MS',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Kathy Hullsiek, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Katelyn Pastick',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Elizabeth Okafor',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'Internet',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'New York',\n", - " 'LocationState': 'New York',\n", - " 'LocationZip': '10001',\n", - " 'LocationCountry': 'United States',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'David Boulware, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactEMail': 'covid19@umn.edu'}]}},\n", - " {'LocationFacility': 'University of Alberta',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Edmonton',\n", - " 'LocationState': 'Alberta',\n", - " 'LocationCountry': 'Canada',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Ilan Schwartz, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactEMail': 'alberta@idtrials.com'}]}},\n", - " {'LocationFacility': 'University of Manitoba',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Winnipeg',\n", - " 'LocationState': 'Manitoba',\n", - " 'LocationCountry': 'Canada',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Ryan Zarychanski, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactEMail': 'manitoba@idtrials.com'},\n", - " {'LocationContactName': 'Lauren E Kelly, PhD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactEMail': 'manitoba@idtrials.com'},\n", - " {'LocationContactName': 'Glen Drobot, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Lauren MacKenzie, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Sylvain Lother, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'Research Institute of the McGill University Heath Centre',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Montréal',\n", - " 'LocationState': 'Quebec',\n", - " 'LocationCountry': 'Canada',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Todd C Lee, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '5149341934',\n", - " 'LocationContactPhoneExt': '32965',\n", - " 'LocationContactEMail': 'quebec@idtrials.com'},\n", - " {'LocationContactName': 'Emily G McDonald, MDCM MSc',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Matthew P Chang, MDCM',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Alek Lefebvre',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", - " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", - " 'InterventionAncestorTerm': 'Antimalarials'},\n", - " {'InterventionAncestorId': 'D000000981',\n", - " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", - " {'InterventionAncestorId': 'D000000977',\n", - " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", - " {'InterventionAncestorId': 'D000000890',\n", - " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", - " {'InterventionAncestorId': 'D000004791',\n", - " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M8523',\n", - " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M2861',\n", - " 'InterventionBrowseLeafName': 'Antimalarials',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2879',\n", - " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2875',\n", - " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2795',\n", - " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19188',\n", - " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", - " 'ConditionMeshTerm': 'Infection'},\n", - " {'ConditionMeshId': 'D000003141',\n", - " 'ConditionMeshTerm': 'Communicable Diseases'},\n", - " {'ConditionMeshId': 'D000018352',\n", - " 'ConditionMeshTerm': 'Coronavirus Infections'},\n", - " {'ConditionMeshId': 'D000045169',\n", - " 'ConditionMeshTerm': 'Severe Acute Respiratory Syndrome'},\n", - " {'ConditionMeshId': 'D000012127',\n", - " 'ConditionMeshTerm': 'Respiratory Distress Syndrome, Newborn'},\n", - " {'ConditionMeshId': 'D000012128',\n", - " 'ConditionMeshTerm': 'Respiratory Distress Syndrome, Adult'},\n", - " {'ConditionMeshId': 'D000055371',\n", - " 'ConditionMeshTerm': 'Acute Lung Injury'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000008171',\n", - " 'ConditionAncestorTerm': 'Lung Diseases'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", - " {'ConditionAncestorId': 'D000012120',\n", - " 'ConditionAncestorTerm': 'Respiration Disorders'},\n", - " {'ConditionAncestorId': 'D000007235',\n", - " 'ConditionAncestorTerm': 'Infant, Premature, Diseases'},\n", - " {'ConditionAncestorId': 'D000007232',\n", - " 'ConditionAncestorTerm': 'Infant, Newborn, Diseases'},\n", - " {'ConditionAncestorId': 'D000014777',\n", - " 'ConditionAncestorTerm': 'Virus Diseases'},\n", - " {'ConditionAncestorId': 'D000055370',\n", - " 'ConditionAncestorTerm': 'Lung Injury'},\n", - " {'ConditionAncestorId': 'D000003333',\n", - " 'ConditionAncestorTerm': 'Coronaviridae Infections'},\n", - " {'ConditionAncestorId': 'D000030341',\n", - " 'ConditionAncestorTerm': 'Nidovirales Infections'},\n", - " {'ConditionAncestorId': 'D000012327',\n", - " 'ConditionAncestorTerm': 'RNA Virus Infections'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafAsFound': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M24032',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Corona Virus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafAsFound': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13547',\n", - " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Newborn',\n", - " 'ConditionBrowseLeafAsFound': 'Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M13548',\n", - " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Adult',\n", - " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M26731',\n", - " 'ConditionBrowseLeafName': 'Acute Lung Injury',\n", - " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M26730',\n", - " 'ConditionBrowseLeafName': 'Lung Injury',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M9751',\n", - " 'ConditionBrowseLeafName': 'Lung Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13540',\n", - " 'ConditionBrowseLeafName': 'Respiration Disorders',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M24456',\n", - " 'ConditionBrowseLeafName': 'Premature Birth',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8862',\n", - " 'ConditionBrowseLeafName': 'Infant, Premature, Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8859',\n", - " 'ConditionBrowseLeafName': 'Infant, Newborn, Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Corona Virus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'T4953',\n", - " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Infant',\n", - " 'ConditionBrowseLeafAsFound': 'Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'T191',\n", - " 'ConditionBrowseLeafName': 'Acute Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC16',\n", - " 'ConditionBrowseBranchName': 'Diseases and Abnormalities at or Before Birth'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC26',\n", - " 'ConditionBrowseBranchName': 'Wounds and Injuries'},\n", - " {'ConditionBrowseBranchAbbrev': 'BXS',\n", - " 'ConditionBrowseBranchName': 'Urinary Tract, Sexual Organs, and Pregnancy Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}},\n", - " {'Rank': 92,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04326725',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '2020-2/1'},\n", - " 'Organization': {'OrgFullName': 'Istinye University',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Proflaxis Using Hydroxychloroquine Plus Vitamins-Zinc During COVID-19 Pandemia',\n", - " 'OfficialTitle': 'Proflaxis for Healthcare Professionals Using Hydroxychloroquine Plus Vitamin Combining Vitamins A, C, D and Zinc During COVID-19 Pandemia: An Observational Study'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 20, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'July 1, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'September 1, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 26, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 27, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 30, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 27, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 30, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Mehmet Mahir Ozmen',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Professor of Surgery, Department of Surgery',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Istinye University'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Istinye University',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'Yes',\n", - " 'IsFDARegulatedDevice': 'No',\n", - " 'IsUSExport': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Healthcare professionals mainly doctors, nurses and their first degree relatives (spouse, father, mother, sister, brother, child) who have been started hydroxychloroquine(plaquenil) 200mg single dose repeated every three weeks plus vitaminC including zinc once a day were included in the study. Study has conducted on 20th of march. Main purpose of the study was to cover participants those who are facing or treating COVID19 infected patients in Ankara.',\n", - " 'DetailedDescription': 'Healthcare professionals mainly doctors, nurses and their first degree relatives (spouse, father, mother, sister, brother, child) who have been started hydroxychloroquine(plaquenil) 200mg single dose repeated every three weeks plus vitaminC including zinc once a day were included in the study. Study has conducted on 20th of march. Main purpose of the study was to cover participants those who are facing or treating COVID19 infected patients.PArticipants, age, sex, BMI, smoking history, comorbid disease were also registered.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['to Evaluate the Efficacy of Hydroxychloroquine Plus vitACD-Zinc as Prevention for COVID19 Infection']},\n", - " 'KeywordList': {'Keyword': ['Hydroxychloroquine',\n", - " 'coronavirus',\n", - " 'prophylaxis',\n", - " 'healthcare professional',\n", - " 'outbreak']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Case-Control']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '80',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Hydroxychloroquine',\n", - " 'ArmGroupDescription': 'Subjects with prophylaxis',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Plaquenil 200Mg Tablet']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Plaquenil 200Mg Tablet',\n", - " 'InterventionDescription': 'health workers under risk who took this medications',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Hydroxychloroquine']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Redoxan']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Protection against COVID-19',\n", - " 'PrimaryOutcomeDescription': 'persons who took this medication should not have an infection',\n", - " 'PrimaryOutcomeTimeFrame': '4 months'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria: 1.person who are working as health professional 2. Their first degree relatives( child, spouse or parents)\\n\\nExclusion Criteria: 1. Already using plaquenil for other reasons(RA etc) 2. person with the diagnosis of COVID infection 3.Person with the condition may cause complications with this medication (severe CVD, av block, already has ophtalmological complications, organ failure of any degree etc)\\n\\n-',\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '20 Years',\n", - " 'MaximumAge': '90 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'Mainly doctors, nurses, health workers in the hospital whereby they have close contacts with possile COVID-19 infected patients were included. Their first degree relatives(spouse, child, parents)',\n", - " 'SamplingMethod': 'Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Mahir M Ozmen, Professor',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+905324246838',\n", - " 'CentralContactEMail': 'ozmenmm@gmail.com'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Istinye University Medical School',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Istanbul',\n", - " 'LocationZip': '34010',\n", - " 'LocationCountry': 'Turkey',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Istinye University M ozmen, Prof',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+905324246838',\n", - " 'LocationContactEMail': 'mahir.ozmen@istinye.edu.tr'}]}}]}},\n", - " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '32145363',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Colson P, Rolain JM, Lagier JC, Brouqui P, Raoult D. Chloroquine and hydroxychloroquine as available weapons to fight COVID-19. Int J Antimicrob Agents. 2020 Mar 4:105932. doi: 10.1016/j.ijantimicag.2020.105932. [Epub ahead of print]'},\n", - " {'ReferencePMID': '32171740',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Devaux CA, Rolain JM, Colson P, Raoult D. New insights on the antiviral effects of chloroquine against coronavirus: what to expect for COVID-19? Int J Antimicrob Agents. 2020 Mar 11:105938. doi: 10.1016/j.ijantimicag.2020.105938. [Epub ahead of print]'},\n", - " {'ReferencePMID': '32173110',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Cortegiani A, Ingoglia G, Ippolito M, Giarratano A, Einav S. A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19. J Crit Care. 2020 Mar 10. pii: S0883-9441(20)30390-7. doi: 10.1016/j.jcrc.2020.03.005. [Epub ahead of print]'},\n", - " {'ReferencePMID': '32074550',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Gao J, Tian Z, Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends. 2020 Mar 16;14(1):72-73. doi: 10.5582/bst.2020.01047. Epub 2020 Feb 19.'},\n", - " {'ReferencePMID': '32147628',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Dong L, Hu S, Gao J. Discovering drugs to treat coronavirus disease 2019 (COVID-19). Drug Discov Ther. 2020;14(1):58-60. doi: 10.5582/ddt.2020.01012.'},\n", - " {'ReferencePMID': '32117569',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Kruse RL. Therapeutic strategies in an outbreak scenario to treat the novel coronavirus originating in Wuhan, China. F1000Res. 2020 Jan 31;9:72. doi: 10.12688/f1000research.22211.2. eCollection 2020. Review.'},\n", - " {'ReferencePMID': '32092748',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Song P, Karako T. COVID-19: Real-time dissemination of scientific information to fight a public health emergency of international concern. Biosci Trends. 2020 Mar 16;14(1):1-2. doi: 10.5582/bst.2020.01056. Epub 2020 Feb 25.'},\n", - " {'ReferencePMID': '32139372',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Lake MA. What we know so far: COVID-19 current clinical knowledge and research. Clin Med (Lond). 2020 Mar;20(2):124-127. doi: 10.7861/clinmed.2019-coron. Epub 2020 Mar 5. Review.'},\n", - " {'ReferencePMID': '32178711',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Cunningham AC, Goh HP, Koh D. Treatment of COVID-19: old tricks for new challenges. Crit Care. 2020 Mar 16;24(1):91. doi: 10.1186/s13054-020-2818-6.'},\n", - " {'ReferencePMID': '29737455',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Plantone D, Koudriavtseva T. Current and Future Use of Chloroquine and Hydroxychloroquine in Infectious, Immune, Neoplastic, and Neurological Diseases: A Mini-Review. Clin Drug Investig. 2018 Aug;38(8):653-671. doi: 10.1007/s40261-018-0656-y. Review.'}]}}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000014815',\n", - " 'InterventionMeshTerm': 'Vitamins'},\n", - " {'InterventionMeshId': 'D000006886',\n", - " 'InterventionMeshTerm': 'Hydroxychloroquine'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000018977',\n", - " 'InterventionAncestorTerm': 'Micronutrients'},\n", - " {'InterventionAncestorId': 'D000078622',\n", - " 'InterventionAncestorTerm': 'Nutrients'},\n", - " {'InterventionAncestorId': 'D000006133',\n", - " 'InterventionAncestorTerm': 'Growth Substances'},\n", - " {'InterventionAncestorId': 'D000045505',\n", - " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", - " {'InterventionAncestorId': 'D000000962',\n", - " 'InterventionAncestorTerm': 'Antimalarials'},\n", - " {'InterventionAncestorId': 'D000000981',\n", - " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", - " {'InterventionAncestorId': 'D000000977',\n", - " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", - " {'InterventionAncestorId': 'D000000890',\n", - " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", - " {'InterventionAncestorId': 'D000004791',\n", - " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M16141',\n", - " 'InterventionBrowseLeafName': 'Vitamins',\n", - " 'InterventionBrowseLeafAsFound': 'Vitamin',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M8523',\n", - " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M16351',\n", - " 'InterventionBrowseLeafName': 'Zinc',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M16127',\n", - " 'InterventionBrowseLeafName': 'Vitamin A',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M217588',\n", - " 'InterventionBrowseLeafName': 'Retinol palmitate',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M15468',\n", - " 'InterventionBrowseLeafName': 'Trace Elements',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19593',\n", - " 'InterventionBrowseLeafName': 'Micronutrients',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M1986',\n", - " 'InterventionBrowseLeafName': 'Nutrients',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2861',\n", - " 'InterventionBrowseLeafName': 'Antimalarials',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2879',\n", - " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2875',\n", - " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2795',\n", - " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19188',\n", - " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'T462',\n", - " 'InterventionBrowseLeafName': 'Retinol',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'T468',\n", - " 'InterventionBrowseLeafName': 'Vitamin A',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Micro',\n", - " 'InterventionBrowseBranchName': 'Micronutrients'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", - " {'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ANeo',\n", - " 'InterventionBrowseBranchName': 'Antineoplastic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'Vi',\n", - " 'InterventionBrowseBranchName': 'Vitamins'}]}},\n", - " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'}]}}}}},\n", - " {'Rank': 93,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04325633',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'APHP200387'},\n", - " 'Organization': {'OrgFullName': 'Assistance Publique - Hôpitaux de Paris',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Efficacy of Addition of Naproxen in the Treatment of Critically Ill Patients Hospitalized for COVID-19 Infection',\n", - " 'OfficialTitle': 'Efficacy of Addition of Naproxen in the Treatment of Critically Ill Patients Hospitalized for COVID-19 Infection',\n", - " 'Acronym': 'ENACOVID'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 27, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 27, 2021',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'June 27, 2021',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 26, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 26, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 27, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 26, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 27, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Assistance Publique - Hôpitaux de Paris',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'The symptoms of respiratory distress caused by COVID-19 may be reduced by drugs combining anti-inflammatory and antiviral effects. This dual effect may simultaneously protect severely-ill patients and reduce the viral load, therefore limiting virus dissemination We want to demonstrate the superiority of naproxen (anti-inflamatory drug) treatment addition to standard of care compared to standard of care in term of 30-day mortality.',\n", - " 'DetailedDescription': 'Coronavirus Disease 2019 (COVID-19) is due to SARS-CoV-2 infection. (1,2) The exacerbated inflammatory response in COVID-19 infected critically ill patients calls for appropriate anti inflammatory therapeutics combined with antiviral effects. Thus, drugs combining anti-inflammatory and antiviral effects may reduce the symptoms of respiratory distress caused by COVID-19. This dual effect may simultaneously protect severely ill patients and reduce the viral load, therefore limiting virus dissemination. Naproxen, an approved anti-inflammatory drug, is an inhibitor of both cyclo oxygenase (COX-2) and of Influenza A virus nucleoprotein (NP). The NP of Coronavirus (CoV), positive-sense single-stranded viruses, share with negative-sense single-stranded viruses as Influenza the ability to bind to- and protect genomic RNA by forming self-associated oligomers in a helical structure with RNA. Naproxen was shown to bind the Influenza A virus NP making electrostatic and hydrophobic interactions with conserved residues of the RNA binding groove and C terminal domain. (3) Consequently, naproxen binding competed with NP association with viral RNA and impeded the NP self-association process which strongly reduced viral transcription/replication. This drug may have the potential to present antiviral properties against SARS-CoV-2 suggested by modelling work based on the structures of CoV NP. The high sequence conservation within the coronavirus family, including severe acute respiratory syndrome (SARS-CoV) and the present SARSCoV-2 coronavirus allows to perform this comparison. (4) A recent clinical trial shown that the combination of clarithromycin, naproxen and oseltamivir reduced mortality of patients hospitalized for H3N2 Influenza infection. (5). Inappropriate inflammatory response in CODIV-19 patients was demonstrated in a recent study where Intensive Care Unit (ICU) patients had higher plasma levels of IL2, IL7, IL10, GSCF, IP10, MCP1, MIP1A, and TNF? compared with non-ICU patients.(2) We suggest that naproxen could combine a broad-spectrum antiviral activity with its well-known anti inflammatory action that could help reducing severe respiratory mortality associated with COVID-19.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']},\n", - " 'KeywordList': {'Keyword': ['COVID-19',\n", - " 'SARS-COV-2',\n", - " 'Naproxen',\n", - " 'Nonsteroidal anti-inflamatory drug']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 3']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '584',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': '1: Naproxen',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Administration of naproxen 250 mg twice and lansoprazole 30 mg daily for prevention of gastropathy induced by stress or a nonsteroidal anti-inflammatory drug (NSAID) in addition to standard of care (SOC)',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: 1: Naproxen',\n", - " 'Drug: 2: Standard of care']}},\n", - " {'ArmGroupLabel': '2: Standard of care',\n", - " 'ArmGroupType': 'Placebo Comparator',\n", - " 'ArmGroupDescription': 'Standard of care',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: 2: Standard of care']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': '1: Naproxen',\n", - " 'InterventionDescription': 'Description : Administration of naproxen 250 mg twice and lansoprazole 30 mg daily for prevention of gastropathy induced by stress or a nonsteroidal anti-inflammatory drug (NSAID) in addition to standard of care (SOC)',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['1: Naproxen']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': '2: Standard of care',\n", - " 'InterventionDescription': 'Standard of care',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['1: Naproxen',\n", - " '2: Standard of care']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Mortality all causes at day30',\n", - " 'PrimaryOutcomeTimeFrame': 'at day30'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Number of days alive free of mechanical ventilation',\n", - " 'SecondaryOutcomeTimeFrame': 'during 30 days after randomization'},\n", - " {'SecondaryOutcomeMeasure': 'Number of days alive outside',\n", - " 'SecondaryOutcomeTimeFrame': 'during 30 days after randomization'},\n", - " {'SecondaryOutcomeMeasure': 'Number of days alive outside hospital',\n", - " 'SecondaryOutcomeTimeFrame': 'during 30 days after randomization'},\n", - " {'SecondaryOutcomeMeasure': 'Maximal changes in Sofa score',\n", - " 'SecondaryOutcomeTimeFrame': 'in the first 7 days after randomization'},\n", - " {'SecondaryOutcomeMeasure': 'Time to negativation of virus titer in the nasopharyngeal aspirate (NPA)',\n", - " 'SecondaryOutcomeTimeFrame': 'during 90 days after randomization'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nCOVID-19 infected patient\\nAge 18 years or older\\nPresence of pneumonia\\nPaO2/FiO2 < 300 mm Hg or SpO2 < 93% in air ambient or need to supplementary oxygen administration in order to maintain SpO2 range in [94-98%] or lung infiltrates > 50%\\nMedical insurance\\n\\nExclusion Criteria:\\n\\nPresence of do-not-resuscitate order\\nPregnancy\\nPrisoners\\nKnown Naproxen allergy or intolerance\\nSevere renal failure',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Frédéric ADNET, MD, PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+33 1-48-96-44-08',\n", - " 'CentralContactEMail': 'frederic.adnet@aphp.fr'},\n", - " {'CentralContactName': 'Anny SLAMA SCHWOK, MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactEMail': 'anny.slama-schwok@inserm.fr'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Frédéric ADNET, MD, PhD',\n", - " 'OverallOfficialAffiliation': 'Assistance Publique - Hôpitaux de Paris',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]}}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000009288',\n", - " 'InterventionMeshTerm': 'Naproxen'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000894',\n", - " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents, Non-Steroidal'},\n", - " {'InterventionAncestorId': 'D000018712',\n", - " 'InterventionAncestorTerm': 'Analgesics, Non-Narcotic'},\n", - " {'InterventionAncestorId': 'D000000700',\n", - " 'InterventionAncestorTerm': 'Analgesics'},\n", - " {'InterventionAncestorId': 'D000018689',\n", - " 'InterventionAncestorTerm': 'Sensory System Agents'},\n", - " {'InterventionAncestorId': 'D000018373',\n", - " 'InterventionAncestorTerm': 'Peripheral Nervous System Agents'},\n", - " {'InterventionAncestorId': 'D000045505',\n", - " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", - " {'InterventionAncestorId': 'D000000893',\n", - " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'},\n", - " {'InterventionAncestorId': 'D000006074',\n", - " 'InterventionAncestorTerm': 'Gout Suppressants'},\n", - " {'InterventionAncestorId': 'D000016861',\n", - " 'InterventionAncestorTerm': 'Cyclooxygenase Inhibitors'},\n", - " {'InterventionAncestorId': 'D000004791',\n", - " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M2798',\n", - " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M10822',\n", - " 'InterventionBrowseLeafName': 'Naproxen',\n", - " 'InterventionBrowseLeafAsFound': 'Naproxen',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M28967',\n", - " 'InterventionBrowseLeafName': 'Dexlansoprazole',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M28966',\n", - " 'InterventionBrowseLeafName': 'Lansoprazole',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2799',\n", - " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents, Non-Steroidal',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2613',\n", - " 'InterventionBrowseLeafName': 'Analgesics',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19370',\n", - " 'InterventionBrowseLeafName': 'Analgesics, Non-Narcotic',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19188',\n", - " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M17792',\n", - " 'InterventionBrowseLeafName': 'Cyclooxygenase Inhibitors',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", - " {'InterventionBrowseBranchAbbrev': 'Infl',\n", - " 'InterventionBrowseBranchName': 'Anti-Inflammatory Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'Analg',\n", - " 'InterventionBrowseBranchName': 'Analgesics'},\n", - " {'InterventionBrowseBranchAbbrev': 'Gast',\n", - " 'InterventionBrowseBranchName': 'Gastrointestinal Agents'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000016638',\n", - " 'ConditionMeshTerm': 'Critical Illness'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000020969',\n", - " 'ConditionAncestorTerm': 'Disease Attributes'},\n", - " {'ConditionAncestorId': 'D000010335',\n", - " 'ConditionAncestorTerm': 'Pathologic Processes'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M17593',\n", - " 'ConditionBrowseLeafName': 'Critical Illness',\n", - " 'ConditionBrowseLeafAsFound': 'Critically Ill',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M21284',\n", - " 'ConditionBrowseLeafName': 'Disease Attributes',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'}]}}}}},\n", - " {'Rank': 94,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04333732',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': '202004xxx'},\n", - " 'Organization': {'OrgFullName': 'Washington University School of Medicine',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'CROWN CORONATION: Chloroquine RepurpOsing to healthWorkers for Novel CORONAvirus mitigaTION',\n", - " 'OfficialTitle': 'A Phase 2, International Multi-site, Bayesian Adaptive, Randomised, Double-blinded, Placebo-controlled Trial Assessing the Effectiveness of Varied Doses of Oral Chloroquine in Preventing or Reducing the Severity of COVID-19 Disease in Healthcare Workers',\n", - " 'Acronym': 'CROWN CORONA'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'February 2021',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'February 2021',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 31, 2020',\n", - " 'StudyFirstSubmitQCDate': 'April 2, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'April 3, 2020',\n", - " 'StudyFirstPostDateType': 'Estimate'},\n", - " 'LastUpdateSubmitDate': 'April 2, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", - " 'LastUpdatePostDateType': 'Estimate'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Michael Avidan',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Professor of Anesthesiology and Surgery',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Washington University School of Medicine'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Washington University School of Medicine',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'Yes',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Healthcare workers are at the frontline of the fight against COVID-19, and as such they are at high risk for infection and possibly for serious infection, linked to the extent of their exposure. The CROWN CORONATION trial prioritizes the protection of healthcare workers as a strategy to prevent collapse of healthcare services.',\n", - " 'DetailedDescription': 'CROWN CORONATION is a large, Bayesian adaptive, pragmatic, participant-level randomized, multi-center, transdisciplinary, international placebo-controlled trial. It has been designed in accordance with CONSORT guidelines. Randomization will be stratified by age (<50 and ≥50) and study site. Participants will be healthcare workers at risk for contracting SARS-CoV-2. Participants will be randomized into one of four arms:\\n\\nLow-dose (300mg chloroquine base weekly);\\nMedium-dose (300mg chloroquine base twice weekly);\\nHigh-dose (150 mg chloroquine base daily);\\nPlacebo.\\n\\nIn all treatment arms, an induction dose of 1200mg chloroquine or hydroxychloroquine base (or equivalent number of placebo tablets in the placebo arm) will be taken in 4 divided daily doses (that is 300mg chloroquine or hydroxychloroquine base per day for four days) before starting the low, medium, or high dose regimen .\\n\\nIn certain countries (especially where malaria is not endemic), hydroxychloroquine is more readily available and will be used instead of chloroquine. Based on in vitro studies and reviews of drug toxicity , we consider 150mg of hydroxychloroquine base to be equivalent to 150mg of chloroquine base in terms of efficacy. New dosage-based arm(s) might be added or removed. The trial will evaluate which of the intervention arms is most effective at decreasing the incidence of severe COVID-19 disease, without unacceptable side effects or safety events.\\n\\nParticipants will complete weekly (smart phone- based) data logs, and follow- up information will be collected until 2 months after enrolment or death. In addition, where possible, we will use telemedicine approaches to collection information on participants. The study flow overview is outlined in Figure 4. We will provide adherence support interventions that have worked and been tested for Human Immunodeficiency Virus Pre-Exposure Prophylaxis (HIV PrEP) (e.g. two-way SMS with check in for those that report symptoms or adverse events). On enrollment, the local trial team will create a new electronic case record from (CRF) on the web-based study database and record basic demographic information. The database will be hosted on UK based servers managed by Net Solving Ltd. Local investigators will have access to the part of the CRF to enable recording of outcome data and/or severity of COVID-19 symptoms. Participants will be given a secure login to enable them to complete an initial participant health questionnaire and the daily data logs.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID 19']},\n", - " 'KeywordList': {'Keyword': ['COVID 19',\n", - " 'Health care workers',\n", - " 'hydroxychloroquine',\n", - " 'chloroquine']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 2']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignInterventionModelDescription': 'A international, multi-site, randomized, double-blinded, placebo-controlled clinical effectiveness',\n", - " 'DesignPrimaryPurpose': 'Prevention',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'Single',\n", - " 'DesignWhoMaskedList': {'DesignWhoMasked': ['Participant']}}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '55000',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': '● Low-dose (300mg chloroquine base weekly)',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Placebo 1 administered orally once daily, Placebo 2 administered orally once weekly, Chloroquine base 300 mg administered orally as chloroquine or hydroxychloroquine once weekly. The decision of whether to offer chloroquine or hydroxychloroquine will be based on local availability.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Low-dose chloroquine/hydroxychloroquine']}},\n", - " {'ArmGroupLabel': '● Medium-dose (300mg chloroquine base twice weekly)',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Placebo 1 administered orally once daily, Chloroquine base 300 mg administered orally as chloroquine or hydroxychloroquine twice weekly',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Mid dose chloroquine or hydroxychloroquine']}},\n", - " {'ArmGroupLabel': '● High-dose (150 mg chloroquine base daily)',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Chloroquine base 150 mg administered orally once daily either a chloroquine or hydroxychloroquine, Placebo 2 administered orally once weekly, Placebo 3 administered orally once weekly',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: High does chloroquine or hydroxychloroquine']}},\n", - " {'ArmGroupLabel': 'Placebo',\n", - " 'ArmGroupType': 'Placebo Comparator',\n", - " 'ArmGroupDescription': 'Placebo 1 administered orally once daily, Placebo 2 administered orally once weekly, Placebo 3 administered orally once weekly',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Placebo']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Low-dose chloroquine/hydroxychloroquine',\n", - " 'InterventionDescription': 'In all treatment arms, an induction dose of 1200mg chloroquine or hydroxychloroquine base (or equivalent number of placebo tablets) will be taken in 4 divided daily doses (that is 300mg chloroquine or hydroxychloroquine base per day for four days) before starting the low, medium, or high dose regimen.\\n\\nPlacebo 1 administered orally once daily, Placebo 2 administered orally once weekly, Chloroquine base 300 mg administered orally as chloroquine or hydroxychloroquine once weekly. The decision of whether to offer chloroquine or hydroxychloroquine will be based on local availability.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['● Low-dose (300mg chloroquine base weekly)']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Aralen or Plaquenil']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Mid dose chloroquine or hydroxychloroquine',\n", - " 'InterventionDescription': 'In all treatment arms, an induction dose of 1200mg chloroquine or hydroxychloroquine base (or equivalent number of placebo tablets) will be taken in 4 divided daily doses (that is 300mg chloroquine or hydroxychloroquine base per day for four days) before starting the low, medium, or high dose regimen.\\n\\nPlacebo 1 administered orally once daily, Chloroquine base 300 mg administered orally as chloroquine or hydroxychloroquine twice weekly',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['● Medium-dose (300mg chloroquine base twice weekly)']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Aralen or Plaquenil']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'High does chloroquine or hydroxychloroquine',\n", - " 'InterventionDescription': 'In all treatment arms, an induction dose of 1200mg chloroquine or hydroxychloroquine base (or equivalent number of placebo tablets) will be taken in 4 divided daily doses (that is 300mg chloroquine or hydroxychloroquine base per day for four days) before starting the low, medium, or high dose regimen.\\n\\nIn all treatment arms, an induction dose of 1200mg chloroquine or hydroxychloroquine base (or equivalent number of placebo tablets) will be taken in 4 divided daily doses (that is 300mg chloroquine or hydroxychloroquine base per day for four days) before starting the low, medium, or high dose regimen.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['● High-dose (150 mg chloroquine base daily)']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Aralen or Plaquenil']}},\n", - " {'InterventionType': 'Drug',\n", - " 'InterventionName': 'Placebo',\n", - " 'InterventionDescription': 'Placebo 1 administered orally once daily, Placebo 2 administered orally once weekly, Placebo 3 administered orally once weekly.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Placebo']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Symptomatic COVID-19',\n", - " 'PrimaryOutcomeDescription': 'Clinical diagnosis of COVID-19 with limitation of activities (WHO Severity Scale 2-8)',\n", - " 'PrimaryOutcomeTimeFrame': '3 months'},\n", - " {'PrimaryOutcomeMeasure': 'Peak severity of COVID-19 over the study period',\n", - " 'PrimaryOutcomeDescription': 'i) Uninfected - no clinical or virological evidence of infection (Score = 0) ii) Ambulatory - no limitation of activities (score=1) or with limitation (Score=2) iii) Hospitalized - mild no oxygen (Score=3) or with oxygen (Score=4) iv) Hospitalized severe - Scores 5-7* v) Dead\\n\\n* Score 5 is non-invasive ventilation or high flow oxygen; Score 6 is intubation with mechanical ventilation; Score 7 is intubation with additional organ support (e.g. pressors, renal replacement therapy, extra corporeal membrane oxygenation [ECMO]) These outcome definitions are based on WHO R&D Blueprint consensus definitions for COVID-19.',\n", - " 'PrimaryOutcomeTimeFrame': '3 months'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nAge ≥18 years.\\nHealthcare worker based in a primary, secondary or tertiary healthcare setting with a high risk of developing COVID-19 due to their potential exposure to patients with SARS-CoV-2 infection.