Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
Study NCT ID:
NCT04583592
Status:
COMPLETED
Last Update Posted:
2022-01-18
First Post:
2020-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Camostat Efficacy vs. Placebo for Outpatient Treatment of COVID-19 (CAMELOT)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C034532', 'term': 'camostat'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ctinkoff@sagentpharma.com', 'phone': '847-908-6913', 'title': 'Cynthia Tinkoff, Pharm.D. Manager, Medical Affairs', 'organization': 'Sagent Pharmaceuticals, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '28 Days', 'description': 'A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).', 'eventGroups': [{'id': 'EG000', 'title': 'Camostat Mesilate', 'description': 'Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.\n\nCamostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.', 'otherNumAtRisk': 195, 'deathsNumAtRisk': 195, 'otherNumAffected': 8, 'seriousNumAtRisk': 195, 'deathsNumAffected': 1, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 14 days in addition to standard of care treatment.\n\nPlacebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 9, 'seriousNumAtRisk': 99, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Respiratory Distress Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oxygen Saturation Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased apetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aguesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anosmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Delusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Respiratory Distress Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Disease Progression at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Camostat Mesilate', 'description': 'Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.\n\nCamostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 14 days in addition to standard of care treatment.\n\nPlacebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.787', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '\\<0.05', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Disease progression will be defined as the number of participants requiring hospitalization (including emergency room visit) or who die due to any cause within 28 days of randomization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat population includes all subjects who were randomized'}, {'type': 'SECONDARY', 'title': 'Survival Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Camostat Mesilate', 'description': 'Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.\n\nCamostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 14 days in addition to standard of care treatment.\n\nPlacebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.'}], 'classes': [{'title': 'Survival Status at Day 15', 'categories': [{'measurements': [{'value': '194', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}, {'title': 'Survival Status at Day 28', 'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 15 and Day 28', 'description': 'The overall survival rate (the number of randomized participants who survive up to Day 15 and Day 28).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Fever Resolution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Camostat Mesilate', 'description': 'Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.\n\nCamostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 14 days in addition to standard of care treatment.\n\nPlacebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '8.0'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 28 days', 'description': 'Time (in days) from initiation of study treatment until normalization of fever (≤ 37.2 °C oral or tympanic) and sustained for at least 3 days only assessed in participants who experienced a fever within 1 day of enrollment up to Day 28.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Resolution of Viral Shedding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Camostat Mesilate', 'description': 'Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.\n\nCamostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 14 days in addition to standard of care treatment.\n\nPlacebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.'}], 'classes': [{'title': 'No Viral Shedding at Day 1', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'No Viral Shedding at Day 7', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'No Viral Shedding at Day 15', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1, Day 7 and Day 15', 'description': 'Number of participants with no viral shedding (yes/no) using reverse transcriptase-polymerase chain reaction (RT-PCR) at Day 7, Day 15, and at early termination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Adverse Events and Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Camostat Mesilate', 'description': 'Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.\n\nCamostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 14 days in addition to standard of care treatment.\n\nPlacebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.'}], 'classes': [{'title': 'Treatment Emergent Adverse Event (TEAE)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Number of participants with Adverse events (AEs) and Serious adverse events (SAEs) of any grade from randomization up to Day 28.