Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2026-01-03 @ 12:57 AM
Study NCT ID:
NCT04843761
Status:
COMPLETED
Last Update Posted:
2025-10-24
First Post:
2021-04-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000606551', 'term': 'remdesivir'}, {'id': 'C438273', 'term': 'aviptadil'}, {'id': 'D014660', 'term': 'Vasoactive Intestinal Peptide'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shwetas@ccbr.umn.edu', 'phone': '612-626-9021', 'title': 'Shweta Sharma Mistry', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed during the screening phase of the study', 'description': 'All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed during the screening phase of the study', 'eventGroups': [{'id': 'EG000', 'title': 'Stratum 1 - Aviptadil + Remdesivir', 'description': 'Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir\n\n* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Stratum 1 - Aviptadil +Remdesivir Placebo', 'description': 'Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir\n\n* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Stratum 1 - Aviptadil Placebo + Remdesivir', 'description': 'Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir\n\n* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Stratum 1 - Aviptadil Placebo + Remdesivir Placebo', 'description': 'Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir\n\n* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Stratum 2 - Aviptadil', 'description': 'Eligible for Aviptadil and Remdesivir contraindicated\n\n* Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal\n* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Stratum 2 - Aviptadil Placebo', 'description': 'Eligible for Aviptadil and Remdesivir contraindicated\n\n* Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal\n* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Stratum 3 - Remdesivir', 'description': 'Eligible for Remdesivir and Aviptadil contraindicated\n\n* Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection\n* Participants enrolled in this arm were analyzed in substudy H2 (NCT06729593)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Stratum 3 - Remdesivir Placebo', 'description': 'Eligible for Remdesivir and Aviptadil contraindicated\n\n* Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection\n* Participants enrolled in this arm were analyzed in substudy H2 (NCT06729593)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Stratum 4 - Aviptadil', 'description': 'Eligible for Aviptadil and prior/current use of Remdesivir\n\n* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Stratum 4 - Aviptadil Placebo', 'description': 'Eligible for Aviptadil and prior/current use of Remdesivir\n\n* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Substudy Analysis Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '183', 'groupId': 'OG008'}, {'value': '180', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Stratum 1 - Aviptadil + Remdesivir', 'description': 'Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir\n\n* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)'}, {'id': 'OG001', 'title': 'Stratum 1 - Aviptadil +Remdesivir Placebo', 'description': 'Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir\n\n* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)'}, {'id': 'OG002', 'title': 'Stratum 1 - Aviptadil Placebo + Remdesivir', 'description': 'Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir\n\n* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)'}, {'id': 'OG003', 'title': 'Stratum 1 - Aviptadil Placebo + Remdesivir Placebo', 'description': 'Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir\n\n* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)'}, {'id': 'OG004', 'title': 'Stratum 2 - Aviptadil', 'description': 'Eligible for Aviptadil and Remdesivir contraindicated\n\n* Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal\n* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)'}, {'id': 'OG005', 'title': 'Stratum 2 - Aviptadil Placebo', 'description': 'Eligible for Aviptadil and Remdesivir contraindicated\n\n* Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal\n* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)'}, {'id': 'OG006', 'title': 'Stratum 3 - Remdesivir', 'description': 'Eligible for Remdesivir and Aviptadil contraindicated\n\n* Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection\n* Participants enrolled in this arm were analyzed in substudy H2 (NCT06729593)'}, {'id': 'OG007', 'title': 'Stratum 3 - Remdesivir Placebo', 'description': 'Eligible for Remdesivir and Aviptadil contraindicated\n\n* Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection\n* Participants enrolled in this arm were analyzed in substudy H2 (NCT06729593)'}, {'id': 