\\n\\nExclusion Criteria:\\n\\n-',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Linda Yun, BS',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '314-273-2240',\n", - " 'CentralContactEMail': 'lindayun@wustl.edu'},\n", - " {'CentralContactName': 'Sherry McKinnon, BS',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '314-286-1768',\n", - " 'CentralContactEMail': 'smckinnon@wustl.edu'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Michael S. Avidan, MBBCh',\n", - " 'OverallOfficialAffiliation': 'Washington Univeristy School of Medicine',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Ramani Moonesinghe, MD',\n", - " 'OverallOfficialAffiliation': 'University College, London',\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Helen Rees, MD',\n", - " 'OverallOfficialAffiliation': 'Wits University',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Washington University School of Medicine',\n", - " 'LocationCity': 'Saint Louis',\n", - " 'LocationState': 'Missouri',\n", - " 'LocationZip': '63110',\n", - " 'LocationCountry': 'United States',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Linda Yun, BS',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '314-273-2240',\n", - " 'LocationContactEMail': 'lindayun@wustl.edu'},\n", - " {'LocationContactName': 'Sherry McKinnon',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '314-286-1768',\n", - " 'LocationContactEMail': 'mckinnos@anest.wustl.edu'},\n", - " {'LocationContactName': 'Michael S. Avidan, MBBCh, FCASA',\n", - " 'LocationContactRole': 'Principal Investigator'},\n", - " {'LocationContactName': 'Mary Politi, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Eric Dubberke, MD',\n", - " 'LocationContactRole': 'Principal Investigator'}]}},\n", - " {'LocationFacility': 'Melbourne Medical School',\n", - " 'LocationCity': 'Melbourne',\n", - " 'LocationState': 'Victoria',\n", - " 'LocationZip': 'VIC 3010',\n", - " 'LocationCountry': 'Australia',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'David Story, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactEMail': 'dastory@unimelb.edu.au'}]}},\n", - " {'LocationFacility': 'Population Health Resarch Institute',\n", - " 'LocationCity': 'Hamilton',\n", - " 'LocationState': 'Ontario',\n", - " 'LocationZip': 'L8L 2X2',\n", - " 'LocationCountry': 'Canada',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Jessica Spence, MD, FRCPC',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactEMail': 'spencej@phri.ca'},\n", - " {'LocationContactName': 'Jessica Spence, MD, FRCPC',\n", - " 'LocationContactRole': 'Principal Investigator'}]}},\n", - " {'LocationFacility': 'University of Toronto',\n", - " 'LocationCity': 'Toronto',\n", - " 'LocationState': 'Ontario',\n", - " 'LocationZip': 'M5G 1E2',\n", - " 'LocationCountry': 'Canada',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'David Mazer, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '(416) 864-5825',\n", - " 'LocationContactEMail': 'David.Mazer@unityhealth.to'},\n", - " {'LocationContactName': 'David Mazer, MD',\n", - " 'LocationContactRole': 'Principal Investigator'}]}},\n", - " {'LocationFacility': \"St James's Hospital\",\n", - " 'LocationCity': 'Dublin',\n", - " 'LocationState': 'Leinster',\n", - " 'LocationZip': 'Dublin 8',\n", - " 'LocationCountry': 'Ireland',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': \"Ellen O'Sullivan, MD, FRCA,FCAI\",\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '353876993178',\n", - " 'LocationContactEMail': 'ellenosullivan2000@gmail.com'}]}},\n", - " {'LocationFacility': 'Wits RHI, University of the Witwatersrand',\n", - " 'LocationCity': 'Johannesburg',\n", - " 'LocationState': 'Gauteng',\n", - " 'LocationZip': '2001',\n", - " 'LocationCountry': 'South Africa',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Sinead Delany-Moretlwe, MBChB, PhD, DTM&H',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+27 82 377 6275',\n", - " 'LocationContactEMail': 'sdelany@wrhi.ac.za'},\n", - " {'LocationContactName': 'Michelle Moorhouse, MBChB',\n", - " 'LocationContactRole': 'Contact'},\n", - " {'LocationContactName': 'Gloria Maimela, MBBCh MBA',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Saiqa Mullick, MBBCh PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Catherine Martin, MBBCh MSc',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}},\n", - " {'LocationFacility': 'University College London',\n", - " 'LocationCity': 'London',\n", - " 'LocationCountry': 'United Kingdom',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Laurence Lovat, MD, PhD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '020 3447 7488',\n", - " 'LocationContactEMail': 'laurence.lovat@nhs.net'},\n", - " {'LocationContactName': 'Laurence Lovat, MD, PhD',\n", - " 'LocationContactRole': 'Principal Investigator'},\n", - " {'LocationContactName': 'Hakim-Moulay Dehbi, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Nick Freemantle, PhD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Dermot McGuckin, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Gemma Jones, MsC',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Ramani Moonesinghe, MD',\n", - " 'LocationContactRole': 'Sub-Investigator'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000006886',\n", - " 'InterventionMeshTerm': 'Hydroxychloroquine'},\n", - " {'InterventionMeshId': 'D000002738',\n", - " 'InterventionMeshTerm': 'Chloroquine'},\n", - " {'InterventionMeshId': 'C000023676',\n", - " 'InterventionMeshTerm': 'Chloroquine diphosphate'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000962',\n", - " 'InterventionAncestorTerm': 'Antimalarials'},\n", - " {'InterventionAncestorId': 'D000000981',\n", - " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", - " {'InterventionAncestorId': 'D000000977',\n", - " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", - " {'InterventionAncestorId': 'D000000890',\n", - " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", - " {'InterventionAncestorId': 'D000004791',\n", - " 'InterventionAncestorTerm': 'Enzyme Inhibitors'},\n", - " {'InterventionAncestorId': 'D000045504',\n", - " 'InterventionAncestorTerm': 'Molecular Mechanisms of Pharmacological Action'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'},\n", - " {'InterventionAncestorId': 'D000000563',\n", - " 'InterventionAncestorTerm': 'Amebicides'},\n", - " {'InterventionAncestorId': 'D000000894',\n", - " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents, Non-Steroidal'},\n", - " {'InterventionAncestorId': 'D000018712',\n", - " 'InterventionAncestorTerm': 'Analgesics, Non-Narcotic'},\n", - " {'InterventionAncestorId': 'D000000700',\n", - " 'InterventionAncestorTerm': 'Analgesics'},\n", - " {'InterventionAncestorId': 'D000018689',\n", - " 'InterventionAncestorTerm': 'Sensory System Agents'},\n", - " {'InterventionAncestorId': 'D000018373',\n", - " 'InterventionAncestorTerm': 'Peripheral Nervous System Agents'},\n", - " {'InterventionAncestorId': 'D000045505',\n", - " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", - " {'InterventionAncestorId': 'D000000893',\n", - " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents'},\n", - " {'InterventionAncestorId': 'D000005369',\n", - " 'InterventionAncestorTerm': 'Filaricides'},\n", - " {'InterventionAncestorId': 'D000000969',\n", - " 'InterventionAncestorTerm': 'Antinematodal Agents'},\n", - " {'InterventionAncestorId': 'D000000871',\n", - " 'InterventionAncestorTerm': 'Anthelmintics'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M4562',\n", - " 'InterventionBrowseLeafName': 'Chloroquine',\n", - " 'InterventionBrowseLeafAsFound': 'Chloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M151035',\n", - " 'InterventionBrowseLeafName': 'Chloroquine diphosphate',\n", - " 'InterventionBrowseLeafAsFound': 'Chloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M8523',\n", - " 'InterventionBrowseLeafName': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafAsFound': 'Hydroxychloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M2861',\n", - " 'InterventionBrowseLeafName': 'Antimalarials',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2879',\n", - " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2875',\n", - " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2795',\n", - " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19188',\n", - " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2798',\n", - " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2799',\n", - " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents, Non-Steroidal',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2613',\n", - " 'InterventionBrowseLeafName': 'Analgesics',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19370',\n", - " 'InterventionBrowseLeafName': 'Analgesics, Non-Narcotic',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2777',\n", - " 'InterventionBrowseLeafName': 'Anthelmintics',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", - " {'InterventionBrowseBranchAbbrev': 'Infl',\n", - " 'InterventionBrowseBranchName': 'Anti-Inflammatory Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'Analg',\n", - " 'InterventionBrowseBranchName': 'Analgesics'}]}},\n", - " 'ConditionBrowseModule': {'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", - " {'Rank': 95,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04276896',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'GIMI-IRB-20001'},\n", - " 'Organization': {'OrgFullName': 'Shenzhen Geno-Immune Medical Institute',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Immunity and Safety of Covid-19 Synthetic Minigene Vaccine',\n", - " 'OfficialTitle': 'Phase I/II Multicenter Trial of Lentiviral Minigene Vaccine (LV-SMENP) of Covid-19 Coronavirus'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 24, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'July 31, 2023',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2024',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'February 17, 2020',\n", - " 'StudyFirstSubmitQCDate': 'February 17, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'February 19, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 17, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 19, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Shenzhen Geno-Immune Medical Institute',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': \"Shenzhen Third People's Hospital\",\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': \"Shenzhen Second People's Hospital\",\n", - " 'CollaboratorClass': 'OTHER'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'In December 2019, viral pneumonia caused by a novel beta-coronavirus (Covid-19) broke out in Wuhan, China. Some patients rapidly progressed and suffered severe acute respiratory failure and died, making it imperative to develop a safe and effective vaccine to treat and prevent severe Covid-19 pneumonia. Based on detailed analysis of the viral genome and search for potential immunogenic targets, a synthetic minigene has been engineered based on conserved domains of the viral structural proteins and a polyprotein protease. The infection of Covid-19 is mediated through binding of the Spike protein to the ACEII receptor, and the viral replication depends on molecular mechanisms of all of these viral proteins. This trial proposes to develop and test innovative Covid-19 minigenes engineered based on multiple viral genes, using an efficient lentiviral vector system (NHP/TYF) to express viral proteins and immune modulatory genes to modify dendritic cells (DCs) and to activate T cells. In this study, the safety and efficacy of this LV vaccine (LV-SMENP) will be investigated.',\n", - " 'DetailedDescription': 'Background: The 2019 discovered new coronavirus, Covid-19, is an enveloped positive strand single strand RNA virus. The number of Covid-19 infected people has increased rapidly and WHO has warned that the spread of Covid-19 may soon become pandemic and have disastrous outcomes. Covid-19 could pose a serious threat to human health and global economy. There is no vaccine available or clinically approved antiviral therapy as yet. This study aims to evaluate the safety and efficacy of treating Covid-19 infections with a novel lentiviral based DC and T cell vaccines.\\n\\nObjective: Primary study objectives: Injection and infusion of LV-SMENP DC and antigen-specific cytotoxic T cell vaccines to healthy volunteers and Covid-19 infected patients to evaluate the safety.\\n\\nSecondary study objectives: To evaluate the anti- Covid-19 efficacy of the LV-SMENP DC and antigen-specific cytotoxic T cell vaccines.\\n\\nDesign:\\n\\nBased on the genomic sequence of the new coronavirus Covid-19, select conserved and critical structural and protease protein domains to engineer lentiviral SMENP minigenes to express Covid-19 antigens.\\nLV-SMENP-DC vaccine is made by modifying DC with lentivirus vectors expressing Covid-19 minigene SMENP and immune modulatory genes. CTLs will be activated by LV-DC presenting Covid-19 specific antigens.\\nLV-DC vaccine and antigen-specific CTLs are prepared in 7~21 days. Subject will receive total 5x10^6 cells of LV-DC vaccine and 1x10^8 antigen-specific CTLs via sub-cutaneous injection and IV infusion, respectively. Patients are followed weekly for one month after the infusion, monthly for 3 months, and then every 3 months until the trial ends.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Pathogen Infection Covid-19 Infection']},\n", - " 'KeywordList': {'Keyword': ['Lentiviral vector',\n", - " 'LV-DC vaccine',\n", - " 'Covid-19 CTL']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 1', 'Phase 2']},\n", - " 'DesignInfo': {'DesignInterventionModel': 'Single Group Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '100',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'pathogen-specific DC and CTLs',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Patients will receive approximately 5x10^6 LV-DC vaccine and 1x10^8 CTLs via sub-cutaneous injections and iv infusions, respectively.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Biological: Injection and infusion of LV-SMENP-DC vaccine and antigen-specific CTLs']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Biological',\n", - " 'InterventionName': 'Injection and infusion of LV-SMENP-DC vaccine and antigen-specific CTLs',\n", - " 'InterventionDescription': 'Patients will receive approximately 5x10^6 LV-DC vaccine and 1x10^8 CTLs via sub-cutaneous injections and iv infusions, respectively.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['pathogen-specific DC and CTLs']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Clinical improvement based on the 7-point scale',\n", - " 'PrimaryOutcomeDescription': 'A decline of 2 points on the 7-point scale from admission means better outcome. The 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).',\n", - " 'PrimaryOutcomeTimeFrame': '28 days after randomization'},\n", - " {'PrimaryOutcomeMeasure': 'Lower Murray lung injury score',\n", - " 'PrimaryOutcomeDescription': 'Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition.',\n", - " 'PrimaryOutcomeTimeFrame': '7 days after randomization'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': '28-day mortality',\n", - " 'SecondaryOutcomeDescription': 'Number of deaths during study follow-up',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured from Day 0 through Day 28'},\n", - " {'SecondaryOutcomeMeasure': 'Duration of mechanical ventilation',\n", - " 'SecondaryOutcomeDescription': 'Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured from Day 0 through Day 28'},\n", - " {'SecondaryOutcomeMeasure': 'Duration of hospitalization',\n", - " 'SecondaryOutcomeDescription': 'Days that a participant spent at the hospital. Multiple hospitalizations are summed up.',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured from Day 0 through Day 28'},\n", - " {'SecondaryOutcomeMeasure': 'Proportion of patients with negative RT-PCR results',\n", - " 'SecondaryOutcomeDescription': 'Proportion of patients with negative RT-PCR results of virus in upper and/or lower respiratory tract samples.',\n", - " 'SecondaryOutcomeTimeFrame': '7 and 14 days after randomization'},\n", - " {'SecondaryOutcomeMeasure': 'Proportion of patients in each category of the 7-point scale',\n", - " 'SecondaryOutcomeDescription': 'Proportion of patients in each category of the 7-point scale, the 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death).',\n", - " 'SecondaryOutcomeTimeFrame': '7,14 and 28 days after randomization'},\n", - " {'SecondaryOutcomeMeasure': 'Proportion of patients with normalized inflammation factors',\n", - " 'SecondaryOutcomeDescription': 'Proportion of patients with different inflammation factors in normalization range.',\n", - " 'SecondaryOutcomeTimeFrame': '7 and 14 days after randomization'},\n", - " {'SecondaryOutcomeMeasure': 'Frequency of vaccine/CTL Events',\n", - " 'SecondaryOutcomeDescription': 'Frequency of vaccine/CTL Events',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured from Day 0 through Day 28'},\n", - " {'SecondaryOutcomeMeasure': 'Frequency of Serious vaccine/CTL Events',\n", - " 'SecondaryOutcomeDescription': 'Frequency of Serious vaccine/CTL Events',\n", - " 'SecondaryOutcomeTimeFrame': 'Measured from Day 0 through Day 28'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nLaboratory (RT-PCR) confirmed Covid-19 infection in throat swab and/or sputum and/or lower respiratory tract samples;\\nThe interval between the onset of symptoms and randomized is within 7 days. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used;\\nWhite blood cells ≥ 3,500 / μl, lymphocytes ≥ 750 / μl;\\nHuman immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or tuberculosis (TB) test is negative;\\nSign the Informed Consent Form on a voluntary basis;\\n\\nExclusion Criteria:\\n\\nSubject infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), or HTLV (HTLV antibody positive).\\nSubject is albumin-intolerant.\\nSubject with life expectancy less than 4 weeks.\\nSubject participated in other investigational somatic cell therapies within past 30 days.\\nSubject with positive pregnancy test result.\\nResearchers consider unsuitable.',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '6 Months',\n", - " 'MaximumAge': '80 Years',\n", - " 'StdAgeList': {'StdAge': ['Child', 'Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Lung-Ji Chang, PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+86(755)8672 5195',\n", - " 'CentralContactEMail': 'c@szgimi.org'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Lung-Ji Chang, PhD',\n", - " 'OverallOfficialAffiliation': 'Shenzhen Geno-Immune Medical Institute',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Shenzhen Geno-immune Medical Institute',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Shenzhen',\n", - " 'LocationState': 'Guangdong',\n", - " 'LocationZip': '518000',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Lung-Ji Chang, PhD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '86-755-86725195',\n", - " 'LocationContactEMail': 'c@szgimi.org'}]}},\n", - " {'LocationFacility': \"Shenzhen Second People's Hospital\",\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Shenzhen',\n", - " 'LocationState': 'Guangdong',\n", - " 'LocationZip': '518000',\n", - " 'LocationCountry': 'China'},\n", - " {'LocationFacility': \"Shenzhen Third People's Hospital\",\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Shenzhen',\n", - " 'LocationState': 'Guangdong',\n", - " 'LocationZip': '518000',\n", - " 'LocationCountry': 'China'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000014612',\n", - " 'InterventionMeshTerm': 'Vaccines'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000007155',\n", - " 'InterventionAncestorTerm': 'Immunologic Factors'},\n", - " {'InterventionAncestorId': 'D000045505',\n", - " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M15943',\n", - " 'InterventionBrowseLeafName': 'Vaccines',\n", - " 'InterventionBrowseLeafAsFound': 'Vaccine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M8784',\n", - " 'InterventionBrowseLeafName': 'Immunologic Factors',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", - " 'ConditionMeshTerm': 'Infection'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafAsFound': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M19074',\n", - " 'ConditionBrowseLeafName': 'Coronavirus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'}]}}}}},\n", - " {'Rank': 96,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04279899',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'CHFudanU_NNICU14'},\n", - " 'Organization': {'OrgFullName': \"Children's Hospital of Fudan University\",\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'The Investigation of the Neonates With or With Risk of COVID-19',\n", - " 'OfficialTitle': 'A Multicenter Observational Study of the Perinatal-neonatal Population With or With Risk of COVID-19 in China'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'February 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'February 1, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'November 30, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'February 18, 2020',\n", - " 'StudyFirstSubmitQCDate': 'February 19, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'February 21, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'February 19, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'February 21, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': \"Children's Hospital of Fudan University\",\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'Since December 2019, there has been an outbreak of novel coronavirus pneumonia in China. As of February 18, 2020, 72,530 cases confirmed with 2019 coronavirus disease(COVID-19) have been reported and 1,870 deaths were declared. Until now, cases of COVID-19 have been reported in 26 countries. This observational study aims to analysis the clinical features of neonates with COVID-19 and the neonates born to mother with COVID-19.',\n", - " 'DetailedDescription': 'Given that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads rapidly and is contagious to the general population, all the suspected or confirmed newborns will be admitted to the neonatal departments in designated hospitals of China. In this study, the diagnosis of neonatal SARS-CoV-2 infection is based on the criterion provided by National Health Commission and the Chinese perinatal-neonatal SARS-CoV-2 Committee. All samples will be treated as biohazardous material. SARS-CoV-2 will be tested in blood, cord blood, amniotic fluid, placenta, respiratory tract, stool, urine from mothers or neonates. The medical information questionnaires are classified into maternal and neonatal version, which include demographic details, epidemical history, clinical manifestations, tests collected time and results, imaging performed time and results and therapeutic data. Two researchers independently checked and recorded the data to ensure the accuracy of the data.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Neonatal Infection',\n", - " 'Perinatal Problems',\n", - " 'Infectious Disease']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Case-Only']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '100',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'The death of newborns with COVID-19',\n", - " 'PrimaryOutcomeTimeFrame': 'The date of discharge，an average of 4 weeks after the admission'},\n", - " {'PrimaryOutcomeMeasure': 'The SARS-CoV-2 infection of neonates born to mothers with COVID-19',\n", - " 'PrimaryOutcomeDescription': 'Neonates born to mothers with COVID-19 will be tested for SARS-CoV-2 after birth.Confirmed cases will meet the diagnosed criterion provided by National Health and Health Commission and the Chinese perinatal-neonatal SARS-CoV-2 Committee.',\n", - " 'PrimaryOutcomeTimeFrame': 'within 7days after the admission'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'The Chinese standardized Denver Developmental Screening Test (DDST) in neonates with or with risk of COVID-19',\n", - " 'SecondaryOutcomeDescription': 'The standardized DDST consists of 104 items and covers four areas of development: (a) personal/social, (b) fine motor/adaptive, (c) language, and (d) gross motor. In the present study, three trained professionals examined the children. The results of the DDST could be normal (no delays), suspect (2 or more caution items and/or 1 or more delays), abnormal (2 or more delays) or untestable (refusal of one or more items completely to the left of the age line or more than one item intersected by the age line in the 75-90% area). The children with suspect or abnormal results were retested 2 or 3 weeks later.',\n", - " 'SecondaryOutcomeTimeFrame': 'Infants ( ≥35 weeks）are at 6 months after birth;Infants（＜ 35weeks） are at a corrected age of 6 months.'},\n", - " {'SecondaryOutcomeMeasure': 'The small for gestational age newborns in the neonates born to mothers with COVID-19',\n", - " 'SecondaryOutcomeDescription': 'The small for gestational age infant is defined as live-born infants weighting less than the 10th percentile for gestational age (22 weeks+0 day to 36 weeks+6days).',\n", - " 'SecondaryOutcomeTimeFrame': 'at birth'},\n", - " {'SecondaryOutcomeMeasure': 'The preterm delivery of neonates born to mothers with COVID-19',\n", - " 'SecondaryOutcomeDescription': 'The preterm infant is defined as the gestational age less than 37weeks+0day.The gestational age range is 22 weeks+0 day to 36 weeks+6days',\n", - " 'SecondaryOutcomeTimeFrame': 'at birth'},\n", - " {'SecondaryOutcomeMeasure': 'The disease severity of neonates with COVID-19',\n", - " 'SecondaryOutcomeDescription': 'Infants with SARS-CoV-2 infection are classified into asymptomatic, mild infection and severe infection, according to the expert consensus provided by the Chinese',\n", - " 'SecondaryOutcomeTimeFrame': 'through study completion, estimated an average of 2 weeks'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nThe neonates with COVID-19,or neonates born by infected mothers\\n\\nExclusion Criteria:\\n\\nThe neonates with major anomalies',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MaximumAge': '28 Days',\n", - " 'StdAgeList': {'StdAge': ['Child']},\n", - " 'StudyPopulation': 'The study participants will be recruited from all the designated hospitals in in 31 provinces/municipalities of the mainland of China during SARS-CoV-2 epidemic.',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'LocationList': {'Location': [{'LocationFacility': 'Maternal and Child Health Hospital of Hubei Province',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Wuhan',\n", - " 'LocationState': 'Hubei',\n", - " 'LocationZip': '430070',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Shiwen Xia, M.D.',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '18971025669',\n", - " 'LocationContactEMail': 'shiwenxia66@163.com'}]}},\n", - " {'LocationFacility': 'Children Hospital of Fudan University',\n", - " 'LocationStatus': 'Not yet recruiting',\n", - " 'LocationCity': 'Shanghai',\n", - " 'LocationState': 'Shanghai',\n", - " 'LocationZip': '201102',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Wenhao Zhou, Doctor',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '(+86)021-64931003',\n", - " 'LocationContactEMail': 'zwhchfu@126.com'}]}}]}}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000003141',\n", - " 'ConditionMeshTerm': 'Communicable Diseases'},\n", - " {'ConditionMeshId': 'D000007239', 'ConditionMeshTerm': 'Infection'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafAsFound': 'Infectious Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafAsFound': 'Infectious Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", - " {'Rank': 97,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04327674',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'COVID-FLUS'},\n", - " 'Organization': {'OrgFullName': 'University of Aarhus',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'The Use of Focused Lung Ultrasound in Patients Suspected of COVID-19',\n", - " 'OfficialTitle': 'The Use of Focused Lung Ultrasound in Patients Suspected of COVID-19'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 14, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'May 15, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'May 15, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 27, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 30, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 31, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 30, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 31, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'University of Aarhus',\n", - " 'LeadSponsorClass': 'OTHER'}},\n", - " 'OversightModule': {'OversightHasDMC': 'No',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'COVID is a major health problem causing massive capacity problems at hospitals. Rapid and accurate diagnostic workflow is of paramount importance. Access to radiological diagnostics tools such as x-ray or computed tomography of the chest are limited even in high-resource settings.\\n\\nFocused lung ultrasound, FLUS, is a point-of-care diagnostic tool that allows rapid and on-site assessment of lung abnormalities. No transportation of the patient is required thus lowering risk of spreading SAR-CoV- inside the hospital.\\n\\nThis study aims to explore the diagnostic value of FLUS in the COVID-19 pandemic and to explore if FLUS findings can predict risk of respiratory failure.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['COVID-19']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'Yes',\n", - " 'TargetDuration': '1 Month',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '375',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'FLUS findings and respiratory failure',\n", - " 'PrimaryOutcomeDescription': 'Analysis of FLUS related to risk of development of respiratory failure.',\n", - " 'PrimaryOutcomeTimeFrame': 'Up to 3 months.'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'FLUS findings and chest x-ray.',\n", - " 'SecondaryOutcomeDescription': 'Analysis of FLUS related to risk of result of chest x-ray',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 3 months.'},\n", - " {'SecondaryOutcomeMeasure': 'FLUS findings and admission to intensive care.',\n", - " 'SecondaryOutcomeDescription': 'Analysis of FLUS related to risk of intensive care admission',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 3 months.'},\n", - " {'SecondaryOutcomeMeasure': 'FLUS findings and SAR-CoV-2 PCR-test result.',\n", - " 'SecondaryOutcomeDescription': 'Analysis of FLUS related to result from SAR-CoV-2 PCR-test',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 3 months.'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nClinical suspicion of COVID-19 requiring contact to a hospital.\\n\\nExclusion Criteria:\\n\\nAge less than 18 years\\nPrevious enrollment in this study.',\n", - " 'HealthyVolunteers': 'Accepts Healthy Volunteers',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']},\n", - " 'StudyPopulation': 'All patients who have symptoms on COVID-19 and is seen at a hospital.',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Søren H Skaarup',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '28911869',\n", - " 'CentralContactEMail': 'soeska@rm.dk'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Søren H Skaarup',\n", - " 'OverallOfficialAffiliation': 'Aarhus Universitets Hospital',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Lungemedicinsk Forskningsafdeling. Aarhus University Hospital',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Aarhus',\n", - " 'LocationZip': '8000',\n", - " 'LocationCountry': 'Denmark',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Søren Helbo SH Skaarup, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactPhone': '+45 28911869',\n", - " 'LocationContactEMail': 'soeska@rm.dk'}]}},\n", - " {'LocationFacility': 'Regionshospitalet Horsens.',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Horsens',\n", - " 'LocationCountry': 'Denmark',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Jesper Weile',\n", - " 'LocationContactRole': 'Contact'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'}}}},\n", - " {'Rank': 98,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04270383',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'BCH Lung 012'},\n", - " 'Organization': {'OrgFullName': \"Beijing Children's Hospital\",\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Clinical Characteristics and Long-term Prognosis of 2019-nCoV Infection in Children',\n", - " 'OfficialTitle': 'A Multicenter Observational Study About the Clinical Characteristics and Long-term Prognosis of 2019-nCoV Infection in Children'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'February 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'February 15, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'December 31, 2020',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'December 31, 2020',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'February 11, 2020',\n", - " 'StudyFirstSubmitQCDate': 'February 13, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'February 17, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'February 14, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'February 17, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Kunling Shen',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Director of National Clinical Research Center for Respiratory Diseases, China',\n", - " 'ResponsiblePartyInvestigatorAffiliation': \"Beijing Children's Hospital\"},\n", - " 'LeadSponsor': {'LeadSponsorName': \"Beijing Children's Hospital\",\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Capital Institute of Pediatrics, China',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'The First Affiliated Hospital of Anhui Medical University',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'China-Japan Friendship Hospital',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'The First Affiliated Hospital of Xiamen University',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': \"Guangzhou Women and Children's Medical Center\",\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': \"Shenzhen Children's Hospital\",\n", - " 'CollaboratorClass': 'OTHER_GOV'},\n", - " {'CollaboratorName': 'First Affiliated Hospital of Guangxi Medical University',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'The Affiliated Hospital Of Guizhou Medical University',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': \"Hainan People's Hospital\",\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': \"Children's Hospital of Hebei Province\",\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': \"Wuhan Women and Children's Medical Center\",\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': \"Changchun Children's Hospital\",\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'Children’s Hospital of Nanjing Medical University',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': \"Jiangxi Province Children's Hospital\",\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'Shengjing Hospital',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': \"Shanxi Provincial Maternity and Children's Hospital\",\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': \"Xian Children's Hospital\",\n", - " 'CollaboratorClass': 'OTHER_GOV'},\n", - " {'CollaboratorName': \"Children's Hospital of Chongqing Medical University\",\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': \"Tianjin Children's Hospital\",\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'Tianjin Medical University Second Hospital',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': \"Kunming Children's Hospital\",\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'Second Affiliated Hospital of Wenzhou Medical University',\n", - " 'CollaboratorClass': 'OTHER'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'The study is designed to clarify the clinical characteristics, risk factors and long-term prognosis of children with 2019-nCoV infection in China.',\n", - " 'DetailedDescription': \"As of February 10th, 2020, more than 40,000 human have been confirmed infected with a novel coronavirus (2019-nCoV) in China, with at least 800 reported deaths. Additional cases have been confirmed in multiple countries, and some are reported in children. Patients with confirmed 2019-nCoV infection have reported respiratory illness with fever, cough, et al. Some are asymptomatic carriers. However, there are relatively few diagnosed cases of children, and the long-term prognosis is unknown. Therefore, a multicenter observational study is needed to better understand the clinical characteristics of 2019-nCoV infection in children.\\n\\nThis observational study will last from February to December 2020. The patients enrolled were diagnosed with 2019-nCoV infection or 2019-nCoV pneumonia by Beijing Children's Hospital and other members of Chinese National Clinical Research Center for Respiratory Diseases in 2019-2020. At the same time, children hospitalized with pneumonia other than 2019-nCoV pneumonia during the same period are classified as the control group by 3~5:1 matching for age and sex to the 2019-nCoV group. After guardians signing the informed consent forms, all the participants' clinical data, laboratory examination results, image data and also the follow-up information after six months of their treatment will be collected.\\n\\nThe trial will be completed in 10 months, with subjects recruited from the hospitals that in partnership with clinical research collaboration of National Clinical Research Center for Respiratory Diseases.\"},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['2019-nCoV']},\n", - " 'KeywordList': {'Keyword': ['2019-nCoV infection',\n", - " '2019-nCoV pneumonia',\n", - " 'Children']}},\n", - " 'DesignModule': {'StudyType': 'Observational',\n", - " 'PatientRegistry': 'No',\n", - " 'DesignInfo': {'DesignObservationalModelList': {'DesignObservationalModel': ['Cohort']},\n", - " 'DesignTimePerspectiveList': {'DesignTimePerspective': ['Prospective']}},\n", - " 'BioSpec': {'BioSpecRetention': 'Samples Without DNA',\n", - " 'BioSpecDescription': 'Serum'},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '500',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': '2019-nCoV infection group',\n", - " 'ArmGroupDescription': 'Children hospitalized with direct laboratory confirmed of novel coronavirus with or without pneumonia are classified as the 2019-nCoV infection group.'},\n", - " {'ArmGroupLabel': 'Control group',\n", - " 'ArmGroupDescription': 'Children hospitalized with pneumonia other than the novel coronavirus pneumonia during the same hospitalization period as 2019-nCoV infection group are classified as the control group.'}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'The cure rate of 2019-nCoV.',\n", - " 'PrimaryOutcomeDescription': 'Percentage',\n", - " 'PrimaryOutcomeTimeFrame': '6 months'},\n", - " {'PrimaryOutcomeMeasure': 'The improvement rate of 2019-nCoV.',\n", - " 'PrimaryOutcomeDescription': 'Percentage',\n", - " 'PrimaryOutcomeTimeFrame': '6 months'},\n", - " {'PrimaryOutcomeMeasure': 'The incidence of long-term adverse outcomes.',\n", - " 'PrimaryOutcomeTimeFrame': '6 months'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Duration of fever',\n", - " 'SecondaryOutcomeDescription': 'Days',\n", - " 'SecondaryOutcomeTimeFrame': '2 weeks'},\n", - " {'SecondaryOutcomeMeasure': 'Duration of respiratory symptoms',\n", - " 'SecondaryOutcomeDescription': 'Days',\n", - " 'SecondaryOutcomeTimeFrame': '2 weeks'},\n", - " {'SecondaryOutcomeMeasure': 'Duration of hospitalization',\n", - " 'SecondaryOutcomeDescription': 'Days',\n", - " 'SecondaryOutcomeTimeFrame': '2 weeks'},\n", - " {'SecondaryOutcomeMeasure': 'Number of participant(s) need intensive care',\n", - " 'SecondaryOutcomeTimeFrame': '2 weeks'},\n", - " {'SecondaryOutcomeMeasure': 'Number of participant(s) with acute respiratory distress syndrome',\n", - " 'SecondaryOutcomeTimeFrame': '2 weeks'},\n", - " {'SecondaryOutcomeMeasure': 'Number of participant(s) with extra-pulmonary complications, including shock, renal failure, multiple organ failure, hemophagocytosis syndrome, et al.',\n", - " 'SecondaryOutcomeTimeFrame': '2 weeks'},\n", - " {'SecondaryOutcomeMeasure': 'Number of participant(s) who died during the trial',\n", - " 'SecondaryOutcomeTimeFrame': '10 months'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'For the 2019-nCoV infection group\\n\\nInclusion Criteria:\\n\\nDiagnosed with 2019-nCoV infection (with direct laboratory evidence).\\n\\nRespiratory or blood samples tested positive for novel coronavirus nucleic acid with RT-PCR.\\nGene sequencing of respiratory or blood samples show highly homologous with known novel coronaviruses.\\n\\nExclusion Criteria:\\n\\nSubjects will be excluded if the children or their parents disagree to conduct this study.\\n\\nFor the control group\\n\\nInclusion Criteria:\\n\\nDiagnosed with pneumonia, and excepted of novel coronavirus infection.\\nThe hospitalization time is the same as that of novel coronavirus pneumonia.\\n\\nExclusion Criteria:\\n\\nSubject will be excluded if she or he has one of the following:\\n\\nFirst diagnosis is not pneumonia.\\nAny one of the novel coronavirus laboratory test results show positive.\\nChildren or their parents disagree to conduct this study.',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MaximumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Child', 'Adult']},\n", - " 'StudyPopulation': 'Patients who are aged 1day to 18 years, and diagnosed with 2019-nCoV infection/pneumonia or pneumonia other than novel coronavirus hospitalized in the same period in China.',\n", - " 'SamplingMethod': 'Non-Probability Sample'},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Baoping Xu, MD,PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '861059616308',\n", - " 'CentralContactEMail': 'xubaopingbch@163.com'},\n", - " {'CentralContactName': 'Kunling Shen, MD,PhD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactEMail': 'kunlingshen1717@163.com'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Kunling Shen, MD,PhD',\n", - " 'OverallOfficialAffiliation': \"Beijing Children's Hospital of Capital Medical University, China\",\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Tianyou Wang, MD,PhD',\n", - " 'OverallOfficialAffiliation': \"Beijing Children's Hospital of Capital Medical University, China\",\n", - " 'OverallOfficialRole': 'Principal Investigator'},\n", - " {'OverallOfficialName': 'Baoping Xu, MD,PhD',\n", - " 'OverallOfficialAffiliation': \"Beijing Children's Hospital of Capital Medical University, China\",\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': \"Beijing Children's Hospital,\",\n", - " 'LocationCity': 'Beijing',\n", - " 'LocationCountry': 'China',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Lina Wang',\n", - " 'LocationContactRole': 'Contact'}]}}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'Undecided'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", - " 'ConditionMeshTerm': 'Infection'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafAsFound': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M12487',\n", - " 'ConditionBrowseLeafName': 'Pneumonia',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'}]}}}}},\n", - " {'Rank': 99,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04328493',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'COVID'},\n", - " 'Organization': {'OrgFullName': 'Oxford University Clinical Research Unit, Vietnam',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'The Vietnam Chloroquine Treatment on COVID-19',\n", - " 'OfficialTitle': 'A Multi Center Randomized Open Label Trial on the Safety and Efficacy of Chloroquine for the Treatment of Hospitalized Adults With Laboratory Confirmed SARS-CoV-2 Infection in Vietnam',\n", - " 'Acronym': 'VICO'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'March 2020',\n", - " 'OverallStatus': 'Not yet recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'April 1, 2020',\n", - " 'StartDateType': 'Anticipated'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 1, 2021',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'April 1, 2022',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 27, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 30, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 31, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'March 30, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'March 31, 2020',\n", - " 'LastUpdatePostDateType': 'Actual'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Sponsor'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Oxford University Clinical Research Unit, Vietnam',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Ministry of Health, Vietnam',\n", - " 'CollaboratorClass': 'OTHER_GOV'},\n", - " {'CollaboratorName': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': 'Cu Chi COVID Hospital, Vietnam',\n", - " 'CollaboratorClass': 'UNKNOWN'},\n", - " {'CollaboratorName': 'Can Gio COVID Hospital, Vietnam',\n", - " 'CollaboratorClass': 'UNKNOWN'},\n", - " {'CollaboratorName': 'Cho Ray Hospital, Vietnam',\n", - " 'CollaboratorClass': 'UNKNOWN'},\n", - " {'CollaboratorName': 'National Hospital for Tropical Diseases, Hanoi, Vietnam',\n", - " 'CollaboratorClass': 'OTHER_GOV'},\n", - " {'CollaboratorName': 'Department of Health, Ho Chi Minh city',\n", - " 'CollaboratorClass': 'UNKNOWN'}]}},\n", - " 'OversightModule': {'OversightHasDMC': 'Yes',\n", - " 'IsFDARegulatedDrug': 'No',\n", - " 'IsFDARegulatedDevice': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent COVID-19 or therapeutic agent to treat COVID-19. This clinical trial is designed to evaluate potential therapeutics for the treatment of hospitalized COVID-19.