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).'}, {'type': 'SECONDARY', 'title': 'Cumulative Rate of Grade 3 and 4 Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Camostat Mesilate', 'description': 'Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.\n\nCamostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 14 days in addition to standard of care treatment.\n\nPlacebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.'}], 'classes': [{'title': 'Grade 3 AEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4 AEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Cumulative number of participants with grade 3 and 4 AEs from randomization up to Day 28.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 295 subjects were randomized (2:1) to receive a 2-week course of Camostat (n=194) or placebo (n=101) One participant randomized to the placebo group decided to withdraw before taking the first dose of study drug, and one subject randomized to the placebo group was erroneously given Camostat mesilate (As Treated Population: Camostat mesilate, n=195 and placebo, n=99).'}, {'type': 'SECONDARY', 'title': 'Rate of Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Camostat Mesilate', 'description': 'Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.\n\nCamostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 14 days in addition to standard of care treatment.\n\nPlacebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Number of participants that discontinued from study due to an AE/SAE (discontinued participants will be followed up to Day 28).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) population includes all subjects who were randomized.'}, {'type': 'SECONDARY', 'title': 'Laboratory Parameter - Platelet Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Camostat Mesilate', 'description': 'Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.\n\nCamostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 14 days in addition to standard of care treatment.\n\nPlacebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.'}], 'classes': [{'title': 'Day 1 Platelet Count', 'categories': [{'measurements': [{'value': '243', 'spread': '71.69', 'groupId': 'OG000'}, {'value': '252.1', 'spread': '80.45', 'groupId': 'OG001'}]}]}, {'title': 'Day 15 Platelet Count', 'categories': [{'measurements': [{'value': '288.3', 'spread': '86.66', 'groupId': 'OG000'}, {'value': '281.5', 'spread': '83.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Day 15', 'description': 'Clinical Laboratory Value of Platelet Count at Day 1 and Day 15', 'unitOfMeasure': '10^9 platelets/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to Treat Population includes all subjects who were randomized.'}, {'type': 'SECONDARY', 'title': 'Laboratory Parameter - Potassium Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Camostat Mesilate', 'description': 'Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.\n\nCamostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 14 days in addition to standard of care treatment.\n\nPlacebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.'}], 'classes': [{'title': 'Day 1 Potassium Level', 'categories': [{'measurements': [{'value': '4.26', 'spread': '0.397', 'groupId': 'OG000'}, {'value': '4.23', 'spread': '0.391', 'groupId': 'OG001'}]}]}, {'title': 'Day 15 Potassium Level', 'categories': [{'measurements': [{'value': '4.30', 'spread': '0.363', 'groupId': 'OG000'}, {'value': '4.29', 'spread': '0.407', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Day 15', 'description': 'Clinical laboratory value of Potassium Levels at Day 1 and Day 15', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Laboratory Parameter - Aspartate Aminotransferase (AST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Camostat Mesilate', 'description': 'Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.\n\nCamostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 14 days in addition to standard of care treatment.\n\nPlacebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.'}], 'classes': [{'title': 'Day 1 AST', 'categories': [{'measurements': [{'value': '24.6', 'spread': '14.71', 'groupId': 'OG000'}, {'value': '25.3', 'spread': '12.33', 'groupId': 'OG001'}]}]}, {'title': 'Day 15 AST', 'categories': [{'measurements': [{'value': '21.8', 'spread': '10.18', 'groupId': 'OG000'}, {'value': '21.8', 'spread': '10.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Day 15', 'description': 'Clinical laboratory values of Aspartate Aminotransferase (AST) at Day 1 and Day 15', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat population includes all subjects who were randomized.'}, {'type': 'SECONDARY', 'title': 'Laboratory Parameter - Alanine Aminotransferase (ALT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Camostat Mesilate', 'description': 'Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.\n\nCamostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 14 days in addition to standard of care treatment.\n\nPlacebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.'}], 'classes': [{'title': 'Day 1 ALT', 'categories': [{'measurements': [{'value': '30.2', 'spread': '27.58', 'groupId': 'OG000'}, {'value': '29.0', 'spread': '17.01', 'groupId': 'OG001'}]}]}, {'title': 'Day 15 ALT', 'categories': [{'measurements': [{'value': '27.9', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '27.9', 'spread': '22.