'OG008', 'title': 'Stratum 4 - Aviptadil', 'description': 'Eligible for Aviptadil and prior/current use of Remdesivir\n\n* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)'}, {'id': 'OG009', 'title': 'Stratum 4 - Aviptadil Placebo', 'description': 'Eligible for Aviptadil and prior/current use of Remdesivir\n\n* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)'}], 'classes': [{'title': 'Aviptadil substudy analysis cohort', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '183', 'groupId': 'OG008'}, {'value': '180', 'groupId': 'OG009'}]}]}, {'title': 'Remdesivir substudy analysis cohort', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening, within 24 hours', 'description': 'The primary analysis for each agent was to pool across applicable groups to compare each agent vs. matched placebo. Refer to the agent-specific records for results by agent (H1 \\[Aviptadil\\]: NCT06729606; H2 \\[Remdesivir\\]: NCT06729593).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stratum 1 - Aviptadil + Remdesivir', 'description': 'Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir\n\n* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)'}, {'id': 'FG001', 'title': 'Stratum 1 - Aviptadil +Remdesivir Placebo', 'description': 'Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir\n\n* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)'}, {'id': 'FG002', 'title': 'Stratum 1 - Aviptadil Placebo + Remdesivir', 'description': 'Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir\n\n* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)'}, {'id': 'FG003', 'title': 'Stratum 1 - Aviptadil Placebo + Remdesivir Placebo', 'description': 'Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir\n\n* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)'}, {'id': 'FG004', 'title': 'Stratum 2 - Aviptadil', 'description': 'Eligible for Aviptadil and Remdesivir contraindicated\n\n* Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal\n* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)'}, {'id': 'FG005', 'title': 'Stratum 2 - Aviptadil Placebo', 'description': 'Eligible for Aviptadil and Remdesivir contraindicated\n\n* Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal\n* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)'}, {'id': 'FG006', 'title': 'Stratum 3 - Remdesivir', 'description': 'Eligible for Remdesivir and Aviptadil contraindicated\n\n* Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection\n* Participants enrolled in this arm were analyzed in substudy H2 (NCT06729593)'}, {'id': 'FG007', 'title': 'Stratum 3 - Remdesivir Placebo', 'description': 'Eligible for Remdesivir and Aviptadil contraindicated\n\n* Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection\n* Participants enrolled in this arm were analyzed in substudy H2 (NCT06729593)'}, {'id': 'FG008', 'title': 'Stratum 4 - Aviptadil', 'description': 'Eligible for Aviptadil and prior/current use of Remdesivir\n\n* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)'}, {'id': 'FG009', 'title': 'Stratum 4 - Aviptadil Placebo', 'description': 'Eligible for Aviptadil and prior/current use of Remdesivir\n\n* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '21'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '183'}, {'groupId': 'FG009', 'numSubjects': '180'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '21'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '183'}, {'groupId': 'FG009', 'numSubjects': '180'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Eligibility for each agent was assessed at the same time.\n\nIf eligible for both, participants were randomized to a 2x2 factorial design of Aviptadil vs. Aviptadil placebo and Remdesivir vs. Remdesivir placebo with 1:1:1:1 allocation to each of the 4 possible combinations. If eligible for only 1, randomization was 1:1 to that agent or its matched placebo (Appendix H2).\n\nThe primary analysis for each agent was to pool across applicable groups to compare each agent vs. matched placebo.', 'preAssignmentDetails': 'The study includes randomization according to 4 strata:\n\n* Stratum 1 eligible for both Aviptadil and Remdesivir (no prior Remdesivir)\n* Stratum 2 eligible for Aviptadil only (Remdesivir contraindicated)\n* Stratum 3 eligible for Remdesivir only (Aviptadil contraindicated)\n* Stratum 4 eligible for Aviptadil and have received prior Remdesivir\n\nThis record presents enrollment data across the full study. Refer to the agent-specific records for results by agent (H1: NCT06729606; H2: NCT06729593)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '183', 'groupId': 'BG008'}, {'value': '180', 'groupId': 'BG009'}, {'value': '473', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'Stratum 1 - Aviptadil + Remdesivir', 