\\n\\nWe hypothesis that chloroquine slows viral replication in patients with COVID-19, attenuating the infection, and resulting in more rapid declines in viral load in throat swabs. This viral attenuation should be associated with improved patient outcomes. Given the enormous experience of its use in malaria chemoprophylaxis, excellent safety and tolerability profile, and its very low cost, if proved effective then chloroquine would be a readily deployable and affordable treatment for patients with COVID-19.\\n\\nThe study is funded and leaded by The Ministry of Health, Vietnam.',\n", - " 'DetailedDescription': 'The study will start with a 10-patient prospective observational pilot study. All these patients will be subject to the same entry and exclusion criteria for the randomized trial, and undergo the same procedures. They will all receive chloroquine at the doses used in the trial (see sections below); they will not be randomized. The purpose of the pilot is to develop the study procedures for the randomized controlled trial, including the safe monitoring of patients, to refine the CRF, and to acquire some preliminary data on the safety of chloroquine in those with COVID-19.\\n\\nOnce the pilot study has been completed, and the data reviewed by the TSC and DMC, and the MOH ethics committee, we will then proceed to the trial. We will aim for minimum delay between completing the pilot study and starting the randomized trial.\\n\\nThe main study is an open label, randomised, controlled trial that will be conducted in 240 in-patients in Ho Chi Minh City. Viet Nam.\\n\\nPatients will have daily assessment as per standard of care while in-patients by the hospital staff. While in-patients the study will collect the following data: peripheral oxygen saturation (pulse oximeter), respiratory rate, and FiO2 6 hourly. The use of ventilator or other assisted breathing device will be recorded each day.\\n\\nPatients will have more detailed clinical assessment recorded once weekly (i.e. on study days, 7, 14, 21 and 28 (±2 days) and on the day of discharge. This will include symptoms, respiratory, and cardiovascular examination, blood investigations and microbiological investigations as per the study schedule, recording of all medication and review of any adverse events.\\n\\nThe decision to discharge patients will be at the discretion of the attending physician and depend upon the clinical status of the patient. According to current standard of care recovery and hospital discharge is dependent upon the patient having had 2 daily consecutive negative PCR throat swabs. Following discharge patients will be seen on days 14, 28, 42 and 56 post-randomization.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['SARS-CoV-2 Infection',\n", - " 'COVID-19']},\n", - " 'KeywordList': {'Keyword': ['SARS-CoV-2', 'COVID-19', 'chloroquine']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 2']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignInterventionModelDescription': \"The main trial is an open label, randomised, controlled trial that will be conducted in in-patients in Ho Chi Minh City. Viet Nam. Randomization will be 1:1, stratified by study site and severity of illness, to either with or without chloroquine for 10 days. All patients will also receive a supportive care/treatment according to VN MoH's guidline for COVID-19\",\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '250',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Control arm',\n", - " 'ArmGroupType': 'No Intervention',\n", - " 'ArmGroupDescription': \"Patients randomized to the control arm will receive a standard of care therapy (a supportive care/treatment according to VN MoH's guideline).\"},\n", - " {'ArmGroupLabel': 'Intervention arm',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Patients randomized to the intervention arm receive chloroquine with a loading dose of 1200mg CQ phosphate base over the first 24 hours after randomization, followed by 300mg CQ phosphate base orally once daily for 9 days, in addition to standard of care therapy.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Chloroquine phosphate']}}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Chloroquine phosphate',\n", - " 'InterventionDescription': 'Chloroquine will be administered orally, as tablets. For unconscious patients chloroquine can be crushed and administered as a suspension via a nasogastric tube.\\n\\nA loading dose of 1200mg chloroquine phosphate base, administered with food where possible, is given on the first 24 hours after randomization. Following, patients will receive a dose of chloroquine phosphate base of 300mg once daily for 9 days (unless they are <60Kg, when the dose will be reduced following its pharmacokinetic properties).\\n\\nThe total duration of treatment with Chloroquine will be 10 days',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Intervention arm']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Chloroquine']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Viral clearance time',\n", - " 'PrimaryOutcomeDescription': 'Viral presence will be determined using RT-PCR to detect SARS-CoV-19 RNA. Throat swabs for viral RNA will be taken daily while in hospital until there have at least 2 consecutive negative results . Virus will be defined as cleared when the patient has had ≥2 consecutive negative PCR tests. The time to viral clearance will be defined as the time following randomization to the first of the negative throat swabs.',\n", - " 'PrimaryOutcomeTimeFrame': 'Up to 56 days post randomization'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Lengh of hospital stay',\n", - " 'SecondaryOutcomeDescription': 'The time since randomization to discharge between study groups',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 56 days post randomization'},\n", - " {'SecondaryOutcomeMeasure': 'Ventilator free days',\n", - " 'SecondaryOutcomeDescription': 'The number of ventilator free days over the first 28 days of treatment',\n", - " 'SecondaryOutcomeTimeFrame': 'first 28 days'},\n", - " {'SecondaryOutcomeMeasure': 'Oxygene free days',\n", - " 'SecondaryOutcomeDescription': 'The number of oxygene free days over the first 28 days of treatment',\n", - " 'SecondaryOutcomeTimeFrame': 'first 28 days'},\n", - " {'SecondaryOutcomeMeasure': 'Time to death',\n", - " 'SecondaryOutcomeDescription': 'The time to (all-cause) death following over the first 7, 10, 14, 28 and 56 days since randomization',\n", - " 'SecondaryOutcomeTimeFrame': 'first 7, 10, 14, 28 and 56 days since randomization'},\n", - " {'SecondaryOutcomeMeasure': 'Adverse events',\n", - " 'SecondaryOutcomeDescription': 'The rates of serious adverse events, rates of grade 3 or 4 adverse events',\n", - " 'SecondaryOutcomeTimeFrame': 'Over the first 28 days (due to the prolonged half-life of Chloroquine)'},\n", - " {'SecondaryOutcomeMeasure': 'Time to viral PCR negative from rectal swab',\n", - " 'SecondaryOutcomeDescription': 'Time since randomization to the first viral PCR negative from rectal swab',\n", - " 'SecondaryOutcomeTimeFrame': 'During the first 56 days post randomization'},\n", - " {'SecondaryOutcomeMeasure': 'fever clearance time',\n", - " 'SecondaryOutcomeDescription': 'Time since randomization to the first defervescence day',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 56 days post randomization'},\n", - " {'SecondaryOutcomeMeasure': 'Ordinal outcome scale',\n", - " 'SecondaryOutcomeDescription': 'WHO Ordinal outcome scale for COVID-19',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 56 days post randomization'},\n", - " {'SecondaryOutcomeMeasure': 'Development of ARDS',\n", - " 'SecondaryOutcomeDescription': 'Development of ARDS defined by the Kigali criteria',\n", - " 'SecondaryOutcomeTimeFrame': 'Up to 56 days post randomization'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen < 48 hours prior to randomization, and requiring hospital admission in the opinion of the attending physician.\\nProvides written informed consent prior to initiation of any study procedures (or legally authorized representative).\\nUnderstands and agrees to comply with planned study procedures.\\nAgrees to the collection of OP swabs and venous blood per protocol.\\nMale or female adult ≥18 years of age at time of enrollment.',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Jeremy Day, PhD. MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+84 8 39237954',\n", - " 'CentralContactEMail': 'jday@oucru.org'},\n", - " {'CentralContactName': 'Dung Nguyen, PhD. MD',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+84 28 3924 1983',\n", - " 'CentralContactEMail': 'CTU-Admin@oucru.org'}]},\n", - " 'OverallOfficialList': {'OverallOfficial': [{'OverallOfficialName': 'Guy Thwaites, PhD. MD',\n", - " 'OverallOfficialAffiliation': 'University of Oxford, UK',\n", - " 'OverallOfficialRole': 'Principal Investigator'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'National Hospital for Tropical Diseases',\n", - " 'LocationCity': 'Hanoi',\n", - " 'LocationCountry': 'Vietnam',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Thach N Pham, PhD. MD',\n", - " 'LocationContactRole': 'Contact'},\n", - " {'LocationContactName': 'Thach N Pham, PhD.MD',\n", - " 'LocationContactRole': 'Principal Investigator'}]}},\n", - " {'LocationFacility': 'Can Gio COVID Hospital',\n", - " 'LocationCity': 'Ho Chi Minh City',\n", - " 'LocationCountry': 'Vietnam',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Manh Hung Le',\n", - " 'LocationContactRole': 'Contact'},\n", - " {'LocationContactName': 'Manh Hung Le',\n", - " 'LocationContactRole': 'Principal Investigator'}]}},\n", - " {'LocationFacility': 'Cho Ray Hospital',\n", - " 'LocationCity': 'Ho Chi Minh City',\n", - " 'LocationCountry': 'Vietnam',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Hung Le Quoc, MD',\n", - " 'LocationContactRole': 'Principal Investigator'}]}},\n", - " {'LocationFacility': 'Cu Chi COVID Hospital',\n", - " 'LocationCity': 'Ho Chi Minh City',\n", - " 'LocationCountry': 'Vietnam',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Thanh Dung Nguyen',\n", - " 'LocationContactRole': 'Contact'},\n", - " {'LocationContactName': 'Thanh Dung Nguyen',\n", - " 'LocationContactRole': 'Principal Investigator'}]}},\n", - " {'LocationFacility': 'Hospital for Tropical Diseases',\n", - " 'LocationCity': 'Ho Chi Minh City',\n", - " 'LocationCountry': 'Vietnam',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Van Vinh Chau Nguyen, PhD, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactEMail': 'nguyenvanvinhchau@gmail.com'},\n", - " {'LocationContactName': 'Thanh Dung Nguyen, Dr',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Thanh Phong Nguyen, Dr',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Thanh Truong Nguyen, Dr',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Nguyen Huy Man Dinh, Dr',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Phuong Thao Huynh, Phar',\n", - " 'LocationContactRole': 'Sub-Investigator'},\n", - " {'LocationContactName': 'Van Vinh Chau Nguyen, Dr',\n", - " 'LocationContactRole': 'Principal Investigator'}]}}]}},\n", - " 'ReferencesModule': {'ReferenceList': {'Reference': [{'ReferencePMID': '25186370',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Biggerstaff M, Cauchemez S, Reed C, Gambhir M, Finelli L. Estimates of the reproduction number for seasonal, pandemic, and zoonotic influenza: a systematic review of the literature. BMC Infect Dis. 2014 Sep 4;14:480. doi: 10.1186/1471-2334-14-480. Review.'},\n", - " {'ReferencePMID': '31987001',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Chan JF, Kok KH, Zhu Z, Chu H, To KK, Yuan S, Yuen KY. Genomic characterization of the 2019 novel human-pathogenic coronavirus isolated from a patient with atypical pneumonia after visiting Wuhan. Emerg Microbes Infect. 2020 Jan 28;9(1):221-236. doi: 10.1080/22221751.2020.1719902. eCollection 2020. Erratum in: Emerg Microbes Infect. 2020 Dec;9(1):540.'},\n", - " {'ReferencePMID': '32054787',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'de Wit E, Feldmann F, Cronin J, Jordan R, Okumura A, Thomas T, Scott D, Cihlar T, Feldmann H. Prophylactic and therapeutic remdesivir (GS-5734) treatment in the rhesus macaque model of MERS-CoV infection. Proc Natl Acad Sci U S A. 2020 Feb 13. pii: 201922083. doi: 10.1073/pnas.1922083117. [Epub ahead of print]'},\n", - " {'ReferencePMID': '32074550',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Gao J, Tian Z, Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends. 2020 Mar 16;14(1):72-73. doi: 10.5582/bst.2020.01047. Epub 2020 Feb 19.'},\n", - " {'ReferencePMID': '32094225',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Gordon CJ, Tchesnokov EP, Feng JY, Porter DP, Gotte M. The antiviral compound remdesivir potently inhibits RNA-dependent RNA polymerase from Middle East respiratory syndrome coronavirus. J Biol Chem. 2020 Feb 24. pii: jbc.AC120.013056. doi: 10.1074/jbc.AC120.013056. [Epub ahead of print]'},\n", - " {'ReferencePMID': '30401979',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Jorge A, Ung C, Young LH, Melles RB, Choi HK. Hydroxychloroquine retinopathy - implications of research advances for rheumatology care. Nat Rev Rheumatol. 2018 Dec;14(12):693-703. doi: 10.1038/s41584-018-0111-8. Review.'},\n", - " {'ReferencePMID': '31995857',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Li M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JTK, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Jan 29. doi: 10.1056/NEJMoa2001316. [Epub ahead of print]'},\n", - " {'ReferencePMID': '32164090',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Liu M, He P, Liu HG, Wang XJ, Li FJ, Chen S, Lin J, Chen P, Liu JH, Li CH. [Clinical characteristics of 30 medical workers infected with new coronavirus pneumonia]. Zhonghua Jie He He Hu Xi Za Zhi. 2020 Mar 12;43(3):209-214. doi: 10.3760/cma.j.issn.1001-0939.2020.03.014. Chinese.'},\n", - " {'ReferencePMID': '6059665',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'McChesney EW, Banks WF Jr, Fabian RJ. Tissue distribution of chloroquine, hydroxychloroquine, and desethylchloroquine in the rat. Toxicol Appl Pharmacol. 1967 May;10(3):501-13.'},\n", - " {'ReferencePMID': '32164085',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'multicenter collaboration group of Department of Science and Technology of Guangdong Province and Health Commission of Guangdong Province for chloroquine in the treatment of novel coronavirus pneumonia. [Expert consensus on chloroquine phosphate for the treatment of novel coronavirus pneumonia]. Zhonghua Jie He He Hu Xi Za Zhi. 2020 Mar 12;43(3):185-188. doi: 10.3760/cma.j.issn.1001-0939.2020.03.009. Chinese.'},\n", - " {'ReferencePMID': '16297415',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Shaw K. The 2003 SARS outbreak and its impact on infection control practices. Public Health. 2006 Jan;120(1):8-14. Epub 2005 Nov 16.'},\n", - " {'ReferencePMID': '17300627',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Villegas L, McGready R, Htway M, Paw MK, Pimanpanarak M, Arunjerdja R, Viladpai-Nguen SJ, Greenwood B, White NJ, Nosten F. Chloroquine prophylaxis against vivax malaria in pregnancy: a randomized, double-blind, placebo-controlled trial. Trop Med Int Health. 2007 Feb;12(2):209-18.'},\n", - " {'ReferencePMID': '16115318',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Vincent MJ, Bergeron E, Benjannet S, Erickson BR, Rollin PE, Ksiazek TG, Seidah NG, Nichol ST. Chloroquine is a potent inhibitor of SARS coronavirus infection and spread. Virol J. 2005 Aug 22;2:69.'},\n", - " {'ReferencePMID': '32020029',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Wang M, Cao R, Zhang L, Yang X, Liu J, Xu M, Shi Z, Hu Z, Zhong W, Xiao G. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020 Mar;30(3):269-271. doi: 10.1038/s41422-020-0282-0. Epub 2020 Feb 4.'},\n", - " {'ReferencePMID': '3054558',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'White NJ, Miller KD, Churchill FC, Berry C, Brown J, Williams SB, Greenwood BM. Chloroquine treatment of severe malaria in children. Pharmacokinetics, toxicity, and new dosage recommendations. N Engl J Med. 1988 Dec 8;319(23):1493-500.'},\n", - " {'ReferencePMID': '23075143',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Zaki AM, van Boheemen S, Bestebroer TM, Osterhaus AD, Fouchier RA. Isolation of a novel coronavirus from a man with pneumonia in Saudi Arabia. N Engl J Med. 2012 Nov 8;367(19):1814-20. doi: 10.1056/NEJMoa1211721. Epub 2012 Oct 17. Erratum in: N Engl J Med. 2013 Jul 25;369(4):394.'},\n", - " {'ReferencePMID': '32007643',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Zhao S, Lin Q, Ran J, Musa SS, Yang G, Wang W, Lou Y, Gao D, Yang L, He D, Wang MH. Preliminary estimation of the basic reproduction number of novel coronavirus (2019-nCoV) in China, from 2019 to 2020: A data-driven analysis in the early phase of the outbreak. Int J Infect Dis. 2020 Mar;92:214-217. doi: 10.1016/j.ijid.2020.01.050. Epub 2020 Jan 30.'},\n", - " {'ReferencePMID': '31978945',\n", - " 'ReferenceType': 'background',\n", - " 'ReferenceCitation': 'Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.'}]},\n", - " 'SeeAlsoLinkList': {'SeeAlsoLink': [{'SeeAlsoLinkLabel': 'in press',\n", - " 'SeeAlsoLinkURL': 'https://doi.org/10.1016/j.ijantimicag.2020.105949'},\n", - " {'SeeAlsoLinkLabel': 'World Health Organization Model List of Essential Medicines',\n", - " 'SeeAlsoLinkURL': 'https://apps.who.int/iris/bitstream/handle/10665/325771/WHO-MVP-EMP-IAU-2019.06-eng.pdf?ua=1'},\n", - " {'SeeAlsoLinkLabel': 'COVID-19 Coronavirus Pandemic updates',\n", - " 'SeeAlsoLinkURL': 'https://www.worldometers.info/coronavirus/'}]}},\n", - " 'IPDSharingStatementModule': {'IPDSharing': 'No'}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000002738',\n", - " 'InterventionMeshTerm': 'Chloroquine'},\n", - " {'InterventionMeshId': 'C000023676',\n", - " 'InterventionMeshTerm': 'Chloroquine diphosphate'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000000563',\n", - " 'InterventionAncestorTerm': 'Amebicides'},\n", - " {'InterventionAncestorId': 'D000000981',\n", - " 'InterventionAncestorTerm': 'Antiprotozoal Agents'},\n", - " {'InterventionAncestorId': 'D000000977',\n", - " 'InterventionAncestorTerm': 'Antiparasitic Agents'},\n", - " {'InterventionAncestorId': 'D000000890',\n", - " 'InterventionAncestorTerm': 'Anti-Infective Agents'},\n", - " {'InterventionAncestorId': 'D000000962',\n", - " 'InterventionAncestorTerm': 'Antimalarials'},\n", - " {'InterventionAncestorId': 'D000018501',\n", - " 'InterventionAncestorTerm': 'Antirheumatic Agents'},\n", - " {'InterventionAncestorId': 'D000000894',\n", - " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents, Non-Steroidal'},\n", - " {'InterventionAncestorId': 'D000018712',\n", - " 'InterventionAncestorTerm': 'Analgesics, Non-Narcotic'},\n", - " {'InterventionAncestorId': 'D000000700',\n", - " 'InterventionAncestorTerm': 'Analgesics'},\n", - " {'InterventionAncestorId': 'D000018689',\n", - " 'InterventionAncestorTerm': 'Sensory System Agents'},\n", - " {'InterventionAncestorId': 'D000018373',\n", - " 'InterventionAncestorTerm': 'Peripheral Nervous System Agents'},\n", - " {'InterventionAncestorId': 'D000045505',\n", - " 'InterventionAncestorTerm': 'Physiological Effects of Drugs'},\n", - " {'InterventionAncestorId': 'D000000893',\n", - " 'InterventionAncestorTerm': 'Anti-Inflammatory Agents'},\n", - " {'InterventionAncestorId': 'D000005369',\n", - " 'InterventionAncestorTerm': 'Filaricides'},\n", - " {'InterventionAncestorId': 'D000000969',\n", - " 'InterventionAncestorTerm': 'Antinematodal Agents'},\n", - " {'InterventionAncestorId': 'D000000871',\n", - " 'InterventionAncestorTerm': 'Anthelmintics'}]},\n", - " 'InterventionBrowseLeafList': {'InterventionBrowseLeaf': [{'InterventionBrowseLeafId': 'M4562',\n", - " 'InterventionBrowseLeafName': 'Chloroquine',\n", - " 'InterventionBrowseLeafAsFound': 'Chloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M151035',\n", - " 'InterventionBrowseLeafName': 'Chloroquine diphosphate',\n", - " 'InterventionBrowseLeafAsFound': 'Chloroquine',\n", - " 'InterventionBrowseLeafRelevance': 'high'},\n", - " {'InterventionBrowseLeafId': 'M2879',\n", - " 'InterventionBrowseLeafName': 'Antiprotozoal Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2875',\n", - " 'InterventionBrowseLeafName': 'Antiparasitic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2795',\n", - " 'InterventionBrowseLeafName': 'Anti-Infective Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2861',\n", - " 'InterventionBrowseLeafName': 'Antimalarials',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19188',\n", - " 'InterventionBrowseLeafName': 'Antirheumatic Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2798',\n", - " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2799',\n", - " 'InterventionBrowseLeafName': 'Anti-Inflammatory Agents, Non-Steroidal',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2613',\n", - " 'InterventionBrowseLeafName': 'Analgesics',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M19370',\n", - " 'InterventionBrowseLeafName': 'Analgesics, Non-Narcotic',\n", - " 'InterventionBrowseLeafRelevance': 'low'},\n", - " {'InterventionBrowseLeafId': 'M2777',\n", - " 'InterventionBrowseLeafName': 'Anthelmintics',\n", - " 'InterventionBrowseLeafRelevance': 'low'}]},\n", - " 'InterventionBrowseBranchList': {'InterventionBrowseBranch': [{'InterventionBrowseBranchAbbrev': 'Infe',\n", - " 'InterventionBrowseBranchName': 'Anti-Infective Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'ARhu',\n", - " 'InterventionBrowseBranchName': 'Antirheumatic Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'All',\n", - " 'InterventionBrowseBranchName': 'All Drugs and Chemicals'},\n", - " {'InterventionBrowseBranchAbbrev': 'Infl',\n", - " 'InterventionBrowseBranchName': 'Anti-Inflammatory Agents'},\n", - " {'InterventionBrowseBranchAbbrev': 'Analg',\n", - " 'InterventionBrowseBranchName': 'Analgesics'}]}},\n", - " 'ConditionBrowseModule': {'ConditionMeshList': {'ConditionMesh': [{'ConditionMeshId': 'D000007239',\n", - " 'ConditionMeshTerm': 'Infection'}]},\n", - " 'ConditionBrowseLeafList': {'ConditionBrowseLeaf': [{'ConditionBrowseLeafId': 'M8866',\n", - " 'ConditionBrowseLeafName': 'Infection',\n", - " 'ConditionBrowseLeafAsFound': 'Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'}]}}}}},\n", - " {'Rank': 100,\n", - " 'Study': {'ProtocolSection': {'IdentificationModule': {'NCTId': 'NCT04305457',\n", - " 'OrgStudyIdInfo': {'OrgStudyId': 'NOgas mildCOVID-19'},\n", - " 'Organization': {'OrgFullName': 'Massachusetts General Hospital',\n", - " 'OrgClass': 'OTHER'},\n", - " 'BriefTitle': 'Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID-19',\n", - " 'OfficialTitle': 'Nitric Oxide Gas Inhalation Therapy in Spontaneous Breathing Patients With Mild/Moderate COVID-19: a Randomized Clinical Trial',\n", - " 'Acronym': 'NoCovid'},\n", - " 'StatusModule': {'StatusVerifiedDate': 'April 2020',\n", - " 'OverallStatus': 'Recruiting',\n", - " 'ExpandedAccessInfo': {'HasExpandedAccess': 'No'},\n", - " 'StartDateStruct': {'StartDate': 'March 21, 2020',\n", - " 'StartDateType': 'Actual'},\n", - " 'PrimaryCompletionDateStruct': {'PrimaryCompletionDate': 'April 1, 2021',\n", - " 'PrimaryCompletionDateType': 'Anticipated'},\n", - " 'CompletionDateStruct': {'CompletionDate': 'April 1, 2022',\n", - " 'CompletionDateType': 'Anticipated'},\n", - " 'StudyFirstSubmitDate': 'March 9, 2020',\n", - " 'StudyFirstSubmitQCDate': 'March 11, 2020',\n", - " 'StudyFirstPostDateStruct': {'StudyFirstPostDate': 'March 12, 2020',\n", - " 'StudyFirstPostDateType': 'Actual'},\n", - " 'LastUpdateSubmitDate': 'April 2, 2020',\n", - " 'LastUpdatePostDateStruct': {'LastUpdatePostDate': 'April 3, 2020',\n", - " 'LastUpdatePostDateType': 'Estimate'}},\n", - " 'SponsorCollaboratorsModule': {'ResponsibleParty': {'ResponsiblePartyType': 'Principal Investigator',\n", - " 'ResponsiblePartyInvestigatorFullName': 'Lorenzo Berra, MD',\n", - " 'ResponsiblePartyInvestigatorTitle': 'Medical Doctor',\n", - " 'ResponsiblePartyInvestigatorAffiliation': 'Massachusetts General Hospital'},\n", - " 'LeadSponsor': {'LeadSponsorName': 'Massachusetts General Hospital',\n", - " 'LeadSponsorClass': 'OTHER'},\n", - " 'CollaboratorList': {'Collaborator': [{'CollaboratorName': 'Xijing Hospital',\n", - " 'CollaboratorClass': 'OTHER'},\n", - " {'CollaboratorName': \"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico\",\n", - " 'CollaboratorClass': 'OTHER'}]}},\n", - " 'OversightModule': {'IsFDARegulatedDrug': 'Yes',\n", - " 'IsFDARegulatedDevice': 'No',\n", - " 'IsUSExport': 'No'},\n", - " 'DescriptionModule': {'BriefSummary': 'The scientific community is in search for novel therapies that can help to face the ongoing epidemics of novel Coronavirus (SARS-Cov-2) originated in China in December 2019. At present, there are no proven interventions to prevent progression of the disease. Some preliminary data on SARS pneumonia suggest that inhaled Nitric Oxide (NO) could have beneficial effects on SARS-CoV-2 due to the genomic similarities between this two coronaviruses. In this study we will test whether inhaled NO therapy prevents progression in patients with mild to moderate COVID-19 disease.',\n", - " 'DetailedDescription': 'To date, no targeted therapeutic treatments for the ongoing COVID-19 outbreak have been identified. Antiviral combined with adjuvant therapies are currently under investigation. The clinical spectrum of the infection is wide, ranging from mild signs of upper respiratory tract infection to severe pneumonia and death.\\n\\nIn the patients who progress, the time period from symptoms onset to development of dyspnea is reported to be between 5 to 10 days, and that one to severe respiratory distress syndrome from 10 to 14 days. Globally, 15 to 18% of patients deteriorates to the need of mechanical ventilation, despite the use of non-invasive ventilatory support in the earliest phases of the disease. Probability of progression to end stage disease is unpredictable, with the majority of these patients dying from multi-organ failure. Preventing progression in spontaneously breathing patients with mild to moderate disease would translate in improved morbidity and mortality and in a lower use of limited healthcare resources.\\n\\nIn 2004, during the SARS-coronavirus (SARS-CoV) outbreak, a pilot study showed that low dose ( max 30 ppm) inhaled NO for 3 days was able to shorten the time of ventilatory support. At the same time, NO donor compound S-nitroso-N-acetylpenicillamine increased survival rate in an in-vitro model of SARS-CoV infected epithelial cells.Based on the genetic similarities between the two viruses, similar effects of NO on SARS-CoV-2 can be hypothesized. While further in-vitro testing is recommended, we proposed a randomized clinical trial to test the effectiveness of inhaled NO in preventing the progression of SARS-CoV-2 related disease, when administered at an early stage.'},\n", - " 'ConditionsModule': {'ConditionList': {'Condition': ['Coronavirus Infections',\n", - " 'Pneumonia, Viral',\n", - " 'Acute Respiratory Distress Syndrome']},\n", - " 'KeywordList': {'Keyword': ['COVID-19',\n", - " 'ARDS',\n", - " 'Mechanical Ventilation',\n", - " 'Nitric Oxide']}},\n", - " 'DesignModule': {'StudyType': 'Interventional',\n", - " 'PhaseList': {'Phase': ['Phase 2']},\n", - " 'DesignInfo': {'DesignAllocation': 'Randomized',\n", - " 'DesignInterventionModel': 'Parallel Assignment',\n", - " 'DesignPrimaryPurpose': 'Treatment',\n", - " 'DesignMaskingInfo': {'DesignMasking': 'None (Open Label)'}},\n", - " 'EnrollmentInfo': {'EnrollmentCount': '240',\n", - " 'EnrollmentType': 'Anticipated'}},\n", - " 'ArmsInterventionsModule': {'ArmGroupList': {'ArmGroup': [{'ArmGroupLabel': 'Nitric Oxide inhalation',\n", - " 'ArmGroupType': 'Experimental',\n", - " 'ArmGroupDescription': 'Nitric Oxide will be delivered through a non invasive CPAP system (with minimal pressure support to decrease discomfort due to the facial mask) or through a non-rebreathing mask system.',\n", - " 'ArmGroupInterventionList': {'ArmGroupInterventionName': ['Drug: Nitric Oxide']}},\n", - " {'ArmGroupLabel': 'Control',\n", - " 'ArmGroupType': 'No Intervention',\n", - " 'ArmGroupDescription': 'Patients assigned to the control group will not receive any gas therapy.'}]},\n", - " 'InterventionList': {'Intervention': [{'InterventionType': 'Drug',\n", - " 'InterventionName': 'Nitric Oxide',\n", - " 'InterventionDescription': 'Nitric Oxide (NO) will be delivered together with the standard of care for a period of 20-30 minutes 2 times per day for 14 consecutive days from time of enrollment. Targeted No inhaled concentration will be maintained between 140 and 180 ppm. The gas will be delivered through a CPAP circuit ensuring an end-expiratory pressure between 2 and 10 cmH2O or through a non-rebreathing mask without positive end-expiratory pressure, depending on the clinical needs of the patient.',\n", - " 'InterventionArmGroupLabelList': {'InterventionArmGroupLabel': ['Nitric Oxide inhalation']},\n", - " 'InterventionOtherNameList': {'InterventionOtherName': ['Nitric Oxide inhalation']}}]}},\n", - " 'OutcomesModule': {'PrimaryOutcomeList': {'PrimaryOutcome': [{'PrimaryOutcomeMeasure': 'Reduction in the incidence of patients with mild/moderate COVID-19 requiring intubation and mechanical ventilation',\n", - " 'PrimaryOutcomeDescription': 'The primary outcome will be the reduction in the incidence of patients requiring intubation and mechanical ventilation, as a marker of deterioration from a mild to a severe form of COVID-19. Patients with indication to intubation and mechanical ventilation but concomitant DNI (Do Not Intubate) or not intubated for any other reason external to the clinical judgment of the attending physician will be considered as meeting the criteria for the primary endpoint.',\n", - " 'PrimaryOutcomeTimeFrame': '28 days'}]},\n", - " 'SecondaryOutcomeList': {'SecondaryOutcome': [{'SecondaryOutcomeMeasure': 'Mortality',\n", - " 'SecondaryOutcomeDescription': 'Proportion of deaths from all causes',\n", - " 'SecondaryOutcomeTimeFrame': '28 days'},\n", - " {'SecondaryOutcomeMeasure': 'Time to clinical recovery',\n", - " 'SecondaryOutcomeDescription': 'Time from initiation of the study to discharge or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air), alleviation of cough (defined as mild or absent in a patient reported scale of severe >>moderate>>mild>>absent) and resolution of hypoxia (defined as SpO2 ≥ 93% in room air or P/F ≥ 300 mmHg). All these improvements must be sustained for 72 hours.',\n", - " 'SecondaryOutcomeTimeFrame': '28 days'}]},\n", - " 'OtherOutcomeList': {'OtherOutcome': [{'OtherOutcomeMeasure': 'Negative conversion of COVID-19 RT-PCR from upper respiratory tract',\n", - " 'OtherOutcomeDescription': 'Proportion of patients with a negative conversion of RT-PCR from an oropharyngeal or oropharyngeal swab.',\n", - " 'OtherOutcomeTimeFrame': '7 days'}]}},\n", - " 'EligibilityModule': {'EligibilityCriteria': 'Inclusion Criteria:\\n\\nLaboratory confirmed COVID19 infection defined with a positive RT-PCR from any specimen and/or detection of SARS-CoV-2 IgM/IgG antibodies.\\n\\nHospital admission with at least one of the following:\\n\\nfever ≥ 36.6 °C from axillary site; or ≥ 37.2°C from oral site; or ≥ 37.6°C from tympanic or rectal site.\\nRespiratory rate ≥ 24 bpm\\ncough\\nSpontaneous breathing with or without hypoxia of any degree. Gas exchange and ventilation maybe assisted by any continuous continuous airway pressure (CPAP), or any system of Non Invasive Ventilation (NIV), with Positive End-Expiratory Pressure (PEEP) ≤ 10 cmH2O.\\n\\nExclusion Criteria:\\n\\nTracheostomy\\nTherapy with high flow nasal cannula\\nAny clinical contraindications, as judged by the attending physician\\nHospitalized and confirmed diagnosis of COVID-19 for more than 72 hours',\n", - " 'HealthyVolunteers': 'No',\n", - " 'Gender': 'All',\n", - " 'MinimumAge': '18 Years',\n", - " 'StdAgeList': {'StdAge': ['Adult', 'Older Adult']}},\n", - " 'ContactsLocationsModule': {'CentralContactList': {'CentralContact': [{'CentralContactName': 'Lorenzo Berra',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+16176437733',\n", - " 'CentralContactEMail': 'lberra@mgh.harvard.edu'},\n", - " {'CentralContactName': 'Lei Chong',\n", - " 'CentralContactRole': 'Contact',\n", - " 'CentralContactPhone': '+86 8629011362',\n", - " 'CentralContactEMail': 'crystalleichong@126.com'}]},\n", - " 'LocationList': {'Location': [{'LocationFacility': 'Massachusetts General Hospital',\n", - " 'LocationStatus': 'Recruiting',\n", - " 'LocationCity': 'Boston',\n", - " 'LocationState': 'Massachusetts',\n", - " 'LocationZip': '02114-2621',\n", - " 'LocationCountry': 'United States',\n", - " 'LocationContactList': {'LocationContact': [{'LocationContactName': 'Lorenzo Berra, MD',\n", - " 'LocationContactRole': 'Contact',\n", - " 'LocationContactEMail': 'lberra@mgh.harvard.edu'}]}}]}}},\n", - " 'DerivedSection': {'MiscInfoModule': {'VersionHolder': 'April 03, 2020'},\n", - " 'InterventionBrowseModule': {'InterventionMeshList': {'InterventionMesh': [{'InterventionMeshId': 'D000009569',\n", - " 'InterventionMeshTerm': 'Nitric Oxide'}]},\n", - " 'InterventionAncestorList': {'InterventionAncestor': [{'InterventionAncestorId': 'D000001993',\n", - " 'InterventionAncestorTerm': 'Bronchodilator Agents'},\n", - " {'InterventionAncestorId': 'D000001337',\n", - " 'InterventionAncestorTerm': 'Autonomic Agents'},\n", - 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" {'ConditionMeshId': 'D000055371',\n", - " 'ConditionMeshTerm': 'Acute Lung Injury'}]},\n", - " 'ConditionAncestorList': {'ConditionAncestor': [{'ConditionAncestorId': 'D000011014',\n", - " 'ConditionAncestorTerm': 'Pneumonia'},\n", - " {'ConditionAncestorId': 'D000008171',\n", - " 'ConditionAncestorTerm': 'Lung Diseases'},\n", - " {'ConditionAncestorId': 'D000012140',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Diseases'},\n", - " {'ConditionAncestorId': 'D000012141',\n", - " 'ConditionAncestorTerm': 'Respiratory Tract Infections'},\n", - " {'ConditionAncestorId': 'D000012120',\n", - " 'ConditionAncestorTerm': 'Respiration Disorders'},\n", - " {'ConditionAncestorId': 'D000007235',\n", - " 'ConditionAncestorTerm': 'Infant, Premature, Diseases'},\n", - " {'ConditionAncestorId': 'D000007232',\n", - " 'ConditionAncestorTerm': 'Infant, Newborn, Diseases'},\n", - " {'ConditionAncestorId': 'D000055370',\n", - " 'ConditionAncestorTerm': 'Lung Injury'},\n", - " {'ConditionAncestorId': 'D000003333',\n", - 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" {'ConditionBrowseLeafId': 'M14938',\n", - " 'ConditionBrowseLeafName': 'Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M4951',\n", - " 'ConditionBrowseLeafName': 'Communicable Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13547',\n", - " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Newborn',\n", - " 'ConditionBrowseLeafAsFound': 'Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M13548',\n", - " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Adult',\n", - " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M12487',\n", - " 'ConditionBrowseLeafName': 'Pneumonia',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M26731',\n", - " 'ConditionBrowseLeafName': 'Acute Lung Injury',\n", - " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M25724',\n", - " 'ConditionBrowseLeafName': 'Respiratory Aspiration',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M12497',\n", - " 'ConditionBrowseLeafName': 'Pneumonia, Viral',\n", - " 'ConditionBrowseLeafAsFound': 'Pneumonia, Viral',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'M26730',\n", - " 'ConditionBrowseLeafName': 'Lung Injury',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M9751',\n", - " 'ConditionBrowseLeafName': 'Lung Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13560',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13561',\n", - " 'ConditionBrowseLeafName': 'Respiratory Tract Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13540',\n", - " 'ConditionBrowseLeafName': 'Respiration Disorders',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M24456',\n", - " 'ConditionBrowseLeafName': 'Premature Birth',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8862',\n", - " 'ConditionBrowseLeafName': 'Infant, Premature, Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M8859',\n", - " 'ConditionBrowseLeafName': 'Infant, Newborn, Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M16105',\n", - " 'ConditionBrowseLeafName': 'Virus Diseases',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'M13732',\n", - " 'ConditionBrowseLeafName': 'RNA Virus Infections',\n", - " 'ConditionBrowseLeafRelevance': 'low'},\n", - " {'ConditionBrowseLeafId': 'T5213',\n", - " 'ConditionBrowseLeafName': 'Severe Acute Respiratory Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Coronavirus Infection',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'T4953',\n", - " 'ConditionBrowseLeafName': 'Respiratory Distress Syndrome, Infant',\n", - " 'ConditionBrowseLeafAsFound': 'Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'},\n", - " {'ConditionBrowseLeafId': 'T191',\n", - " 'ConditionBrowseLeafName': 'Acute Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafAsFound': 'Acute Respiratory Distress Syndrome',\n", - " 'ConditionBrowseLeafRelevance': 'high'}]},\n", - " 'ConditionBrowseBranchList': {'ConditionBrowseBranch': [{'ConditionBrowseBranchAbbrev': 'BC01',\n", - " 'ConditionBrowseBranchName': 'Bacterial and Fungal Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'All',\n", - " 'ConditionBrowseBranchName': 'All Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC02',\n", - " 'ConditionBrowseBranchName': 'Viral Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC08',\n", - " 'ConditionBrowseBranchName': 'Respiratory Tract (Lung and Bronchial) Diseases'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC23',\n", - " 'ConditionBrowseBranchName': 'Symptoms and General Pathology'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC16',\n", - " 'ConditionBrowseBranchName': 'Diseases and Abnormalities at or Before Birth'},\n", - " {'ConditionBrowseBranchAbbrev': 'BC26',\n", - " 'ConditionBrowseBranchName': 'Wounds and Injuries'},\n", - " {'ConditionBrowseBranchAbbrev': 'BXS',\n", - " 'ConditionBrowseBranchName': 'Urinary Tract, Sexual Organs, and Pregnancy Conditions'},\n", - " {'ConditionBrowseBranchAbbrev': 'Rare',\n", - " 'ConditionBrowseBranchName': 'Rare Diseases'}]}}}}}]}}" + " DrugBank ID Accession Numbers Common name CAS UNII Synonyms Standard InChI Key\n", + "0 DB00001 BIOD00024 | BTD00024 Lepirudin 138068-37-8 Y43GF64R34 Hirudin variant-1 | Lepirudin recombinant NaN \n", + "1 DB00002 BIOD00071 | BTD00071 Cetuximab 205923-56-4 PQX0D8J21J Cetuximab | Cétuximab | Cetuximabum | Immunoglobulin G 1 (human-mouse monoclonal C 225 gamma 1 - chain anti-human epidermal growt factor receptor), disulfide wit human-mouse monoclonal C 225 kappa - chain, dimer NaN \n", + "2 DB00003 BIOD00001 | BTD00001 Dornase alfa 143831-71-4 953A26OA1Y Deoxyribonuclease (human clone 18-1 protein moiety) | Dornasa alfa | Dornase alfa, recombinant | Dornase alpha | Recombinant deoxyribonuclease (DNAse) NaN \n", + "3 DB00004 BIOD00084 | BTD00084 Denileukin diftitox 173146-27-5 25E79B5CTM Denileukin | Interleukin-2/diptheria toxin fusion protein NaN \n", + "4 DB00005 BIOD00052 | BTD00052 Etanercept 185243-69-0 OP401G7OJC Etanercept | etanercept-szzs | etanercept-ykro | Recombinant human TNF | rhu TNFR:Fc | rhu-TNFR:Fc | TNFR-Immunoadhesin NaN \n", + "5 DB00006 BIOD00076 | BTD00076 | DB02351 | EXPT03302 Bivalirudin 128270-60-0 TN9BEX005G Bivalirudin | Bivalirudina | Bivalirudinum OIRCOABEOLEUMC-GEJPAHFPSA-N\n", + "6 DB00007 BIOD00009 | BTD00009 Leuprolide 53714-56-0 EFY6W0M8TG Leuprorelin | Leuprorelina | Leuproreline | Leuprorelinum GFIJNRVAKGFPGQ-LIJARHBVSA-N\n", + "7 DB00008 BIOD00043 | BTD00043 Peginterferon alfa-2a 198153-51-4 Q46947FE7K PEG-IFN alfa-2A | PEG-Interferon alfa-2A | Peginterferon alfa-2a | Pegylated Interfeaon alfa-2A | Pegylated interferon alfa-2a | Pegylated interferon alpha-2a | Pegylated-interferon alfa 2a NaN \n", + "8 DB00009 BIOD00050 | BTD00050 Alteplase 105857-23-6 1RXS4UE564 Alteplasa | Alteplase (genetical recombination) | Alteplase, recombinant | Alteplase,recombinant | Plasminogen activator (human tissue-type protein moiety) | rt-PA | t-PA | t-plasminogen activator | Tissue plasminogen activator | Tissue plasminogen activator alteplase | Tissue plasminogen activator, recombinant | tPA NaN \n", + "9 DB00010 BIOD00033 | BTD00033 Sermorelin 86168-78-7 89243S03TE NaN NaN \n", + "10 DB00011 BIOD00096 | BTD00096 | DB00084 Interferon alfa-n1 74899-72-2 41697D4Z5C Interferon alpha-n1 (INS) NaN \n", + "11 DB00012 BIOD00032 | BTD00032 Darbepoetin alfa 209810-58-2 15UQ94PT4P Darbepoetin | Darbepoetin alfa,recombinant | Darbepoetina alfa NaN \n", + "12 DB00013 BIOD00030 | BTD00030 Urokinase 9039-53-6 83G67E21XI Kinase (enzyme-activating), uro-urokinase | TCUK | Tissue culture urokinase | Two-chain urokinase | Urochinasi | Urokinase | Urokinasum | Uroquinasa NaN \n", + "13 DB00014 BIOD00113 | BTD00113 Goserelin 65807-02-5 0F65R8P09N Goserelin | Goserelina BLCLNMBMMGCOAS-URPVMXJPSA-N\n", + "14 DB00015 BIOD00013 | BTD00013 Reteplase 133652-38-7 DQA630RIE9 Human t-PA (residues 1-3 and 176-527) | Reteplasa | Reteplase, recombinant | Reteplase,recombinant NaN \n", + "15 DB00016 BIOD00103 | BTD00103 | DB08923 Erythropoietin 11096-26-7 64FS3BFH5W E.P.O. | Epoetin alfa | Epoetin alfa rDNA | Epoetin alfa-epbx | Epoetin alfa, recombinant | Epoetin beta | Epoetin beta rDNA | Epoetin epsilon | Epoetin gamma | Epoetin gamma rDNA | Epoetin kappa | Epoetin omega | Epoetin theta | Epoetin zeta | Epoetina alfa | Epoetina beta | Epoetina dseta | Epoetina zeta | Epoétine zêta | Epoetinum zeta | Erythropoiesis stimulating factor | Erythropoietin (human, recombinant) | Erythropoietin (recombinant human) | ESF | SH-polypeptide-72 NaN \n", + "16 DB00017 BIOD00025 | BTD00025 Salmon Calcitonin 47931-85-1 7SFC6U2VI5 Calcitonin (Salmon Synthetic) | Calcitonin Salmon | Calcitonin salmon recombinant | Calcitonin-salmon | Calcitonin, salmon | Calcitonina salmón sintética | Recombinant salmon calcitonin | Salmon calcitonin NaN \n", + "17 DB00018 BIOD00023 | BTD00023 Interferon alfa-n3 NaN 47BPR3V3MP NaN NaN \n", + "18 DB00019 BIOD00094 | BTD00094 Pegfilgrastim 208265-92-3 3A58010674 Granulocyte colony-stimulating factor pegfilgrastim | peg-filgrastim | pegfilgrastim-bmez | pegfilgrastim-cbqv | pegfilgrastim-jmdb NaN \n", + "19 DB00020 BIOD00035 | BTD00035 Sargramostim 123774-72-1 5TAA004E22 Recombinant human granulocyte-macrophage colony stimulating factor | rGM-CSF | rHu GM-CSF | Sargramostim NaN " ] }, - "execution_count": 32, + "execution_count": 43, "metadata": {}, "output_type": "execute_result" } ], "source": [ - "apiWrapper(\"covid-19\",1)" + "vocab.head(20)" ] }, { From 22d418a1f39211a1a8e317bb18d083f8f60f5abd Mon Sep 17 00:00:00 2001 From: Ziyao Wei Date: Sun, 5 Apr 2020 10:38:24 -0400 Subject: [PATCH 24/47] Dockerize pipeline and add instructions --- .dockerignore | 1 + infra/pipelines/docker/Dockerfile | 10 +++ infra/pipelines/docker/entrypoint.sh | 12 +++ infra/prefect/docker/docker-compose.yml | 17 ----- modules/Neo4jDataAccess.py | 98 ++++++++++++------------- pipelines/Makefile | 28 +++++++ Pipeline.py => pipelines/Pipeline.py | 1 - pipelines/README.md | 16 ++++ 8 files changed, 116 insertions(+), 67 deletions(-) create mode 100644 .dockerignore create mode 100644 infra/pipelines/docker/Dockerfile create mode 100755 infra/pipelines/docker/entrypoint.sh create mode 100644 pipelines/Makefile rename Pipeline.py => pipelines/Pipeline.py (99%) create mode 100644 pipelines/README.md diff --git a/.dockerignore b/.dockerignore new file mode 100644 index 0000000..f3b6411 --- /dev/null +++ b/.dockerignore @@ -0,0 +1 @@ +**/.git diff --git a/infra/pipelines/docker/Dockerfile b/infra/pipelines/docker/Dockerfile new file mode 100644 index 0000000..3d70dc6 --- /dev/null +++ b/infra/pipelines/docker/Dockerfile @@ -0,0 +1,10 @@ +FROM prefecthq/prefect + +RUN pip install supervisor arrow graphistry pyarrow simplejson twarc neo4j +RUN prefect agent install local > supervisord.conf + +COPY . . +RUN prefect backend server + +RUN date > /dev/null +CMD ["./infra/pipelines/docker/entrypoint.sh"] diff --git a/infra/pipelines/docker/entrypoint.sh b/infra/pipelines/docker/entrypoint.sh new file mode 100755 index 0000000..1480ec6 --- /dev/null +++ b/infra/pipelines/docker/entrypoint.sh @@ -0,0 +1,12 @@ +#!