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Day 15', 'description': 'Clinical laboratory value of Alanine Aminotransferase (ALT) at Day 1 and Day 15', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat population includes all subjects who were randomized.'}, {'type': 'SECONDARY', 'title': 'Laboratory Parameter - Alkaline Phosphatase (ALP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Camostat Mesilate', 'description': 'Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.\n\nCamostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 14 days in addition to standard of care treatment.\n\nPlacebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.'}], 'classes': [{'title': 'Day 1 ALP', 'categories': [{'measurements': [{'value': '76.3', 'spread': '24.44', 'groupId': 'OG000'}, {'value': '80.5', 'spread': '25.55', 'groupId': 'OG001'}]}]}, {'title': 'Day 15 ALP', 'categories': [{'measurements': [{'value': '77.8', 'spread': '27.60', 'groupId': 'OG000'}, {'value': '78.6', 'spread': '24.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Day 15', 'description': 'Clinical laboratory value of Alkaline Phosphatase (ALP) at Day 1 and Day 15', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat population includes all subjects who were randomized.'}, {'type': 'SECONDARY', 'title': 'Laboratory Parameter - Gamma-Glutamyl Transferase (GGT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Camostat Mesilate', 'description': 'Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.\n\nCamostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 14 days in addition to standard of care treatment.\n\nPlacebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.'}], 'classes': [{'title': 'Day 1 GGT', 'categories': [{'measurements': [{'value': '33.5', 'spread': '25.61', 'groupId': 'OG000'}, {'value': '33.4', 'spread': '29.91', 'groupId': 'OG001'}]}]}, {'title': 'Day 15 GGT', 'categories': [{'measurements': [{'value': '34.1', 'spread': '30.50', 'groupId': 'OG000'}, {'value': '31.1', 'spread': '20.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Day 15', 'description': 'Clinical laboratory value of Gamma-Glutamyl Transferase (GGT) at Day 1 and Day 15', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat population includes all subjects who were randomized.'}, {'type': 'SECONDARY', 'title': 'Vital Signs - Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Camostat Mesilate', 'description': 'Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.\n\nCamostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 14 days in addition to standard of care treatment.\n\nPlacebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.'}], 'classes': [{'title': 'Heart rate Day 1', 'categories': [{'measurements': [{'value': '81.2', 'spread': '10.25', 'groupId': 'OG000'}, {'value': '80.1', 'spread': '10.48', 'groupId': 'OG001'}]}]}, {'title': 'Heart rate Day 7', 'categories': [{'measurements': [{'value': '81.2', 'spread': '10.07', 'groupId': 'OG000'}, {'value': '80.5', 'spread': '9.09', 'groupId': 'OG001'}]}]}, {'title': 'Heart rate Day 15', 'categories': [{'measurements': [{'value': '79.8', 'spread': '10.16', 'groupId': 'OG000'}, {'value': '79.2', 'spread': '9.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 7 and Day 15', 'description': 'Heart rate at Day 1, Day 7 and Day 15', 'unitOfMeasure': 'Beats/Minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat population includes all subjects who were randomized.'}, {'type': 'SECONDARY', 'title': 'Vital Signs - Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Camostat Mesilate', 'description': 'Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.\n\nCamostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 14 days in addition to standard of care treatment.\n\nPlacebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.'}], 'classes': [{'title': 'Systolic BP Day 1', 'categories': [{'measurements': [{'value': '128.7', 'spread': '13.87', 'groupId': 'OG000'}, {'value': '129.6', 'spread': '13.97', 'groupId': 'OG001'}]}]}, {'title': 'Systolic BP Day 7', 'categories': [{'measurements': [{'value': '128.2', 'spread': '16.61', 'groupId': 'OG000'}, {'value': '129.2', 'spread': '15.54', 'groupId': 'OG001'}]}]}, {'title': 'Systolic BP Day 15', 'categories': [{'measurements': [{'value': '128.1', 'spread': '16.61', 'groupId': 'OG000'}, {'value': '129.2', 'spread': '15.54', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic BP Day 1', 'categories': [{'measurements': [{'value': '80.7', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '80.8', 'spread': '7.43', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic BP Day 7', 'categories': [{'measurements': [{'value': '80.2', 'spread': '9.34', 'groupId': 'OG000'}, {'value': '80.9', 'spread': '9.6', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic BP Day 15', 'categories': [{'measurements': [{'value': '78.9', 'spread': '8.72', 'groupId': 'OG000'}, {'value': '81.3', 'spread': '10.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 7 and Day 15', 'description': 'Blood pressure (BP) at Day 1, Day 7 and Day 15', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat population includes all subjects who were randomized.'}, {'type': 'SECONDARY', 'title': 'Vital Signs - Peripheral Capillary Oxygen Saturation (SpO2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Camostat Mesilate', 'description': 'Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.