'description': 'Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir\n\n* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)'}, {'id': 'BG001', 'title': 'Stratum 1 - Aviptadil +Remdesivir Placebo', 'description': 'Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir\n\n* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)'}, {'id': 'BG002', 'title': 'Stratum 1 - Aviptadil Placebo + Remdesivir', 'description': 'Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir\n\n* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)'}, {'id': 'BG003', 'title': 'Stratum 1 - Aviptadil Placebo + Remdesivir Placebo', 'description': 'Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir\n\n* Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)'}, {'id': 'BG004', 'title': 'Stratum 2 - Aviptadil', 'description': 'Eligible for Aviptadil and Remdesivir contraindicated\n\n* Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal\n* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)'}, {'id': 'BG005', 'title': 'Stratum 2 - Aviptadil Placebo', 'description': 'Eligible for Aviptadil and Remdesivir contraindicated\n\n* Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal\n* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)'}, {'id': 'BG006', 'title': 'Stratum 3 - Remdesivir', 'description': 'Eligible for Remdesivir and Aviptadil contraindicated\n\n* Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection\n* Participants enrolled in this arm were analyzed in substudy H2 (NCT06729593)'}, {'id': 'BG007', 'title': 'Stratum 3 - Remdesivir Placebo', 'description': 'Eligible for Remdesivir and Aviptadil contraindicated\n\n* Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection\n* Participants enrolled in this arm were analyzed in substudy H2 (NCT06729593)'}, {'id': 'BG008', 'title': 'Stratum 4 - Aviptadil', 'description': 'Eligible for Aviptadil and prior/current use of Remdesivir\n\n* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)'}, {'id': 'BG009', 'title': 'Stratum 4 - Aviptadil Placebo', 'description': 'Eligible for Aviptadil and prior/current use of Remdesivir\n\n* Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '13', 'groupId': 'BG000'}, {'value': '55', 'spread': '14', 'groupId': 'BG001'}, {'value': '56', 'spread': '15', 'groupId': 'BG002'}, {'value': '56', 'spread': '11', 'groupId': 'BG003'}, {'value': '60', 'spread': '20', 'groupId': 'BG004'}, {'value': '54', 'spread': '21', 'groupId': 'BG005'}, {'value': '71', 'spread': '0', 'groupId': 'BG006'}, {'value': '70', 'spread': '0', 'groupId': 'BG007'}, {'value': '57', 'spread': '15', 'groupId': 'BG008'}, {'value': '57', 'spread': '15', 'groupId': 'BG009'}, {'value': '57', 'spread': '15', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<= 18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '123', 'groupId': 'BG008'}, {'value': '126', 'groupId': 'BG009'}, {'value': '322', 'groupId': 'BG010'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '60', 'groupId': 'BG008'}, {'value': '54', 'groupId': 'BG009'}, {'value': '151', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '74', 'groupId': 'BG008'}, {'value': '71', 'groupId': 'BG009'}, {'value': '185', 'groupId': 'BG010'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '109', 'groupId': 'BG008'}, {'value': '109', 'groupId': 'BG009'}, {'value': '288', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '46', 'groupId': 'BG008'}, {'value': '40', 'groupId': 'BG009'}, {'value': '122', 'groupId': 'BG010'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '137', 'groupId': 'BG008'}, {'value': '140', 'groupId': 'BG009'}, {'value': '351', 'groupId': 'BG010'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 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{'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '9', 'groupId': 'BG009'}, {'value': '17', 'groupId': 'BG010'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': 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{'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '29', 'groupId': 'BG008'}, {'value': '23', 'groupId': 'BG009'}, {'value': '76', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-08', 'size': 1692673, 'label': 'Study Protocol: Master', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_008.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-06T13:04', 'hasProtocol': True}, {'date': '2022-03-08', 'size': 1036650, 'label': 'Study Protocol: Aviptadil (H1)', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_009.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-06T13:05', 'hasProtocol': True}, {'date': '2021-04-01', 'size': 1151224, 'label': 'Study Protocol: Remdesivir (H2)', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_010.