/bin/bash + +# Run prefect agent using supervisord +# supervisord + +# Register pipelines +# git fetch && git checkout wzy/dockerizePipelines + +python -m pipelines.Pipeline + +# Keep the container running +prefect agent start diff --git a/infra/prefect/docker/docker-compose.yml b/infra/prefect/docker/docker-compose.yml index 2ff5164..0be80a4 100644 --- a/infra/prefect/docker/docker-compose.yml +++ b/infra/prefect/docker/docker-compose.yml @@ -1,22 +1,5 @@ # Copied from https://github.com/PrefectHQ/prefect/blob/master/src/prefect/cli/docker-compose.yml # -# Example command: -# APOLLO_HOST_PORT=4200 \ -# GRAPHQL_HOST_PORT=4201 \ -# HASURA_HOST_PORT=3000 \ -# POSTGRES_HOST_PORT=5432 \ -# UI_HOST_PORT=8080 \ -# POSTGRES_USER=prefect \ -# POSTGRES_PASSWORD=test-password \ -# POSTGRES_DB=prefect_server \ -# DB_CONNECTION_URL=postgresql://$POSTGRES_USER:$POSTGRES_PASSWORD@postgres:$POSTGRES_HOST_PORT/$POSTGRES_DB \ -# HASURA_API_URL=http://hasura:$HASURA_HOST_PORT/v1alpha1/graphql \ -# HASURA_WS_URL=ws://hasura:$HASURA_HOST_PORT/v1alpha1/graphql \ -# PREFECT_API_HEALTH_URL=http://graphql:$GRAPHQL_HOST_PORT/health \ -# PREFECT_API_URL=http://graphql:$GRAPHQL_HOST_PORT/graphql/ \ -# PREFECT_SERVER_DB_CMD='prefect-server database upgrade -y' \ -# docker-compose up -# # Note: The server port cannot be overriden (issue: https://github.com/PrefectHQ/prefect/issues/2237); # When support is added APOLLO_HOST_PORT should be set to the server port number. diff --git a/modules/Neo4jDataAccess.py b/modules/Neo4jDataAccess.py index 771df07..3b3c338 100644 --- a/modules/Neo4jDataAccess.py +++ b/modules/Neo4jDataAccess.py @@ -23,9 +23,9 @@ def __init__(self, debug=False, neo4j_creds=None, batch_size=2000, timeout="60s" self.batch_size = batch_size self.tweetsandaccounts = """ UNWIND $tweets AS t - //Add the Tweet + //Add the Tweet MERGE (tweet:Tweet {id:t.tweet_id}) - ON CREATE SET + ON CREATE SET tweet.text = t.text, tweet.created_at = t.tweet_created_at, tweet.favorite_count = t.favorite_count, @@ -36,7 +36,7 @@ def __init__(self, debug=False, neo4j_creds=None, batch_size=2000, timeout="60s" tweet.hashtags = t.hashtags, tweet.hydrated = 'FULL', tweet.type = t.tweet_type - ON MATCH SET + ON MATCH SET tweet.text = t.text, tweet.favorite_count = t.favorite_count, tweet.retweet_count = t.retweet_count, @@ -46,10 +46,10 @@ def __init__(self, debug=False, neo4j_creds=None, batch_size=2000, timeout="60s" tweet.hashtags = t.hashtags, tweet.hydrated = 'FULL', tweet.type = t.tweet_type - + //Add Account - MERGE (user:Account {id:t.user_id}) - ON CREATE SET + MERGE (user:Account {id:t.user_id}) + ON CREATE SET user.id = t.user_id, user.name = t.name, user.screen_name = t.user_screen_name, @@ -61,7 +61,7 @@ def __init__(self, debug=False, neo4j_creds=None, batch_size=2000, timeout="60s" user.record_created_at = timestamp(), user.job_name = t.job_name, user.job_id = t.job_id - ON MATCH SET + ON MATCH SET user.name = t.user_name, user.screen_name = t.user_screen_name, user.followers_count = t.user_followers_count, @@ -71,31 +71,31 @@ def __init__(self, debug=False, neo4j_creds=None, batch_size=2000, timeout="60s" user.created_at = t.user_created_at, user.record_updated_at = timestamp(), user.job_name = t.job_name, - user.job_id = t.job_id + user.job_id = t.job_id //Add Reply to tweets if needed - FOREACH(ignoreMe IN CASE WHEN t.tweet_type='REPLY' THEN [1] ELSE [] END | - MERGE (retweet:Tweet {id:t.reply_tweet_id}) + FOREACH(ignoreMe IN CASE WHEN t.tweet_type='REPLY' THEN [1] ELSE [] END | + MERGE (retweet:Tweet {id:t.reply_tweet_id}) ON CREATE SET retweet.id=t.reply_tweet_id, retweet.record_created_at = timestamp(), retweet.job_name = t.job_name, retweet.job_id = t.job_id, retweet.hydrated = 'PARTIAL' ) - + //Add QUOTE_RETWEET to tweets if needed - FOREACH(ignoreMe IN CASE WHEN t.tweet_type='QUOTE_RETWEET' THEN [1] ELSE [] END | - MERGE (quoteTweet:Tweet {id:t.quoted_status_id}) + FOREACH(ignoreMe IN CASE WHEN t.tweet_type='QUOTE_RETWEET' THEN [1] ELSE [] END | + MERGE (quoteTweet:Tweet {id:t.quoted_status_id}) ON CREATE SET quoteTweet.id=t.quoted_status_id, quoteTweet.record_created_at = timestamp(), quoteTweet.job_name = t.job_name, quoteTweet.job_id = t.job_id, quoteTweet.hydrated = 'PARTIAL' ) - + //Add RETWEET to tweets if needed - FOREACH(ignoreMe IN CASE WHEN t.tweet_type='RETWEET' THEN [1] ELSE [] END | - MERGE (retweet:Tweet {id:t.retweet_id}) + FOREACH(ignoreMe IN CASE WHEN t.tweet_type='RETWEET' THEN [1] ELSE [] END | + MERGE (retweet:Tweet {id:t.retweet_id}) ON CREATE SET retweet.id=t.retweet_id, retweet.record_created_at = timestamp(), retweet.job_name = t.job_name, @@ -106,70 +106,70 @@ def __init__(self, debug=False, neo4j_creds=None, batch_size=2000, timeout="60s" self.tweeted_rel = """UNWIND $tweets AS t MATCH (user:Account {id:t.user_id}) - MATCH (tweet:Tweet {id:t.tweet_id}) - OPTIONAL MATCH (replied:Tweet {id:t.reply_tweet_id}) - OPTIONAL MATCH (quoteTweet:Tweet {id:t.quoted_status_id}) - OPTIONAL MATCH (retweet:Tweet {id:t.retweet_id}) + MATCH (tweet:Tweet {id:t.tweet_id}) + OPTIONAL MATCH (replied:Tweet {id:t.reply_tweet_id}) + OPTIONAL MATCH (quoteTweet:Tweet {id:t.quoted_status_id}) + OPTIONAL MATCH (retweet:Tweet {id:t.retweet_id}) WITH user, tweet, replied, quoteTweet, retweet - + MERGE (user)-[r:TWEETED]->(tweet) - - FOREACH(ignoreMe IN CASE WHEN tweet.type='REPLY' AND replied.id>0 THEN [1] ELSE [] END | + + FOREACH(ignoreMe IN CASE WHEN tweet.type='REPLY' AND replied.id>0 THEN [1] ELSE [] END | MERGE (tweet)-[:REPLYED]->(replied) ) - - FOREACH(ignoreMe IN CASE WHEN tweet.type='QUOTE_RETWEET' AND quoteTweet.id>0 THEN [1] ELSE [] END | + + FOREACH(ignoreMe IN CASE WHEN tweet.type='QUOTE_RETWEET' AND quoteTweet.id>0 THEN [1] ELSE [] END | MERGE (tweet)-[:QUOTED]->(quoteTweet) ) - - FOREACH(ignoreMe IN CASE WHEN tweet.type='RETWEET' AND retweet.id>0 THEN [1] ELSE [] END | + + FOREACH(ignoreMe IN CASE WHEN tweet.type='RETWEET' AND retweet.id>0 THEN [1] ELSE [] END | MERGE (tweet)-[:RETWEETED]->(retweet) ) - + """ - self.mentions = """UNWIND $mentions AS t + self.mentions = """UNWIND $mentions AS t MATCH (tweet:Tweet {id:t.tweet_id}) - MERGE (user:Account {id:t.user_id}) - ON CREATE SET + MERGE (user:Account {id:t.user_id}) + ON CREATE SET user.id = t.user_id, user.mentioned_name = t.name, user.mentioned_screen_name = t.user_screen_name, user.record_created_at = timestamp(), user.job_name = t.job_name, user.job_id = t.job_id - WITH user, tweet - MERGE (tweet)-[:MENTIONED]->(user) + WITH user, tweet + MERGE (tweet)-[:MENTIONED]->(user) """ - self.urls = """UNWIND $urls AS t + self.urls = """UNWIND $urls AS t MATCH (tweet:Tweet {id:t.tweet_id}) - MERGE (url:Url {full_url:t.url}) - ON CREATE SET + MERGE (url:Url {full_url:t.url}) + ON CREATE SET url.full_url = t.url, url.job_name = t.job_name, url.job_id = t.job_id, url.record_created_at = timestamp(), - url.schema=t.scheme, - url.netloc=t.netloc, - url.path=t.path, - url.params=t.params, - url.query=t.query, - url.fragment=t.fragment, - url.username=t.username, - url.password=t.password, - url.hostname=t.hostname, + url.schema=t.scheme, + url.netloc=t.netloc, + url.path=t.path, + url.params=t.params, + url.query=t.query, + url.fragment=t.fragment, + url.username=t.username, + url.password=t.password, + url.hostname=t.hostname, url.port=t.port - WITH url, tweet - MERGE (tweet)-[:INCLUDES]->(url) + WITH url, tweet + MERGE (tweet)-[:INCLUDES]->(url) """ - self.fetch_tweet_status = """UNWIND $ids AS i + self.fetch_tweet_status = """UNWIND $ids AS i MATCH (tweet:Tweet {id:i.id}) RETURN tweet.id, tweet.hydrated """ - self.fetch_tweet = """UNWIND $ids AS i + self.fetch_tweet = """UNWIND $ids AS i MATCH (tweet:Tweet {id:i.id}) RETURN tweet """ diff --git a/pipelines/Makefile b/pipelines/Makefile new file mode 100644 index 0000000..76899ef --- /dev/null +++ b/pipelines/Makefile @@ -0,0 +1,28 @@ +prefect-up : + export APOLLO_HOST_PORT=4200 \ + GRAPHQL_HOST_PORT=4201 \ + HASURA_HOST_PORT=3000 \ + POSTGRES_HOST_PORT=5432 \ + UI_HOST_PORT=8080 \ + POSTGRES_USER=prefect \ + POSTGRES_PASSWORD=test-password \ + POSTGRES_DB=prefect_server && \ + export DB_CONNECTION_URL=postgresql://$$POSTGRES_USER:$$POSTGRES_PASSWORD@postgres:$$POSTGRES_HOST_PORT/$$POSTGRES_DB \ + HASURA_API_URL=http://hasura:$$HASURA_HOST_PORT/v1alpha1/graphql \ + HASURA_WS_URL=ws://hasura:$$HASURA_HOST_PORT/v1alpha1/graphql \ + PREFECT_API_HEALTH_URL=http://graphql:$$GRAPHQL_HOST_PORT/health \ + PREFECT_API_URL=http://graphql:$$GRAPHQL_HOST_PORT/graphql/ \ + PREFECT_SERVER_DB_CMD='prefect-server database upgrade -y' && \ + docker-compose -f ../infra/prefect/docker/docker-compose.yml up + +agent : + cd .. && \ + prefect backend server && \ + python -m pipelines.Pipeline && \ + prefect agent start + +agent-docker : + cd .. && \ + docker run -e PREFECT__SERVER__HOST=http://host.docker.internal \ + -e PREFECT__SERVER__PORT=4200 \ + $$(docker build -f infra/pipelines/docker/Dockerfile -q .) diff --git a/Pipeline.py b/pipelines/Pipeline.py similarity index 99% rename from Pipeline.py rename to pipelines/Pipeline.py index 07eff40..77d02ce 100644 --- a/Pipeline.py +++ b/pipelines/Pipeline.py @@ -199,4 +199,3 @@ def sample(tweets): flow.run() else: flow.register(project_name="rehydrate") - flow.run_agent() diff --git a/pipelines/README.md b/pipelines/README.md new file mode 100644 index 0000000..391b17b --- /dev/null +++ b/pipelines/README.md @@ -0,0 +1,16 @@ +# Pipelines + +This folder contains the data ingestion pipelines. It uses [Prefect](http://prefect.io) as the orchestrator. + +To run the pipelines locally, we need to start the Prefect UI + server container by running `make prefect-up`. Wait for the message (it should take a few seconds) + +``` +Server ready at http://0.0.0.0:4200/ 🚀 +``` + +You can then access the Prefect UI at http://localhost:8080. + +To deploy the pipelines to Prefect, we need to run the Prefect agent (which registers flows to the Prefect server and polls for flow runs). We can either use (in a separate CLI): + +1. `make agent` (preferred for development): this script runs the Prefect agent/pipelines locally. +2. `make agent-docker` (sanity check before merging changes): this script packs a Prefect agent and this repository into a docker container, and runs them inside the container. It takes a while to build the container, but it is also what we use in production, so before merging changes into master it's a great sanity check. From 07409e423745b626a7ccb557f5b8c805b0e0871d Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Mon, 6 Apr 2020 16:21:14 +1000 Subject: [PATCH 25/47] confortable neo4j import setup --- modules/TempNB/IngestDrugSynonyms.ipynb | 223 +++++++++++++++++++----- 1 file changed, 179 insertions(+), 44 deletions(-) diff --git a/modules/TempNB/IngestDrugSynonyms.ipynb b/modules/TempNB/IngestDrugSynonyms.ipynb index 9829536..1b57fd6 100644 --- a/modules/TempNB/IngestDrugSynonyms.ipynb +++ b/modules/TempNB/IngestDrugSynonyms.ipynb @@ -2,7 +2,7 @@ "cells": [ { "cell_type": "code", - "execution_count": 2, + "execution_count": 86, "metadata": {}, "outputs": [], "source": [ @@ -14,7 +14,9 @@ "import xlrd\n", "import csv\n", "import os\n", - "import tempfile" + "import tempfile\n", + "import numpy as np\n", + "from typing import Optional" ] }, { @@ -234,7 +236,7 @@ }, { "cell_type": "code", - "execution_count": 15, + "execution_count": 44, "metadata": {}, "outputs": [ { @@ -248,68 +250,35 @@ } ], "source": [ - "all_studies_by_keyword:dict = {}\n", + "all_US_studies_by_keyword:dict = {}\n", "queries:list = [\"covid-19\", \"SARS-CoV-2\", \"coronavirus\"]\n", "\n", "for key in queries:\n", - " all_studies_by_keyword[key] = getAllStudiesByQuery(key)" + " all_US_studies_by_keyword[key] = getAllStudiesByQuery(key)" ] }, { "cell_type": "code", - "execution_count": 16, - "metadata": {}, - "outputs": [ - { - "data": { - "text/plain": [ - "3" - ] - }, - "execution_count": 16, - "metadata": {}, - "output_type": "execute_result" - } - ], - "source": [ - "len(all_studies_by_keyword)" - ] - }, - { - "cell_type": "code", - "execution_count": 18, + "execution_count": 47, "metadata": {}, "outputs": [ { "name": "stdout", "output_type": "stream", "text": [ - "--2020-04-06 12:25:17-- https://www.drugbank.ca/releases/5-1-5/downloads/all-drugbank-vocabulary\n", - "Resolving www.drugbank.ca (www.drugbank.ca)... 104.26.5.2, 104.26.4.2, 2606:4700:20::681a:502, ...\n", - "Connecting to www.drugbank.ca (www.drugbank.ca)|104.26.5.2|:443... connected.\n", - "HTTP request sent, awaiting response... 302 Found\n", - "Location: https://drugbank.s3.us-west-2.amazonaws.com/public_downloads/downloads/000/003/618/original/drugbank_all_drugbank_vocabulary.csv.zip?X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=AKIAJTZC3DSCEEG75A6Q%2F20200406%2Fus-west-2%2Fs3%2Faws4_request&X-Amz-Date=20200406T022518Z&X-Amz-Expires=30&X-Amz-SignedHeaders=host&X-Amz-Signature=89010fbf368ddcaf2609a7d92048b5bd201e1e834e1813f7c116de05036b5d8b [following]\n", - "--2020-04-06 12:25:19-- https://drugbank.s3.us-west-2.amazonaws.com/public_downloads/downloads/000/003/618/original/drugbank_all_drugbank_vocabulary.csv.zip?X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=AKIAJTZC3DSCEEG75A6Q%2F20200406%2Fus-west-2%2Fs3%2Faws4_request&X-Amz-Date=20200406T022518Z&X-Amz-Expires=30&X-Amz-SignedHeaders=host&X-Amz-Signature=89010fbf368ddcaf2609a7d92048b5bd201e1e834e1813f7c116de05036b5d8b\n", - "Resolving drugbank.s3.us-west-2.amazonaws.com (drugbank.s3.us-west-2.amazonaws.com)... 52.218.225.129\n", - "Connecting to drugbank.s3.us-west-2.amazonaws.com (drugbank.s3.us-west-2.amazonaws.com)|52.218.225.129|:443... connected.\n", - "HTTP request sent, awaiting response... 200 OK\n", - "Length: 712150 (695K) [application/zip]\n", - "Saving to: 'drug_vocab.csv.zip’\n", - "\n", - "drug_vocab.csv.zip 100%[===================>] 695.46K 366KB/s in 1.9s \n", - "\n", - "2020-04-06 12:25:22 (366 KB/s) - 'drug_vocab.csv.zip’ saved [712150/712150]\n", - "\n" + "3\n" ] } ], "source": [ - "! wget -O drug_vocab.csv.zip https://www.drugbank.ca/releases/5-1-5/downloads/all-drugbank-vocabulary" + "print(len(all_US_studies_by_keyword))\n", + "with open('all_US_studies_by_keyword.json', 'w', encoding='utf-8') as f:\n", + " json.dump(all_US_studies_by_keyword, f, ensure_ascii=False, indent=4)" ] }, { "cell_type": "code", - "execution_count": 42, + "execution_count": 49, "metadata": {}, "outputs": [], "source": [ @@ -317,6 +286,26 @@ "vocab = urlToDF(drug_url,csvZipHandler) " ] }, + { + "cell_type": "code", + "execution_count": 50, + "metadata": {}, + "outputs": [ + { + "data": { + "text/plain": [ + "Index(['DrugBank ID', 'Accession Numbers', 'Common name', 'CAS', 'UNII', 'Synonyms', 'Standard InChI Key'], dtype='object')" + ] + }, + "execution_count": 50, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "vocab.columns" + ] + }, { "cell_type": "code", "execution_count": 43, @@ -590,6 +579,152 @@ "vocab.head(20)" ] }, + { + "cell_type": "code", + "execution_count": 52, + "metadata": {}, + "outputs": [], + "source": [ + "#vocab.to_csv(\"vocab.csv\")" + ] + }, + { + "cell_type": "code", + "execution_count": 62, + "metadata": {}, + "outputs": [], + "source": [ + "vocab_red = vocab[['Common name', 'Synonyms']]" + ] + }, + { + "cell_type": "code", + "execution_count": 63, + "metadata": {}, + "outputs": [], + "source": [ + "drug_vocab:dict = {}" + ] + }, + { + "cell_type": "code", + "execution_count": 80, + "metadata": {}, + "outputs": [], + "source": [ + "for index, row in vocab_red.iterrows():\n", + " drug_vocab[row['Common name']] = row[\"Synonyms\"].split(\"|\") if isinstance(row[\"Synonyms\"],str) else row[\"Synonyms\"]" + ] + }, + { + "cell_type": "code", + "execution_count": 81, + "metadata": {}, + "outputs": [], + "source": [ + "from neo4j import GraphDatabase" + ] + }, + { + "cell_type": "code", + "execution_count": 83, + "metadata": {}, + "outputs": [], + "source": [ + "class DrugSynonimDataToNeo4j(object):\n", + "\n", + " def __init__(self, uri, user, password):\n", + " self._driver = GraphDatabase.driver(uri, auth=(user, password))\n", + "\n", + " def close(self):\n", + " self._driver.close()\n", + " \n", + " def upload_drugs_and_synonims(self,drug_vocab):\n", + " with self._driver.session() as session:\n", + " for key in drub_vocab.keys():\n", + " for synonym in drug_vocab[key]:\n", + " \n", + " resp = session.write_transaction(self._merge_node, message)\n", + " print(resp) \n", + " \n", + " @staticmethod\n", + " def _merge_node(tx, node_type, properties=None):\n", + " data:dict = {\n", + " \"node_type\":node_type\n", + " \"properties\":self._dict_to_property_str(properties)\n", + " }\n", + " # '{first} {last}'.format(**data)\n", + " base_cypher = \"\"\"\n", + " MERGE (n:{node_type}) {{ {properties} }})\n", + " RETURN id(n)\n", + " \"\"\"\n", + " result = tx.run(base_cypher.format(**data))\n", + " \n", + " return result\n", + " \n", + " @staticmethod\n", + " def _merge_edge(tx, from_id, to_id, ):\n", + " result = tx.run(\"CREATE (a:Greeting) \"\n", + " \"SET a.message = $message \"\n", + " \"RETURN a.message + ', from node ' + id(a)\", message=message)\n", + " return result\n", + " \n", + " @staticmethod\n", + " def _dict_to_property_str(properties:Optional[dict] = None) -> str:\n", + " def property_type_checker(property_value):\n", + " if isinstance(property_value,int) or isinstance(property_value,float):\n", + " pass\n", + " elif isinstance(property_value,str):\n", + " property_value = \"\"\"'\"\"\" + property_value + \"\"\"'\"\"\"\n", + " return property_value\n", + "\n", + " resp = \"\"\n", + " if not properties:\n", + " resp = \"{\"\n", + " for key in properties.keys():\n", + " resp += \"\"\"{key}:{value},\"\"\".format(key=key,value=property_type_checker(properties[key]))\n", + " resp = resp[:-1] + \"}\"\n", + " return resp" + ] + }, + { + "cell_type": "code", + "execution_count": 88, + "metadata": {}, + "outputs": [], + "source": [ + "test:dict = {\n", + " \"a\":\"B\",\n", + " \"c\":\"D\",\n", + "}" + ] + }, + { + "cell_type": "code", + "execution_count": 90, + "metadata": {}, + "outputs": [], + "source": [ + "asd = \"asd,\"" + ] + }, + { + "cell_type": "code", + "execution_count": 91, + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "asd}\n" + ] + } + ], + "source": [ + "print(asd[:-1]+\"}\")" + ] + }, { "cell_type": "code", "execution_count": null, From 8cf111b1641f1bb5d6d711be04589180672c3563 Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Mon, 6 Apr 2020 16:41:04 +1000 Subject: [PATCH 26/47] confortable edge inserting into neo4j --- modules/TempNB/IngestDrugSynonyms.ipynb | 49 ++++++++++++++++++++----- 1 file changed, 39 insertions(+), 10 deletions(-) diff --git a/modules/TempNB/IngestDrugSynonyms.ipynb b/modules/TempNB/IngestDrugSynonyms.ipynb index 1b57fd6..1310f73 100644 --- a/modules/TempNB/IngestDrugSynonyms.ipynb +++ b/modules/TempNB/IngestDrugSynonyms.ipynb @@ -627,11 +627,20 @@ }, { "cell_type": "code", - "execution_count": 83, + "execution_count": 92, "metadata": {}, - "outputs": [], + "outputs": [ + { + "ename": "IndentationError", + "evalue": "expected an indented block (, line 14)", + "output_type": "error", + "traceback": [ + "\u001b[0;36m File \u001b[0;32m\"\"\u001b[0;36m, line \u001b[0;32m14\u001b[0m\n\u001b[0;31m resp = session.write_transaction(self._merge_node, message)\u001b[0m\n\u001b[0m ^\u001b[0m\n\u001b[0;31mIndentationError\u001b[0m\u001b[0;31m:\u001b[0m expected an indented block\n" + ] + } + ], "source": [ - "class DrugSynonimDataToNeo4j(object):\n", + "class DrugSynonymDataToNeo4j(object):\n", "\n", " def __init__(self, uri, user, password):\n", " self._driver = GraphDatabase.driver(uri, auth=(user, password))\n", @@ -642,10 +651,20 @@ " def upload_drugs_and_synonims(self,drug_vocab):\n", " with self._driver.session() as session:\n", " for key in drub_vocab.keys():\n", + " node_type = \"Drug\"\n", + " properties:dict = {\n", + " \"name\":key\n", + " }\n", + " drug_id = session.write_transaction(self._merge_node, node_type, properties)\n", " for synonym in drug_vocab[key]:\n", - " \n", - " resp = session.write_transaction(self._merge_node, message)\n", - " print(resp) \n", + " node_type = \"Synonym\"\n", + " properties:dict = {\n", + " \"name\":synonym\n", + " }\n", + " synonym_id = session.write_transaction(self._merge_node, node_type, properties)\n", + " edge_type = \"HAS\"\n", + " session.write_transaction(self._merge_edge, drug_id, synonym_id, edge_type)\n", + " print(\"Done\") \n", " \n", " @staticmethod\n", " def _merge_node(tx, node_type, properties=None):\n", @@ -663,10 +682,20 @@ " return result\n", " \n", " @staticmethod\n", - " def _merge_edge(tx, from_id, to_id, ):\n", - " result = tx.run(\"CREATE (a:Greeting) \"\n", - " \"SET a.message = $message \"\n", - " \"RETURN a.message + ', from node ' + id(a)\", message=message)\n", + " def _merge_edge(tx, from_id, to_id, edge_type, direction = \">\"):\n", + " if not direction in [\">\",\"\"]:\n", + " raise ValueError\n", + " data:dict = {\n", + " \"from_id\":int(from_id),\n", + " \"to_id\":int(to_id),\n", + " \"edge_type\":edge_type,\n", + " \"directon\":direction \n", + " }\n", + " base_cypher = \"\"\" \n", + " MERGE (Node({from_id}))-[r:{edge_type}]-{direction}(Node({to_id}))\n", + " RETURN id(r)\n", + " \"\"\"\n", + " result = tx.run(base_cypher.format(**data))\n", " return result\n", " \n", " @staticmethod\n", From 4e6c3ec5cf3eb7c023119ba99d79d26081d1363d Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Mon, 6 Apr 2020 16:41:57 +1000 Subject: [PATCH 27/47] flexible insertion into neo4j --- modules/TempNB/IngestDrugSynonyms.ipynb | 46 ++++++------------------- 1 file changed, 10 insertions(+), 36 deletions(-) diff --git a/modules/TempNB/IngestDrugSynonyms.ipynb b/modules/TempNB/IngestDrugSynonyms.ipynb index 1310f73..fe8acdd 100644 --- a/modules/TempNB/IngestDrugSynonyms.ipynb +++ b/modules/TempNB/IngestDrugSynonyms.ipynb @@ -627,18 +627,9 @@ }, { "cell_type": "code", - "execution_count": 92, + "execution_count": 94, "metadata": {}, - "outputs": [ - { - "ename": "IndentationError", - "evalue": "expected an indented block (, line 14)", - "output_type": "error", - "traceback": [ - "\u001b[0;36m File \u001b[0;32m\"\"\u001b[0;36m, line \u001b[0;32m14\u001b[0m\n\u001b[0;31m resp = session.write_transaction(self._merge_node, message)\u001b[0m\n\u001b[0m ^\u001b[0m\n\u001b[0;31mIndentationError\u001b[0m\u001b[0;31m:\u001b[0m expected an indented block\n" - ] - } - ], + "outputs": [], "source": [ "class DrugSynonymDataToNeo4j(object):\n", "\n", @@ -669,7 +660,7 @@ " @staticmethod\n", " def _merge_node(tx, node_type, properties=None):\n", " data:dict = {\n", - " \"node_type\":node_type\n", + " \"node_type\":node_type,\n", " \"properties\":self._dict_to_property_str(properties)\n", " }\n", " # '{first} {last}'.format(**data)\n", @@ -718,41 +709,24 @@ }, { "cell_type": "code", - "execution_count": 88, + "execution_count": 95, "metadata": {}, "outputs": [], - "source": [ - "test:dict = {\n", - " \"a\":\"B\",\n", - " \"c\":\"D\",\n", - "}" - ] + "source": [] }, { "cell_type": "code", - "execution_count": 90, + "execution_count": 96, "metadata": {}, "outputs": [], - "source": [ - "asd = \"asd,\"" - ] + "source": [] }, { "cell_type": "code", - "execution_count": 91, + "execution_count": null, "metadata": {}, - "outputs": [ - { - "name": "stdout", - "output_type": "stream", - "text": [ - "asd}\n" - ] - } - ], - "source": [ - "print(asd[:-1]+\"}\")" - ] + "outputs": [], + "source": [] }, { "cell_type": "code", From a4aa10f4999c62823deea17a7fbb8001b6adcfaa Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Mon, 6 Apr 2020 16:42:31 +1000 Subject: [PATCH 28/47] add config --- modules/TempNB/config.json | 5 +++++ 1 file changed, 5 insertions(+) create mode 100644 modules/TempNB/config.json diff --git a/modules/TempNB/config.json b/modules/TempNB/config.json new file mode 100644 index 0000000..ffab88d --- /dev/null +++ b/modules/TempNB/config.json @@ -0,0 +1,5 @@ +{ + "URL_USA":"https://www.clinicaltrials.gov/api/query/full_studies?expr={}&min_rnk={}&max_rnk={}&fmt=json", + "URL_INT":"https://www.who.int/docs/default-source/coronaviruse/covid-19-trials.xls", + "URL_DRUGBANK": "https://www.drugbank.ca/releases/5-1-5/downloads/all-drugbank-vocabulary" +} \ No newline at end of file From f1831f62db23e260f67d8c7adde5f047e79a3bbd Mon Sep 17 00:00:00 2001 From: Dave Date: Mon, 6 Apr 2020 16:43:36 -0800 Subject: [PATCH 29/47] Made minor tweaks to get the prefect ui stuff to run correctly on the prod host --- infra/prefect/docker/docker-compose.yml | 55 ++++++++++++------------- pipelines/Makefile | 2 +- 2 files changed, 28 insertions(+), 29 deletions(-) diff --git a/infra/prefect/docker/docker-compose.yml b/infra/prefect/docker/docker-compose.yml index 0be80a4..b9317f9 100644 --- a/infra/prefect/docker/docker-compose.yml +++ b/infra/prefect/docker/docker-compose.yml @@ -3,44 +3,44 @@ # Note: The server port cannot be overriden (issue: https://github.com/PrefectHQ/prefect/issues/2237); # When support is added APOLLO_HOST_PORT should be set to the server port number. -version: "3.7" +version: '3.3' services: postgres: - image: "postgres:11" + image: 'postgres:11' ports: - - "${POSTGRES_HOST_PORT:-5432}:5432" + - '${POSTGRES_HOST_PORT:-5432}:5432' environment: POSTGRES_USER: ${POSTGRES_USER} POSTGRES_PASSWORD: ${POSTGRES_PASSWORD} POSTGRES_DB: ${POSTGRES_DB} networks: - prefect-server - restart: "always" + restart: 'always' command: - - "postgres" + - 'postgres' # explicitly set max connections - - "-c" - - "max_connections=150" + - '-c' + - 'max_connections=150' hasura: - image: "hasura/graphql-engine:v1.1.0" + image: 'hasura/graphql-engine:v1.1.0' ports: - - "${HASURA_HOST_PORT:-3000}:3000" - command: "graphql-engine serve" + - '${HASURA_HOST_PORT:-3000}:3000' + command: 'graphql-engine serve' environment: HASURA_GRAPHQL_DATABASE_URL: ${DB_CONNECTION_URL} - HASURA_GRAPHQL_ENABLE_CONSOLE: "true" - HASURA_GRAPHQL_SERVER_PORT: "3000" + HASURA_GRAPHQL_ENABLE_CONSOLE: 'true' + HASURA_GRAPHQL_SERVER_PORT: '3000' HASURA_GRAPHQL_QUERY_PLAN_CACHE_SIZE: 100 networks: - prefect-server - restart: "always" + restart: 'always' depends_on: - postgres graphql: - image: "prefecthq/server:${PREFECT_SERVER_TAG:-latest}" + image: 'prefecthq/server:${PREFECT_SERVER_TAG:-latest}' ports: - - "${GRAPHQL_HOST_PORT:-4201}:4201" + - '${GRAPHQL_HOST_PORT:-4201}:4201' command: bash -c "${PREFECT_SERVER_DB_CMD} && python src/prefect_server/services/graphql/server.py" environment: PREFECT_SERVER_DB_CMD: ${PREFECT_SERVER_DB_CMD:-"echo 'DATABASE MIGRATIONS SKIPPED'"} @@ -49,45 +49,44 @@ services: PREFECT_SERVER__HASURA__HOST: hasura networks: - prefect-server - restart: "always" + restart: 'always' depends_on: - hasura scheduler: - image: "prefecthq/server:${PREFECT_SERVER_TAG:-latest}" - command: "python src/prefect_server/services/scheduler/scheduler.py" + image: 'prefecthq/server:${PREFECT_SERVER_TAG:-latest}' + command: 'python src/prefect_server/services/scheduler/scheduler.py' environment: PREFECT_SERVER__HASURA__ADMIN_SECRET: ${PREFECT_SERVER__HASURA__ADMIN_SECRET:-hasura-secret-admin-secret} PREFECT_SERVER__HASURA__HOST: hasura networks: - prefect-server - restart: "always" + restart: 'always' depends_on: - graphql apollo: - image: "prefecthq/apollo:${PREFECT_SERVER_TAG:-latest}" + image: 'prefecthq/apollo:${PREFECT_SERVER_TAG:-latest}' ports: - - "${APOLLO_HOST_PORT:-4200}:4200" - command: "npm run serve" + - '${APOLLO_HOST_PORT:-4200}:4200' + command: 'npm run serve' environment: HASURA_API_URL: ${HASURA_API_URL:-http://hasura:3000/v1alpha1/graphql} PREFECT_API_URL: ${PREFECT_API_URL:-http://graphql:4201/graphql/} PREFECT_API_HEALTH_URL: ${PREFECT_API_HEALTH_URL:-http://graphql:4201/health} networks: - prefect-server - restart: "always" + restart: 'always' depends_on: - graphql ui: - image: "prefecthq/ui:${PREFECT_SERVER_TAG:-latest}" + image: 'prefecthq/ui:${PREFECT_SERVER_TAG:-latest}' ports: - - "${UI_HOST_PORT:-8080}:8080" - command: "/intercept.sh" + - '${UI_HOST_PORT:-8080}:8080' + command: '/intercept.sh' networks: - prefect-server - restart: "always" + restart: 'always' depends_on: - apollo networks: prefect-server: - name: prefect-server diff --git a/pipelines/Makefile b/pipelines/Makefile index 76899ef..a8d5db1 100644 --- a/pipelines/Makefile +++ b/pipelines/Makefile @@ -13,7 +13,7 @@ prefect-up : PREFECT_API_HEALTH_URL=http://graphql:$$GRAPHQL_HOST_PORT/health \ PREFECT_API_URL=http://graphql:$$GRAPHQL_HOST_PORT/graphql/ \ PREFECT_SERVER_DB_CMD='prefect-server database upgrade -y' && \ - docker-compose -f ../infra/prefect/docker/docker-compose.yml up + docker-compose -f ../infra/prefect/docker/docker-compose.yml up -d agent : cd .. && \ From c96adf3dc8337cc83f06ee91020b68b02c4c044c Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Tue, 7 Apr 2020 12:01:56 +1000 Subject: [PATCH 30/47] data scraping into class --- modules/TempNB/DrugSynonymDataToNeo4j.py | 78 ++ modules/TempNB/IngestDrugSynonyms.ipynb | 944 +++++++++-------------- modules/TempNB/IngestDrugSynonyms.py | 110 +++ modules/TempNB/config.json | 7 +- 4 files changed, 566 insertions(+), 573 deletions(-) create mode 100644 modules/TempNB/DrugSynonymDataToNeo4j.py create mode 100644 modules/TempNB/IngestDrugSynonyms.py diff --git a/modules/TempNB/DrugSynonymDataToNeo4j.py b/modules/TempNB/DrugSynonymDataToNeo4j.py new file mode 100644 index 0000000..1d2e37e --- /dev/null +++ b/modules/TempNB/DrugSynonymDataToNeo4j.py @@ -0,0 +1,78 @@ +from neo4j import GraphDatabase +from typing import Optional + +class DrugSynonymDataToNeo4j(object): + + def __init__(self, uri, user, password): + self._driver = GraphDatabase.driver(uri, auth=(user, password)) + + def close(self): + self._driver.close() + + def upload_drugs_and_synonims(self,drug_vocab): + with self._driver.session() as session: + for key in drub_vocab.keys(): + node_type = "Drug" + properties:dict = { + "name":key + } + drug_id = session.write_transaction(self._merge_node, node_type, properties) + for synonym in drug_vocab[key]: + node_type = "Synonym" + properties:dict = { + "name":synonym + } + synonym_id = session.write_transaction(self._merge_node, node_type, properties) + edge_type = "HAS" + session.write_transaction(self._merge_edge, drug_id, synonym_id, edge_type) + print("Done") + + @staticmethod + def _merge_node(tx, node_type, properties=None): + data:dict = { + "node_type":node_type, + "properties":self._dict_to_property_str(properties) + } + # '{first} {last}'.format(**data) + base_cypher = """ + MERGE (n:{node_type}) {{ {properties} }}) + RETURN id(n) + """ + result = tx.run(base_cypher.format(**data)) + + return result + + @staticmethod + def _merge_edge(tx, from_id, to_id, edge_type, direction = ">"): + if not direction in [">",""]: + raise ValueError + data:dict = { + "from_id":int(from_id), + "to_id":int(to_id), + "edge_type":edge_type, + "directon":direction + } + base_cypher = """ + MERGE (Node({from_id}))-[r:{edge_type}]-{direction}(Node({to_id})) + RETURN id(r) + """ + result = tx.run(base_cypher.format(**data)) + return result + + @staticmethod + def _dict_to_property_str(properties:Optional[dict] = None) -> str: + def property_type_checker(property_value): + if isinstance(property_value,int) or isinstance(property_value,float): + pass + elif isinstance(property_value,str): + property_value = """'""" + property_value + """'""" + return property_value + + resp = "" + if not properties: + resp = "{" + for key in properties.keys(): + resp += """{key}:{value},""".format(key=key,value=property_type_checker(properties[key])) + resp = resp[:-1] + "}" + return resp + diff --git a/modules/TempNB/IngestDrugSynonyms.ipynb b/modules/TempNB/IngestDrugSynonyms.ipynb index fe8acdd..948c215 100644 --- a/modules/TempNB/IngestDrugSynonyms.ipynb +++ b/modules/TempNB/IngestDrugSynonyms.ipynb @@ -2,26 +2,45 @@ "cells": [ { "cell_type": "code", - "execution_count": 86, + "execution_count": 56, "metadata": {}, "outputs": [], "source": [ - "import requests\n", - "import pandas as pd\n", - "import json\n", - "import sys\n", - "from pathlib import Path\n", - "import xlrd\n", - "import csv\n", - "import os\n", - "import tempfile\n", - "import numpy as np\n", - "from typing import Optional" + "from DrugSynonymDataToNeo4j import DrugSynonymDataToNeo4j\n", + "from IngestDrugSynonyms import DrugSynonymIngest" ] }, { "cell_type": "code", - "execution_count": 17, + "execution_count": 57, + "metadata": {}, + "outputs": [], + "source": [ + "import pandas as pd" + ] + }, + { + "cell_type": "code", + "execution_count": 58, + "metadata": {}, + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "The autoreload extension is already loaded. To reload it, use:\n", + " %reload_ext autoreload\n" + ] + } + ], + "source": [ + "%load_ext autoreload\n", + "%autoreload 2" + ] + }, + { + "cell_type": "code", + "execution_count": 59, "metadata": {}, "outputs": [ { @@ -56,260 +75,369 @@ }, { "cell_type": "code", - "execution_count": 4, - "metadata": {}, - "outputs": [], - "source": [ - "with open(\"config.json\") as f:\n", - " config = json.load(f)\n", - " for key in config:\n", - " os.environ[key] = config[key]" - ] - }, - { - "cell_type": "code", - "execution_count": 21, - "metadata": {}, - "outputs": [], - "source": [ - "def xlsHandler(r):\n", - " df = pd.DataFrame()\n", - " with tempfile.NamedTemporaryFile(\"wb\") as xls_file:\n", - " xls_file.write(r.content)\n", - " \n", - " try:\n", - " book = xlrd.open_workbook(xls_file.name,encoding_override=\"utf-8\") \n", - " except:\n", - " book = xlrd.open_workbook(xls_file.name,encoding_override=\"cp1251\")\n", - "\n", - " sh = book.sheet_by_index(0)\n", - " with tempfile.NamedTemporaryFile(\"w\") as csv_file:\n", - " wr = csv.writer(csv_file, quoting=csv.QUOTE_ALL)\n", - "\n", - " for rownum in range(sh.nrows):\n", - " wr.writerow(sh.row_values(rownum))\n", - " df = pd.read_csv(csv_file.name)\n", - " csv_file.close()\n", - "\n", - " xls_file.close()\n", - " return df" - ] - }, - { - "cell_type": "code", - "execution_count": 39, - "metadata": {}, - "outputs": [], - "source": [ - "def csvZipHandler(r):\n", - " df = pd.DataFrame()\n", - " with tempfile.NamedTemporaryFile(\"wb\",suffix='.csv.zip') as file:\n", - " file.write(r.content)\n", - " df = pd.read_csv(file.name)\n", - " file.close()\n", - " return df" - ] - }, - { - "cell_type": "code", - "execution_count": 22, + "execution_count": 60, "metadata": {}, "outputs": [], "source": [ - "def urlToDF(url:str,respHandler) -> pd.DataFrame:\n", - " r = requests.get(url, allow_redirects=True)\n", - " df = pd.DataFrame()\n", - " return respHandler(r)" + "drugSynonym = DrugSynonymIngest()" ] }, { "cell_type": "code", - "execution_count": 23, - "metadata": {}, - "outputs": [], - "source": [ - "def api(query,from_study,to_study):\n", - " url = os.environ[\"URL_USA\"].format(query,from_study,to_study)\n", - " response = requests.request(\"GET\", url)\n", - " return response.json()" - ] - }, - { - "cell_type": "code", - "execution_count": 24, - "metadata": {}, - "outputs": [], - "source": [ - "def apiWrapper(query,from_study):\n", - " return api(query,from_study,from_study+99)" - ] - }, - { - "cell_type": "code", - "execution_count": 25, - "metadata": {}, - "outputs": [], - "source": [ - "def getAllStudiesByQuery(query:str) -> list:\n", - " studies:list = []\n", - " from_study = 1\n", - " temp = apiWrapper(query,from_study)\n", - " nstudies = temp['FullStudiesResponse']['NStudiesFound']\n", - " print(\"> {} studies found by '{}' keyword\".format(nstudies,query))\n", - " if nstudies > 0:\n", - " studies = temp['FullStudiesResponse']['FullStudies']\n", - " for study_index in range(from_study+100,nstudies,100):\n", - " temp = apiWrapper(query,study_index)\n", - " studies.extend(temp['FullStudiesResponse']['FullStudies'])\n", - " \n", - " return studies" - ] - }, - { - "cell_type": "code", - "execution_count": 27, - "metadata": {}, - "outputs": [], - "source": [ - "url_int = os.environ[\"URL_INT\"]" - ] - }, - { - "cell_type": "code", - "execution_count": 31, - "metadata": {}, - "outputs": [], - "source": [ - "internationalstudies = urlToDF(url_int,xlsHandler)" - ] - }, - { - "cell_type": "code", - "execution_count": 29, - "metadata": {}, - "outputs": [ - { - "data": { - "text/plain": [ - "Index(['TrialID', 'Last Refreshed on', 'Public title', 'Scientific title', 'Acronym', 'Primary sponsor', 'Date registration', 'Date registration3', 'Export date', 'Source Register', 'web address', 'Recruitment Status', 'other records', 'Inclusion agemin', 'Inclusion agemax', 'Inclusion gender', 'Date enrollement', 'Target size', 'Study type', 'Study design', 'Phase', 'Countries', 'Contact Firstname', 'Contact Lastname', 'Contact Address', 'Contact Email', 'Contact Tel', 'Contact Affiliation', 'Inclusion Criteria', 'Exclusion Criteria', 'Condition', 'Intervention', 'Primary outcome', 'results date posted', 'results date completed', 'results url link', 'Retrospective flag', 'Bridging flag truefalse', 'Bridged type', 'results yes no'], dtype='object')" - ] - }, - "execution_count": 29, - "metadata": {}, - "output_type": "execute_result" - } - ], - "source": [ - "internationalstudies.columns" - ] - }, - { - "cell_type": "code", - "execution_count": 30, - "metadata": {}, - "outputs": [ - { - "data": { - "text/plain": [ - "0 survival group:none;died:none; \n", - "1 Case series:Treated with conventional treatment combined with Chloroquine Phosphate; \n", - "2 experimental group:standardized comprehensive treatment combined with convalescent plasma treatment;control group:standardized comprehensive treatment; \n", - "3 control group:Western Medicine;experimental group:Integrated Traditional Chinese and Western Medicine; \n", - "4 Diagnostic Test: Recombinase aided amplification (RAA) assay \n", - " ... \n", - "774 Experimental treatment group:Oral chloroquine phosphate tablets (treatment group);control group:Oral placebo group (control group); \n", - "775 Case series:?; \n", - "776 CM group:Xinguan No. 2 / Xinguan No. 3 alone or + regular treatment;WM group:Regular Ttreatment; \n", - "777 Suspected case treatment group:TCM formula 1 or TCM formula 2;Suspected case control group:null;Confirmed case treatment group:Western medicine+(TCM formula 3 or TCM formula 4 or TCM formula 5 or TCM formula 6);Confirmed case control group:Western medici\n", - "778 experimental group:Fitness Qigong Yangfei prescription;control group:general advice and related psychological comfort.; \n", - "Name: Intervention, Length: 779, dtype: object" - ] - }, - "execution_count": 30, - "metadata": {}, - "output_type": "execute_result" - } - ], - "source": [ - "internationalstudies[\"Intervention\"]" - ] - }, - { - "cell_type": "code", - "execution_count": 44, - "metadata": {}, - "outputs": [ - { - "name": "stdout", - "output_type": "stream", - "text": [ - "> 318 studies found by 'covid-19' keyword\n", - "> 318 studies found by 'SARS-CoV-2' keyword\n", - "> 288 studies found by 'coronavirus' keyword\n" - ] - } - ], - "source": [ - "all_US_studies_by_keyword:dict = {}\n", - "queries:list = [\"covid-19\", \"SARS-CoV-2\", \"coronavirus\"]\n", - "\n", - "for key in queries:\n", - " all_US_studies_by_keyword[key] = getAllStudiesByQuery(key)" - ] - }, - { - "cell_type": "code", - "execution_count": 47, + "execution_count": 61, "metadata": {}, "outputs": [ { "name": "stdout", "output_type": "stream", "text": [ - "3\n" + "> 351 studies found by 'covid-19' keyword\n", + "> 351 studies found by 'SARS-CoV-2' keyword\n", + "> 301 studies found by 'coronavirus' keyword\n" ] } ], "source": [ - "print(len(all_US_studies_by_keyword))\n", - "with open('all_US_studies_by_keyword.json', 'w', encoding='utf-8') as f:\n", - " json.dump(all_US_studies_by_keyword, f, ensure_ascii=False, indent=4)" + "drugSynonym.scrapeData()" ] }, { "cell_type": "code", - "execution_count": 49, + "execution_count": 63, "metadata": {}, "outputs": [], "source": [ - "drug_url = os.environ[\"URL_DRUGBANK\"]\n", - "vocab = urlToDF(drug_url,csvZipHandler) " + "drugSynonym.filterData()" ] }, { "cell_type": "code", - "execution_count": 50, - "metadata": {}, + "execution_count": 64, + "metadata": { + "collapsed": true + }, "outputs": [ { "data": { + "text/html": [ + "