\n\nCamostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 14 days in addition to standard of care treatment.\n\nPlacebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.'}], 'classes': [{'title': 'SpO2 Day 1', 'categories': [{'measurements': [{'value': '97.3', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '97.4', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'SpO2 Day 7', 'categories': [{'measurements': [{'value': '97.3', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '97.3', 'spread': '1.43', 'groupId': 'OG001'}]}]}, {'title': 'SpO2 Day 15', 'categories': [{'measurements': [{'value': '97.6', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '97.5', 'spread': '2.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 7 and Day 15', 'description': 'Peripheral Capillary Oxygen Saturation (SpO2) at Day 1, Day 7 and Day 15', 'unitOfMeasure': 'Percentage of SpO2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat population includes all subjects who were randomized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Camostat Mesilate', 'description': 'Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.\n\nCamostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 14 days in addition to standard of care treatment.\n\nPlacebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '194'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '194'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was performed between November 09, 2020 to March, 30 2021. Subjects were recruited from \\~25 sites across United States.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Camostat Mesilate', 'description': 'Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.\n\nCamostat Mesilate: Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants will receive placebo for 14 days in addition to standard of care treatment.\n\nPlacebo: Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 55 years', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}]}, {'title': '> or = 55 years', 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Intent-to-Treat population includes all subjects who were randomized.', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Intent-to-Treat population includes all subjects who were randomized. \\[Note: Subjects may have more than one risk factor upon entry into study.\\]'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-07', 'size': 903474, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-12-09T14:26', 'hasProtocol': True}, {'date': '2021-03-31', 'size': 1700699, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-12-09T16:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 295}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-13', 'studyFirstSubmitDate': '2020-10-07', 'resultsFirstSubmitDate': '2021-12-14', 'studyFirstSubmitQcDate': '2020-10-08', 'lastUpdatePostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-13', 'studyFirstPostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease Progression at Day 28', 'timeFrame': '28 days', 'description': 'Disease progression will be defined as the number of participants requiring hospitalization (including emergency room visit) or who die due to any cause within 28 days of randomization.'}], 'secondaryOutcomes': [{'measure': 'Survival Rate', 'timeFrame': 'Up to Day 15 and Day 28', 'description': 'The overall survival rate (the number of randomized participants who survive up to Day 15 and Day 28).'}, {'measure': 'Time to Fever Resolution', 'timeFrame': 'Up to 28 days', 'description': 'Time (in days) from initiation of study treatment until normalization of fever (≤ 37.2 °C oral or tympanic) and sustained for at least 3 days only assessed in participants who experienced a fever within 1 day of enrollment up to Day 28.'}, {'measure': 'Resolution of Viral Shedding', 'timeFrame': 'Day 1, Day 7 and Day 15', 'description': 'Number of participants with no viral shedding (yes/no) using reverse transcriptase-polymerase chain reaction (RT-PCR) at Day 7, Day 15, and at early termination.'}, {'measure': 'Rate of Adverse Events and Serious Adverse Events', 'timeFrame': '28 days', 'description': 'Number of participants with Adverse events (AEs) and Serious adverse events (SAEs) of any grade from randomization up to Day 28.'}, {'measure': 'Cumulative Rate of Grade 3 and 4 Adverse Events', 'timeFrame': '28 days', 'description': 'Cumulative number of participants with grade 3 and 4 AEs from randomization up to Day 28.'}, {'measure': 'Rate of Discontinuation', 'timeFrame': '28 days', 'description': 'Number of participants that discontinued from study due to an AE/SAE (discontinued participants will be followed up to Day 28).'}, {'measure': 'Laboratory Parameter - Platelet Count', 'timeFrame': 'Day 1 and Day 15', 'description': 'Clinical Laboratory Value of Platelet Count at Day 1 and Day 15'}, {'measure': 'Laboratory Parameter - Potassium Level', 'timeFrame': 'Day 1 and Day 15', 'description': 'Clinical laboratory value of Potassium Levels at Day 1 and Day 15'}, {'measure': 'Laboratory Parameter - Aspartate Aminotransferase (AST)', 'timeFrame': 'Day 1 and Day 15', 'description': 'Clinical laboratory values of Aspartate Aminotransferase (AST) at Day 1 and Day 15'}, {'measure': 'Laboratory Parameter - Alanine Aminotransferase (ALT)', 'timeFrame': 'Day 1 and Day 15', 'description': 'Clinical laboratory value of Alanine Aminotransferase (ALT) at Day 1 and Day 15'}, {'measure': 'Laboratory Parameter - Alkaline Phosphatase (ALP)', 'timeFrame': 'Day 1 and Day 15', 'description': 'Clinical laboratory value of Alkaline Phosphatase (ALP) at Day 1 and Day 15'}, {'measure': 'Laboratory Parameter - Gamma-Glutamyl Transferase (GGT)', 'timeFrame': 'Day 1 and Day 15', 'description': 'Clinical laboratory value of Gamma-Glutamyl Transferase (GGT) at Day 1 and Day 15'}, {'measure': 'Vital Signs - Heart Rate', 'timeFrame': 'Day 1, Day 7 and Day 15', 'description': 'Heart rate at Day 1, Day 7 and Day 15'}, {'measure': 'Vital Signs - Blood Pressure', 'timeFrame': 'Day 1, Day 7 and Day 15', 'description': 'Blood pressure (BP) at Day 1, Day 7 and Day 15'}, {'measure': 'Vital Signs - Peripheral Capillary Oxygen Saturation (SpO2)', 'timeFrame': 'Day 1, Day 7 and Day 15', 'description': 'Peripheral Capillary Oxygen Saturation (SpO2) at Day 1, Day 7 and Day 15'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled study of camostat mesilate in ambulatory patients with confirmed COVID-19 with at least one risk factor for severe illness.', 'detailedDescription': 'Participants will be randomized in a 2:1 ratio of camostat:placebo. Approximately 300 participants are planned to be enrolled (200 participants to camostat mesilate and 100 participants to placebo). Participants will be treated with camostat mesilate 200 mg or placebo drug orally 4 times a day for 14 days, and receive local standard of care (SOC) in addition to study drug. Participants will be followed until Day 28. Participants will be seen in the clinic for assessments, blood draws, and mid-turbinate nasal samples on Screening/Day 1, Day 7, Day 15 and early termination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adults willing and able to provide informed consent before performing study procedures\n2. Adults ≥18 years of age at time of informed consent\n3. Participants must have written notification of laboratory confirmed COVID-19 infection performed prior to screening, at a local laboratory by RT-PCR or other commercial or public health assay in any specimen; and participants must be randomized within 72 hours of receiving the above notification of laboratory confirmed COVID-19\n4. Have a mild or moderate form of COVID-19 defined as SpO2 \\> 94% at screening\n5. Participants must have at least 1 of the following risk factors for severe illness\n\n 1. Aged 65 years or older\n 2. Hypertension\n 3. Diabetes mellitus\n 4. Chronic lung disease including asthma, chronic obstructive pulmonary disease (COPD), and interstitial lung disease (eg, idiopathic pulmonary fibrosis)\n 5. Chronic cardiac conditions, including coronary artery disease (CAD), heart failure, congenital heart disease, cardiomyopathy\n 6. Severe obesity (body mass index \\[BMI\\] ≥ 40 kg/m\\^2)\n 7. Chronic liver disease, including cirrhosis\n6. Must agree not to enroll in another study of an investigational agent or take any other drug that has been granted Emergency Use Authorization prior to completion of Day 28\n7. If women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP, must be able and willing to use at least 1 highly effective method of contraception during the study and for 90 days after receiving the last dose of study drug\n\nExclusion Criteria:\n\n1. Physician makes a decision that trial involvement is not in participants' best interest, or has any condition that does not allow the protocol to be followed safely\n2. Known severe liver disease (eg, Child Pugh score \\> 12, AST \\>5 times upper limit)\n3. SaO2/SPO2 ≤94% on room air condition, or the Pa02/Fi02 ratio \\< 300 mgHg\n4. Known allergic reaction to camostat mesilate or one of its excipients\n5. Known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m\\^2) or receiving dialysis\n6. Pregnant or breastfeeding, or positive pregnancy test in a predose examination\n7. Receipt of any experimental treatment for COVID-19, including agents with demonstrated or possible direct acting antiviral activity, including, but not limited to, remdesivir, hydroxychloroquine, lopinavir/ritonavir, tocilizumab, or ivermectin, within the 30 days prior to the time of the screening evaluation. No off label use of a drug for COVID 19 is allowed.\n8. History of human immunodeficiency virus infection on highly active antiretroviral therapy (HAART)"}, 'identificationModule': {'nctId': 'NCT04583592', 'briefTitle': 'Camostat Efficacy vs. Placebo for Outpatient Treatment of COVID-19 (CAMELOT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sagent Pharmaceuticals Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy of Camostat Mesilate for Treatment of COVID-19 in Outpatients', 'orgStudyIdInfo': {'id': 'NI03-CV19-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Camostat Mesilate', 'description': 'Participants will receive camostat mesilate for 14 days in addition to standard of care treatment.', 'interventionNames': ['Drug: Camostat Mesilate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo for 14 days in addition to standard of care treatment.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Camostat Mesilate', 'type': 'DRUG', 'otherNames': ['Camostat Mesylate', 'Foipan®'], 'description': 'Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.', 'armGroupLabels': ['Camostat Mesilate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Palmtree Clinical Research, Inc. 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