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TrialIDLast Refreshed onPublic titleScientific titleAcronymPrimary sponsorDate registrationDate registration3Export dateSource Registerweb addressRecruitment Statusother recordsInclusion ageminInclusion agemaxInclusion genderDate enrollementTarget sizeStudy typeStudy designPhaseCountriesContact FirstnameContact LastnameContact AddressContact EmailContact TelContact AffiliationInclusion CriteriaExclusion CriteriaConditionInterventionPrimary outcomeresults date postedresults date completedresults url linkRetrospective flagBridging flag truefalseBridged typeresults yes no
0ChiCTR200002995343878.0Construction and Analysis of Prognostic Predictive Model of Novel Coronavirus Pneumonia (COVID-19)Construction and Analysis of Prognostic Predictive Model of Novel Coronavirus Pneumonia (COVID-19)NaNZhongnan Hospital of Wuhan University43878.020200217.043834.660579ChiCTRhttp://www.chictr.org.cn/showproj.aspx?proj=49217Not RecruitingNoNaNNaNBoth43862.0survival group:200;died:200;Observational studyFactorialNaNChinaYan ZhaoNaN169 Donghu Road, Wuchang District, Wuhan, Hubei, Chinadoctoryanzhao@whu.edu.cn+86 13995577963Emergency Department of Zhongnan Hospital of Wuhan UniversityInclusion criteria: 2019-nCoV-infected pneumonia diagnosed patients, the diagnostic criteria refer to \"guideline of the diagnose and treatment of 2019-nCoV (trial)\" published by National Health Committees of Peoples' Republic Country \"Exclusion criteria: Patients diagnosed with pneumonia of age <15 years diagnosed according to\"guideline of the diagnose and treatment of 2019-nCoV (tested)\" published by National Health Committees of Peoples' Republic Country; Suspected patient with vira2019-nCoV Pneumoniasurvival group:none;died:none;duration of in hospital;in hospital mortality;the 28s day' mortality after admission;duration of ICU stay;NaNNaNNaNNo0NaN
1ChiCTR200002993543878.0A Single-arm Clinical Trial for Chloroquine Phosphate in the treatment of Novel Coronavirus Pneumonia 2019 (COVID-19)A Single-arm Clinical Trial for Chloroquine Phosphate in the treatment of Novel Coronavirus Pneumonia 2019 (COVID-19)NaNHwaMei Hospital, University of Chinese Academy of Sciences43877.020200216.043834.660579ChiCTRhttp://www.chictr.org.cn/showproj.aspx?proj=49607RecruitingNoNaNNaNBoth43867.0Case series:100;Interventional studySingle armNaNChinaTing CaiNaN41 Xibei Street, Ningbo, Zhejiang, Chinacaiting@ucas.ac.cn+86 13738498188HwaMei Hospital, University of Chinese Academy of SciencesInclusion criteria: Patients aged 18 or older, and meet the diagnostic criteria of Diagnosis and Treatment Scheme of Novel Coronavirus Infected Pneumonia published by the National Health Commission.\\r<br>Criteria for diagnosis (meet all the following criteExclusion criteria: 1. Female patients during pregnancy; \\r<br>2. Patients with known allergy to chloroquine; \\r<br>3. Patients with haematological diseases; \\r<br>4. Patients with chronic liver or kidney diseases at the end stage; \\r<br>5. Patients with arrhNovel Coronavirus Pneumonia (COVID-19)Case series:Treated with conventional treatment combined with Chloroquine Phosphate;Length of hospital stay;NaNNaNNaNNo0NaN
2ChiCTR200002985043878.0Study on convalescent plasma treatment for severe patients with novel coronavirus pneumonia (COVID-19)Effecacy and safty of convalescent plasma treatment for severe patients with novel coronavirus pneumonia (COVID-19): a prospective cohort studyNaNThe First Affiliated Hospital of Zhejiang University School of Medicine43876.020200215.043834.660579ChiCTRhttp://www.chictr.org.cn/showproj.aspx?proj=49533RecruitingNo16.099.0Male43876.0experimental group:10;control group:10;Interventional studyNon randomized control0.0ChinaXiaowei XuNaN79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, Chinaxxw69@126.com+86 13605708066The First Affiliated Hospital of Zhejiang University, State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious DiseaseInclusion criteria: 1. Laboratory confirmed diagnosis of COVID19 infection by RT-PCR;\\r<br>2. Aged > 18 years;\\r<br>3. Written informed consent given by the patient or next-of-kin;\\r<br>4. Clinical deterioration despite conventional treatment that required iExclusion criteria: 1. Hypersensitive to immunoglobulin;\\r<br>2. Have immunoglobulin A deficiency.Novel Coronavirus Pneumonia (COVID-19)experimental group:standardized comprehensive treatment combined with convalescent plasma treatment;control group:standardized comprehensive treatment;Fatality rate;NaNNaNNaNYes0NaN
3ChiCTR200002981443878.0Clinical Trial for Integrated Chinese and Western Medicine in the Treatment of Children with Novel Coronavirus Pneumonia (COVID-19)Clinical Trial for Integrated Chinese and Western Medicine in the Treatment of Children with Novel Coronavirus Pneumonia (COVID-19)NaNChildren's Hospital of Fudan University43875.020200214.043834.660579ChiCTRhttp://www.chictr.org.cn/showproj.aspx?proj=49387RecruitingNo0.018.0Both43875.0control group:15;experimental group:15;Interventional studyNon randomized control0.0ChinaZhai XiaowenNaN399 Wanyuan Road, Minhang District, Shanghaizhaixiaowendy@163.com+86 64931902Children's Hospital of Fudan UniversityInclusion criteria: Children diagnosed with novel coronavirus pneumonia through epidemiological history, clinical symptoms, and nucleic acid test results.Exclusion criteria: No exclusion criteriaNovel Coronavirus Pneumonia (COVID-19)control group:Western Medicine;experimental group:Integrated Traditional Chinese and Western Medicine;Time fo fever reduction;Time of nucleic acid negative;Severe conversion rate;Improvement time of respiratory symptoms;NaNNaNNaNYes0NaN
4NCT0424563143878.0Development of a Simple, Fast and Portable Recombinase Aided Amplification Assay for 2019-nCoVDevelopment of a Simple, Fast and Portable Recombinase Aided Amplification (RAA) Assay for 2019-nCoVNaNBeijing Ditan Hospital43856.020200126.043834.660579ClinicalTrials.govhttps://clinicaltrials.gov/show/NCT04245631RecruitingNo1 Year90 YearsAll43831.050.0ObservationalNaNNaNChina; ;Yao Xie, Doctor;Yao Xie, Doctor;Yao Xie, DoctorNaN;xieyao00120184@sina.com;xieyao00120184@sina.com;8610-84322200;8610-84322200Department of Hepatology, Division 2, Beijing Ditan Hospital;\\r<br> Inclusion Criteria:\\r<br>\\r<br> - 1. Suspected cases (formerly observed cases)\\r<br>\\r<br> Meet the following 2 at the same time:\\r<br>\\r<br> Epidemiological history There was a history of travel or residence in Wuhan withinNaNNew CoronavirusDiagnostic Test: Recombinase aided amplification (RAA) assayDetection sensitivity is greater than 95%;Detection specificity is greater than 95%NaNNaNNaNYes0NaN
\n", + "
" + ], "text/plain": [ - "Index(['DrugBank ID', 'Accession Numbers', 'Common name', 'CAS', 'UNII', 'Synonyms', 'Standard InChI Key'], dtype='object')" + " TrialID Last Refreshed on Public title Scientific title Acronym Primary sponsor Date registration Date registration3 Export date Source Register web address Recruitment Status other records Inclusion agemin Inclusion agemax Inclusion gender Date enrollement Target size Study type Study design Phase Countries Contact Firstname Contact Lastname Contact Address \\\n", + "0 ChiCTR2000029953 43878.0 Construction and Analysis of Prognostic Predictive Model of Novel Coronavirus Pneumonia (COVID-19) Construction and Analysis of Prognostic Predictive Model of Novel Coronavirus Pneumonia (COVID-19) NaN Zhongnan Hospital of Wuhan University 43878.0 20200217.0 43834.660579 ChiCTR http://www.chictr.org.cn/showproj.aspx?proj=49217 Not Recruiting No NaN NaN Both 43862.0 survival group:200;died:200; Observational study Factorial NaN China Yan Zhao NaN 169 Donghu Road, Wuchang District, Wuhan, Hubei, China \n", + "1 ChiCTR2000029935 43878.0 A Single-arm Clinical Trial for Chloroquine Phosphate in the treatment of Novel Coronavirus Pneumonia 2019 (COVID-19) A Single-arm Clinical Trial for Chloroquine Phosphate in the treatment of Novel Coronavirus Pneumonia 2019 (COVID-19) NaN HwaMei Hospital, University of Chinese Academy of Sciences 43877.0 20200216.0 43834.660579 ChiCTR http://www.chictr.org.cn/showproj.aspx?proj=49607 Recruiting No NaN NaN Both 43867.0 Case series:100; Interventional study Single arm NaN China Ting Cai NaN 41 Xibei Street, Ningbo, Zhejiang, China \n", + "2 ChiCTR2000029850 43878.0 Study on convalescent plasma treatment for severe patients with novel coronavirus pneumonia (COVID-19) Effecacy and safty of convalescent plasma treatment for severe patients with novel coronavirus pneumonia (COVID-19): a prospective cohort study NaN The First Affiliated Hospital of Zhejiang University School of Medicine 43876.0 20200215.0 43834.660579 ChiCTR http://www.chictr.org.cn/showproj.aspx?proj=49533 Recruiting No 16.0 99.0 Male 43876.0 experimental group:10;control group:10; Interventional study Non randomized control 0.0 China Xiaowei Xu NaN 79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, China \n", + "3 ChiCTR2000029814 43878.0 Clinical Trial for Integrated Chinese and Western Medicine in the Treatment of Children with Novel Coronavirus Pneumonia (COVID-19) Clinical Trial for Integrated Chinese and Western Medicine in the Treatment of Children with Novel Coronavirus Pneumonia (COVID-19) NaN Children's Hospital of Fudan University 43875.0 20200214.0 43834.660579 ChiCTR http://www.chictr.org.cn/showproj.aspx?proj=49387 Recruiting No 0.0 18.0 Both 43875.0 control group:15;experimental group:15; Interventional study Non randomized control 0.0 China Zhai Xiaowen NaN 399 Wanyuan Road, Minhang District, Shanghai \n", + "4 NCT04245631 43878.0 Development of a Simple, Fast and Portable Recombinase Aided Amplification Assay for 2019-nCoV Development of a Simple, Fast and Portable Recombinase Aided Amplification (RAA) Assay for 2019-nCoV NaN Beijing Ditan Hospital 43856.0 20200126.0 43834.660579 ClinicalTrials.gov https://clinicaltrials.gov/show/NCT04245631 Recruiting No 1 Year 90 Years All 43831.0 50.0 Observational NaN NaN China ; ; Yao Xie, Doctor;Yao Xie, Doctor;Yao Xie, Doctor NaN \n", + "\n", + " Contact Email Contact Tel Contact Affiliation Inclusion Criteria Exclusion Criteria Condition Intervention \\\n", + "0 doctoryanzhao@whu.edu.cn +86 13995577963 Emergency Department of Zhongnan Hospital of Wuhan University Inclusion criteria: 2019-nCoV-infected pneumonia diagnosed patients, the diagnostic criteria refer to \"guideline of the diagnose and treatment of 2019-nCoV (trial)\" published by National Health Committees of Peoples' Republic Country \" Exclusion criteria: Patients diagnosed with pneumonia of age <15 years diagnosed according to\"guideline of the diagnose and treatment of 2019-nCoV (tested)\" published by National Health Committees of Peoples' Republic Country; Suspected patient with vira 2019-nCoV Pneumonia survival group:none;died:none; \n", + "1 caiting@ucas.ac.cn +86 13738498188 HwaMei Hospital, University of Chinese Academy of Sciences Inclusion criteria: Patients aged 18 or older, and meet the diagnostic criteria of Diagnosis and Treatment Scheme of Novel Coronavirus Infected Pneumonia published by the National Health Commission.\\r
Criteria for diagnosis (meet all the following crite Exclusion criteria: 1. Female patients during pregnancy; \\r
2. Patients with known allergy to chloroquine; \\r
3. Patients with haematological diseases; \\r
4. Patients with chronic liver or kidney diseases at the end stage; \\r
5. Patients with arrh Novel Coronavirus Pneumonia (COVID-19) Case series:Treated with conventional treatment combined with Chloroquine Phosphate; \n", + "2 xxw69@126.com +86 13605708066 The First Affiliated Hospital of Zhejiang University, State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Disease Inclusion criteria: 1. Laboratory confirmed diagnosis of COVID19 infection by RT-PCR;\\r
2. Aged > 18 years;\\r
3. Written informed consent given by the patient or next-of-kin;\\r
4. Clinical deterioration despite conventional treatment that required i Exclusion criteria: 1. Hypersensitive to immunoglobulin;\\r
2. Have immunoglobulin A deficiency. Novel Coronavirus Pneumonia (COVID-19) experimental group:standardized comprehensive treatment combined with convalescent plasma treatment;control group:standardized comprehensive treatment; \n", + "3 zhaixiaowendy@163.com +86 64931902 Children's Hospital of Fudan University Inclusion criteria: Children diagnosed with novel coronavirus pneumonia through epidemiological history, clinical symptoms, and nucleic acid test results. Exclusion criteria: No exclusion criteria Novel Coronavirus Pneumonia (COVID-19) control group:Western Medicine;experimental group:Integrated Traditional Chinese and Western Medicine; \n", + "4 ;xieyao00120184@sina.com;xieyao00120184@sina.com ;8610-84322200;8610-84322200 Department of Hepatology, Division 2, Beijing Ditan Hospital; \\r
Inclusion Criteria:\\r
\\r
- 1. Suspected cases (formerly observed cases)\\r
\\r
Meet the following 2 at the same time:\\r
\\r
Epidemiological history There was a history of travel or residence in Wuhan within NaN New Coronavirus Diagnostic Test: Recombinase aided amplification (RAA) assay \n", + "\n", + " Primary outcome results date posted results date completed results url link Retrospective flag Bridging flag truefalse Bridged type results yes no \n", + "0 duration of in hospital;in hospital mortality;the 28s day' mortality after admission;duration of ICU stay; NaN NaN NaN No 0 NaN \n", + "1 Length of hospital stay; NaN NaN NaN No 0 NaN \n", + "2 Fatality rate; NaN NaN NaN Yes 0 NaN \n", + "3 Time fo fever reduction;Time of nucleic acid negative;Severe conversion rate;Improvement time of respiratory symptoms; NaN NaN NaN Yes 0 NaN \n", + "4 Detection sensitivity is greater than 95%;Detection specificity is greater than 95% NaN NaN NaN Yes 0 NaN " ] }, - "execution_count": 50, + "execution_count": 64, "metadata": {}, "output_type": "execute_result" } ], "source": [ - "vocab.columns" + "drugSynonym.internationalstudies.head()" ] }, { "cell_type": "code", - "execution_count": 43, - "metadata": {}, + "execution_count": 66, + "metadata": { + "collapsed": true + }, "outputs": [ { "data": { @@ -332,402 +460,78 @@ " \n", " \n", " \n", - " DrugBank ID\n", - " Accession Numbers\n", " Common name\n", - " CAS\n", - " UNII\n", " Synonyms\n", - " Standard InChI Key\n", " \n", " \n", " \n", " \n", " 0\n", - " DB00001\n", - " BIOD00024 | BTD00024\n", " Lepirudin\n", - " 138068-37-8\n", - " Y43GF64R34\n", " Hirudin variant-1 | Lepirudin recombinant\n", - " NaN\n", " \n", " \n", " 1\n", - " DB00002\n", - " BIOD00071 | BTD00071\n", " Cetuximab\n", - " 205923-56-4\n", - " PQX0D8J21J\n", " Cetuximab | Cétuximab | Cetuximabum | Immunoglobulin G 1 (human-mouse monoclonal C 225 gamma 1 - chain anti-human epidermal growt factor receptor), disulfide wit human-mouse monoclonal C 225 kappa - chain, dimer\n", - " NaN\n", " \n", " \n", " 2\n", - " DB00003\n", - " BIOD00001 | BTD00001\n", " Dornase alfa\n", - " 143831-71-4\n", - " 953A26OA1Y\n", " Deoxyribonuclease (human clone 18-1 protein moiety) | Dornasa alfa | Dornase alfa, recombinant | Dornase alpha | Recombinant deoxyribonuclease (DNAse)\n", - " NaN\n", " \n", " \n", " 3\n", - " DB00004\n", - " BIOD00084 | BTD00084\n", " Denileukin diftitox\n", - " 173146-27-5\n", - " 25E79B5CTM\n", " Denileukin | Interleukin-2/diptheria toxin fusion protein\n", - " NaN\n", " \n", " \n", " 4\n", - " DB00005\n", - " BIOD00052 | BTD00052\n", " Etanercept\n", - " 185243-69-0\n", - " OP401G7OJC\n", " Etanercept | etanercept-szzs | etanercept-ykro | Recombinant human TNF | rhu TNFR:Fc | rhu-TNFR:Fc | TNFR-Immunoadhesin\n", - " NaN\n", - " \n", - " \n", - " 5\n", - " DB00006\n", - " BIOD00076 | BTD00076 | DB02351 | EXPT03302\n", - " Bivalirudin\n", - " 128270-60-0\n", - " TN9BEX005G\n", - " Bivalirudin | Bivalirudina | Bivalirudinum\n", - " OIRCOABEOLEUMC-GEJPAHFPSA-N\n", - " \n", - " \n", - " 6\n", - " DB00007\n", - " BIOD00009 | BTD00009\n", - " Leuprolide\n", - " 53714-56-0\n", - " EFY6W0M8TG\n", - " Leuprorelin | Leuprorelina | Leuproreline | Leuprorelinum\n", - " GFIJNRVAKGFPGQ-LIJARHBVSA-N\n", - " \n", - " \n", - " 7\n", - " DB00008\n", - " BIOD00043 | BTD00043\n", - " Peginterferon alfa-2a\n", - " 198153-51-4\n", - " Q46947FE7K\n", - " PEG-IFN alfa-2A | PEG-Interferon alfa-2A | Peginterferon alfa-2a | Pegylated Interfeaon alfa-2A | Pegylated interferon alfa-2a | Pegylated interferon alpha-2a | Pegylated-interferon alfa 2a\n", - " NaN\n", - " \n", - " \n", - " 8\n", - " DB00009\n", - " BIOD00050 | BTD00050\n", - " Alteplase\n", - " 105857-23-6\n", - " 1RXS4UE564\n", - " Alteplasa | Alteplase (genetical recombination) | Alteplase, recombinant | Alteplase,recombinant | Plasminogen activator (human tissue-type protein moiety) | rt-PA | t-PA | t-plasminogen activator | Tissue plasminogen activator | Tissue plasminogen activator alteplase | Tissue plasminogen activator, recombinant | tPA\n", - " NaN\n", - " \n", - " \n", - " 9\n", - " DB00010\n", - " BIOD00033 | BTD00033\n", - " Sermorelin\n", - " 86168-78-7\n", - " 89243S03TE\n", - " NaN\n", - " NaN\n", - " \n", - " \n", - " 10\n", - " DB00011\n", - " BIOD00096 | BTD00096 | DB00084\n", - " Interferon alfa-n1\n", - " 74899-72-2\n", - " 41697D4Z5C\n", - " Interferon alpha-n1 (INS)\n", - " NaN\n", - " \n", - " \n", - " 11\n", - " DB00012\n", - " BIOD00032 | BTD00032\n", - " Darbepoetin alfa\n", - " 209810-58-2\n", - " 15UQ94PT4P\n", - " Darbepoetin | Darbepoetin alfa,recombinant | Darbepoetina alfa\n", - " NaN\n", - " \n", - " \n", - " 12\n", - " DB00013\n", - " BIOD00030 | BTD00030\n", - " Urokinase\n", - " 9039-53-6\n", - " 83G67E21XI\n", - " Kinase (enzyme-activating), uro-urokinase | TCUK | Tissue culture urokinase | Two-chain urokinase | Urochinasi | Urokinase | Urokinasum | Uroquinasa\n", - " NaN\n", - " \n", - " \n", - " 13\n", - " DB00014\n", - " BIOD00113 | BTD00113\n", - " Goserelin\n", - " 65807-02-5\n", - " 0F65R8P09N\n", - " Goserelin | Goserelina\n", - " BLCLNMBMMGCOAS-URPVMXJPSA-N\n", - " \n", - " \n", - " 14\n", - " DB00015\n", - " BIOD00013 | BTD00013\n", - " Reteplase\n", - " 133652-38-7\n", - " DQA630RIE9\n", - " Human t-PA (residues 1-3 and 176-527) | Reteplasa | Reteplase, recombinant | Reteplase,recombinant\n", - " NaN\n", - " \n", - " \n", - " 15\n", - " DB00016\n", - " BIOD00103 | BTD00103 | DB08923\n", - " Erythropoietin\n", - " 11096-26-7\n", - " 64FS3BFH5W\n", - " E.P.O. | Epoetin alfa | Epoetin alfa rDNA | Epoetin alfa-epbx | Epoetin alfa, recombinant | Epoetin beta | Epoetin beta rDNA | Epoetin epsilon | Epoetin gamma | Epoetin gamma rDNA | Epoetin kappa | Epoetin omega | Epoetin theta | Epoetin zeta | Epoetina alfa | Epoetina beta | Epoetina dseta | Epoetina zeta | Epoétine zêta | Epoetinum zeta | Erythropoiesis stimulating factor | Erythropoietin (human, recombinant) | Erythropoietin (recombinant human) | ESF | SH-polypeptide-72\n", - " NaN\n", - " \n", - " \n", - " 16\n", - " DB00017\n", - " BIOD00025 | BTD00025\n", - " Salmon Calcitonin\n", - " 47931-85-1\n", - " 7SFC6U2VI5\n", - " Calcitonin (Salmon Synthetic) | Calcitonin Salmon | Calcitonin salmon recombinant | Calcitonin-salmon | Calcitonin, salmon | Calcitonina salmón sintética | Recombinant salmon calcitonin | Salmon calcitonin\n", - " NaN\n", - " \n", - " \n", - " 17\n", - " DB00018\n", - " BIOD00023 | BTD00023\n", - " Interferon alfa-n3\n", - " NaN\n", - " 47BPR3V3MP\n", - " NaN\n", - " NaN\n", - " \n", - " \n", - " 18\n", - " DB00019\n", - " BIOD00094 | BTD00094\n", - " Pegfilgrastim\n", - " 208265-92-3\n", - " 3A58010674\n", - " Granulocyte colony-stimulating factor pegfilgrastim | peg-filgrastim | pegfilgrastim-bmez | pegfilgrastim-cbqv | pegfilgrastim-jmdb\n", - " NaN\n", - " \n", - " \n", - " 19\n", - " DB00020\n", - " BIOD00035 | BTD00035\n", - " Sargramostim\n", - " 123774-72-1\n", - " 5TAA004E22\n", - " Recombinant human granulocyte-macrophage colony stimulating factor | rGM-CSF | rHu GM-CSF | Sargramostim\n", - " NaN\n", " \n", " \n", "\n", "" ], "text/plain": [ - " DrugBank ID Accession Numbers Common name CAS UNII Synonyms Standard InChI Key\n", - "0 DB00001 BIOD00024 | BTD00024 Lepirudin 138068-37-8 Y43GF64R34 Hirudin variant-1 | Lepirudin recombinant NaN \n", - "1 DB00002 BIOD00071 | BTD00071 Cetuximab 205923-56-4 PQX0D8J21J Cetuximab | Cétuximab | Cetuximabum | Immunoglobulin G 1 (human-mouse monoclonal C 225 gamma 1 - chain anti-human epidermal growt factor receptor), disulfide wit human-mouse monoclonal C 225 kappa - chain, dimer NaN \n", - "2 DB00003 BIOD00001 | BTD00001 Dornase alfa 143831-71-4 953A26OA1Y Deoxyribonuclease (human clone 18-1 protein moiety) | Dornasa alfa | Dornase alfa, recombinant | Dornase alpha | Recombinant deoxyribonuclease (DNAse) NaN \n", - "3 DB00004 BIOD00084 | BTD00084 Denileukin diftitox 173146-27-5 25E79B5CTM Denileukin | Interleukin-2/diptheria toxin fusion protein NaN \n", - "4 DB00005 BIOD00052 | BTD00052 Etanercept 185243-69-0 OP401G7OJC Etanercept | etanercept-szzs | etanercept-ykro | Recombinant human TNF | rhu TNFR:Fc | rhu-TNFR:Fc | TNFR-Immunoadhesin NaN \n", - "5 DB00006 BIOD00076 | BTD00076 | DB02351 | EXPT03302 Bivalirudin 128270-60-0 TN9BEX005G Bivalirudin | Bivalirudina | Bivalirudinum OIRCOABEOLEUMC-GEJPAHFPSA-N\n", - "6 DB00007 BIOD00009 | BTD00009 Leuprolide 53714-56-0 EFY6W0M8TG Leuprorelin | Leuprorelina | Leuproreline | Leuprorelinum GFIJNRVAKGFPGQ-LIJARHBVSA-N\n", - "7 DB00008 BIOD00043 | BTD00043 Peginterferon alfa-2a 198153-51-4 Q46947FE7K PEG-IFN alfa-2A | PEG-Interferon alfa-2A | Peginterferon alfa-2a | Pegylated Interfeaon alfa-2A | Pegylated interferon alfa-2a | Pegylated interferon alpha-2a | Pegylated-interferon alfa 2a NaN \n", - "8 DB00009 BIOD00050 | BTD00050 Alteplase 105857-23-6 1RXS4UE564 Alteplasa | Alteplase (genetical recombination) | Alteplase, recombinant | Alteplase,recombinant | Plasminogen activator (human tissue-type protein moiety) | rt-PA | t-PA | t-plasminogen activator | Tissue plasminogen activator | Tissue plasminogen activator alteplase | Tissue plasminogen activator, recombinant | tPA NaN \n", - "9 DB00010 BIOD00033 | BTD00033 Sermorelin 86168-78-7 89243S03TE NaN NaN \n", - "10 DB00011 BIOD00096 | BTD00096 | DB00084 Interferon alfa-n1 74899-72-2 41697D4Z5C Interferon alpha-n1 (INS) NaN \n", - "11 DB00012 BIOD00032 | BTD00032 Darbepoetin alfa 209810-58-2 15UQ94PT4P Darbepoetin | Darbepoetin alfa,recombinant | Darbepoetina alfa NaN \n", - "12 DB00013 BIOD00030 | BTD00030 Urokinase 9039-53-6 83G67E21XI Kinase (enzyme-activating), uro-urokinase | TCUK | Tissue culture urokinase | Two-chain urokinase | Urochinasi | Urokinase | Urokinasum | Uroquinasa NaN \n", - "13 DB00014 BIOD00113 | BTD00113 Goserelin 65807-02-5 0F65R8P09N Goserelin | Goserelina BLCLNMBMMGCOAS-URPVMXJPSA-N\n", - "14 DB00015 BIOD00013 | BTD00013 Reteplase 133652-38-7 DQA630RIE9 Human t-PA (residues 1-3 and 176-527) | Reteplasa | Reteplase, recombinant | Reteplase,recombinant NaN \n", - "15 DB00016 BIOD00103 | BTD00103 | DB08923 Erythropoietin 11096-26-7 64FS3BFH5W E.P.O. | Epoetin alfa | Epoetin alfa rDNA | Epoetin alfa-epbx | Epoetin alfa, recombinant | Epoetin beta | Epoetin beta rDNA | Epoetin epsilon | Epoetin gamma | Epoetin gamma rDNA | Epoetin kappa | Epoetin omega | Epoetin theta | Epoetin zeta | Epoetina alfa | Epoetina beta | Epoetina dseta | Epoetina zeta | Epoétine zêta | Epoetinum zeta | Erythropoiesis stimulating factor | Erythropoietin (human, recombinant) | Erythropoietin (recombinant human) | ESF | SH-polypeptide-72 NaN \n", - "16 DB00017 BIOD00025 | BTD00025 Salmon Calcitonin 47931-85-1 7SFC6U2VI5 Calcitonin (Salmon Synthetic) | Calcitonin Salmon | Calcitonin salmon recombinant | Calcitonin-salmon | Calcitonin, salmon | Calcitonina salmón sintética | Recombinant salmon calcitonin | Salmon calcitonin NaN \n", - "17 DB00018 BIOD00023 | BTD00023 Interferon alfa-n3 NaN 47BPR3V3MP NaN NaN \n", - "18 DB00019 BIOD00094 | BTD00094 Pegfilgrastim 208265-92-3 3A58010674 Granulocyte colony-stimulating factor pegfilgrastim | peg-filgrastim | pegfilgrastim-bmez | pegfilgrastim-cbqv | pegfilgrastim-jmdb NaN \n", - "19 DB00020 BIOD00035 | BTD00035 Sargramostim 123774-72-1 5TAA004E22 Recombinant human granulocyte-macrophage colony stimulating factor | rGM-CSF | rHu GM-CSF | Sargramostim NaN " + " Common name Synonyms\n", + "0 Lepirudin Hirudin variant-1 | Lepirudin recombinant \n", + "1 Cetuximab Cetuximab | Cétuximab | Cetuximabum | Immunoglobulin G 1 (human-mouse monoclonal C 225 gamma 1 - chain anti-human epidermal growt factor receptor), disulfide wit human-mouse monoclonal C 225 kappa - chain, dimer\n", + "2 Dornase alfa Deoxyribonuclease (human clone 18-1 protein moiety) | Dornasa alfa | Dornase alfa, recombinant | Dornase alpha | Recombinant deoxyribonuclease (DNAse) \n", + "3 Denileukin diftitox Denileukin | Interleukin-2/diptheria toxin fusion protein \n", + "4 Etanercept Etanercept | etanercept-szzs | etanercept-ykro | Recombinant human TNF | rhu TNFR:Fc | rhu-TNFR:Fc | TNFR-Immunoadhesin " ] }, - "execution_count": 43, + "execution_count": 66, "metadata": {}, "output_type": "execute_result" } ], "source": [ - "vocab.head(20)" + "drugSynonym.drug_vocab_reduced.head()" ] }, { "cell_type": "code", - "execution_count": 52, + "execution_count": 67, "metadata": {}, - "outputs": [], - "source": [ - "#vocab.to_csv(\"vocab.csv\")" - ] - }, - { - "cell_type": "code", - "execution_count": 62, - "metadata": {}, - "outputs": [], - "source": [ - "vocab_red = vocab[['Common name', 'Synonyms']]" - ] - }, - { - "cell_type": "code", - "execution_count": 63, - "metadata": {}, - "outputs": [], - "source": [ - "drug_vocab:dict = {}" - ] - }, - { - "cell_type": "code", - "execution_count": 80, - "metadata": {}, - "outputs": [], - "source": [ - "for index, row in vocab_red.iterrows():\n", - " drug_vocab[row['Common name']] = row[\"Synonyms\"].split(\"|\") if isinstance(row[\"Synonyms\"],str) else row[\"Synonyms\"]" - ] - }, - { - "cell_type": "code", - "execution_count": 81, - "metadata": {}, - "outputs": [], - "source": [ - "from neo4j import GraphDatabase" - ] - }, - { - "cell_type": "code", - "execution_count": 94, - "metadata": {}, - "outputs": [], + "outputs": [ + { + "data": { + "text/plain": [ + "13475" + ] + }, + "execution_count": 67, + "metadata": {}, + "output_type": "execute_result" + } + ], "source": [ - "class DrugSynonymDataToNeo4j(object):\n", - "\n", - " def __init__(self, uri, user, password):\n", - " self._driver = GraphDatabase.driver(uri, auth=(user, password))\n", - "\n", - " def close(self):\n", - " self._driver.close()\n", - " \n", - " def upload_drugs_and_synonims(self,drug_vocab):\n", - " with self._driver.session() as session:\n", - " for key in drub_vocab.keys():\n", - " node_type = \"Drug\"\n", - " properties:dict = {\n", - " \"name\":key\n", - " }\n", - " drug_id = session.write_transaction(self._merge_node, node_type, properties)\n", - " for synonym in drug_vocab[key]:\n", - " node_type = \"Synonym\"\n", - " properties:dict = {\n", - " \"name\":synonym\n", - " }\n", - " synonym_id = session.write_transaction(self._merge_node, node_type, properties)\n", - " edge_type = \"HAS\"\n", - " session.write_transaction(self._merge_edge, drug_id, synonym_id, edge_type)\n", - " print(\"Done\") \n", - " \n", - " @staticmethod\n", - " def _merge_node(tx, node_type, properties=None):\n", - " data:dict = {\n", - " \"node_type\":node_type,\n", - " \"properties\":self._dict_to_property_str(properties)\n", - " }\n", - " # '{first} {last}'.format(**data)\n", - " base_cypher = \"\"\"\n", - " MERGE (n:{node_type}) {{ {properties} }})\n", - " RETURN id(n)\n", - " \"\"\"\n", - " result = tx.run(base_cypher.format(**data))\n", - " \n", - " return result\n", - " \n", - " @staticmethod\n", - " def _merge_edge(tx, from_id, to_id, edge_type, direction = \">\"):\n", - " if not direction in [\">\",\"\"]:\n", - " raise ValueError\n", - " data:dict = {\n", - " \"from_id\":int(from_id),\n", - " \"to_id\":int(to_id),\n", - " \"edge_type\":edge_type,\n", - " \"directon\":direction \n", - " }\n", - " base_cypher = \"\"\" \n", - " MERGE (Node({from_id}))-[r:{edge_type}]-{direction}(Node({to_id}))\n", - " RETURN id(r)\n", - " \"\"\"\n", - " result = tx.run(base_cypher.format(**data))\n", - " return result\n", - " \n", - " @staticmethod\n", - " def _dict_to_property_str(properties:Optional[dict] = None) -> str:\n", - " def property_type_checker(property_value):\n", - " if isinstance(property_value,int) or isinstance(property_value,float):\n", - " pass\n", - " elif isinstance(property_value,str):\n", - " property_value = \"\"\"'\"\"\" + property_value + \"\"\"'\"\"\"\n", - " return property_value\n", - "\n", - " resp = \"\"\n", - " if not properties:\n", - " resp = \"{\"\n", - " for key in properties.keys():\n", - " resp += \"\"\"{key}:{value},\"\"\".format(key=key,value=property_type_checker(properties[key]))\n", - " resp = resp[:-1] + \"}\"\n", - " return resp" + "len(drugSynonym.drug_vocab)" ] }, - { - "cell_type": "code", - "execution_count": 95, - "metadata": {}, - "outputs": [], - "source": [] - }, - { - "cell_type": "code", - "execution_count": 96, - "metadata": {}, - "outputs": [], - "source": [] - }, - { - "cell_type": "code", - "execution_count": null, - "metadata": {}, - "outputs": [], - "source": [] - }, { "cell_type": "code", "execution_count": null, diff --git a/modules/TempNB/IngestDrugSynonyms.py b/modules/TempNB/IngestDrugSynonyms.py new file mode 100644 index 0000000..80fdde1 --- /dev/null +++ b/modules/TempNB/IngestDrugSynonyms.py @@ -0,0 +1,110 @@ +import requests +import pandas as pd +import json +import sys +from pathlib import Path +import xlrd +import csv +import os +import tempfile +import numpy as np +from typing import Optional +from functools import partial + +class DrugSynonymIngest(): + + def __init__(self,configPath:Path=Path("config.json")): + self.checkConfig(configPath) + self.url_international:str = os.environ["URL_INT"] if isinstance(os.environ["URL_INT"],str) else None + self.url_USA:str = os.environ["URL_USA"] if isinstance(os.environ["URL_USA"],str) else None + self.url_drugbank:str = os.environ["URL_DRUGBANK"] if isinstance(os.environ["URL_DRUGBANK"],str) else None + self.query_keywords:[] = os.environ["QUERY_KEYWORDS"].split(",") if isinstance(os.environ["QUERY_KEYWORDS"],str) else None + + @staticmethod + def checkConfig(configPath:Path=Path("config.json")): + if configPath.exists: + with open(configPath) as f: + config = json.load(f) + for key in config: + os.environ[key] = config[key] + + @staticmethod + def api(query,from_study,to_study,url): + url = url.format(query,from_study,to_study) + response = requests.request("GET", url) + return response.json() + + def apiWrapper(self,query,from_study): + return self.api(query,from_study,from_study+99,self.url_USA) + + def getAllStudiesByQuery(self,query:str) -> list: + studies:list = [] + from_study = 1 + temp = self.apiWrapper(query,from_study) + nstudies = temp['FullStudiesResponse']['NStudiesFound'] + print("> {} studies found by '{}' keyword".format(nstudies,query)) + if nstudies > 0: + studies = temp['FullStudiesResponse']['FullStudies'] + for study_index in range(from_study+100,nstudies,100): + temp = self.apiWrapper(query,study_index) + studies.extend(temp['FullStudiesResponse']['FullStudies']) + + return studies + + @staticmethod + def xlsHandler(r): + df = pd.DataFrame() + with tempfile.NamedTemporaryFile("wb") as xls_file: + xls_file.write(r.content) + + try: + book = xlrd.open_workbook(xls_file.name,encoding_override="utf-8") + except: + book = xlrd.open_workbook(xls_file.name,encoding_override="cp1251") + + sh = book.sheet_by_index(0) + with tempfile.NamedTemporaryFile("w") as csv_file: + wr = csv.writer(csv_file, quoting=csv.QUOTE_ALL) + + for rownum in range(sh.nrows): + wr.writerow(sh.row_values(rownum)) + df = pd.read_csv(csv_file.name) + csv_file.close() + + xls_file.close() + return df + + @staticmethod + def csvZipHandler(r): + df = pd.DataFrame() + with tempfile.NamedTemporaryFile("wb",suffix='.csv.zip') as file: + file.write(r.content) + df = pd.read_csv(file.name) + file.close() + return df + + @staticmethod + def urlToDF(url:str,respHandler) -> pd.DataFrame: + r = requests.get(url, allow_redirects=True) + return respHandler(r) + + def scrapeData(self): + self.internationalstudies = self.urlToDF(self.url_international,self.xlsHandler) + self.drug_vocab_df = self.urlToDF(self.url_drugbank,self.csvZipHandler) + self.all_US_studies_by_keyword:dict = {} + for key in self.query_keywords: + self.all_US_studies_by_keyword[key] = self.getAllStudiesByQuery(key) + + def filterData(self): + self.drug_vocab_reduced = self.drug_vocab_df[['Common name', 'Synonyms']] + self.drug_vocab:dict = {} + for index, row in self.drug_vocab_reduced.iterrows(): + self.drug_vocab[row['Common name']] = row["Synonyms"].split("|") if isinstance(row["Synonyms"],str) else row["Synonyms"] + + def saveDataToFile(self): + """Saving data option for debug purposes""" + print("Only Use it for debug purposes") + self.internationalstudies.to_csv("internationalstudies.csv") + self.drug_vocab.to_csv("drug_vocab.csv") + with open('all_US_studies_by_keyword.json', 'w', encoding='utf-8') as f: + json.dump(self.all_US_studies_by_keyword, f, ensure_ascii=False, indent=4) diff --git a/modules/TempNB/config.json b/modules/TempNB/config.json index ffab88d..b5e16e9 100644 --- a/modules/TempNB/config.json +++ b/modules/TempNB/config.json @@ -1,5 +1,6 @@ { - "URL_USA":"https://www.clinicaltrials.gov/api/query/full_studies?expr={}&min_rnk={}&max_rnk={}&fmt=json", - "URL_INT":"https://www.who.int/docs/default-source/coronaviruse/covid-19-trials.xls", - "URL_DRUGBANK": "https://www.drugbank.ca/releases/5-1-5/downloads/all-drugbank-vocabulary" + "URL_USA": "https://www.clinicaltrials.gov/api/query/full_studies?expr={}&min_rnk={}&max_rnk={}&fmt=json", + "URL_INT": "https://www.who.int/docs/default-source/coronaviruse/covid-19-trials.xls", + "URL_DRUGBANK": "https://www.drugbank.ca/releases/5-1-5/downloads/all-drugbank-vocabulary", + "QUERY_KEYWORDS": "covid-19,SARS-CoV-2,coronavirus" } \ No newline at end of file From c9c89f1a29e155df186bec0e0288a6d3380bbf34 Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Tue, 7 Apr 2020 12:02:57 +1000 Subject: [PATCH 31/47] updated gitignore --- .gitignore | 5 +++++ 1 file changed, 5 insertions(+) diff --git a/.gitignore b/.gitignore index f14d479..9d2d70c 100644 --- a/.gitignore +++ b/.gitignore @@ -146,3 +146,8 @@ static .DominoEnv/ .vscode/ data/ +.Domino/ +.XLS2CSV/ +modules/TempNB/all_US_studies_by_keyword.json +modules/TempNB/drug_vocab.csv.zip +modules/TempNB/vocab.csv From 3f6f5c5aecc3993fb42b6c097b06d288e2862378 Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Tue, 7 Apr 2020 15:43:40 +1000 Subject: [PATCH 32/47] all drugs and synonyms are imported --- modules/TempNB/DrugSynonymDataToNeo4j.py | 126 ++++++---- modules/TempNB/IngestDrugSynonyms.ipynb | 297 ++++++++++++++++++++--- modules/TempNB/IngestDrugSynonyms.py | 8 +- 3 files changed, 350 insertions(+), 81 deletions(-) diff --git a/modules/TempNB/DrugSynonymDataToNeo4j.py b/modules/TempNB/DrugSynonymDataToNeo4j.py index 1d2e37e..d090282 100644 --- a/modules/TempNB/DrugSynonymDataToNeo4j.py +++ b/modules/TempNB/DrugSynonymDataToNeo4j.py @@ -1,78 +1,112 @@ from neo4j import GraphDatabase from typing import Optional +import logging +logging.basicConfig(format='%(asctime)s - %(message)s', level=logging.INFO) +logger = logging.getLogger('ds-neo4j') + +def dict_to_property_str(properties:Optional[dict] = None) -> str: + + def property_type_checker(property_value): + if isinstance(property_value,int) or isinstance(property_value,float): + pass + elif isinstance(property_value,str): + property_value = '''"''' + property_value + '''"''' + return property_value + + resp:str = "" + if properties: + resp = "{" + for key in properties.keys(): + resp += """{key}:{value},""".format(key=key,value=property_type_checker(properties[key])) + resp = resp[:-1] + "}" + return resp + +def cypher_template_filler(cypher_template:str,data:dict) -> str: + return cypher_template.format(**data).replace("\n","") class DrugSynonymDataToNeo4j(object): - def __init__(self, uri, user, password): - self._driver = GraphDatabase.driver(uri, auth=(user, password)) + def __init__(self, uri="bolt://localhost:7687", user="neo4j", password="letmein", encrypted=False): + self._driver = GraphDatabase.driver(uri, auth=(user, password), encrypted=encrypted) def close(self): self._driver.close() - def upload_drugs_and_synonims(self,drug_vocab): + def upload_drugs_and_synonyms(self,drug_vocab): + node_merging_func = self._merge_node + edge_merging_func = self._merge_edge with self._driver.session() as session: - for key in drub_vocab.keys(): + logger.info("> Importing Drugs and Synonyms Job is Started") + count_node = 0 + count_edge = 0 + prev_count_node = 0 + prev_count_edge = 0 + + for key in drug_vocab.keys(): node_type = "Drug" properties:dict = { "name":key } - drug_id = session.write_transaction(self._merge_node, node_type, properties) - for synonym in drug_vocab[key]: - node_type = "Synonym" - properties:dict = { - "name":synonym - } - synonym_id = session.write_transaction(self._merge_node, node_type, properties) - edge_type = "HAS" - session.write_transaction(self._merge_edge, drug_id, synonym_id, edge_type) - print("Done") + + drug_id = session.write_transaction(node_merging_func, node_type, properties) + count_node += 1 + if isinstance(drug_vocab[key],list): + for synonym in drug_vocab[key]: + node_type = "Synonym" + properties:dict = { + "name":synonym + } + synonym_id = session.write_transaction(node_merging_func, node_type, properties) + count_node += 1 + + edge_type = "KNOWN_AS" + session.write_transaction(edge_merging_func, drug_id, synonym_id, edge_type) + count_edge += 1 + + if count_node > prev_count_node + 1000 or count_edge > prev_count_edge + 1000: + prev_count_node = count_node + prev_count_edge = count_edge + logger.info("> {} nodes and {} edges already imported".format(count_node,count_edge)) + + logger.info("> Importing Drugs and Synonyms Job is >> Done << with {} nodes and {} edges imported".format(count_node,count_edge)) @staticmethod - def _merge_node(tx, node_type, properties=None): + def _merge_node(tx, node_type, properties:Optional[dict] = None): + + + data:dict = { "node_type":node_type, - "properties":self._dict_to_property_str(properties) + "properties":dict_to_property_str(properties) } - # '{first} {last}'.format(**data) base_cypher = """ - MERGE (n:{node_type}) {{ {properties} }}) - RETURN id(n) + MERGE (n:{node_type} {properties}) + RETURN id(n) """ - result = tx.run(base_cypher.format(**data)) - - return result + + result = tx.run(cypher_template_filler(base_cypher,data)) + return result.single()[0] @staticmethod - def _merge_edge(tx, from_id, to_id, edge_type, direction = ">"): + def _merge_edge(tx, from_id, to_id, edge_type, properties:Optional[dict] = None, direction = ">"): if not direction in [">",""]: raise ValueError + data:dict = { "from_id":int(from_id), "to_id":int(to_id), "edge_type":edge_type, - "directon":direction + "direction":direction, + "properties":dict_to_property_str(properties) } - base_cypher = """ - MERGE (Node({from_id}))-[r:{edge_type}]-{direction}(Node({to_id})) - RETURN id(r) + base_cypher = """ + MATCH (from) + WHERE ID(from) = {from_id} + MATCH (to) + WHERE ID(to) = {to_id} + MERGE (from)-[r:{edge_type} {properties}]-{direction}(to) + RETURN id(r) """ - result = tx.run(base_cypher.format(**data)) - return result - - @staticmethod - def _dict_to_property_str(properties:Optional[dict] = None) -> str: - def property_type_checker(property_value): - if isinstance(property_value,int) or isinstance(property_value,float): - pass - elif isinstance(property_value,str): - property_value = """'""" + property_value + """'""" - return property_value - - resp = "" - if not properties: - resp = "{" - for key in properties.keys(): - resp += """{key}:{value},""".format(key=key,value=property_type_checker(properties[key])) - resp = resp[:-1] + "}" - return resp + result = tx.run(cypher_template_filler(base_cypher,data)) + return result.single()[0] diff --git a/modules/TempNB/IngestDrugSynonyms.ipynb b/modules/TempNB/IngestDrugSynonyms.ipynb index 948c215..ca0dcc9 100644 --- a/modules/TempNB/IngestDrugSynonyms.ipynb +++ b/modules/TempNB/IngestDrugSynonyms.ipynb @@ -2,17 +2,17 @@ "cells": [ { "cell_type": "code", - "execution_count": 56, + "execution_count": 95, "metadata": {}, "outputs": [], "source": [ - "from DrugSynonymDataToNeo4j import DrugSynonymDataToNeo4j\n", - "from IngestDrugSynonyms import DrugSynonymIngest" + "\n", + "from IngestDrugSynonyms import IngestDrugSynonyms" ] }, { "cell_type": "code", - "execution_count": 57, + "execution_count": 83, "metadata": {}, "outputs": [], "source": [ @@ -21,7 +21,7 @@ }, { "cell_type": "code", - "execution_count": 58, + "execution_count": 84, "metadata": {}, "outputs": [ { @@ -40,7 +40,7 @@ }, { "cell_type": "code", - "execution_count": 59, + "execution_count": 85, "metadata": {}, "outputs": [ { @@ -75,35 +75,25 @@ }, { "cell_type": "code", - "execution_count": 60, + "execution_count": 96, "metadata": {}, "outputs": [], "source": [ - "drugSynonym = DrugSynonymIngest()" + "drugSynonym = IngestDrugSynonyms()" ] }, { "cell_type": "code", - "execution_count": 61, + "execution_count": 97, "metadata": {}, - "outputs": [ - { - "name": "stdout", - "output_type": "stream", - "text": [ - "> 351 studies found by 'covid-19' keyword\n", - "> 351 studies found by 'SARS-CoV-2' keyword\n", - "> 301 studies found by 'coronavirus' keyword\n" - ] - } - ], + "outputs": [], "source": [ "drugSynonym.scrapeData()" ] }, { "cell_type": "code", - "execution_count": 63, + "execution_count": 98, "metadata": {}, "outputs": [], "source": [ @@ -112,10 +102,8 @@ }, { "cell_type": "code", - "execution_count": 64, - "metadata": { - "collapsed": true - }, + "execution_count": 99, + "metadata": {}, "outputs": [ { "data": { @@ -423,7 +411,7 @@ "4 Detection sensitivity is greater than 95%;Detection specificity is greater than 95% NaN NaN NaN Yes 0 NaN " ] }, - "execution_count": 64, + "execution_count": 99, "metadata": {}, "output_type": "execute_result" } @@ -434,10 +422,8 @@ }, { "cell_type": "code", - "execution_count": 66, - "metadata": { - "collapsed": true - }, + "execution_count": 100, + "metadata": {}, "outputs": [ { "data": { @@ -503,7 +489,7 @@ "4 Etanercept Etanercept | etanercept-szzs | etanercept-ykro | Recombinant human TNF | rhu TNFR:Fc | rhu-TNFR:Fc | TNFR-Immunoadhesin " ] }, - "execution_count": 66, + "execution_count": 100, "metadata": {}, "output_type": "execute_result" } @@ -514,7 +500,7 @@ }, { "cell_type": "code", - "execution_count": 67, + "execution_count": 101, "metadata": {}, "outputs": [ { @@ -523,7 +509,7 @@ "13475" ] }, - "execution_count": 67, + "execution_count": 101, "metadata": {}, "output_type": "execute_result" } @@ -532,6 +518,251 @@ "len(drugSynonym.drug_vocab)" ] }, + { + "cell_type": "code", + "execution_count": 205, + "metadata": {}, + "outputs": [], + "source": [ + "from DrugSynonymDataToNeo4j import DrugSynonymDataToNeo4j" + ] + }, + { + "cell_type": "code", + "execution_count": 206, + "metadata": {}, + "outputs": [], + "source": [ + "neo4jBridge = DrugSynonymDataToNeo4j()" + ] + }, + { + "cell_type": "code", + "execution_count": 207, + "metadata": {}, + "outputs": [ + { + "name": "stderr", + "output_type": "stream", + "text": [ + "2020-04-07 15:15:01,631 - > Importing Drug and Synonyms Job is Done\n" + ] + } + ], + "source": [ + "neo4jBridge.upload_drugs_and_synonyms(drugSynonym.drug_vocab)" + ] + }, + { + "cell_type": "code", + "execution_count": 162, + "metadata": {}, + "outputs": [], + "source": [ + "base_cypher = \"\"\"\n", + "MERGE (n:{node_type} {{ {properties} }})\n", + "RETURN id(n)\n", + "\"\"\"" + ] + }, + { + "cell_type": "code", + "execution_count": 108, + "metadata": {}, + "outputs": [], + "source": [ + "data = {\n", + " \"node_type\":\"Drug\",\n", + " \"properties\":\"name:'Vitamin C'\"\n", + "}" + ] + }, + { + "cell_type": "code", + "execution_count": 110, + "metadata": {}, + "outputs": [ + { + "data": { + "text/plain": [ + "\" MERGE (n:Drug { name:'Vitamin C' }) RETURN id(n) \"" + ] + }, + "execution_count": 110, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "base_cypher.format(**data).replace(\"\\n\",\"\")" + ] + }, + { + "cell_type": "code", + "execution_count": 121, + "metadata": {}, + "outputs": [ + { + "data": { + "text/plain": [ + "0" + ] + }, + "execution_count": 121, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "int('0')" + ] + }, + { + "cell_type": "code", + "execution_count": 177, + "metadata": {}, + "outputs": [], + "source": [ + "synonym = \"VitaC\"\n", + "properties:dict = {\n", + " \"name\":synonym,\n", + " \"id\":1\n", + "}" + ] + }, + { + "cell_type": "code", + "execution_count": 178, + "metadata": {}, + "outputs": [], + "source": [ + "from typing import Optional\n", + "def dict_to_property_str(properties:Optional[dict] = None) -> str:\n", + " def property_type_checker(property_value):\n", + " if isinstance(property_value,int) or isinstance(property_value,float):\n", + " pass\n", + " elif isinstance(property_value,str):\n", + " property_value = \"\"\"'\"\"\" + property_value + \"\"\"'\"\"\"\n", + " return property_value\n", + "\n", + " resp:str = \"\"\n", + " if properties:\n", + " resp = \"{\"\n", + " for key in properties.keys():\n", + " resp += \"\"\"{key}:{value},\"\"\".format(key=key,value=property_type_checker(properties[key]))\n", + " resp = resp[:-1] + \"}\"\n", + " return resp" + ] + }, + { + "cell_type": "code", + "execution_count": 179, + "metadata": {}, + "outputs": [ + { + "data": { + "text/plain": [ + "\"{name:'VitaC',id:1}\"" + ] + }, + "execution_count": 179, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "dict_to_property_str(properties)" + ] + }, + { + "cell_type": "code", + "execution_count": 180, + "metadata": {}, + "outputs": [], + "source": [ + "prop = None\n", + "if prop:\n", + " print(\"asd\")" + ] + }, + { + "cell_type": "code", + "execution_count": 181, + "metadata": {}, + "outputs": [ + { + "data": { + "text/plain": [ + "{'name': 'VitaC', 'id': 1}" + ] + }, + "execution_count": 181, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "properties" + ] + }, + { + "cell_type": "code", + "execution_count": 194, + "metadata": {}, + "outputs": [], + "source": [ + "from_id = 0\n", + "to_id = 1\n", + "edge_type = \"KNOWN_AS\"\n", + "direction = \">\"\n", + "\n", + "data:dict = {\n", + " \"from_id\":int(from_id),\n", + " \"to_id\":int(to_id),\n", + " \"edge_type\":edge_type,\n", + " \"direction\":direction,\n", + " \"properties\":dict_to_property_str(properties) \n", + "}\n", + "base_cypher = \"\"\"\n", + " MATCH (from)\n", + " WHERE ID(from) = {from_id}\n", + " MATCH (to)\n", + " WHERE ID(to) = {to_id}\n", + " MERGE (from)-[r:{edge_type} {properties}]-{direction}(to)\n", + " RETURN id(r)\n", + "\"\"\"" + ] + }, + { + "cell_type": "code", + "execution_count": 195, + "metadata": {}, + "outputs": [], + "source": [ + "def cypher_template_filler(cypher_template:str,data:dict) -> str:\n", + " return cypher_template.format(**data).replace(\"\\n\",\"\")" + ] + }, + { + "cell_type": "code", + "execution_count": 196, + "metadata": {}, + "outputs": [ + { + "data": { + "text/plain": [ + "\" MATCH (from) WHERE ID(from) = 0 MATCH (to) WHERE ID(to) = 1 MERGE (from)-[r:KNOWN_AS {name:'VitaC',id:1}]->(to) RETURN id(r)\"" + ] + }, + "execution_count": 196, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "cypher_template_filler(base_cypher,data)" + ] + }, { "cell_type": "code", "execution_count": null, diff --git a/modules/TempNB/IngestDrugSynonyms.py b/modules/TempNB/IngestDrugSynonyms.py index 80fdde1..f3e2fcc 100644 --- a/modules/TempNB/IngestDrugSynonyms.py +++ b/modules/TempNB/IngestDrugSynonyms.py @@ -10,8 +10,12 @@ import numpy as np from typing import Optional from functools import partial +import logging +logging.basicConfig(format='%(asctime)s - %(message)s', level=logging.INFO) +logger = logging.getLogger('ds') -class DrugSynonymIngest(): + +class IngestDrugSynonyms(): def __init__(self,configPath:Path=Path("config.json")): self.checkConfig(configPath) @@ -42,7 +46,7 @@ def getAllStudiesByQuery(self,query:str) -> list: from_study = 1 temp = self.apiWrapper(query,from_study) nstudies = temp['FullStudiesResponse']['NStudiesFound'] - print("> {} studies found by '{}' keyword".format(nstudies,query)) + logger.info("> {} studies found by '{}' keyword".format(nstudies,query)) if nstudies > 0: studies = temp['FullStudiesResponse']['FullStudies'] for study_index in range(from_study+100,nstudies,100): From 52be179f22f6c0ab8fc50c7f199dc153f822b4e5 Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Tue, 7 Apr 2020 15:45:21 +1000 Subject: [PATCH 33/47] cleanup --- modules/TempNB/IngestDrugSynonymsWF.py | 10 ++ modules/clinicaltrialsapi.py | 177 ------------------------- modules/drugbank_vocab.py | 53 -------- 3 files changed, 10 insertions(+), 230 deletions(-) create mode 100644 modules/TempNB/IngestDrugSynonymsWF.py delete mode 100644 modules/clinicaltrialsapi.py delete mode 100644 modules/drugbank_vocab.py diff --git a/modules/TempNB/IngestDrugSynonymsWF.py b/modules/TempNB/IngestDrugSynonymsWF.py new file mode 100644 index 0000000..b71c6d6 --- /dev/null +++ b/modules/TempNB/IngestDrugSynonymsWF.py @@ -0,0 +1,10 @@ + +from IngestDrugSynonyms import IngestDrugSynonyms +from DrugSynonymDataToNeo4j import DrugSynonymDataToNeo4j + +drugSynonym = IngestDrugSynonyms() +drugSynonym.scrapeData() +drugSynonym.filterData() + +neo4jBridge = DrugSynonymDataToNeo4j() +neo4jBridge.upload_drugs_and_synonyms(drugSynonym.drug_vocab) \ No newline at end of file diff --git a/modules/clinicaltrialsapi.py b/modules/clinicaltrialsapi.py deleted file mode 100644 index baec3f3..0000000 --- a/modules/clinicaltrialsapi.py +++ /dev/null @@ -1,177 +0,0 @@ -#!/usr/bin/env python -# coding: utf-8 - -# In[16]: - - -import requests -import pandas as pd -import json -import sys -from pathlib import Path -import xlrd -import csv -import os -import tempfile - - -# In[23]: - - -pd.set_option('display.max_colwidth', -1) -pd.set_option('display.max_rows', 500) -pd.set_option('display.max_columns', 500) -pd.set_option('display.width', 1000) - - -# In[17]: - - -from IPython.core.display import display, HTML -display(HTML("")) - - -# In[41]: - - -def xlsUrlToDF(url:str) -> pd.DataFrame: - r = requests.get(url, allow_redirects=True) - df = pd.DataFrame() - with tempfile.NamedTemporaryFile("wb") as xls_file: - xls_file.write(r.content) - - try: - book = xlrd.open_workbook(xls_file.name,encoding_override="cp1251") - except: - book = xlrd.open_workbook(file) - - sh = book.sheet_by_index(0) - with tempfile.NamedTemporaryFile("w") as csv_file: - wr = csv.writer(csv_file, quoting=csv.QUOTE_ALL) - - for rownum in range(sh.nrows): - wr.writerow(sh.row_values(rownum)) - df = pd.read_csv(csv_file.name) - csv_file.close() - - xls_file.close() - return df - - -# In[113]: - - -def api(query,from_study,to_study): - url = "https://www.clinicaltrials.gov/api/query/full_studies?expr={}&min_rnk={}&max_rnk={}&fmt=json".format(query,from_study,to_study) - response = requests.request("GET", url) - return response.json() - - -# In[75]: - - -def apiWrapper(query,from_study): - return api(query,from_study,from_study+99) - - -# In[100]: - - -def getAllStudiesByQuery(query:str) -> list: - studies:list = [] - from_study = 1 - temp = apiWrapper(query,from_study) - nstudies = temp['FullStudiesResponse']['NStudiesFound'] - print("> {} studies found by '{}' keyword".format(nstudies,query)) - if nstudies > 0: - studies = temp['FullStudiesResponse']['FullStudies'] - for study_index in range(from_study+100,nstudies,100): - temp = apiWrapper(query,study_index) - studies.extend(temp['FullStudiesResponse']['FullStudies']) - - return studies - - -# In[111]: - - -all_studies_by_keyword:dict = {} -queries:list = ["covid-19 Lopinavir","covid-19 Ritonavir" ,"covid-19 chloroquine"] - -for key in queries: - all_studies_by_keyword[key] = getAllStudiesByQuery(key) - - -# In[107]: - - -print(all_studies_by_keyword.keys()) -print([len(all_studies_by_keyword[key]) for key in all_studies_by_keyword.keys()]) - - -# In[89]: - - - -temp = api(query="covid-19",from_study=201,to_study=300) - - -# In[90]: - - -# dict_keys(['APIVrs', 'DataVrs', 'Expression', 'NStudiesAvail', 'NStudiesFound', 'MinRank', 'MaxRank', 'NStudiesReturned', 'FullStudies']) -print(temp['FullStudiesResponse']['NStudiesFound']) -print(temp['FullStudiesResponse']['FullStudies'][-1]["Rank"]) - - -# ## api query - -# In[114]: - - -api(query="covid-19 Lopinavir",from_study=1,to_study=from_study+99) - - -# In[28]: - - -df = pd.DataFrame(api(query="coronavirus",from_study=101,to_study=200)) - - -# In[11]: - - -df - - -# ## who database - -# In[29]: - - -url = "https://www.who.int/docs/default-source/coronaviruse/covid-19-trials.xls" - - -# In[30]: - - -internationalstudies = xlsUrlToDF(url) - - -# In[31]: - - -internationalstudies - - -# In[34]: - - -internationalstudies.count() - - -# In[ ]: - - - - diff --git a/modules/drugbank_vocab.py b/modules/drugbank_vocab.py deleted file mode 100644 index 6d66aa4..0000000 --- a/modules/drugbank_vocab.py +++ /dev/null @@ -1,53 +0,0 @@ -#!/usr/bin/env python -# coding: utf-8 - -# In[1]: - - -import pandas as pd - - -# In[2]: - - -pd.set_option('display.max_colwidth', -1) -pd.set_option('display.max_rows', 500) -pd.set_option('display.max_columns', 500) -pd.set_option('display.width', 1000) - - -# In[17]: - - -get_ipython().system(' wget -O drug_vocab.csv.zip https://www.drugbank.ca/releases/5-1-5/downloads/all-drugbank-vocabulary') - - -# In[18]: - - -vocab=pd.read_csv("drug_vocab.csv.zip") - - -# In[21]: - - -vocab.head(20) - - -# In[ ]: - - - - - -# In[ ]: - - - - - -# In[ ]: - - - - From 6e554effbb8a1d672a727c61aba17f6fe2ea1c30 Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Tue, 7 Apr 2020 15:54:49 +1000 Subject: [PATCH 34/47] refactor --- modules/IngestDrugSynonyms.py | 58 ----- modules/TempNB/IngestDrugSynonyms.ipynb | 286 +++--------------------- 2 files changed, 29 insertions(+), 315 deletions(-) delete mode 100644 modules/IngestDrugSynonyms.py diff --git a/modules/IngestDrugSynonyms.py b/modules/IngestDrugSynonyms.py deleted file mode 100644 index a99603b..0000000 --- a/modules/IngestDrugSynonyms.py +++ /dev/null @@ -1,58 +0,0 @@ -import requests -import pandas as pd -import json -import sys -from pathlib import Path -import xlrd -import csv -import os -import tempfile - - -def api(query,from_study,to_study): - url = "https://www.clinicaltrials.gov/api/query/full_studies?expr={}&min_rnk={}&max_rnk={}&fmt=json".format(query,from_study,to_study) - response = requests.request("GET", url) - return response.json() - -def apiWrapper(query,from_study): - return api(query,from_study,from_study+99) - -def xlsUrlToDF(url:str) -> pd.DataFrame: - r = requests.get(url, allow_redirects=True) - df = pd.DataFrame() - with tempfile.NamedTemporaryFile("wb") as xls_file: - xls_file.write(r.content) - - try: - book = xlrd.open_workbook(xls_file.name,encoding_override="cp1251") - except: - book = xlrd.open_workbook(file) - - sh = book.sheet_by_index(0) - with tempfile.NamedTemporaryFile("w") as csv_file: - wr = csv.writer(csv_file, quoting=csv.QUOTE_ALL) - - for rownum in range(sh.nrows): - wr.writerow(sh.row_values(rownum)) - df = pd.read_csv(csv_file.name) - csv_file.close() - - xls_file.close() - return df - -def getAllStudiesByQuery(query:str) -> list: - studies:list = [] - from_study = 1 - temp = apiWrapper(query,from_study) - nstudies = temp['FullStudiesResponse']['NStudiesFound'] - print("> {} studies found by '{}' keyword".format(nstudies,query)) - if nstudies > 0: - studies = temp['FullStudiesResponse']['FullStudies'] - for study_index in range(from_study+100,nstudies,100): - temp = apiWrapper(query,study_index) - studies.extend(temp['FullStudiesResponse']['FullStudies']) - - return studies - -url = "https://www.who.int/docs/default-source/coronaviruse/covid-19-trials.xls" -internationalstudies = xlsUrlToDF(url) \ No newline at end of file diff --git a/modules/TempNB/IngestDrugSynonyms.ipynb b/modules/TempNB/IngestDrugSynonyms.ipynb index ca0dcc9..ca9af80 100644 --- a/modules/TempNB/IngestDrugSynonyms.ipynb +++ b/modules/TempNB/IngestDrugSynonyms.ipynb @@ -2,7 +2,7 @@ "cells": [ { "cell_type": "code", - "execution_count": 95, + "execution_count": 1, "metadata": {}, "outputs": [], "source": [ @@ -12,7 +12,7 @@ }, { "cell_type": "code", - "execution_count": 83, + "execution_count": 2, "metadata": {}, "outputs": [], "source": [ @@ -21,18 +21,9 @@ }, { "cell_type": "code", - "execution_count": 84, + "execution_count": 3, "metadata": {}, - "outputs": [ - { - "name": "stdout", - "output_type": "stream", - "text": [ - "The autoreload extension is already loaded. To reload it, use:\n", - " %reload_ext autoreload\n" - ] - } - ], + "outputs": [], "source": [ "%load_ext autoreload\n", "%autoreload 2" @@ -40,7 +31,7 @@ }, { "cell_type": "code", - "execution_count": 85, + "execution_count": 4, "metadata": {}, "outputs": [ { @@ -75,7 +66,7 @@ }, { "cell_type": "code", - "execution_count": 96, + "execution_count": 5, "metadata": {}, "outputs": [], "source": [ @@ -84,16 +75,26 @@ }, { "cell_type": "code", - "execution_count": 97, + "execution_count": 6, "metadata": {}, - "outputs": [], + "outputs": [ + { + "name": "stderr", + "output_type": "stream", + "text": [ + "2020-04-07 15:51:58,259 - > 351 studies found by 'covid-19' keyword\n", + "2020-04-07 15:52:11,769 - > 351 studies found by 'SARS-CoV-2' keyword\n", + "2020-04-07 15:52:25,084 - > 301 studies found by 'coronavirus' keyword\n" + ] + } + ], "source": [ "drugSynonym.scrapeData()" ] }, { "cell_type": "code", - "execution_count": 98, + "execution_count": 7, "metadata": {}, "outputs": [], "source": [ @@ -102,7 +103,7 @@ }, { "cell_type": "code", - "execution_count": 99, + "execution_count": 8, "metadata": {}, "outputs": [ { @@ -411,7 +412,7 @@ "4 Detection sensitivity is greater than 95%;Detection specificity is greater than 95% NaN NaN NaN Yes 0 NaN " ] }, - "execution_count": 99, + "execution_count": 8, "metadata": {}, "output_type": "execute_result" } @@ -422,7 +423,7 @@ }, { "cell_type": "code", - "execution_count": 100, + "execution_count": 9, "metadata": {}, "outputs": [ { @@ -489,7 +490,7 @@ "4 Etanercept Etanercept | etanercept-szzs | etanercept-ykro | Recombinant human TNF | rhu TNFR:Fc | rhu-TNFR:Fc | TNFR-Immunoadhesin " ] }, - "execution_count": 100, + "execution_count": 9, "metadata": {}, "output_type": "execute_result" } @@ -500,7 +501,7 @@ }, { "cell_type": "code", - "execution_count": 101, + "execution_count": 10, "metadata": {}, "outputs": [ { @@ -509,7 +510,7 @@ "13475" ] }, - "execution_count": 101, + "execution_count": 10, "metadata": {}, "output_type": "execute_result" } @@ -520,248 +521,19 @@ }, { "cell_type": "code", - "execution_count": 205, - "metadata": {}, - "outputs": [], - "source": [ - "from DrugSynonymDataToNeo4j import DrugSynonymDataToNeo4j" - ] - }, - { - "cell_type": "code", - "execution_count": 206, - "metadata": {}, - "outputs": [], - "source": [ - "neo4jBridge = DrugSynonymDataToNeo4j()" - ] - }, - { - "cell_type": "code", - "execution_count": 207, - "metadata": {}, - "outputs": [ - { - "name": "stderr", - "output_type": "stream", - "text": [ - "2020-04-07 15:15:01,631 - > Importing Drug and Synonyms Job is Done\n" - ] - } - ], - "source": [ - "neo4jBridge.upload_drugs_and_synonyms(drugSynonym.drug_vocab)" - ] - }, - { - "cell_type": "code", - "execution_count": 162, - "metadata": {}, - "outputs": [], - "source": [ - "base_cypher = \"\"\"\n", - "MERGE (n:{node_type} {{ {properties} }})\n", - "RETURN id(n)\n", - "\"\"\"" - ] - }, - { - "cell_type": "code", - "execution_count": 108, - "metadata": {}, - "outputs": [], - "source": [ - "data = {\n", - " \"node_type\":\"Drug\",\n", - " \"properties\":\"name:'Vitamin C'\"\n", - "}" - ] - }, - { - "cell_type": "code", - "execution_count": 110, - "metadata": {}, - "outputs": [ - { - "data": { - "text/plain": [ - "\" MERGE (n:Drug { name:'Vitamin C' }) RETURN id(n) \"" - ] - }, - "execution_count": 110, - "metadata": {}, - "output_type": "execute_result" - } - ], - "source": [ - "base_cypher.format(**data).replace(\"\\n\",\"\")" - ] - }, - { - "cell_type": "code", - "execution_count": 121, - "metadata": {}, - "outputs": [ - { - "data": { - "text/plain": [ - "0" - ] - }, - "execution_count": 121, - "metadata": {}, - "output_type": "execute_result" - } - ], - "source": [ - "int('0')" - ] - }, - { - "cell_type": "code", - "execution_count": 177, - "metadata": {}, - "outputs": [], - "source": [ - "synonym = \"VitaC\"\n", - "properties:dict = {\n", - " \"name\":synonym,\n", - " \"id\":1\n", - "}" - ] - }, - { - "cell_type": "code", - "execution_count": 178, - "metadata": {}, - "outputs": [], - "source": [ - "from typing import Optional\n", - "def dict_to_property_str(properties:Optional[dict] = None) -> str:\n", - " def property_type_checker(property_value):\n", - " if isinstance(property_value,int) or isinstance(property_value,float):\n", - " pass\n", - " elif isinstance(property_value,str):\n", - " property_value = \"\"\"'\"\"\" + property_value + \"\"\"'\"\"\"\n", - " return property_value\n", - "\n", - " resp:str = \"\"\n", - " if properties:\n", - " resp = \"{\"\n", - " for key in properties.keys():\n", - " resp += \"\"\"{key}:{value},\"\"\".format(key=key,value=property_type_checker(properties[key]))\n", - " resp = resp[:-1] + \"}\"\n", - " return resp" - ] - }, - { - "cell_type": "code", - "execution_count": 179, - "metadata": {}, - "outputs": [ - { - "data": { - "text/plain": [ - "\"{name:'VitaC',id:1}\"" - ] - }, - "execution_count": 179, - "metadata": {}, - "output_type": "execute_result" - } - ], - "source": [ - "dict_to_property_str(properties)" - ] - }, - { - "cell_type": "code", - "execution_count": 180, + "execution_count": 11, "metadata": {}, "outputs": [], "source": [ - "prop = None\n", - "if prop:\n", - " print(\"asd\")" + "inter = drugSynonym.internationalstudies" ] }, { "cell_type": "code", - "execution_count": 181, - "metadata": {}, - "outputs": [ - { - "data": { - "text/plain": [ - "{'name': 'VitaC', 'id': 1}" - ] - }, - "execution_count": 181, - "metadata": {}, - "output_type": "execute_result" - } - ], - "source": [ - "properties" - ] - }, - { - "cell_type": "code", - "execution_count": 194, - "metadata": {}, - "outputs": [], - "source": [ - "from_id = 0\n", - "to_id = 1\n", - "edge_type = \"KNOWN_AS\"\n", - "direction = \">\"\n", - "\n", - "data:dict = {\n", - " \"from_id\":int(from_id),\n", - " \"to_id\":int(to_id),\n", - " \"edge_type\":edge_type,\n", - " \"direction\":direction,\n", - " \"properties\":dict_to_property_str(properties) \n", - "}\n", - "base_cypher = \"\"\"\n", - " MATCH (from)\n", - " WHERE ID(from) = {from_id}\n", - " MATCH (to)\n", - " WHERE ID(to) = {to_id}\n", - " MERGE (from)-[r:{edge_type} {properties}]-{direction}(to)\n", - " RETURN id(r)\n", - "\"\"\"" - ] - }, - { - "cell_type": "code", - "execution_count": 195, + "execution_count": null, "metadata": {}, "outputs": [], - "source": [ - "def cypher_template_filler(cypher_template:str,data:dict) -> str:\n", - " return cypher_template.format(**data).replace(\"\\n\",\"\")" - ] - }, - { - "cell_type": "code", - "execution_count": 196, - "metadata": {}, - "outputs": [ - { - "data": { - "text/plain": [ - "\" MATCH (from) WHERE ID(from) = 0 MATCH (to) WHERE ID(to) = 1 MERGE (from)-[r:KNOWN_AS {name:'VitaC',id:1}]->(to) RETURN id(r)\"" - ] - }, - "execution_count": 196, - "metadata": {}, - "output_type": "execute_result" - } - ], - "source": [ - "cypher_template_filler(base_cypher,data)" - ] + "source": [] }, { "cell_type": "code", From 7a030d6e6dbee00f24e7293086f381483747d1ef Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Tue, 7 Apr 2020 16:13:10 +1000 Subject: [PATCH 35/47] filtering international studies --- modules/TempNB/IngestDrugSynonyms.ipynb | 520 +++++++++++------------- modules/TempNB/IngestDrugSynonyms.py | 1 + 2 files changed, 228 insertions(+), 293 deletions(-) diff --git a/modules/TempNB/IngestDrugSynonyms.ipynb b/modules/TempNB/IngestDrugSynonyms.ipynb index ca9af80..0c0af57 100644 --- a/modules/TempNB/IngestDrugSynonyms.ipynb +++ b/modules/TempNB/IngestDrugSynonyms.ipynb @@ -2,7 +2,7 @@ "cells": [ { "cell_type": "code", - "execution_count": 1, + "execution_count": 23, "metadata": {}, "outputs": [], "source": [ @@ -12,7 +12,7 @@ }, { "cell_type": "code", - "execution_count": 2, + "execution_count": 24, "metadata": {}, "outputs": [], "source": [ @@ -21,9 +21,18 @@ }, { "cell_type": "code", - "execution_count": 3, + "execution_count": 25, "metadata": {}, - "outputs": [], + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "The autoreload extension is already loaded. To reload it, use:\n", + " %reload_ext autoreload\n" + ] + } + ], "source": [ "%load_ext autoreload\n", "%autoreload 2" @@ -31,7 +40,7 @@ }, { "cell_type": "code", - "execution_count": 4, + "execution_count": 26, "metadata": {}, "outputs": [ { @@ -66,7 +75,7 @@ }, { "cell_type": "code", - "execution_count": 5, + "execution_count": 27, "metadata": {}, "outputs": [], "source": [ @@ -75,16 +84,16 @@ }, { "cell_type": "code", - "execution_count": 6, + "execution_count": 28, "metadata": {}, "outputs": [ { "name": "stderr", "output_type": "stream", "text": [ - "2020-04-07 15:51:58,259 - > 351 studies found by 'covid-19' keyword\n", - "2020-04-07 15:52:11,769 - > 351 studies found by 'SARS-CoV-2' keyword\n", - "2020-04-07 15:52:25,084 - > 301 studies found by 'coronavirus' keyword\n" + "2020-04-07 15:58:04,110 - > 351 studies found by 'covid-19' keyword\n", + "2020-04-07 15:58:17,331 - > 351 studies found by 'SARS-CoV-2' keyword\n", + "2020-04-07 15:58:31,478 - > 301 studies found by 'coronavirus' keyword\n" ] } ], @@ -94,7 +103,7 @@ }, { "cell_type": "code", - "execution_count": 7, + "execution_count": 29, "metadata": {}, "outputs": [], "source": [ @@ -103,7 +112,134 @@ }, { "cell_type": "code", - "execution_count": 8, + "execution_count": 31, + "metadata": {}, + "outputs": [ + { + "data": { + "text/html": [ + "
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Common nameSynonyms
0LepirudinHirudin variant-1 | Lepirudin recombinant
1CetuximabCetuximab | Cétuximab | Cetuximabum | Immunoglobulin G 1 (human-mouse monoclonal C 225 gamma 1 - chain anti-human epidermal growt factor receptor), disulfide wit human-mouse monoclonal C 225 kappa - chain, dimer
2Dornase alfaDeoxyribonuclease (human clone 18-1 protein moiety) | Dornasa alfa | Dornase alfa, recombinant | Dornase alpha | Recombinant deoxyribonuclease (DNAse)
3Denileukin diftitoxDenileukin | Interleukin-2/diptheria toxin fusion protein
4EtanerceptEtanercept | etanercept-szzs | etanercept-ykro | Recombinant human TNF | rhu TNFR:Fc | rhu-TNFR:Fc | TNFR-Immunoadhesin
\n", + "
" + ], + "text/plain": [ + " Common name Synonyms\n", + "0 Lepirudin Hirudin variant-1 | Lepirudin recombinant \n", + "1 Cetuximab Cetuximab | Cétuximab | Cetuximabum | Immunoglobulin G 1 (human-mouse monoclonal C 225 gamma 1 - chain anti-human epidermal growt factor receptor), disulfide wit human-mouse monoclonal C 225 kappa - chain, dimer\n", + "2 Dornase alfa Deoxyribonuclease (human clone 18-1 protein moiety) | Dornasa alfa | Dornase alfa, recombinant | Dornase alpha | Recombinant deoxyribonuclease (DNAse) \n", + "3 Denileukin diftitox Denileukin | Interleukin-2/diptheria toxin fusion protein \n", + "4 Etanercept Etanercept | etanercept-szzs | etanercept-ykro | Recombinant human TNF | rhu TNFR:Fc | rhu-TNFR:Fc | TNFR-Immunoadhesin " + ] + }, + "execution_count": 31, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "drugSynonym.drug_vocab_reduced.head()" + ] + }, + { + "cell_type": "code", + "execution_count": 32, + "metadata": {}, + "outputs": [ + { + "data": { + "text/plain": [ + "13475" + ] + }, + "execution_count": 32, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "len(drugSynonym.drug_vocab)" + ] + }, + { + "cell_type": "code", + "execution_count": 53, + "metadata": {}, + "outputs": [ + { + "data": { + "text/plain": [ + "Index(['TrialID', 'Last Refreshed on', 'Public title', 'Scientific title', 'Acronym', 'Primary sponsor', 'Date registration', 'Date registration3', 'Export date', 'Source Register', 'web address', 'Recruitment Status', 'other records', 'Inclusion agemin', 'Inclusion agemax', 'Inclusion gender', 'Date enrollement', 'Target size', 'Study type', 'Study design', 'Phase', 'Countries', 'Contact Firstname', 'Contact Lastname', 'Contact Address', 'Contact Email', 'Contact Tel', 'Contact Affiliation', 'Inclusion Criteria', 'Exclusion Criteria', 'Condition', 'Intervention', 'Primary outcome', 'results date posted', 'results date completed', 'results url link', 'Retrospective flag', 'Bridging flag truefalse', 'Bridged type', 'results yes no'], dtype='object')" + ] + }, + "execution_count": 53, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "drugSynonym.internationalstudies.columns" + ] + }, + { + "cell_type": "code", + "execution_count": 54, + "metadata": {}, + "outputs": [], + "source": [ + "internationalstudies = drugSynonym.internationalstudies[['TrialID', 'Intervention','Study type']]" + ] + }, + { + "cell_type": "code", + "execution_count": 55, "metadata": {}, "outputs": [ { @@ -128,304 +264,80 @@ " \n", " \n", " TrialID\n", - " Last Refreshed on\n", - " Public title\n", - " Scientific title\n", - " Acronym\n", - " Primary sponsor\n", - " Date registration\n", - " Date registration3\n", - " Export date\n", - " Source Register\n", - " web address\n", - " Recruitment Status\n", - " other records\n", - " Inclusion agemin\n", - " Inclusion agemax\n", - " Inclusion gender\n", - " Date enrollement\n", - " Target size\n", - " Study type\n", - " Study design\n", - " Phase\n", - " Countries\n", - " Contact Firstname\n", - " Contact Lastname\n", - " Contact Address\n", - " Contact Email\n", - " Contact Tel\n", - " Contact Affiliation\n", - " Inclusion Criteria\n", - " Exclusion Criteria\n", - " Condition\n", " Intervention\n", - " Primary outcome\n", - " results date posted\n", - " results date completed\n", - " results url link\n", - " Retrospective flag\n", - " Bridging flag truefalse\n", - " Bridged type\n", - " results yes no\n", + " Study type\n", " \n", " \n", " \n", " \n", " 0\n", " ChiCTR2000029953\n", - " 43878.0\n", - " Construction and Analysis of Prognostic Predictive Model of Novel Coronavirus Pneumonia (COVID-19)\n", - " Construction and Analysis of Prognostic Predictive Model of Novel Coronavirus Pneumonia (COVID-19)\n", - " NaN\n", - " Zhongnan Hospital of Wuhan University\n", - " 43878.0\n", - " 20200217.0\n", - " 43834.660579\n", - " ChiCTR\n", - " http://www.chictr.org.cn/showproj.aspx?proj=49217\n", - " Not Recruiting\n", - " No\n", - " NaN\n", - " NaN\n", - " Both\n", - " 43862.0\n", - " survival group:200;died:200;\n", - " Observational study\n", - " Factorial\n", - " NaN\n", - " China\n", - " Yan Zhao\n", - " NaN\n", - " 169 Donghu Road, Wuchang District, Wuhan, Hubei, China\n", - " doctoryanzhao@whu.edu.cn\n", - " +86 13995577963\n", - " Emergency Department of Zhongnan Hospital of Wuhan University\n", - " Inclusion criteria: 2019-nCoV-infected pneumonia diagnosed patients, the diagnostic criteria refer to \"guideline of the diagnose and treatment of 2019-nCoV (trial)\" published by National Health Committees of Peoples' Republic Country \"\n", - " Exclusion criteria: Patients diagnosed with pneumonia of age <15 years diagnosed according to\"guideline of the diagnose and treatment of 2019-nCoV (tested)\" published by National Health Committees of Peoples' Republic Country; Suspected patient with vira\n", - " 2019-nCoV Pneumonia\n", " survival group:none;died:none;\n", - " duration of in hospital;in hospital mortality;the 28s day' mortality after admission;duration of ICU stay;\n", - " NaN\n", - " NaN\n", - " NaN\n", - " No\n", - " 0\n", - " \n", - " NaN\n", + " Observational study\n", " \n", " \n", " 1\n", " ChiCTR2000029935\n", - " 43878.0\n", - " A Single-arm Clinical Trial for Chloroquine Phosphate in the treatment of Novel Coronavirus Pneumonia 2019 (COVID-19)\n", - " A Single-arm Clinical Trial for Chloroquine Phosphate in the treatment of Novel Coronavirus Pneumonia 2019 (COVID-19)\n", - " NaN\n", - " HwaMei Hospital, University of Chinese Academy of Sciences\n", - " 43877.0\n", - " 20200216.0\n", - " 43834.660579\n", - " ChiCTR\n", - " http://www.chictr.org.cn/showproj.aspx?proj=49607\n", - " Recruiting\n", - " No\n", - " NaN\n", - " NaN\n", - " Both\n", - " 43867.0\n", - " Case series:100;\n", - " Interventional study\n", - " Single arm\n", - " NaN\n", - " China\n", - " Ting Cai\n", - " NaN\n", - " 41 Xibei Street, Ningbo, Zhejiang, China\n", - " caiting@ucas.ac.cn\n", - " +86 13738498188\n", - " HwaMei Hospital, University of Chinese Academy of Sciences\n", - " Inclusion criteria: Patients aged 18 or older, and meet the diagnostic criteria of Diagnosis and Treatment Scheme of Novel Coronavirus Infected Pneumonia published by the National Health Commission.\\r<br>Criteria for diagnosis (meet all the following crite\n", - " Exclusion criteria: 1. Female patients during pregnancy; \\r<br>2. Patients with known allergy to chloroquine; \\r<br>3. Patients with haematological diseases; \\r<br>4. Patients with chronic liver or kidney diseases at the end stage; \\r<br>5. Patients with arrh\n", - " Novel Coronavirus Pneumonia (COVID-19)\n", " Case series:Treated with conventional treatment combined with Chloroquine Phosphate;\n", - " Length of hospital stay;\n", - " NaN\n", - " NaN\n", - " NaN\n", - " No\n", - " 0\n", - " \n", - " NaN\n", + " Interventional study\n", " \n", " \n", " 2\n", " ChiCTR2000029850\n", - " 43878.0\n", - " Study on convalescent plasma treatment for severe patients with novel coronavirus pneumonia (COVID-19)\n", - " Effecacy and safty of convalescent plasma treatment for severe patients with novel coronavirus pneumonia (COVID-19): a prospective cohort study\n", - " NaN\n", - " The First Affiliated Hospital of Zhejiang University School of Medicine\n", - " 43876.0\n", - " 20200215.0\n", - " 43834.660579\n", - " ChiCTR\n", - " http://www.chictr.org.cn/showproj.aspx?proj=49533\n", - " Recruiting\n", - " No\n", - " 16.0\n", - " 99.0\n", - " Male\n", - " 43876.0\n", - " experimental group:10;control group:10;\n", - " Interventional study\n", - " Non randomized control\n", - " 0.0\n", - " China\n", - " Xiaowei Xu\n", - " NaN\n", - " 79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, China\n", - " xxw69@126.com\n", - " +86 13605708066\n", - " The First Affiliated Hospital of Zhejiang University, State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Disease\n", - " Inclusion criteria: 1. Laboratory confirmed diagnosis of COVID19 infection by RT-PCR;\\r<br>2. Aged > 18 years;\\r<br>3. Written informed consent given by the patient or next-of-kin;\\r<br>4. Clinical deterioration despite conventional treatment that required i\n", - " Exclusion criteria: 1. Hypersensitive to immunoglobulin;\\r<br>2. Have immunoglobulin A deficiency.\n", - " Novel Coronavirus Pneumonia (COVID-19)\n", " experimental group:standardized comprehensive treatment combined with convalescent plasma treatment;control group:standardized comprehensive treatment;\n", - " Fatality rate;\n", - " NaN\n", - " NaN\n", - " NaN\n", - " Yes\n", - " 0\n", - " \n", - " NaN\n", + " Interventional study\n", " \n", " \n", " 3\n", " ChiCTR2000029814\n", - " 43878.0\n", - " Clinical Trial for Integrated Chinese and Western Medicine in the Treatment of Children with Novel Coronavirus Pneumonia (COVID-19)\n", - " Clinical Trial for Integrated Chinese and Western Medicine in the Treatment of Children with Novel Coronavirus Pneumonia (COVID-19)\n", - " NaN\n", - " Children's Hospital of Fudan University\n", - " 43875.0\n", - " 20200214.0\n", - " 43834.660579\n", - " ChiCTR\n", - " http://www.chictr.org.cn/showproj.aspx?proj=49387\n", - " Recruiting\n", - " No\n", - " 0.0\n", - " 18.0\n", - " Both\n", - " 43875.0\n", - " control group:15;experimental group:15;\n", - " Interventional study\n", - " Non randomized control\n", - " 0.0\n", - " China\n", - " Zhai Xiaowen\n", - " NaN\n", - " 399 Wanyuan Road, Minhang District, Shanghai\n", - " zhaixiaowendy@163.com\n", - " +86 64931902\n", - " Children's Hospital of Fudan University\n", - " Inclusion criteria: Children diagnosed with novel coronavirus pneumonia through epidemiological history, clinical symptoms, and nucleic acid test results.\n", - " Exclusion criteria: No exclusion criteria\n", - " Novel Coronavirus Pneumonia (COVID-19)\n", " control group:Western Medicine;experimental group:Integrated Traditional Chinese and Western Medicine;\n", - " Time fo fever reduction;Time of nucleic acid negative;Severe conversion rate;Improvement time of respiratory symptoms;\n", - " NaN\n", - " NaN\n", - " NaN\n", - " Yes\n", - " 0\n", - " \n", - " NaN\n", + " Interventional study\n", " \n", " \n", " 4\n", " NCT04245631\n", - " 43878.0\n", - " Development of a Simple, Fast and Portable Recombinase Aided Amplification Assay for 2019-nCoV\n", - " Development of a Simple, Fast and Portable Recombinase Aided Amplification (RAA) Assay for 2019-nCoV\n", - " NaN\n", - " Beijing Ditan Hospital\n", - " 43856.0\n", - " 20200126.0\n", - " 43834.660579\n", - " ClinicalTrials.gov\n", - " https://clinicaltrials.gov/show/NCT04245631\n", - " Recruiting\n", - " No\n", - " 1 Year\n", - " 90 Years\n", - " All\n", - " 43831.0\n", - " 50.0\n", - " Observational\n", - " NaN\n", - " NaN\n", - " China\n", - " ; ;\n", - " Yao Xie, Doctor;Yao Xie, Doctor;Yao Xie, Doctor\n", - " NaN\n", - " ;xieyao00120184@sina.com;xieyao00120184@sina.com\n", - " ;8610-84322200;8610-84322200\n", - " Department of Hepatology, Division 2, Beijing Ditan Hospital;\n", - " \\r<br> Inclusion Criteria:\\r<br>\\r<br> - 1. Suspected cases (formerly observed cases)\\r<br>\\r<br> Meet the following 2 at the same time:\\r<br>\\r<br> Epidemiological history There was a history of travel or residence in Wuhan within\n", - " NaN\n", - " New Coronavirus\n", " Diagnostic Test: Recombinase aided amplification (RAA) assay\n", - " Detection sensitivity is greater than 95%;Detection specificity is greater than 95%\n", - " NaN\n", - " NaN\n", - " NaN\n", - " Yes\n", - " 0\n", - " \n", - " NaN\n", + " Observational\n", " \n", " \n", "\n", "" ], "text/plain": [ - " TrialID Last Refreshed on Public title Scientific title Acronym Primary sponsor Date registration Date registration3 Export date Source Register web address Recruitment Status other records Inclusion agemin Inclusion agemax Inclusion gender Date enrollement Target size Study type Study design Phase Countries Contact Firstname Contact Lastname Contact Address \\\n", - "0 ChiCTR2000029953 43878.0 Construction and Analysis of Prognostic Predictive Model of Novel Coronavirus Pneumonia (COVID-19) Construction and Analysis of Prognostic Predictive Model of Novel Coronavirus Pneumonia (COVID-19) NaN Zhongnan Hospital of Wuhan University 43878.0 20200217.0 43834.660579 ChiCTR http://www.chictr.org.cn/showproj.aspx?proj=49217 Not Recruiting No NaN NaN Both 43862.0 survival group:200;died:200; Observational study Factorial NaN China Yan Zhao NaN 169 Donghu Road, Wuchang District, Wuhan, Hubei, China \n", - "1 ChiCTR2000029935 43878.0 A Single-arm Clinical Trial for Chloroquine Phosphate in the treatment of Novel Coronavirus Pneumonia 2019 (COVID-19) A Single-arm Clinical Trial for Chloroquine Phosphate in the treatment of Novel Coronavirus Pneumonia 2019 (COVID-19) NaN HwaMei Hospital, University of Chinese Academy of Sciences 43877.0 20200216.0 43834.660579 ChiCTR http://www.chictr.org.cn/showproj.aspx?proj=49607 Recruiting No NaN NaN Both 43867.0 Case series:100; Interventional study Single arm NaN China Ting Cai NaN 41 Xibei Street, Ningbo, Zhejiang, China \n", - "2 ChiCTR2000029850 43878.0 Study on convalescent plasma treatment for severe patients with novel coronavirus pneumonia (COVID-19) Effecacy and safty of convalescent plasma treatment for severe patients with novel coronavirus pneumonia (COVID-19): a prospective cohort study NaN The First Affiliated Hospital of Zhejiang University School of Medicine 43876.0 20200215.0 43834.660579 ChiCTR http://www.chictr.org.cn/showproj.aspx?proj=49533 Recruiting No 16.0 99.0 Male 43876.0 experimental group:10;control group:10; Interventional study Non randomized control 0.0 China Xiaowei Xu NaN 79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, China \n", - "3 ChiCTR2000029814 43878.0 Clinical Trial for Integrated Chinese and Western Medicine in the Treatment of Children with Novel Coronavirus Pneumonia (COVID-19) Clinical Trial for Integrated Chinese and Western Medicine in the Treatment of Children with Novel Coronavirus Pneumonia (COVID-19) NaN Children's Hospital of Fudan University 43875.0 20200214.0 43834.660579 ChiCTR http://www.chictr.org.cn/showproj.aspx?proj=49387 Recruiting No 0.0 18.0 Both 43875.0 control group:15;experimental group:15; Interventional study Non randomized control 0.0 China Zhai Xiaowen NaN 399 Wanyuan Road, Minhang District, Shanghai \n", - "4 NCT04245631 43878.0 Development of a Simple, Fast and Portable Recombinase Aided Amplification Assay for 2019-nCoV Development of a Simple, Fast and Portable Recombinase Aided Amplification (RAA) Assay for 2019-nCoV NaN Beijing Ditan Hospital 43856.0 20200126.0 43834.660579 ClinicalTrials.gov https://clinicaltrials.gov/show/NCT04245631 Recruiting No 1 Year 90 Years All 43831.0 50.0 Observational NaN NaN China ; ; Yao Xie, Doctor;Yao Xie, Doctor;Yao Xie, Doctor NaN \n", - "\n", - " Contact Email Contact Tel Contact Affiliation Inclusion Criteria Exclusion Criteria Condition Intervention \\\n", - "0 doctoryanzhao@whu.edu.cn +86 13995577963 Emergency Department of Zhongnan Hospital of Wuhan University Inclusion criteria: 2019-nCoV-infected pneumonia diagnosed patients, the diagnostic criteria refer to \"guideline of the diagnose and treatment of 2019-nCoV (trial)\" published by National Health Committees of Peoples' Republic Country \" Exclusion criteria: Patients diagnosed with pneumonia of age <15 years diagnosed according to\"guideline of the diagnose and treatment of 2019-nCoV (tested)\" published by National Health Committees of Peoples' Republic Country; Suspected patient with vira 2019-nCoV Pneumonia survival group:none;died:none; \n", - "1 caiting@ucas.ac.cn +86 13738498188 HwaMei Hospital, University of Chinese Academy of Sciences Inclusion criteria: Patients aged 18 or older, and meet the diagnostic criteria of Diagnosis and Treatment Scheme of Novel Coronavirus Infected Pneumonia published by the National Health Commission.\\r
Criteria for diagnosis (meet all the following crite Exclusion criteria: 1. Female patients during pregnancy; \\r
2. Patients with known allergy to chloroquine; \\r
3. Patients with haematological diseases; \\r
4. Patients with chronic liver or kidney diseases at the end stage; \\r
5. Patients with arrh Novel Coronavirus Pneumonia (COVID-19) Case series:Treated with conventional treatment combined with Chloroquine Phosphate; \n", - "2 xxw69@126.com +86 13605708066 The First Affiliated Hospital of Zhejiang University, State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Disease Inclusion criteria: 1. Laboratory confirmed diagnosis of COVID19 infection by RT-PCR;\\r
2. Aged > 18 years;\\r
3. Written informed consent given by the patient or next-of-kin;\\r
4. Clinical deterioration despite conventional treatment that required i Exclusion criteria: 1. Hypersensitive to immunoglobulin;\\r
2. Have immunoglobulin A deficiency. Novel Coronavirus Pneumonia (COVID-19) experimental group:standardized comprehensive treatment combined with convalescent plasma treatment;control group:standardized comprehensive treatment; \n", - "3 zhaixiaowendy@163.com +86 64931902 Children's Hospital of Fudan University Inclusion criteria: Children diagnosed with novel coronavirus pneumonia through epidemiological history, clinical symptoms, and nucleic acid test results. Exclusion criteria: No exclusion criteria Novel Coronavirus Pneumonia (COVID-19) control group:Western Medicine;experimental group:Integrated Traditional Chinese and Western Medicine; \n", - "4 ;xieyao00120184@sina.com;xieyao00120184@sina.com ;8610-84322200;8610-84322200 Department of Hepatology, Division 2, Beijing Ditan Hospital; \\r
Inclusion Criteria:\\r
\\r
- 1. Suspected cases (formerly observed cases)\\r
\\r
Meet the following 2 at the same time:\\r
\\r
Epidemiological history There was a history of travel or residence in Wuhan within NaN New Coronavirus Diagnostic Test: Recombinase aided amplification (RAA) assay \n", - "\n", - " Primary outcome results date posted results date completed results url link Retrospective flag Bridging flag truefalse Bridged type results yes no \n", - "0 duration of in hospital;in hospital mortality;the 28s day' mortality after admission;duration of ICU stay; NaN NaN NaN No 0 NaN \n", - "1 Length of hospital stay; NaN NaN NaN No 0 NaN \n", - "2 Fatality rate; NaN NaN NaN Yes 0 NaN \n", - "3 Time fo fever reduction;Time of nucleic acid negative;Severe conversion rate;Improvement time of respiratory symptoms; NaN NaN NaN Yes 0 NaN \n", - "4 Detection sensitivity is greater than 95%;Detection specificity is greater than 95% NaN NaN NaN Yes 0 NaN " + " TrialID Intervention Study type\n", + "0 ChiCTR2000029953 survival group:none;died:none; Observational study \n", + "1 ChiCTR2000029935 Case series:Treated with conventional treatment combined with Chloroquine Phosphate; Interventional study\n", + "2 ChiCTR2000029850 experimental group:standardized comprehensive treatment combined with convalescent plasma treatment;control group:standardized comprehensive treatment; Interventional study\n", + "3 ChiCTR2000029814 control group:Western Medicine;experimental group:Integrated Traditional Chinese and Western Medicine; Interventional study\n", + "4 NCT04245631 Diagnostic Test: Recombinase aided amplification (RAA) assay Observational " ] }, - "execution_count": 8, + "execution_count": 55, "metadata": {}, "output_type": "execute_result" } ], "source": [ - "drugSynonym.internationalstudies.head()" + "internationalstudies.head()" ] }, { "cell_type": "code", - "execution_count": 9, + "execution_count": 56, "metadata": {}, "outputs": [ + { + "name": "stderr", + "output_type": "stream", + "text": [ + "/home/ben/Projects/Graphs4GoodHackathon/ProjectDomino/.Domino/lib/python3.7/site-packages/pandas/core/indexing.py:1048: SettingWithCopyWarning: \n", + "A value is trying to be set on a copy of a slice from a DataFrame.\n", + "Try using .loc[row_indexer,col_indexer] = value instead\n", + "\n", + "See the caveats in the documentation: https://pandas.pydata.org/pandas-docs/stable/user_guide/indexing.html#returning-a-view-versus-a-copy\n", + " self.obj[item_labels[indexer[info_axis]]] = value\n" + ] + }, { "data": { "text/html": [ @@ -447,100 +359,122 @@ " \n", " \n", " \n", - " Common name\n", - " Synonyms\n", + " TrialID\n", + " Intervention\n", + " Study type\n", " \n", " \n", " \n", " \n", " 0\n", - " Lepirudin\n", - " Hirudin variant-1 | Lepirudin recombinant\n", + " ChiCTR2000029953\n", + " survival group:none;died:none;\n", + " observational study\n", " \n", " \n", " 1\n", - " Cetuximab\n", - " Cetuximab | Cétuximab | Cetuximabum | Immunoglobulin G 1 (human-mouse monoclonal C 225 gamma 1 - chain anti-human epidermal growt factor receptor), disulfide wit human-mouse monoclonal C 225 kappa - chain, dimer\n", + " ChiCTR2000029935\n", + " Case series:Treated with conventional treatment combined with Chloroquine Phosphate;\n", + " interventional study\n", " \n", " \n", " 2\n", - " Dornase alfa\n", - " Deoxyribonuclease (human clone 18-1 protein moiety) | Dornasa alfa | Dornase alfa, recombinant | Dornase alpha | Recombinant deoxyribonuclease (DNAse)\n", + " ChiCTR2000029850\n", + " experimental group:standardized comprehensive treatment combined with convalescent plasma treatment;control group:standardized comprehensive treatment;\n", + " interventional study\n", " \n", " \n", " 3\n", - " Denileukin diftitox\n", - " Denileukin | Interleukin-2/diptheria toxin fusion protein\n", + " ChiCTR2000029814\n", + " control group:Western Medicine;experimental group:Integrated Traditional Chinese and Western Medicine;\n", + " interventional study\n", " \n", " \n", " 4\n", - " Etanercept\n", - " Etanercept | etanercept-szzs | etanercept-ykro | Recombinant human TNF | rhu TNFR:Fc | rhu-TNFR:Fc | TNFR-Immunoadhesin\n", + " NCT04245631\n", + " Diagnostic Test: Recombinase aided amplification (RAA) assay\n", + " observational\n", " \n", " \n", "\n", "" ], "text/plain": [ - " Common name Synonyms\n", - "0 Lepirudin Hirudin variant-1 | Lepirudin recombinant \n", - "1 Cetuximab Cetuximab | Cétuximab | Cetuximabum | Immunoglobulin G 1 (human-mouse monoclonal C 225 gamma 1 - chain anti-human epidermal growt factor receptor), disulfide wit human-mouse monoclonal C 225 kappa - chain, dimer\n", - "2 Dornase alfa Deoxyribonuclease (human clone 18-1 protein moiety) | Dornasa alfa | Dornase alfa, recombinant | Dornase alpha | Recombinant deoxyribonuclease (DNAse) \n", - "3 Denileukin diftitox Denileukin | Interleukin-2/diptheria toxin fusion protein \n", - "4 Etanercept Etanercept | etanercept-szzs | etanercept-ykro | Recombinant human TNF | rhu TNFR:Fc | rhu-TNFR:Fc | TNFR-Immunoadhesin " + " TrialID Intervention Study type\n", + "0 ChiCTR2000029953 survival group:none;died:none; observational study \n", + "1 ChiCTR2000029935 Case series:Treated with conventional treatment combined with Chloroquine Phosphate; interventional study\n", + "2 ChiCTR2000029850 experimental group:standardized comprehensive treatment combined with convalescent plasma treatment;control group:standardized comprehensive treatment; interventional study\n", + "3 ChiCTR2000029814 control group:Western Medicine;experimental group:Integrated Traditional Chinese and Western Medicine; interventional study\n", + "4 NCT04245631 Diagnostic Test: Recombinase aided amplification (RAA) assay observational " ] }, - "execution_count": 9, + "execution_count": 56, "metadata": {}, "output_type": "execute_result" } ], "source": [ - "drugSynonym.drug_vocab_reduced.head()" + "internationalstudies.loc[:,'Study type'] = internationalstudies['Study type'].str.lower()\n", + "internationalstudies.head()" ] }, { "cell_type": "code", - "execution_count": 10, + "execution_count": 57, "metadata": {}, "outputs": [ { "data": { "text/plain": [ - "13475" + "779" ] }, - "execution_count": 10, + "execution_count": 57, "metadata": {}, "output_type": "execute_result" } ], "source": [ - "len(drugSynonym.drug_vocab)" + "len(internationalstudies)" ] }, { "cell_type": "code", - "execution_count": 11, + "execution_count": 59, "metadata": {}, "outputs": [], "source": [ - "inter = drugSynonym.internationalstudies" + "filtered_int_studies = internationalstudies[internationalstudies['Study type'].str.contains(\"intervention\")]" ] }, { "cell_type": "code", - "execution_count": null, + "execution_count": 45, "metadata": {}, - "outputs": [], - "source": [] + "outputs": [ + { + "data": { + "text/plain": [ + "8" + ] + }, + "execution_count": 45, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "len(filtered_int_studies)" + ] }, { "cell_type": "code", "execution_count": null, "metadata": {}, "outputs": [], - "source": [] + "source": [ + "remainig_int_studies = internationalstudies[internationalstudies['Study type'].str.contains(\"intervention\")]" + ] } ], "metadata": { diff --git a/modules/TempNB/IngestDrugSynonyms.py b/modules/TempNB/IngestDrugSynonyms.py index f3e2fcc..cfedfd3 100644 --- a/modules/TempNB/IngestDrugSynonyms.py +++ b/modules/TempNB/IngestDrugSynonyms.py @@ -101,6 +101,7 @@ def scrapeData(self): def filterData(self): self.drug_vocab_reduced = self.drug_vocab_df[['Common name', 'Synonyms']] + self.internationalstudies_reduced = self.internationalstudies[['TrialID', 'Intervention','Study type']] self.drug_vocab:dict = {} for index, row in self.drug_vocab_reduced.iterrows(): self.drug_vocab[row['Common name']] = row["Synonyms"].split("|") if isinstance(row["Synonyms"],str) else row["Synonyms"] From 31db1027b1814c8c9ee7810837d7c9e4e0a6862a Mon Sep 17 00:00:00 2001 From: lmeyerov Date: Tue, 7 Apr 2020 11:14:25 -0700 Subject: [PATCH 36/47] docs(README.md): infra links --- README.md | 10 ++++++++-- 1 file changed, 8 insertions(+), 2 deletions(-) diff --git a/README.md b/README.md index c2f1e6a..1690aa0 100644 --- a/README.md +++ b/README.md @@ -2,14 +2,20 @@ ## Scaling COVID public behavior change and anti-misinformation -* [Private repository](https://github.com/graphistry/ProjectDomino-internal) - * [Community Slack channel: #COVID](https://thedataridealongs.slack.com/) via an [open invite link](https://join.slack.com/t/thedataridealongs/shared_invite/zt-d06nq64h-P1_3sENXG4Gg0MjWh1jPEw) * [Meetings: Google calendar](https://calendar.google.com/calendar?cid=Z3JhcGhpc3RyeS5jb21fdTQ3bmQ3YTdiZzB0aTJtaW9kYTJybGx2cTBAZ3JvdXAuY2FsZW5kYXIuZ29vZ2xlLmNvbQ) * Project Tackers: [Core](https://github.com/TheDataRideAlongs/ProjectDomino/projects/1), [Interventions](https://github.com/TheDataRideAlongs/ProjectDomino/projects/2), and [Issues](https://github.com/TheDataRideAlongs/ProjectDomino/issues) +* Infra - ask for account access in Slack + * [Private repository](https://github.com/graphistry/ProjectDomino-internal) + * Observability - [Grafana](http://13.68.225.97:10007/d/n__-I5jZk/neo4j-4-dashboard?orgId=1) + * DB - Neo4j + * Orchestration - Prefect + * Key sharing - Keybase team + * CI - Github Actions + * **Graph4good contributors:** We're excited to work with you! Check out the subprojects below we are actively seeking help on, look at some of the Github Issues, and ping on Slack for which you're curious about tackling and others not here. We can then share our current thoughts and tips for getting started. Most will be useful as pure Python [Google Collab notebook](https://colab.research.google.com) proveouts and local Neo4j Docker + Python proveouts: You can move quickly, and we can more easily integrate into our automation pipelines. **One of the most important steps in stopping the COVID-19 pandemic is influencing mass behavior change for citizens to take appropriate, swift action on mitigating infection and human-to-human contact.** Government officials at all levels have advocated misinformed practices such as dining out or participating in outdoor gatherings that have contributed to amplifying the curve rather than flattening it. At time of writing, the result of poor crisis emergency risk communication has led to over 14,000 US citizens testing positive, 2-20X more are likely untested, and over 200 deaths. The need to influence appropriate behavior and mitigation actions are extreme: The US has shot up from untouched to become the 6th most infected nation. From 9b137f1fd15676197c996235326dec6c2ca993d7 Mon Sep 17 00:00:00 2001 From: Dave Date: Wed, 8 Apr 2020 14:36:20 -0800 Subject: [PATCH 37/47] Added metrics configuration --- infra/metrics/docker-compose.yml | 44 ++++++++++++++++++++ infra/metrics/prometheus/prometheus.yml | 30 ++++++++++++++ infra/neo4j/docker/docker-compose.yml | 52 +++++++++++++++++++++--- infra/neo4j/scripts/neo4j-indexes.cypher | 20 ++++++++- 4 files changed, 140 insertions(+), 6 deletions(-) create mode 100644 infra/metrics/docker-compose.yml create mode 100644 infra/metrics/prometheus/prometheus.yml diff --git a/infra/metrics/docker-compose.yml b/infra/metrics/docker-compose.yml new file mode 100644 index 0000000..1bfdb6b --- /dev/null +++ b/infra/metrics/docker-compose.yml @@ -0,0 +1,44 @@ +version: '3.3' + +networks: + lan: + external: + name: i-already-created-this + +services: + prometheus: + image: prom/prometheus + network_mode: 'bridge' + ports: + - 10005:9090 + volumes: + - /datadrive/prometheus:/etc/prometheus + - /datadrive/prometheus/storage:/prometheus + command: + - '--config.file=/etc/prometheus/prometheus.yml' + - '--storage.tsdb.path=/prometheus' + restart: always + + cadvisor: + image: google/cadvisor:latest + volumes: + - /:/rootfs:ro + - /var/run:/var/run:rw + - /sys:/sys:ro + - /var/lib/docker/:/var/lib/docker:ro + ports: + - 10006:8080 + network_mode: 'bridge' + restart: always + + grafana: + image: grafana/grafana + depends_on: + - prometheus + network_mode: 'bridge' + ports: + - 10007:3000 + volumes: + - /datadrive/grafana/storage:/var/lib/grafana + - /datadrive/grafana/provisioning/:/etc/grafana/provisioning/ + restart: always diff --git a/infra/metrics/prometheus/prometheus.yml b/infra/metrics/prometheus/prometheus.yml new file mode 100644 index 0000000..f0a5b91 --- /dev/null +++ b/infra/metrics/prometheus/prometheus.yml @@ -0,0 +1,30 @@ +global: + scrape_interval: 15s + scrape_timeout: 10s + evaluation_interval: 15s + alerting: + alertmanagers: + - static_configs: + - targets: [] + scheme: http + timeout: 10s + api_version: v1 + scrape_configs: + - job_name: prometheus + honor_timestamps: true + scrape_interval: 15s + scrape_timeout: 10s + metrics_path: /metrics + scheme: http + static_configs: + - targets: + - localhost:9090 + - job_name: neo4j-prometheus + honor_timestamps: true + scrape_interval: 10s + scrape_timeout: 10s + metrics_path: /metrics + scheme: http + static_configs: + - targets: + - 172.17.0.3:2004 \ No newline at end of file diff --git a/infra/neo4j/docker/docker-compose.yml b/infra/neo4j/docker/docker-compose.yml index f730ef6..aba53b4 100644 --- a/infra/neo4j/docker/docker-compose.yml +++ b/infra/neo4j/docker/docker-compose.yml @@ -1,17 +1,21 @@ +version: '3.3' + services: neo4j: image: neo4j:4.0.2-enterprise - network_mode: "bridge" + container_name: neo4j-server ports: - - "10001:7687" - - "10002:7473" - - "10003:7474" + - '10001:7687' + - '10002:7473' + - '10003:7474' + - '2400:2400' restart: unless-stopped volumes: - /datadrive/neo4j/plugins:/plugins - /datadrive/neo4j/data:/data - /datadrive/neo4j/import:/import - /datadrive/neo4j/logs:/logs + - /datadrive/neo4j/conf:/conf environment: - NEO4JLABS_PLUGINS=["apoc"] - NEO4J_AUTH=neo4j/neo123 @@ -22,4 +26,42 @@ services: - NEO4J_dbms_transaction_timeout=60s logging: options: - tag: "ImageName:{{.ImageName}}/Name:{{.Name}}/ID:{{.ID}}/ImageFullID:{{.ImageFullID}}" + tag: 'ImageName:{{.ImageName}}/Name:{{.Name}}/ID:{{.ID}}/ImageFullID:{{.ImageFullID}}' + + prometheus: + image: prom/prometheus + network_mode: 'bridge' + ports: + - 10005:9090 + volumes: + - /datadrive/prometheus:/etc/prometheus + - /datadrive/prometheus/prometheus.yml:/etc/prometheus/prometheus.yml + - /datadrive/prometheus/storage:/prometheus + command: + - '--config.file=/etc/prometheus/prometheus.yml' + - '--storage.tsdb.path=/prometheus' + restart: always + + cadvisor: + image: google/cadvisor:latest + volumes: + - /:/rootfs:ro + - /var/run:/var/run:rw + - /sys:/sys:ro + - /var/lib/docker/:/var/lib/docker:ro + ports: + - 10006:8080 + network_mode: 'bridge' + restart: always + + grafana: + image: grafana/grafana + depends_on: + - prometheus + network_mode: 'bridge' + ports: + - 10007:3000 + volumes: + - /datadrive/grafana/storage:/var/lib/grafana + - /datadrive/grafana/provisioning/:/etc/grafana/provisioning/ + restart: always diff --git a/infra/neo4j/scripts/neo4j-indexes.cypher b/infra/neo4j/scripts/neo4j-indexes.cypher index a9605a6..6b08847 100644 --- a/infra/neo4j/scripts/neo4j-indexes.cypher +++ b/infra/neo4j/scripts/neo4j-indexes.cypher @@ -9,4 +9,22 @@ ON (n:Url) ASSERT n.full_url IS UNIQUE CREATE INDEX tweet_by_type FOR (n:Tweet) -ON (n.tweet_type) \ No newline at end of file +ON (n.tweet_type) + +CREATE INDEX tweet_by_hydrated +FOR (n:Tweet) +ON (n.hydrated) + +CREATE INDEX tweet_by_text +FOR (n:Tweet) +ON (n.text) + +CREATE INDEX tweet_by_created_at +FOR (n:Tweet) +ON (n.created_at) + +CREATE INDEX tweet_by_record_created_at +FOR (n:Tweet) +ON (n.record_created_at) + +CALL db.index.fulltext.createNodeIndex("tweet_by_text_fulltext",["Tweet"],["text"]) \ No newline at end of file From 0d7e2e5f392968032579f3eea85015509f375280 Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Thu, 9 Apr 2020 09:42:20 +1000 Subject: [PATCH 38/47] drug analysis --- modules/TempNB/IngestDrugSynonyms.ipynb | 234 ++++++++++++++++++++---- 1 file changed, 196 insertions(+), 38 deletions(-) diff --git a/modules/TempNB/IngestDrugSynonyms.ipynb b/modules/TempNB/IngestDrugSynonyms.ipynb index 0c0af57..6d08595 100644 --- a/modules/TempNB/IngestDrugSynonyms.ipynb +++ b/modules/TempNB/IngestDrugSynonyms.ipynb @@ -2,7 +2,7 @@ "cells": [ { "cell_type": "code", - "execution_count": 23, + "execution_count": 1, "metadata": {}, "outputs": [], "source": [ @@ -12,7 +12,7 @@ }, { "cell_type": "code", - "execution_count": 24, + "execution_count": 2, "metadata": {}, "outputs": [], "source": [ @@ -21,18 +21,9 @@ }, { "cell_type": "code", - "execution_count": 25, + "execution_count": 3, "metadata": {}, - "outputs": [ - { - "name": "stdout", - "output_type": "stream", - "text": [ - "The autoreload extension is already loaded. To reload it, use:\n", - " %reload_ext autoreload\n" - ] - } - ], + "outputs": [], "source": [ "%load_ext autoreload\n", "%autoreload 2" @@ -40,7 +31,7 @@ }, { "cell_type": "code", - "execution_count": 26, + "execution_count": 4, "metadata": {}, "outputs": [ { @@ -75,7 +66,7 @@ }, { "cell_type": "code", - "execution_count": 27, + "execution_count": 5, "metadata": {}, "outputs": [], "source": [ @@ -84,16 +75,16 @@ }, { "cell_type": "code", - "execution_count": 28, + "execution_count": 6, "metadata": {}, "outputs": [ { "name": "stderr", "output_type": "stream", "text": [ - "2020-04-07 15:58:04,110 - > 351 studies found by 'covid-19' keyword\n", - "2020-04-07 15:58:17,331 - > 351 studies found by 'SARS-CoV-2' keyword\n", - "2020-04-07 15:58:31,478 - > 301 studies found by 'coronavirus' keyword\n" + "2020-04-08 15:41:03,144 - > 380 studies found by 'covid-19' keyword\n", + "2020-04-08 15:41:19,323 - > 380 studies found by 'SARS-CoV-2' keyword\n", + "2020-04-08 15:41:34,916 - > 316 studies found by 'coronavirus' keyword\n" ] } ], @@ -103,7 +94,7 @@ }, { "cell_type": "code", - "execution_count": 29, + "execution_count": 7, "metadata": {}, "outputs": [], "source": [ @@ -112,7 +103,7 @@ }, { "cell_type": "code", - "execution_count": 31, + "execution_count": 8, "metadata": {}, "outputs": [ { @@ -179,7 +170,7 @@ "4 Etanercept Etanercept | etanercept-szzs | etanercept-ykro | Recombinant human TNF | rhu TNFR:Fc | rhu-TNFR:Fc | TNFR-Immunoadhesin " ] }, - "execution_count": 31, + "execution_count": 8, "metadata": {}, "output_type": "execute_result" } @@ -190,7 +181,7 @@ }, { "cell_type": "code", - "execution_count": 32, + "execution_count": 9, "metadata": {}, "outputs": [ { @@ -199,7 +190,7 @@ "13475" ] }, - "execution_count": 32, + "execution_count": 9, "metadata": {}, "output_type": "execute_result" } @@ -210,7 +201,7 @@ }, { "cell_type": "code", - "execution_count": 53, + "execution_count": 10, "metadata": {}, "outputs": [ { @@ -219,7 +210,7 @@ "Index(['TrialID', 'Last Refreshed on', 'Public title', 'Scientific title', 'Acronym', 'Primary sponsor', 'Date registration', 'Date registration3', 'Export date', 'Source Register', 'web address', 'Recruitment Status', 'other records', 'Inclusion agemin', 'Inclusion agemax', 'Inclusion gender', 'Date enrollement', 'Target size', 'Study type', 'Study design', 'Phase', 'Countries', 'Contact Firstname', 'Contact Lastname', 'Contact Address', 'Contact Email', 'Contact Tel', 'Contact Affiliation', 'Inclusion Criteria', 'Exclusion Criteria', 'Condition', 'Intervention', 'Primary outcome', 'results date posted', 'results date completed', 'results url link', 'Retrospective flag', 'Bridging flag truefalse', 'Bridged type', 'results yes no'], dtype='object')" ] }, - "execution_count": 53, + "execution_count": 10, "metadata": {}, "output_type": "execute_result" } @@ -230,7 +221,7 @@ }, { "cell_type": "code", - "execution_count": 54, + "execution_count": 11, "metadata": {}, "outputs": [], "source": [ @@ -239,7 +230,7 @@ }, { "cell_type": "code", - "execution_count": 55, + "execution_count": 12, "metadata": {}, "outputs": [ { @@ -312,7 +303,7 @@ "4 NCT04245631 Diagnostic Test: Recombinase aided amplification (RAA) assay Observational " ] }, - "execution_count": 55, + "execution_count": 12, "metadata": {}, "output_type": "execute_result" } @@ -323,7 +314,7 @@ }, { "cell_type": "code", - "execution_count": 56, + "execution_count": 13, "metadata": {}, "outputs": [ { @@ -408,7 +399,7 @@ "4 NCT04245631 Diagnostic Test: Recombinase aided amplification (RAA) assay observational " ] }, - "execution_count": 56, + "execution_count": 13, "metadata": {}, "output_type": "execute_result" } @@ -420,7 +411,7 @@ }, { "cell_type": "code", - "execution_count": 57, + "execution_count": 14, "metadata": {}, "outputs": [ { @@ -429,7 +420,7 @@ "779" ] }, - "execution_count": 57, + "execution_count": 14, "metadata": {}, "output_type": "execute_result" } @@ -440,7 +431,7 @@ }, { "cell_type": "code", - "execution_count": 59, + "execution_count": 15, "metadata": {}, "outputs": [], "source": [ @@ -449,16 +440,16 @@ }, { "cell_type": "code", - "execution_count": 45, + "execution_count": 16, "metadata": {}, "outputs": [ { "data": { "text/plain": [ - "8" + "437" ] }, - "execution_count": 45, + "execution_count": 16, "metadata": {}, "output_type": "execute_result" } @@ -469,12 +460,179 @@ }, { "cell_type": "code", - "execution_count": null, + "execution_count": 18, "metadata": {}, "outputs": [], "source": [ "remainig_int_studies = internationalstudies[internationalstudies['Study type'].str.contains(\"intervention\")]" ] + }, + { + "cell_type": "code", + "execution_count": 19, + "metadata": {}, + "outputs": [], + "source": [ + "US_studies = drugSynonym.all_US_studies_by_keyword" + ] + }, + { + "cell_type": "code", + "execution_count": 39, + "metadata": {}, + "outputs": [], + "source": [ + "NCT_ids:list = []\n", + "for key in US_studies.keys():\n", + " for study in US_studies[key]:\n", + " NCT_ids.append(study[\"Study\"][\"ProtocolSection\"][\"IdentificationModule\"][\"NCTId\"])" + ] + }, + { + "cell_type": "code", + "execution_count": 40, + "metadata": {}, + "outputs": [ + { + "data": { + "text/plain": [ + "1076" + ] + }, + "execution_count": 40, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "len(NCT_ids)" + ] + }, + { + "cell_type": "code", + "execution_count": 41, + "metadata": {}, + "outputs": [ + { + "data": { + "text/plain": [ + "437" + ] + }, + "execution_count": 41, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "len(list(set(NCT_ids)))" + ] + }, + { + "cell_type": "code", + "execution_count": 42, + "metadata": {}, + "outputs": [], + "source": [ + "trial_ids:list = list(internationalstudies[\"TrialID\"])" + ] + }, + { + "cell_type": "code", + "execution_count": 43, + "metadata": {}, + "outputs": [ + { + "data": { + "text/plain": [ + "779" + ] + }, + "execution_count": 43, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "len(trial_ids)" + ] + }, + { + "cell_type": "code", + "execution_count": 44, + "metadata": {}, + "outputs": [ + { + "data": { + "text/plain": [ + "779" + ] + }, + "execution_count": 44, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "len(list(set(trial_ids)))" + ] + }, + { + "cell_type": "code", + "execution_count": 45, + "metadata": {}, + "outputs": [], + "source": [ + "all_ids = trial_ids[:]\n", + "all_ids.extend(NCT_ids)" + ] + }, + { + "cell_type": "code", + "execution_count": 46, + "metadata": {}, + "outputs": [ + { + "data": { + "text/plain": [ + "1855" + ] + }, + "execution_count": 46, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "len(all_ids)" + ] + }, + { + "cell_type": "code", + "execution_count": 48, + "metadata": {}, + "outputs": [ + { + "data": { + "text/plain": [ + "-189" + ] + }, + "execution_count": 48, + "metadata": {}, + "output_type": "execute_result" + } + ], + "source": [ + "len(list(set(all_ids))) - (len(list(set(trial_ids))) + len(list(set(NCT_ids))))" + ] + }, + { + "cell_type": "code", + "execution_count": null, + "metadata": {}, + "outputs": [], + "source": [] } ], "metadata": { From 6df6b15d20d968b3a4019ad373e4e88bea83d3dd Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Thu, 9 Apr 2020 13:13:54 +1000 Subject: [PATCH 39/47] table merging WIP --- modules/TempNB/IngestDrugSynonyms.ipynb | 138 ++++++++++++++---------- modules/TempNB/IngestDrugSynonyms.py | 11 +- 2 files changed, 90 insertions(+), 59 deletions(-) diff --git a/modules/TempNB/IngestDrugSynonyms.ipynb b/modules/TempNB/IngestDrugSynonyms.ipynb index 6d08595..9cba3ae 100644 --- a/modules/TempNB/IngestDrugSynonyms.ipynb +++ b/modules/TempNB/IngestDrugSynonyms.ipynb @@ -2,7 +2,7 @@ "cells": [ { "cell_type": "code", - "execution_count": 1, + "execution_count": 2, "metadata": {}, "outputs": [], "source": [ @@ -12,7 +12,7 @@ }, { "cell_type": "code", - "execution_count": 2, + "execution_count": 3, "metadata": {}, "outputs": [], "source": [ @@ -21,7 +21,7 @@ }, { "cell_type": "code", - "execution_count": 3, + "execution_count": 4, "metadata": {}, "outputs": [], "source": [ @@ -31,7 +31,7 @@ }, { "cell_type": "code", - "execution_count": 4, + "execution_count": 5, "metadata": {}, "outputs": [ { @@ -66,7 +66,7 @@ }, { "cell_type": "code", - "execution_count": 5, + "execution_count": 6, "metadata": {}, "outputs": [], "source": [ @@ -75,16 +75,16 @@ }, { "cell_type": "code", - "execution_count": 6, + "execution_count": 7, "metadata": {}, "outputs": [ { "name": "stderr", "output_type": "stream", "text": [ - "2020-04-08 15:41:03,144 - > 380 studies found by 'covid-19' keyword\n", - "2020-04-08 15:41:19,323 - > 380 studies found by 'SARS-CoV-2' keyword\n", - "2020-04-08 15:41:34,916 - > 316 studies found by 'coronavirus' keyword\n" + "2020-04-09 09:45:16,809 - > 403 studies found by 'covid-19' keyword\n", + "2020-04-09 09:45:32,147 - > 403 studies found by 'SARS-CoV-2' keyword\n", + "2020-04-09 09:45:47,940 - > 332 studies found by 'coronavirus' keyword\n" ] } ], @@ -94,7 +94,7 @@ }, { "cell_type": "code", - "execution_count": 7, + "execution_count": 8, "metadata": {}, "outputs": [], "source": [ @@ -103,7 +103,7 @@ }, { "cell_type": "code", - "execution_count": 8, + "execution_count": 9, "metadata": {}, "outputs": [ { @@ -170,7 +170,7 @@ "4 Etanercept Etanercept | etanercept-szzs | etanercept-ykro | Recombinant human TNF | rhu TNFR:Fc | rhu-TNFR:Fc | TNFR-Immunoadhesin " ] }, - "execution_count": 8, + "execution_count": 9, "metadata": {}, "output_type": "execute_result" } @@ -181,7 +181,7 @@ }, { "cell_type": "code", - "execution_count": 9, + "execution_count": 10, "metadata": {}, "outputs": [ { @@ -190,7 +190,7 @@ "13475" ] }, - "execution_count": 9, + "execution_count": 10, "metadata": {}, "output_type": "execute_result" } @@ -201,7 +201,7 @@ }, { "cell_type": "code", - "execution_count": 10, + "execution_count": 11, "metadata": {}, "outputs": [ { @@ -210,7 +210,7 @@ "Index(['TrialID', 'Last Refreshed on', 'Public title', 'Scientific title', 'Acronym', 'Primary sponsor', 'Date registration', 'Date registration3', 'Export date', 'Source Register', 'web address', 'Recruitment Status', 'other records', 'Inclusion agemin', 'Inclusion agemax', 'Inclusion gender', 'Date enrollement', 'Target size', 'Study type', 'Study design', 'Phase', 'Countries', 'Contact Firstname', 'Contact Lastname', 'Contact Address', 'Contact Email', 'Contact Tel', 'Contact Affiliation', 'Inclusion Criteria', 'Exclusion Criteria', 'Condition', 'Intervention', 'Primary outcome', 'results date posted', 'results date completed', 'results url link', 'Retrospective flag', 'Bridging flag truefalse', 'Bridged type', 'results yes no'], dtype='object')" ] }, - "execution_count": 10, + "execution_count": 11, "metadata": {}, "output_type": "execute_result" } @@ -221,16 +221,16 @@ }, { "cell_type": "code", - "execution_count": 11, + "execution_count": 31, "metadata": {}, "outputs": [], "source": [ - "internationalstudies = drugSynonym.internationalstudies[['TrialID', 'Intervention','Study type']]" + "internationalstudies = drugSynonym.internationalstudies[['TrialID', 'Intervention','Study type','web address','Target size','results url link']]" ] }, { "cell_type": "code", - "execution_count": 12, + "execution_count": 32, "metadata": {}, "outputs": [ { @@ -257,6 +257,9 @@ " TrialID\n", " Intervention\n", " Study type\n", + " web address\n", + " Target size\n", + " results url link\n", " \n", " \n", " \n", @@ -265,45 +268,60 @@ " ChiCTR2000029953\n", " survival group:none;died:none;\n", " Observational study\n", + " http://www.chictr.org.cn/showproj.aspx?proj=49217\n", + " survival group:200;died:200;\n", + " NaN\n", " \n", " \n", " 1\n", " ChiCTR2000029935\n", " Case series:Treated with conventional treatment combined with Chloroquine Phosphate;\n", " Interventional study\n", + " http://www.chictr.org.cn/showproj.aspx?proj=49607\n", + " Case series:100;\n", + " NaN\n", " \n", " \n", " 2\n", " ChiCTR2000029850\n", " experimental group:standardized comprehensive treatment combined with convalescent plasma treatment;control group:standardized comprehensive treatment;\n", " Interventional study\n", + " http://www.chictr.org.cn/showproj.aspx?proj=49533\n", + " experimental group:10;control group:10;\n", + " NaN\n", " \n", " \n", " 3\n", " ChiCTR2000029814\n", " control group:Western Medicine;experimental group:Integrated Traditional Chinese and Western Medicine;\n", " Interventional study\n", + " http://www.chictr.org.cn/showproj.aspx?proj=49387\n", + " control group:15;experimental group:15;\n", + " NaN\n", " \n", " \n", " 4\n", " NCT04245631\n", " Diagnostic Test: Recombinase aided amplification (RAA) assay\n", " Observational\n", + " https://clinicaltrials.gov/show/NCT04245631\n", + " 50.0\n", + " NaN\n", " \n", " \n", "\n", "" ], "text/plain": [ - " TrialID Intervention Study type\n", - "0 ChiCTR2000029953 survival group:none;died:none; Observational study \n", - "1 ChiCTR2000029935 Case series:Treated with conventional treatment combined with Chloroquine Phosphate; Interventional study\n", - "2 ChiCTR2000029850 experimental group:standardized comprehensive treatment combined with convalescent plasma treatment;control group:standardized comprehensive treatment; Interventional study\n", - "3 ChiCTR2000029814 control group:Western Medicine;experimental group:Integrated Traditional Chinese and Western Medicine; Interventional study\n", - "4 NCT04245631 Diagnostic Test: Recombinase aided amplification (RAA) assay Observational " + " TrialID Intervention Study type web address Target size results url link\n", + "0 ChiCTR2000029953 survival group:none;died:none; Observational study http://www.chictr.org.cn/showproj.aspx?proj=49217 survival group:200;died:200; NaN \n", + "1 ChiCTR2000029935 Case series:Treated with conventional treatment combined with Chloroquine Phosphate; Interventional study http://www.chictr.org.cn/showproj.aspx?proj=49607 Case series:100; NaN \n", + "2 ChiCTR2000029850 experimental group:standardized comprehensive treatment combined with convalescent plasma treatment;control group:standardized comprehensive treatment; Interventional study http://www.chictr.org.cn/showproj.aspx?proj=49533 experimental group:10;control group:10; NaN \n", + "3 ChiCTR2000029814 control group:Western Medicine;experimental group:Integrated Traditional Chinese and Western Medicine; Interventional study http://www.chictr.org.cn/showproj.aspx?proj=49387 control group:15;experimental group:15; NaN \n", + "4 NCT04245631 Diagnostic Test: Recombinase aided amplification (RAA) assay Observational https://clinicaltrials.gov/show/NCT04245631 50.0 NaN " ] }, - "execution_count": 12, + "execution_count": 32, "metadata": {}, "output_type": "execute_result" } @@ -314,7 +332,7 @@ }, { "cell_type": "code", - "execution_count": 13, + "execution_count": 14, "metadata": {}, "outputs": [ { @@ -353,6 +371,7 @@ " TrialID\n", " Intervention\n", " Study type\n", + " web address\n", " \n", " \n", " \n", @@ -361,45 +380,50 @@ " ChiCTR2000029953\n", " survival group:none;died:none;\n", " observational study\n", + " http://www.chictr.org.cn/showproj.aspx?proj=49217\n", " \n", " \n", " 1\n", " ChiCTR2000029935\n", " Case series:Treated with conventional treatment combined with Chloroquine Phosphate;\n", " interventional study\n", + " http://www.chictr.org.cn/showproj.aspx?proj=49607\n", " \n", " \n", " 2\n", " ChiCTR2000029850\n", " experimental group:standardized comprehensive treatment combined with convalescent plasma treatment;control group:standardized comprehensive treatment;\n", " interventional study\n", + " http://www.chictr.org.cn/showproj.aspx?proj=49533\n", " \n", " \n", " 3\n", " ChiCTR2000029814\n", " control group:Western Medicine;experimental group:Integrated Traditional Chinese and Western Medicine;\n", " interventional study\n", + " http://www.chictr.org.cn/showproj.aspx?proj=49387\n", " \n", " \n", " 4\n", " NCT04245631\n", " Diagnostic Test: Recombinase aided amplification (RAA) assay\n", " observational\n", + " https://clinicaltrials.gov/show/NCT04245631\n", " \n", " \n", "\n", "" ], "text/plain": [ - " TrialID Intervention Study type\n", - "0 ChiCTR2000029953 survival group:none;died:none; observational study \n", - "1 ChiCTR2000029935 Case series:Treated with conventional treatment combined with Chloroquine Phosphate; interventional study\n", - "2 ChiCTR2000029850 experimental group:standardized comprehensive treatment combined with convalescent plasma treatment;control group:standardized comprehensive treatment; interventional study\n", - "3 ChiCTR2000029814 control group:Western Medicine;experimental group:Integrated Traditional Chinese and Western Medicine; interventional study\n", - "4 NCT04245631 Diagnostic Test: Recombinase aided amplification (RAA) assay observational " + " TrialID Intervention Study type web address\n", + "0 ChiCTR2000029953 survival group:none;died:none; observational study http://www.chictr.org.cn/showproj.aspx?proj=49217\n", + "1 ChiCTR2000029935 Case series:Treated with conventional treatment combined with Chloroquine Phosphate; interventional study http://www.chictr.org.cn/showproj.aspx?proj=49607\n", + "2 ChiCTR2000029850 experimental group:standardized comprehensive treatment combined with convalescent plasma treatment;control group:standardized comprehensive treatment; interventional study http://www.chictr.org.cn/showproj.aspx?proj=49533\n", + "3 ChiCTR2000029814 control group:Western Medicine;experimental group:Integrated Traditional Chinese and Western Medicine; interventional study http://www.chictr.org.cn/showproj.aspx?proj=49387\n", + "4 NCT04245631 Diagnostic Test: Recombinase aided amplification (RAA) assay observational https://clinicaltrials.gov/show/NCT04245631 " ] }, - "execution_count": 13, + "execution_count": 14, "metadata": {}, "output_type": "execute_result" } @@ -411,7 +435,7 @@ }, { "cell_type": "code", - "execution_count": 14, + "execution_count": 15, "metadata": {}, "outputs": [ { @@ -420,7 +444,7 @@ "779" ] }, - "execution_count": 14, + "execution_count": 15, "metadata": {}, "output_type": "execute_result" } @@ -431,7 +455,7 @@ }, { "cell_type": "code", - "execution_count": 15, + "execution_count": 16, "metadata": {}, "outputs": [], "source": [ @@ -440,7 +464,7 @@ }, { "cell_type": "code", - "execution_count": 16, + "execution_count": 17, "metadata": {}, "outputs": [ { @@ -449,7 +473,7 @@ "437" ] }, - "execution_count": 16, + "execution_count": 17, "metadata": {}, "output_type": "execute_result" } @@ -478,7 +502,7 @@ }, { "cell_type": "code", - "execution_count": 39, + "execution_count": 20, "metadata": {}, "outputs": [], "source": [ @@ -490,16 +514,16 @@ }, { "cell_type": "code", - "execution_count": 40, + "execution_count": 21, "metadata": {}, "outputs": [ { "data": { "text/plain": [ - "1076" + "1138" ] }, - "execution_count": 40, + "execution_count": 21, "metadata": {}, "output_type": "execute_result" } @@ -510,16 +534,16 @@ }, { "cell_type": "code", - "execution_count": 41, + "execution_count": 22, "metadata": {}, "outputs": [ { "data": { "text/plain": [ - "437" + "460" ] }, - "execution_count": 41, + "execution_count": 22, "metadata": {}, "output_type": "execute_result" } @@ -530,7 +554,7 @@ }, { "cell_type": "code", - "execution_count": 42, + "execution_count": 23, "metadata": {}, "outputs": [], "source": [ @@ -539,7 +563,7 @@ }, { "cell_type": "code", - "execution_count": 43, + "execution_count": 24, "metadata": {}, "outputs": [ { @@ -548,7 +572,7 @@ "779" ] }, - "execution_count": 43, + "execution_count": 24, "metadata": {}, "output_type": "execute_result" } @@ -559,7 +583,7 @@ }, { "cell_type": "code", - "execution_count": 44, + "execution_count": 25, "metadata": {}, "outputs": [ { @@ -568,7 +592,7 @@ "779" ] }, - "execution_count": 44, + "execution_count": 25, "metadata": {}, "output_type": "execute_result" } @@ -579,7 +603,7 @@ }, { "cell_type": "code", - "execution_count": 45, + "execution_count": 26, "metadata": {}, "outputs": [], "source": [ @@ -589,16 +613,16 @@ }, { "cell_type": "code", - "execution_count": 46, + "execution_count": 27, "metadata": {}, "outputs": [ { "data": { "text/plain": [ - "1855" + "1917" ] }, - "execution_count": 46, + "execution_count": 27, "metadata": {}, "output_type": "execute_result" } @@ -609,7 +633,7 @@ }, { "cell_type": "code", - "execution_count": 48, + "execution_count": 28, "metadata": {}, "outputs": [ { @@ -618,7 +642,7 @@ "-189" ] }, - "execution_count": 48, + "execution_count": 28, "metadata": {}, "output_type": "execute_result" } diff --git a/modules/TempNB/IngestDrugSynonyms.py b/modules/TempNB/IngestDrugSynonyms.py index cfedfd3..d9190d8 100644 --- a/modules/TempNB/IngestDrugSynonyms.py +++ b/modules/TempNB/IngestDrugSynonyms.py @@ -101,7 +101,14 @@ def scrapeData(self): def filterData(self): self.drug_vocab_reduced = self.drug_vocab_df[['Common name', 'Synonyms']] - self.internationalstudies_reduced = self.internationalstudies[['TrialID', 'Intervention','Study type']] + self.internationalstudies_reduced = self.internationalstudies[['TrialID', 'Intervention','Study type','web address','Target size', "Public title"]] + self.internationalstudies_reduced.columns = [col.replace(" ","_").lower() for col in self.internationalstudies_reduced.columns] + cols_to_replace:dict = { + "trialid":"trial_id", + "web_address":"study_url" + } + self.internationalstudies_reduced.columns = [[cols_to_replace.get(n, n) for n in self.internationalstudies_reduced.columns]] + self.drug_vocab:dict = {} for index, row in self.drug_vocab_reduced.iterrows(): self.drug_vocab[row['Common name']] = row["Synonyms"].split("|") if isinstance(row["Synonyms"],str) else row["Synonyms"] @@ -110,6 +117,6 @@ def saveDataToFile(self): """Saving data option for debug purposes""" print("Only Use it for debug purposes") self.internationalstudies.to_csv("internationalstudies.csv") - self.drug_vocab.to_csv("drug_vocab.csv") + self.drug_vocab_df.to_csv("drug_vocab.csv") with open('all_US_studies_by_keyword.json', 'w', encoding='utf-8') as f: json.dump(self.all_US_studies_by_keyword, f, ensure_ascii=False, indent=4) From 1567927435c025932bfdc98f56c4a725279a6b2a Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Thu, 9 Apr 2020 14:14:33 +1000 Subject: [PATCH 40/47] studies normalized into one table from 2 different sources --- modules/TempNB/IngestDrugSynonyms.py | 2 +- 1 file changed, 1 insertion(+), 1 deletion(-) diff --git a/modules/TempNB/IngestDrugSynonyms.py b/modules/TempNB/IngestDrugSynonyms.py index d9190d8..67ffb96 100644 --- a/modules/TempNB/IngestDrugSynonyms.py +++ b/modules/TempNB/IngestDrugSynonyms.py @@ -107,7 +107,7 @@ def filterData(self): "trialid":"trial_id", "web_address":"study_url" } - self.internationalstudies_reduced.columns = [[cols_to_replace.get(n, n) for n in self.internationalstudies_reduced.columns]] + self.internationalstudies_reduced.columns = [cols_to_replace.get(n, n) for n in self.internationalstudies_reduced.columns] self.drug_vocab:dict = {} for index, row in self.drug_vocab_reduced.iterrows(): From 98c9e193bc1064420218dd2b16d6373f77df0277 Mon Sep 17 00:00:00 2001 From: Dave Date: Wed, 8 Apr 2020 20:39:29 -0800 Subject: [PATCH 41/47] #39 - Added method to allow for adding enrichment properties to a node --- modules/Neo4jDataAccess.py | 42 +++++++++++++++++++++--- modules/tests/test_Neo4jDataAccess.py | 47 +++++++++++++++++++++++++-- 2 files changed, 83 insertions(+), 6 deletions(-) diff --git a/modules/Neo4jDataAccess.py b/modules/Neo4jDataAccess.py index 3b3c338..f83281f 100644 --- a/modules/Neo4jDataAccess.py +++ b/modules/Neo4jDataAccess.py @@ -2,6 +2,7 @@ import json import time import re +import enum from datetime import datetime import pandas as pd @@ -15,6 +16,18 @@ class Neo4jDataAccess: + class NodeLabel(enum.Enum): + Tweet = 'Tweet' + Url = 'Url' + Account = 'Account' + + class RelationshipLabel(enum.Enum): + TWEETED = 'TWEETED' + MENTIONED = 'MENTIONED' + QUOTED = 'QUOTED' + REPLIED = 'REPLIED' + RETWEETED = 'RETWEETED' + INCLUDES = 'INCLUDES' def __init__(self, debug=False, neo4j_creds=None, batch_size=2000, timeout="60s"): self.creds = neo4j_creds @@ -201,8 +214,7 @@ def get_from_neo(self, cypher, limit=1000): with graph.session() as session: result = session.run(cypher, timeout=self.timeout) df = pd.DataFrame([dict(record) for record in result]) - rdf = df.head(limit) - return rdf + return df.head(limit) def get_tweet_by_id(self, df, cols=[]): if 'id' in df: @@ -228,10 +240,32 @@ def get_tweet_by_id(self, df, cols=[]): pdf = pdf.append(props, ignore_index=True) return pdf else: - logging.debug('df columns %s', df.columns) - raise Exception( + raise TypeError( 'Parameter df must be a DataFrame with a column named "id" ') + def save_enrichment_df_to_graph(self, label: NodeLabel, df: pd.DataFrame, job_name: str, job_id=None): + if not isinstance(label, self.NodeLabel): + raise TypeError('The label parameter is not of type NodeType') + + if not isinstance(df, pd.DataFrame): + raise TypeError( + 'The df parameter is not of type Pandas.DataFrame') + + idColName = 'full_url' if label == self.NodeLabel.Url else 'id' + statement = 'UNWIND $rows AS t' + statement += ' MERGE (n:' + label.value + \ + ' {' + idColName + ':t.' + idColName + '}) ' + \ + ' SET ' + + for column in df: + if not column == idColName: + statement += f' n.{column} = t.{column} ' + + graph = self.__get_neo4j_graph('writer') + with graph.session() as session: + result = session.run( + statement, rows=df.to_dict(orient='records'), timeout=self.timeout) + def save_parquet_df_to_graph(self, df, job_name, job_id=None): pdf = DfHelper().normalize_parquet_dataframe(df) logging.info('Saving to Neo4j') diff --git a/modules/tests/test_Neo4jDataAccess.py b/modules/tests/test_Neo4jDataAccess.py index d3dc285..aba8a83 100644 --- a/modules/tests/test_Neo4jDataAccess.py +++ b/modules/tests/test_Neo4jDataAccess.py @@ -39,7 +39,7 @@ def setup_class(cls): traversal = '''UNWIND $tweets AS t MERGE (tweet:Tweet {id:t.tweet_id}) - ON CREATE SET + ON CREATE SET tweet.text = t.text, tweet.hydrated = t.hydrated ''' @@ -76,7 +76,7 @@ def test_save_parquet_to_graph(self): # Test get_tweet_by_id def test_get_tweet_by_id(self): - df = pd.DataFrame([{"id": 1}]) + df = pd.DataFrame([{'id': 1}]) df = Neo4jDataAccess( neo4j_creds=self.creds).get_tweet_by_id(df) assert len(df) == 1 @@ -93,6 +93,12 @@ def test_get_tweet_by_id_with_cols(self): assert df.at[0, 'id'] == 1 assert df.at[0, 'text'] == 'Tweet 1' + def test_get_tweet_by_id_wrong_parameter(self): + with pytest.raises(TypeError) as excinfo: + df = Neo4jDataAccess( + neo4j_creds=self.creds).get_tweet_by_id('test') + assert "df" in str(excinfo.value) + def test_get_from_neo(self): df = Neo4jDataAccess(neo4j_creds=self.creds).get_from_neo( 'MATCH (n:Tweet) WHERE n.hydrated=\'FULL\' RETURN n.id, n.text LIMIT 5') @@ -111,6 +117,43 @@ def test_get_from_neo_with_limit_only(self): assert len(df) == 1 assert len(df.columns) == 2 + def test_save_enrichment_df_to_graph_wrong_parameter_types(self): + with pytest.raises(TypeError) as excinfo: + res = Neo4jDataAccess(neo4j_creds=self.creds).save_enrichment_df_to_graph( + 'test', pd.DataFrame(), 'test') + assert "label parameter" in str(excinfo.value) + with pytest.raises(TypeError) as excinfo: + res = Neo4jDataAccess(neo4j_creds=self.creds).save_enrichment_df_to_graph( + Neo4jDataAccess.NodeLabel.Tweet, [], 'test') + assert "Pandas.DataFrame" in str(excinfo.value) + + def test_save_enrichment_df_to_graph(self): + df = pd.DataFrame([{'id': 111, 'text': 'Tweet 123'}, + {'id': 222, 'text': 'Tweet 234'} + ]) + + res = Neo4jDataAccess(neo4j_creds=self.creds).save_enrichment_df_to_graph( + Neo4jDataAccess.NodeLabel.Tweet, df, 'test') + + df = Neo4jDataAccess(neo4j_creds=self.creds).get_tweet_by_id( + df['id'].to_frame()) + assert len(df) == 2 + assert df.at[0, 'text'] == 'Tweet 123' + assert df.at[1, 'text'] == 'Tweet 234' + + def test_save_enrichment_df_to_graph_new_nodes(self): + df = pd.DataFrame([{'id': 555, 'text': 'Tweet 123'}, + {'id': 666, 'text': 'Tweet 234'} + ]) + Neo4jDataAccess(neo4j_creds=self.creds).save_enrichment_df_to_graph( + Neo4jDataAccess.NodeLabel.Tweet, df, 'test') + + df = Neo4jDataAccess(neo4j_creds=self.creds).get_tweet_by_id( + df['id'].to_frame()) + assert len(df) == 2 + assert df.at[0, 'text'] == 'Tweet 123' + assert df.at[1, 'text'] == 'Tweet 234' + def setup_cleanup(self): print("I want to perfrom some cleanup action!") From 2a9afb0d746e2947810167fbf728a4bc79b8fa95 Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Thu, 9 Apr 2020 16:27:30 +1000 Subject: [PATCH 42/47] studies to neo4j is done --- modules/TempNB/DrugSynonymDataToNeo4j.py | 25 ++++++++- modules/TempNB/IngestDrugSynonyms.py | 69 ++++++++++++++++++++---- modules/TempNB/IngestDrugSynonymsWF.py | 5 +- 3 files changed, 84 insertions(+), 15 deletions(-) diff --git a/modules/TempNB/DrugSynonymDataToNeo4j.py b/modules/TempNB/DrugSynonymDataToNeo4j.py index d090282..d47e75e 100644 --- a/modules/TempNB/DrugSynonymDataToNeo4j.py +++ b/modules/TempNB/DrugSynonymDataToNeo4j.py @@ -1,5 +1,7 @@ from neo4j import GraphDatabase from typing import Optional +from pandas import DataFrame +from numpy import isnan import logging logging.basicConfig(format='%(asctime)s - %(message)s', level=logging.INFO) logger = logging.getLogger('ds-neo4j') @@ -10,7 +12,9 @@ def property_type_checker(property_value): if isinstance(property_value,int) or isinstance(property_value,float): pass elif isinstance(property_value,str): - property_value = '''"''' + property_value + '''"''' + property_value = '''"''' + property_value.replace('"',r"\"") + '''"''' + elif not property_value: + property_value = "" return property_value resp:str = "" @@ -31,7 +35,26 @@ def __init__(self, uri="bolt://localhost:7687", user="neo4j", password="letmein" def close(self): self._driver.close() + + def upload_studies(self,studies:DataFrame): + node_merging_func = self._merge_node + with self._driver.session() as session: + logger.info("> Importing Studies Job is Started") + count_node = 0 + prev_count_node = 0 + + for study in studies.T.to_dict().values(): + node_type = "Study" + properties:dict = study + session.write_transaction(node_merging_func, node_type, properties) + count_node += 1 + if count_node > prev_count_node + 100: + prev_count_node = count_node + logger.info("> {} nodes already imported".format(count_node)) + + logger.info("> Importing Studies Job is >> Done << with {} nodes imported".format(count_node)) + def upload_drugs_and_synonyms(self,drug_vocab): node_merging_func = self._merge_node edge_merging_func = self._merge_edge diff --git a/modules/TempNB/IngestDrugSynonyms.py b/modules/TempNB/IngestDrugSynonyms.py index 67ffb96..389055d 100644 --- a/modules/TempNB/IngestDrugSynonyms.py +++ b/modules/TempNB/IngestDrugSynonyms.py @@ -38,25 +38,25 @@ def api(query,from_study,to_study,url): response = requests.request("GET", url) return response.json() - def apiWrapper(self,query,from_study): + def api_wrapper(self,query,from_study): return self.api(query,from_study,from_study+99,self.url_USA) def getAllStudiesByQuery(self,query:str) -> list: studies:list = [] from_study = 1 - temp = self.apiWrapper(query,from_study) + temp = self.api_wrapper(query,from_study) nstudies = temp['FullStudiesResponse']['NStudiesFound'] logger.info("> {} studies found by '{}' keyword".format(nstudies,query)) if nstudies > 0: studies = temp['FullStudiesResponse']['FullStudies'] for study_index in range(from_study+100,nstudies,100): - temp = self.apiWrapper(query,study_index) + temp = self.api_wrapper(query,study_index) studies.extend(temp['FullStudiesResponse']['FullStudies']) return studies @staticmethod - def xlsHandler(r): + def xls_handler(r): df = pd.DataFrame() with tempfile.NamedTemporaryFile("wb") as xls_file: xls_file.write(r.content) @@ -79,7 +79,7 @@ def xlsHandler(r): return df @staticmethod - def csvZipHandler(r): + def csvzip_handler(r): df = pd.DataFrame() with tempfile.NamedTemporaryFile("wb",suffix='.csv.zip') as file: file.write(r.content) @@ -92,14 +92,47 @@ def urlToDF(url:str,respHandler) -> pd.DataFrame: r = requests.get(url, allow_redirects=True) return respHandler(r) - def scrapeData(self): - self.internationalstudies = self.urlToDF(self.url_international,self.xlsHandler) - self.drug_vocab_df = self.urlToDF(self.url_drugbank,self.csvZipHandler) + @staticmethod + def _convert_US_studies(US_studies:dict) -> pd.DataFrame: + list_of_US_studies:list = [] + for key in US_studies.keys(): + for study in US_studies[key]: + temp_dict:dict = {} + + temp_dict["trial_id"] = study["Study"]["ProtocolSection"]["IdentificationModule"]["NCTId"] + temp_dict["study_url"] = "https://clinicaltrials.gov/show/" + temp_dict["trial_id"] + + try: + temp_dict["intervention"] = study["Study"]["ProtocolSection"]["ArmsInterventionsModule"]["ArmGroupList"]["ArmGroup"][0]["ArmGroupInterventionList"]["ArmGroupInterventionName"][0] + except: + temp_dict["intervention"] = "" + try: + temp_dict["study_type"] = study["Study"]["ProtocolSection"]["DesignModule"]["StudyType"] + except: + temp_dict["study_type"] = "" + try: + temp_dict["target_size"] = study["Study"]["ProtocolSection"]["DesignModule"]["EnrollmentInfo"]["EnrollmentCount"] + except: + temp_dict["target_size"] = "" + try: + if "OfficialTitle" in study["Study"]["ProtocolSection"]["IdentificationModule"].keys(): + temp_dict["public_title"] = study["Study"]["ProtocolSection"]["IdentificationModule"]["OfficialTitle"] + else: + temp_dict["public_title"] = study["Study"]["ProtocolSection"]["IdentificationModule"]["BriefTitle"] + except: + temp_dict["public_title"] = "" + list_of_US_studies.append(temp_dict) + US_studies_df:pd.DataFrame = pd.DataFrame(list_of_US_studies) + return US_studies_df + + def _scrapeData(self): + self.internationalstudies = self.urlToDF(self.url_international,self.xls_handler) + self.drug_vocab_df = self.urlToDF(self.url_drugbank,self.csvzip_handler) self.all_US_studies_by_keyword:dict = {} for key in self.query_keywords: self.all_US_studies_by_keyword[key] = self.getAllStudiesByQuery(key) - def filterData(self): + def _filterData(self): self.drug_vocab_reduced = self.drug_vocab_df[['Common name', 'Synonyms']] self.internationalstudies_reduced = self.internationalstudies[['TrialID', 'Intervention','Study type','web address','Target size', "Public title"]] self.internationalstudies_reduced.columns = [col.replace(" ","_").lower() for col in self.internationalstudies_reduced.columns] @@ -113,10 +146,24 @@ def filterData(self): for index, row in self.drug_vocab_reduced.iterrows(): self.drug_vocab[row['Common name']] = row["Synonyms"].split("|") if isinstance(row["Synonyms"],str) else row["Synonyms"] - def saveDataToFile(self): + self.US_studies_df = self._convert_US_studies(self.all_US_studies_by_keyword) + + self.all_studies_df = pd.concat([self.US_studies_df,self.internationalstudies_reduced]) + self.all_studies_df.drop_duplicates(subset="trial_id",inplace=True) + self.all_studies_df.fillna("",inplace=True) + logger.info("> {} distinct studies found".format(len(self.all_studies_df))) + + def save_data_to_fiile(self): """Saving data option for debug purposes""" - print("Only Use it for debug purposes") + logger.warning("Only Use it for debug purposes!!!") self.internationalstudies.to_csv("internationalstudies.csv") self.drug_vocab_df.to_csv("drug_vocab.csv") with open('all_US_studies_by_keyword.json', 'w', encoding='utf-8') as f: json.dump(self.all_US_studies_by_keyword, f, ensure_ascii=False, indent=4) + + def auto_get_and_clean_data(self): + self._scrapeData() + self._filterData() + + def create_drug_study_link(self): + pass \ No newline at end of file diff --git a/modules/TempNB/IngestDrugSynonymsWF.py b/modules/TempNB/IngestDrugSynonymsWF.py index b71c6d6..a99f2e1 100644 --- a/modules/TempNB/IngestDrugSynonymsWF.py +++ b/modules/TempNB/IngestDrugSynonymsWF.py @@ -3,8 +3,7 @@ from DrugSynonymDataToNeo4j import DrugSynonymDataToNeo4j drugSynonym = IngestDrugSynonyms() -drugSynonym.scrapeData() -drugSynonym.filterData() +drugSynonym.auto_get_and_clean_data() neo4jBridge = DrugSynonymDataToNeo4j() -neo4jBridge.upload_drugs_and_synonyms(drugSynonym.drug_vocab) \ No newline at end of file +# neo4jBridge.upload_drugs_and_synonyms(drugSynonym.drug_vocab) \ No newline at end of file From 4c17c8c75177e5f6b77e591cee2ff154872dac6a Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Thu, 9 Apr 2020 16:42:31 +1000 Subject: [PATCH 43/47] WF --- modules/TempNB/IngestDrugSynonyms.py | 13 ++++++++++--- modules/TempNB/IngestDrugSynonymsWF.py | 3 ++- 2 files changed, 12 insertions(+), 4 deletions(-) diff --git a/modules/TempNB/IngestDrugSynonyms.py b/modules/TempNB/IngestDrugSynonyms.py index 389055d..4b182a4 100644 --- a/modules/TempNB/IngestDrugSynonyms.py +++ b/modules/TempNB/IngestDrugSynonyms.py @@ -18,19 +18,26 @@ class IngestDrugSynonyms(): def __init__(self,configPath:Path=Path("config.json")): - self.checkConfig(configPath) + self.check_config(configPath) self.url_international:str = os.environ["URL_INT"] if isinstance(os.environ["URL_INT"],str) else None self.url_USA:str = os.environ["URL_USA"] if isinstance(os.environ["URL_USA"],str) else None self.url_drugbank:str = os.environ["URL_DRUGBANK"] if isinstance(os.environ["URL_DRUGBANK"],str) else None self.query_keywords:[] = os.environ["QUERY_KEYWORDS"].split(",") if isinstance(os.environ["QUERY_KEYWORDS"],str) else None @staticmethod - def checkConfig(configPath:Path=Path("config.json")): - if configPath.exists: + def check_config(configPath:Path=Path("config.json")): + def load_config(configPath:Path): with open(configPath) as f: config = json.load(f) for key in config: os.environ[key] = config[key] + rel_path:Path = Path(os.path.realpath(__file__)).parents[0] / configPath + if rel_path.exists: + load_config(rel_path) + elif configPath.exists: + load_config(configPath) + else: + logger.warning("Could not load config file from: {}".format(configPath)) @staticmethod def api(query,from_study,to_study,url): diff --git a/modules/TempNB/IngestDrugSynonymsWF.py b/modules/TempNB/IngestDrugSynonymsWF.py index a99f2e1..2aa3664 100644 --- a/modules/TempNB/IngestDrugSynonymsWF.py +++ b/modules/TempNB/IngestDrugSynonymsWF.py @@ -6,4 +6,5 @@ drugSynonym.auto_get_and_clean_data() neo4jBridge = DrugSynonymDataToNeo4j() -# neo4jBridge.upload_drugs_and_synonyms(drugSynonym.drug_vocab) \ No newline at end of file +neo4jBridge.upload_drugs_and_synonyms(drugSynonym.drug_vocab) +neo4jBridge.upload_studies(drugSynonym.all_studies_df) \ No newline at end of file From 6c4bc2bdac66c433e16764011f52f4114ca0c49b Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Thu, 9 Apr 2020 17:23:36 +1000 Subject: [PATCH 44/47] study import fix --- modules/TempNB/IngestDrugSynonyms.py | 3 +++ 1 file changed, 3 insertions(+) diff --git a/modules/TempNB/IngestDrugSynonyms.py b/modules/TempNB/IngestDrugSynonyms.py index 4b182a4..30976bb 100644 --- a/modules/TempNB/IngestDrugSynonyms.py +++ b/modules/TempNB/IngestDrugSynonyms.py @@ -156,7 +156,10 @@ def _filterData(self): self.US_studies_df = self._convert_US_studies(self.all_US_studies_by_keyword) self.all_studies_df = pd.concat([self.US_studies_df,self.internationalstudies_reduced]) + print(len(self.all_studies_df)) self.all_studies_df.drop_duplicates(subset="trial_id",inplace=True) + print(len(self.all_studies_df)) + self.all_studies_df.reset_index(drop=True, inplace=True) self.all_studies_df.fillna("",inplace=True) logger.info("> {} distinct studies found".format(len(self.all_studies_df))) From 46fdf2b0ba1ed6122697a294fe701786fd7a65f0 Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Thu, 9 Apr 2020 18:18:49 +1000 Subject: [PATCH 45/47] drug-study links --- modules/TempNB/IngestDrugSynonyms.ipynb | 582 +++--------------------- modules/TempNB/IngestDrugSynonyms.py | 2 - 2 files changed, 68 insertions(+), 516 deletions(-) diff --git a/modules/TempNB/IngestDrugSynonyms.ipynb b/modules/TempNB/IngestDrugSynonyms.ipynb index 9cba3ae..4e79e74 100644 --- a/modules/TempNB/IngestDrugSynonyms.ipynb +++ b/modules/TempNB/IngestDrugSynonyms.ipynb @@ -2,17 +2,16 @@ "cells": [ { "cell_type": "code", - "execution_count": 2, + "execution_count": 1, "metadata": {}, "outputs": [], "source": [ - "\n", "from IngestDrugSynonyms import IngestDrugSynonyms" ] }, { "cell_type": "code", - "execution_count": 3, + "execution_count": 2, "metadata": {}, "outputs": [], "source": [ @@ -21,7 +20,7 @@ }, { "cell_type": "code", - "execution_count": 4, + "execution_count": 3, "metadata": {}, "outputs": [], "source": [ @@ -31,7 +30,7 @@ }, { "cell_type": "code", - "execution_count": 5, + "execution_count": 4, "metadata": {}, "outputs": [ { @@ -59,14 +58,13 @@ "from IPython.core.display import display, HTML\n", "display(HTML(\"\"))\n", "pd.set_option('display.max_colwidth', -1)\n", - "pd.set_option('display.max_rows', 500)\n", "pd.set_option('display.max_columns', 500)\n", "pd.set_option('display.width', 1000)" ] }, { "cell_type": "code", - "execution_count": 6, + "execution_count": 5, "metadata": {}, "outputs": [], "source": [ @@ -75,588 +73,144 @@ }, { "cell_type": "code", - "execution_count": 7, + "execution_count": 8, "metadata": {}, "outputs": [ { "name": "stderr", "output_type": "stream", "text": [ - "2020-04-09 09:45:16,809 - > 403 studies found by 'covid-19' keyword\n", - "2020-04-09 09:45:32,147 - > 403 studies found by 'SARS-CoV-2' keyword\n", - "2020-04-09 09:45:47,940 - > 332 studies found by 'coronavirus' keyword\n" + "2020-04-09 17:57:44,679 - > 403 studies found by 'covid-19' keyword\n", + "2020-04-09 17:58:07,131 - > 403 studies found by 'SARS-CoV-2' keyword\n", + "2020-04-09 17:58:29,969 - > 332 studies found by 'coronavirus' keyword\n", + "2020-04-09 17:58:46,243 - > 1050 distinct studies found\n" ] } ], "source": [ - "drugSynonym.scrapeData()" + "drugSynonym.auto_get_and_clean_data()" ] }, { "cell_type": "code", - "execution_count": 8, + "execution_count": 11, "metadata": {}, "outputs": [], "source": [ - "drugSynonym.filterData()" - ] - }, - { - "cell_type": "code", - "execution_count": 9, - "metadata": {}, - "outputs": [ - { - "data": { - "text/html": [ - "
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Common nameSynonyms
0LepirudinHirudin variant-1 | Lepirudin recombinant
1CetuximabCetuximab | Cétuximab | Cetuximabum | Immunoglobulin G 1 (human-mouse monoclonal C 225 gamma 1 - chain anti-human epidermal growt factor receptor), disulfide wit human-mouse monoclonal C 225 kappa - chain, dimer
2Dornase alfaDeoxyribonuclease (human clone 18-1 protein moiety) | Dornasa alfa | Dornase alfa, recombinant | Dornase alpha | Recombinant deoxyribonuclease (DNAse)
3Denileukin diftitoxDenileukin | Interleukin-2/diptheria toxin fusion protein
4EtanerceptEtanercept | etanercept-szzs | etanercept-ykro | Recombinant human TNF | rhu TNFR:Fc | rhu-TNFR:Fc | TNFR-Immunoadhesin
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" - ], - "text/plain": [ - " Common name Synonyms\n", - "0 Lepirudin Hirudin variant-1 | Lepirudin recombinant \n", - "1 Cetuximab Cetuximab | Cétuximab | Cetuximabum | Immunoglobulin G 1 (human-mouse monoclonal C 225 gamma 1 - chain anti-human epidermal growt factor receptor), disulfide wit human-mouse monoclonal C 225 kappa - chain, dimer\n", - "2 Dornase alfa Deoxyribonuclease (human clone 18-1 protein moiety) | Dornasa alfa | Dornase alfa, recombinant | Dornase alpha | Recombinant deoxyribonuclease (DNAse) \n", - "3 Denileukin diftitox Denileukin | Interleukin-2/diptheria toxin fusion protein \n", - "4 Etanercept Etanercept | etanercept-szzs | etanercept-ykro | Recombinant human TNF | rhu TNFR:Fc | rhu-TNFR:Fc | TNFR-Immunoadhesin " - ] - }, - "execution_count": 9, - "metadata": {}, - "output_type": "execute_result" - } - ], - "source": [ - "drugSynonym.drug_vocab_reduced.head()" - ] - }, - { - "cell_type": "code", - "execution_count": 10, - "metadata": {}, - "outputs": [ - { - "data": { - "text/plain": [ - "13475" - ] - }, - "execution_count": 10, - "metadata": {}, - "output_type": "execute_result" - } - ], - "source": [ - "len(drugSynonym.drug_vocab)" + "drug_vocab = drugSynonym.drug_vocab\n", + "drugs_and_syms:list = list(drug_vocab.keys())\n", + "\n", + "drugs_and_syms.extend( item for key in drug_vocab.keys() if isinstance(drug_vocab[key],list) for item in drug_vocab[key])" ] }, { "cell_type": "code", - "execution_count": 11, + "execution_count": 12, "metadata": {}, "outputs": [ { "data": { "text/plain": [ - "Index(['TrialID', 'Last Refreshed on', 'Public title', 'Scientific title', 'Acronym', 'Primary sponsor', 'Date registration', 'Date registration3', 'Export date', 'Source Register', 'web address', 'Recruitment Status', 'other records', 'Inclusion agemin', 'Inclusion agemax', 'Inclusion gender', 'Date enrollement', 'Target size', 'Study type', 'Study design', 'Phase', 'Countries', 'Contact Firstname', 'Contact Lastname', 'Contact Address', 'Contact Email', 'Contact Tel', 'Contact Affiliation', 'Inclusion Criteria', 'Exclusion Criteria', 'Condition', 'Intervention', 'Primary outcome', 'results date posted', 'results date completed', 'results url link', 'Retrospective flag', 'Bridging flag truefalse', 'Bridged type', 'results yes no'], dtype='object')" + "39481" ] }, - "execution_count": 11, + "execution_count": 12, "metadata": {}, "output_type": "execute_result" } ], "source": [ - "drugSynonym.internationalstudies.columns" + "len(drugs_and_syms)" ] }, { "cell_type": "code", - "execution_count": 31, + "execution_count": null, "metadata": {}, "outputs": [], "source": [ - "internationalstudies = drugSynonym.internationalstudies[['TrialID', 'Intervention','Study type','web address','Target size','results url link']]" + "import time" ] }, { "cell_type": "code", - "execution_count": 32, - "metadata": {}, - "outputs": [ - { - "data": { - "text/html": [ - "
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TrialIDInterventionStudy typeweb addressTarget sizeresults url link
0ChiCTR2000029953survival group:none;died:none;Observational studyhttp://www.chictr.org.cn/showproj.aspx?proj=49217survival group:200;died:200;NaN
1ChiCTR2000029935Case series:Treated with conventional treatment combined with Chloroquine Phosphate;Interventional studyhttp://www.chictr.org.cn/showproj.aspx?proj=49607Case series:100;NaN
2ChiCTR2000029850experimental group:standardized comprehensive treatment combined with convalescent plasma treatment;control group:standardized comprehensive treatment;Interventional studyhttp://www.chictr.org.cn/showproj.aspx?proj=49533experimental group:10;control group:10;NaN
3ChiCTR2000029814control group:Western Medicine;experimental group:Integrated Traditional Chinese and Western Medicine;Interventional studyhttp://www.chictr.org.cn/showproj.aspx?proj=49387control group:15;experimental group:15;NaN
4NCT04245631Diagnostic Test: Recombinase aided amplification (RAA) assayObservationalhttps://clinicaltrials.gov/show/NCT0424563150.0NaN
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" - ], - "text/plain": [ - " TrialID Intervention Study type web address Target size results url link\n", - "0 ChiCTR2000029953 survival group:none;died:none; Observational study http://www.chictr.org.cn/showproj.aspx?proj=49217 survival group:200;died:200; NaN \n", - "1 ChiCTR2000029935 Case series:Treated with conventional treatment combined with Chloroquine Phosphate; Interventional study http://www.chictr.org.cn/showproj.aspx?proj=49607 Case series:100; NaN \n", - "2 ChiCTR2000029850 experimental group:standardized comprehensive treatment combined with convalescent plasma treatment;control group:standardized comprehensive treatment; Interventional study http://www.chictr.org.cn/showproj.aspx?proj=49533 experimental group:10;control group:10; NaN \n", - "3 ChiCTR2000029814 control group:Western Medicine;experimental group:Integrated Traditional Chinese and Western Medicine; Interventional study http://www.chictr.org.cn/showproj.aspx?proj=49387 control group:15;experimental group:15; NaN \n", - "4 NCT04245631 Diagnostic Test: Recombinase aided amplification (RAA) assay Observational https://clinicaltrials.gov/show/NCT04245631 50.0 NaN " - ] - }, - "execution_count": 32, - "metadata": {}, - "output_type": "execute_result" - } - ], - "source": [ - "internationalstudies.head()" - ] - }, - { - "cell_type": "code", - "execution_count": 14, + "execution_count": null, "metadata": {}, "outputs": [ { - "name": "stderr", + "name": "stdout", "output_type": "stream", "text": [ - "/home/ben/Projects/Graphs4GoodHackathon/ProjectDomino/.Domino/lib/python3.7/site-packages/pandas/core/indexing.py:1048: SettingWithCopyWarning: \n", - "A value is trying to be set on a copy of a slice from a DataFrame.\n", - "Try using .loc[row_indexer,col_indexer] = value instead\n", - "\n", - "See the caveats in the documentation: https://pandas.pydata.org/pandas-docs/stable/user_guide/indexing.html#returning-a-view-versus-a-copy\n", - " self.obj[item_labels[indexer[info_axis]]] = value\n" + "1586419734.402499\n", + "1586419818.246048\n", + "83.84361219406128\n", + "1586419901.5618382\n", + "167.15940022468567\n", + "1586419985.5537164\n", + "251.15127801895142\n", + "1586420069.5865138\n", + "335.1840934753418\n", + "1586420153.0173287\n", + "418.61490273475647\n", + "1586420235.5331979\n", + "501.13076305389404\n", + "1586420318.3730078\n", + "583.9705700874329\n" ] - }, - { - "data": { - "text/html": [ - "
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TrialIDInterventionStudy typeweb address
0ChiCTR2000029953survival group:none;died:none;observational studyhttp://www.chictr.org.cn/showproj.aspx?proj=49217
1ChiCTR2000029935Case series:Treated with conventional treatment combined with Chloroquine Phosphate;interventional studyhttp://www.chictr.org.cn/showproj.aspx?proj=49607
2ChiCTR2000029850experimental group:standardized comprehensive treatment combined with convalescent plasma treatment;control group:standardized comprehensive treatment;interventional studyhttp://www.chictr.org.cn/showproj.aspx?proj=49533
3ChiCTR2000029814control group:Western Medicine;experimental group:Integrated Traditional Chinese and Western Medicine;interventional studyhttp://www.chictr.org.cn/showproj.aspx?proj=49387
4NCT04245631Diagnostic Test: Recombinase aided amplification (RAA) assayobservationalhttps://clinicaltrials.gov/show/NCT04245631
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" - ], - "text/plain": [ - " TrialID Intervention Study type web address\n", - "0 ChiCTR2000029953 survival group:none;died:none; observational study http://www.chictr.org.cn/showproj.aspx?proj=49217\n", - "1 ChiCTR2000029935 Case series:Treated with conventional treatment combined with Chloroquine Phosphate; interventional study http://www.chictr.org.cn/showproj.aspx?proj=49607\n", - "2 ChiCTR2000029850 experimental group:standardized comprehensive treatment combined with convalescent plasma treatment;control group:standardized comprehensive treatment; interventional study http://www.chictr.org.cn/showproj.aspx?proj=49533\n", - "3 ChiCTR2000029814 control group:Western Medicine;experimental group:Integrated Traditional Chinese and Western Medicine; interventional study http://www.chictr.org.cn/showproj.aspx?proj=49387\n", - "4 NCT04245631 Diagnostic Test: Recombinase aided amplification (RAA) assay observational https://clinicaltrials.gov/show/NCT04245631 " - ] - }, - "execution_count": 14, - "metadata": {}, - "output_type": "execute_result" } ], "source": [ - "internationalstudies.loc[:,'Study type'] = internationalstudies['Study type'].str.lower()\n", - "internationalstudies.head()" + "studies = drugSynonym.all_studies_df\n", + "appeared_in_edges:list = []\n", + "start = time.time()\n", + "print(start)\n", + "count = 0\n", + "prev = 0\n", + "for drug in drugs_and_syms:\n", + " \n", + " for index,row in studies.iterrows():\n", + " if drug in row[\"intervention\"]:\n", + " appeared_in_edges.append((drug,row[\"trial_id\"]))\n", + " count += 1\n", + " if count > prev + 1000:\n", + " print(time.time())\n", + " print(time.time() - start)\n", + " prev = count\n", + " \n", + "end = time.time()\n", + "print(end - start)\n", + "print(end)\n" ] }, { "cell_type": "code", - "execution_count": 15, - "metadata": {}, - "outputs": [ - { - "data": { - "text/plain": [ - "779" - ] - }, - "execution_count": 15, - "metadata": {}, - "output_type": "execute_result" - } - ], - "source": [ - "len(internationalstudies)" - ] - }, - { - "cell_type": "code", - "execution_count": 16, - "metadata": {}, - "outputs": [], - "source": [ - "filtered_int_studies = internationalstudies[internationalstudies['Study type'].str.contains(\"intervention\")]" - ] - }, - { - "cell_type": "code", - "execution_count": 17, - "metadata": {}, - "outputs": [ - { - "data": { - "text/plain": [ - "437" - ] - }, - "execution_count": 17, - "metadata": {}, - "output_type": "execute_result" - } - ], - "source": [ - "len(filtered_int_studies)" - ] - }, - { - "cell_type": "code", - "execution_count": 18, - "metadata": {}, - "outputs": [], - "source": [ - "remainig_int_studies = internationalstudies[internationalstudies['Study type'].str.contains(\"intervention\")]" - ] - }, - { - "cell_type": "code", - "execution_count": 19, - "metadata": {}, - "outputs": [], - "source": [ - "US_studies = drugSynonym.all_US_studies_by_keyword" - ] - }, - { - "cell_type": "code", - "execution_count": 20, + "execution_count": null, "metadata": {}, "outputs": [], "source": [ - "NCT_ids:list = []\n", - "for key in US_studies.keys():\n", - " for study in US_studies[key]:\n", - " NCT_ids.append(study[\"Study\"][\"ProtocolSection\"][\"IdentificationModule\"][\"NCTId\"])" - ] - }, - { - "cell_type": "code", - "execution_count": 21, - "metadata": {}, - "outputs": [ - { - "data": { - "text/plain": [ - "1138" - ] - }, - "execution_count": 21, - "metadata": {}, - "output_type": "execute_result" - } - ], - "source": [ - "len(NCT_ids)" + "start = time.time()\n", + "appeared_in_edges:list = [(drug,row[\"trial_id\"]) for drug in drugs_and_syms for index,row in studies.iterrows() if drug in row[\"intervention\"]]\n", + "end = time.time()\n", + "print(end - start)" ] }, { "cell_type": "code", - "execution_count": 22, - "metadata": {}, - "outputs": [ - { - "data": { - "text/plain": [ - "460" - ] - }, - "execution_count": 22, - "metadata": {}, - "output_type": "execute_result" - } - ], - "source": [ - "len(list(set(NCT_ids)))" - ] - }, - { - "cell_type": "code", - "execution_count": 23, + "execution_count": null, "metadata": {}, "outputs": [], "source": [ - "trial_ids:list = list(internationalstudies[\"TrialID\"])" - ] - }, - { - "cell_type": "code", - "execution_count": 24, - "metadata": {}, - "outputs": [ - { - "data": { - "text/plain": [ - "779" - ] - }, - "execution_count": 24, - "metadata": {}, - "output_type": "execute_result" - } - ], - "source": [ - "len(trial_ids)" - ] - }, - { - "cell_type": "code", - "execution_count": 25, - "metadata": {}, - "outputs": [ - { - "data": { - "text/plain": [ - "779" - ] - }, - "execution_count": 25, - "metadata": {}, - "output_type": "execute_result" - } - ], - "source": [ - "len(list(set(trial_ids)))" + "39481 * 83" ] }, { "cell_type": "code", - "execution_count": 26, + "execution_count": null, "metadata": {}, "outputs": [], "source": [ - "all_ids = trial_ids[:]\n", - "all_ids.extend(NCT_ids)" + "GPU?" ] - }, - { - "cell_type": "code", - "execution_count": 27, - "metadata": {}, - "outputs": [ - { - "data": { - "text/plain": [ - "1917" - ] - }, - "execution_count": 27, - "metadata": {}, - "output_type": "execute_result" - } - ], - "source": [ - "len(all_ids)" - ] - }, - { - "cell_type": "code", - "execution_count": 28, - "metadata": {}, - "outputs": [ - { - "data": { - "text/plain": [ - "-189" - ] - }, - "execution_count": 28, - "metadata": {}, - "output_type": "execute_result" - } - ], - "source": [ - "len(list(set(all_ids))) - (len(list(set(trial_ids))) + len(list(set(NCT_ids))))" - ] - }, - { - "cell_type": "code", - "execution_count": null, - "metadata": {}, - "outputs": [], - "source": [] } ], "metadata": { diff --git a/modules/TempNB/IngestDrugSynonyms.py b/modules/TempNB/IngestDrugSynonyms.py index 30976bb..24f75e2 100644 --- a/modules/TempNB/IngestDrugSynonyms.py +++ b/modules/TempNB/IngestDrugSynonyms.py @@ -156,9 +156,7 @@ def _filterData(self): self.US_studies_df = self._convert_US_studies(self.all_US_studies_by_keyword) self.all_studies_df = pd.concat([self.US_studies_df,self.internationalstudies_reduced]) - print(len(self.all_studies_df)) self.all_studies_df.drop_duplicates(subset="trial_id",inplace=True) - print(len(self.all_studies_df)) self.all_studies_df.reset_index(drop=True, inplace=True) self.all_studies_df.fillna("",inplace=True) logger.info("> {} distinct studies found".format(len(self.all_studies_df))) From 9aa0a1358e23de2c54800d59b8e8cba87d24c6fd Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Fri, 10 Apr 2020 09:28:10 +1000 Subject: [PATCH 46/47] cudf set up --- modules/TempNB/IngestDrugSynonyms.ipynb | 97 +++++++++++++++++++++++-- modules/TempNB/cudf_test.py | 3 + 2 files changed, 94 insertions(+), 6 deletions(-) create mode 100644 modules/TempNB/cudf_test.py diff --git a/modules/TempNB/IngestDrugSynonyms.ipynb b/modules/TempNB/IngestDrugSynonyms.ipynb index 4e79e74..8f38e1c 100644 --- a/modules/TempNB/IngestDrugSynonyms.ipynb +++ b/modules/TempNB/IngestDrugSynonyms.ipynb @@ -134,7 +134,7 @@ }, { "cell_type": "code", - "execution_count": null, + "execution_count": 20, "metadata": {}, "outputs": [ { @@ -155,7 +155,73 @@ "1586420235.5331979\n", "501.13076305389404\n", "1586420318.3730078\n", - "583.9705700874329\n" + "583.9705700874329\n", + "1586420401.3945472\n", + "666.9921083450317\n", + "1586420484.51531\n", + "750.1128664016724\n", + "1586420568.2253563\n", + "833.8229167461395\n", + "1586420651.7354705\n", + "917.3330311775208\n", + "1586420735.1248071\n", + "1000.7223672866821\n", + "1586420818.3368707\n", + "1083.9344317913055\n", + "1586420901.8185306\n", + "1167.4160959720612\n", + "1586420986.0851562\n", + "1251.6827161312103\n", + "1586421070.07279\n", + "1335.6703515052795\n", + "1586421153.7543426\n", + "1419.351904630661\n", + "1586421237.545393\n", + "1503.1429777145386\n", + "1586421320.8366966\n", + "1586.4342572689056\n", + "1586421404.006324\n", + "1669.6038839817047\n", + "1586421487.4593859\n", + "1753.0569460391998\n", + "1586421570.824374\n", + "1836.4219362735748\n", + "1586421654.610131\n", + "1920.20769405365\n", + "1586421737.9467065\n", + "2003.5442702770233\n", + "1586421821.3660948\n", + "2086.9636595249176\n", + "1586421906.288895\n", + "2171.886456489563\n", + "1586421991.4019985\n", + "2256.999561071396\n", + "1586422076.0194333\n", + "2341.6169979572296\n", + "1586422160.2064266\n", + "2425.8039889335632\n", + "1586422244.7931771\n", + "2510.390773296356\n", + "1586422329.1514266\n", + "2594.748988866806\n", + "1586422413.5586252\n", + "2679.156194448471\n", + "1586422497.0366716\n", + "2762.634252309799\n", + "1586422579.8006713\n", + "2845.39825296402\n", + "1586422662.2891464\n", + "2927.886730670929\n", + "1586422745.0294447\n", + "3010.6270241737366\n", + "1586422827.7157333\n", + "3093.313295841217\n", + "1586422910.6985836\n", + "3176.296145915985\n", + "1586422994.586706\n", + "3260.1842737197876\n", + "3297.177438735962\n", + "1586423031.5799377\n" ] } ], @@ -184,9 +250,17 @@ }, { "cell_type": "code", - "execution_count": null, + "execution_count": 21, "metadata": {}, - "outputs": [], + "outputs": [ + { + "name": "stdout", + "output_type": "stream", + "text": [ + "3269.469130039215\n" + ] + } + ], "source": [ "start = time.time()\n", "appeared_in_edges:list = [(drug,row[\"trial_id\"]) for drug in drugs_and_syms for index,row in studies.iterrows() if drug in row[\"intervention\"]]\n", @@ -196,9 +270,20 @@ }, { "cell_type": "code", - "execution_count": null, + "execution_count": 22, "metadata": {}, - "outputs": [], + "outputs": [ + { + "data": { + "text/plain": [ + "3276923" + ] + }, + "execution_count": 22, + "metadata": {}, + "output_type": "execute_result" + } + ], "source": [ "39481 * 83" ] diff --git a/modules/TempNB/cudf_test.py b/modules/TempNB/cudf_test.py new file mode 100644 index 0000000..e90eefd --- /dev/null +++ b/modules/TempNB/cudf_test.py @@ -0,0 +1,3 @@ +import cudf + +df.to_dict('records') \ No newline at end of file From 212a9e24c4f0c40ca4ca2cc1956b11c03e40ddbf Mon Sep 17 00:00:00 2001 From: ben <007vasy@gmail.com> Date: Fri, 10 Apr 2020 09:32:08 +1000 Subject: [PATCH 47/47] dict to cypher property code merge for make it available for others --- .../{TempNB => }/DrugSynonymDataToNeo4j.py | 0 modules/{TempNB => }/IngestDrugSynonyms.py | 0 modules/{TempNB => }/IngestDrugSynonymsWF.py | 0 modules/TempNB/IngestDrugSynonyms.ipynb | 322 ------------------ modules/TempNB/cudf_test.py | 3 - modules/{TempNB => }/config.json | 0 6 files changed, 325 deletions(-) rename modules/{TempNB => }/DrugSynonymDataToNeo4j.py (100%) rename modules/{TempNB => }/IngestDrugSynonyms.py (100%) rename modules/{TempNB => }/IngestDrugSynonymsWF.py (100%) delete mode 100644 modules/TempNB/IngestDrugSynonyms.ipynb delete mode 100644 modules/TempNB/cudf_test.py rename modules/{TempNB => }/config.json (100%) diff --git a/modules/TempNB/DrugSynonymDataToNeo4j.py b/modules/DrugSynonymDataToNeo4j.py similarity index 100% rename from modules/TempNB/DrugSynonymDataToNeo4j.py rename to modules/DrugSynonymDataToNeo4j.py diff --git a/modules/TempNB/IngestDrugSynonyms.py b/modules/IngestDrugSynonyms.py similarity index 100% rename from modules/TempNB/IngestDrugSynonyms.py rename to modules/IngestDrugSynonyms.py diff --git a/modules/TempNB/IngestDrugSynonymsWF.py b/modules/IngestDrugSynonymsWF.py similarity index 100% rename from modules/TempNB/IngestDrugSynonymsWF.py rename to modules/IngestDrugSynonymsWF.py diff --git a/modules/TempNB/IngestDrugSynonyms.ipynb b/modules/TempNB/IngestDrugSynonyms.ipynb deleted file mode 100644 index 8f38e1c..0000000 --- a/modules/TempNB/IngestDrugSynonyms.ipynb +++ /dev/null @@ -1,322 +0,0 @@ -{ - "cells": [ - { - "cell_type": "code", - "execution_count": 1, - "metadata": {}, - "outputs": [], - "source": [ - "from IngestDrugSynonyms import IngestDrugSynonyms" - ] - }, - { - "cell_type": "code", - "execution_count": 2, - "metadata": {}, - "outputs": [], - "source": [ - "import pandas as pd" - ] - }, - { - "cell_type": "code", - "execution_count": 3, - "metadata": {}, - "outputs": [], - "source": [ - "%load_ext autoreload\n", - "%autoreload 2" - ] - }, - { - "cell_type": "code", - "execution_count": 4, - "metadata": {}, - "outputs": [ - { - "data": { - "text/html": [ - "" - ], - "text/plain": [ - "" - ] - }, - "metadata": {}, - "output_type": "display_data" - }, - { - "name": "stderr", - "output_type": "stream", - "text": [ - "/home/ben/Projects/Graphs4GoodHackathon/ProjectDomino/.Domino/lib/python3.7/site-packages/ipykernel_launcher.py:3: FutureWarning: Passing a negative integer is deprecated in version 1.0 and will not be supported in future version. Instead, use None to not limit the column width.\n", - " This is separate from the ipykernel package so we can avoid doing imports until\n" - ] - } - ], - "source": [ - "from IPython.core.display import display, HTML\n", - "display(HTML(\"\"))\n", - "pd.set_option('display.max_colwidth', -1)\n", - "pd.set_option('display.max_columns', 500)\n", - "pd.set_option('display.width', 1000)" - ] - }, - { - "cell_type": "code", - "execution_count": 5, - "metadata": {}, - "outputs": [], - "source": [ - "drugSynonym = IngestDrugSynonyms()" - ] - }, - { - "cell_type": "code", - "execution_count": 8, - "metadata": {}, - "outputs": [ - { - "name": "stderr", - "output_type": "stream", - "text": [ - "2020-04-09 17:57:44,679 - > 403 studies found by 'covid-19' keyword\n", - "2020-04-09 17:58:07,131 - > 403 studies found by 'SARS-CoV-2' keyword\n", - "2020-04-09 17:58:29,969 - > 332 studies found by 'coronavirus' keyword\n", - "2020-04-09 17:58:46,243 - > 1050 distinct studies found\n" - ] - } - ], - "source": [ - "drugSynonym.auto_get_and_clean_data()" - ] - }, - { - "cell_type": "code", - "execution_count": 11, - "metadata": {}, - "outputs": [], - "source": [ - "drug_vocab = drugSynonym.drug_vocab\n", - "drugs_and_syms:list = list(drug_vocab.keys())\n", - "\n", - "drugs_and_syms.extend( item for key in drug_vocab.keys() if isinstance(drug_vocab[key],list) for item in drug_vocab[key])" - ] - }, - { - "cell_type": "code", - "execution_count": 12, - "metadata": {}, - "outputs": [ - { - "data": { - "text/plain": [ - "39481" - ] - }, - "execution_count": 12, - "metadata": {}, - "output_type": "execute_result" - } - ], - "source": [ - "len(drugs_and_syms)" - ] - }, - { - "cell_type": "code", - "execution_count": null, - "metadata": {}, - "outputs": [], - "source": [ - "import time" - ] - }, - { - "cell_type": "code", - "execution_count": 20, - "metadata": {}, - "outputs": [ - { - "name": "stdout", - "output_type": "stream", - "text": [ - "1586419734.402499\n", - "1586419818.246048\n", - "83.84361219406128\n", - "1586419901.5618382\n", - "167.15940022468567\n", - "1586419985.5537164\n", - "251.15127801895142\n", - "1586420069.5865138\n", - "335.1840934753418\n", - "1586420153.0173287\n", - "418.61490273475647\n", - "1586420235.5331979\n", - "501.13076305389404\n", - "1586420318.3730078\n", - "583.9705700874329\n", - "1586420401.3945472\n", - "666.9921083450317\n", - "1586420484.51531\n", - "750.1128664016724\n", - "1586420568.2253563\n", - "833.8229167461395\n", - "1586420651.7354705\n", - "917.3330311775208\n", - "1586420735.1248071\n", - "1000.7223672866821\n", - "1586420818.3368707\n", - "1083.9344317913055\n", - "1586420901.8185306\n", - "1167.4160959720612\n", - "1586420986.0851562\n", - "1251.6827161312103\n", - "1586421070.07279\n", - "1335.6703515052795\n", - "1586421153.7543426\n", - "1419.351904630661\n", - "1586421237.545393\n", - "1503.1429777145386\n", - "1586421320.8366966\n", - "1586.4342572689056\n", - "1586421404.006324\n", - "1669.6038839817047\n", - "1586421487.4593859\n", - "1753.0569460391998\n", - "1586421570.824374\n", - "1836.4219362735748\n", - "1586421654.610131\n", - "1920.20769405365\n", - "1586421737.9467065\n", - "2003.5442702770233\n", - "1586421821.3660948\n", - "2086.9636595249176\n", - "1586421906.288895\n", - "2171.886456489563\n", - "1586421991.4019985\n", - "2256.999561071396\n", - "1586422076.0194333\n", - "2341.6169979572296\n", - "1586422160.2064266\n", - "2425.8039889335632\n", - "1586422244.7931771\n", - "2510.390773296356\n", - "1586422329.1514266\n", - "2594.748988866806\n", - "1586422413.5586252\n", - "2679.156194448471\n", - "1586422497.0366716\n", - "2762.634252309799\n", - "1586422579.8006713\n", - "2845.39825296402\n", - "1586422662.2891464\n", - "2927.886730670929\n", - "1586422745.0294447\n", - "3010.6270241737366\n", - "1586422827.7157333\n", - "3093.313295841217\n", - "1586422910.6985836\n", - "3176.296145915985\n", - "1586422994.586706\n", - "3260.1842737197876\n", - "3297.177438735962\n", - "1586423031.5799377\n" - ] - } - ], - "source": [ - "studies = drugSynonym.all_studies_df\n", - "appeared_in_edges:list = []\n", - "start = time.time()\n", - "print(start)\n", - "count = 0\n", - "prev = 0\n", - "for drug in drugs_and_syms:\n", - " \n", - " for index,row in studies.iterrows():\n", - " if drug in row[\"intervention\"]:\n", - " appeared_in_edges.append((drug,row[\"trial_id\"]))\n", - " count += 1\n", - " if count > prev + 1000:\n", - " print(time.time())\n", - " print(time.time() - start)\n", - " prev = count\n", - " \n", - "end = time.time()\n", - "print(end - start)\n", - "print(end)\n" - ] - }, - { - "cell_type": "code", - "execution_count": 21, - "metadata": {}, - "outputs": [ - { - "name": "stdout", - "output_type": "stream", - "text": [ - "3269.469130039215\n" - ] - } - ], - "source": [ - "start = time.time()\n", - "appeared_in_edges:list = [(drug,row[\"trial_id\"]) for drug in drugs_and_syms for index,row in studies.iterrows() if drug in row[\"intervention\"]]\n", - "end = time.time()\n", - "print(end - start)" - ] - }, - { - "cell_type": "code", - "execution_count": 22, - "metadata": {}, - "outputs": [ - { - "data": { - "text/plain": [ - "3276923" - ] - }, - "execution_count": 22, - "metadata": {}, - "output_type": "execute_result" - } - ], - "source": [ - "39481 * 83" - ] - }, - { - "cell_type": "code", - "execution_count": null, - "metadata": {}, - "outputs": [], - "source": [ - "GPU?" - ] - } - ], - "metadata": { - "kernelspec": { - "display_name": "Python 3", - "language": "python", - "name": "python3" - }, - "language_info": { - "codemirror_mode": { - "name": "ipython", - "version": 3 - }, - "file_extension": ".py", - "mimetype": "text/x-python", - "name": "python", - "nbconvert_exporter": "python", - "pygments_lexer": "ipython3", - "version": "3.7.7" - } - }, - "nbformat": 4, - "nbformat_minor": 4 -} diff --git a/modules/TempNB/cudf_test.py b/modules/TempNB/cudf_test.py deleted file mode 100644 index e90eefd..0000000 --- a/modules/TempNB/cudf_test.py +++ /dev/null @@ -1,3 +0,0 @@ -import cudf - -df.to_dict('records') \ No newline at end of file diff --git a/modules/TempNB/config.json b/modules/config.json similarity index 100% rename from modules/TempNB/config.json rename to modules/config.json