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-06T13:05', 'hasProtocol': True}, {'date': '2025-08-05', 'size': 99459, 'label': 'Study Protocol: Overview of Study Documents', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_011.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-06T13:08', 'hasProtocol': True}, {'date': '2021-08-05', 'size': 1662912, 'label': 'Statistical Analysis Plan: Main', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_012.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-08-06T13:05', 'hasProtocol': False}, {'date': '2022-05-01', 'size': 898356, 'label': 'Statistical Analysis Plan: Addendum', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_013.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-08-06T13:06', 'hasProtocol': False}, {'date': '2022-03-08', 'size': 1079106, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_014.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-08-06T13:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 473}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-09', 'studyFirstSubmitDate': '2021-04-09', 'resultsFirstSubmitDate': '2024-05-22', 'studyFirstSubmitQcDate': '2021-04-09', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-09', 'studyFirstPostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Substudy Analysis Cohorts', 'timeFrame': 'Screening, within 24 hours', 'description': 'The primary analysis for each agent was to pool across applicable groups to compare each agent vs. matched placebo. Refer to the agent-specific records for results by agent (H1 \\[Aviptadil\\]: NCT06729606; H2 \\[Remdesivir\\]: NCT06729593).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'COVID 19', 'Coronaviridae Infections', 'Coronavirus Infections', 'RNA Virus Infections', 'Virus Diseases', 'Nidovirales Infections', 'SARS-CoV-2', 'SARS Coronavirus', 'ACTIV-3', 'ACTIV3'], 'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '37348524', 'type': 'DERIVED', 'citation': "Brown SM, Barkauskas CE, Grund B, Sharma S, Phillips AN, Leither L, Peltan ID, Lanspa M, Gilstrap DL, Mourad A, Lane K, Beitler JR, Serra AL, Garcia I, Almasri E, Fayed M, Hubel K, Harris ES, Middleton EA, Barrios MAG, Mathews KS, Goel NN, Acquah S, Mosier J, Hypes C, Salvagio Campbell E, Khan A, Hough CL, Wilson JG, Levitt JE, Duggal A, Dugar S, Goodwin AJ, Terry C, Chen P, Torbati S, Iyer N, Sandkovsky US, Johnson NJ, Robinson BRH, Matthay MA, Aggarwal NR, Douglas IS, Casey JD, Hache-Marliere M, Georges Youssef J, Nkemdirim W, Leshnower B, Awan O, Pannu S, O'Mahony DS, Manian P, Awori Hayanga JW, Wortmann GW, Tomazini BM, Miller RF, Jensen JU, Murray DD, Bickell NA, Zatakia J, Burris S, Higgs ES, Natarajan V, Dewar RL, Schechner A, Kang N, Arenas-Pinto A, Hudson F, Ginde AA, Self WH, Rogers AJ, Oldmixon CF, Morin H, Sanchez A, Weintrob AC, Cavalcanti AB, Davis-Karim A, Engen N, Denning E, Taylor Thompson B, Gelijns AC, Kan V, Davey VJ, Lundgren JD, Babiker AG, Neaton JD, Lane HC; ACTIV-3b/Therapeutics for Severely Ill Inpatients with COVID-19 (TESICO) Study Group. Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial. Lancet Respir Med. 2023 Sep;11(9):791-803. doi: 10.1016/S2213-2600(23)00147-9. Epub 2023 Jun 19."}, {'pmid': '36695483', 'type': 'DERIVED', 'citation': 'Grundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2.'}, {'pmid': '34825704', 'type': 'DERIVED', 'citation': 'Tsiatis AA, Davidian M, Holloway ST. Estimation of the odds ratio in a proportional odds model with censored time-lagged outcome in a randomized clinical trial. Biometrics. 2023 Jun;79(2):975-987. doi: 10.1111/biom.13603. Epub 2021 Dec 17.'}], 'seeAlsoLinks': [{'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}, {'url': 'https://www.cdc.gov/coronavirus/2019-nCoV/index.html', 'label': 'CDC (Centers for Disease Control and Prevention): Coronavirus (COVID-19) website'}, {'url': 'https://www.niaid.nih.gov/clinical-trials/participant-guide', 'label': "A Participant's Guide to Clinical Trials (NIAID)"}, {'url': 'https://www.niaid.nih.gov/clinical-trials/find-a-clinical-trial', 'label': 'Find a Clinical Trial (NIAID)'}, {'url': 'https://www.niaid.nih.gov/clinical-trials', 'label': 'Clinical Trials at NIAID'}, {'url': 'https://www.niaid.nih.gov/', 'label': 'National Institute for Allergy and Infectious Diseases (NIAID)'}, {'url': 'https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/patient-management', 'label': 'WHO COVID-19 treatment guidelines'}]}, 'descriptionModule': {'briefSummary': 'This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection and who have acute respiratory failure. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.\n\nSubstudy H1: Aviptadil for Severely Ill Inpatients With COVID-19 (NCT06729606)\n\nSubstudy H2: Remdesivir for Severely Ill Inpatients With COVID-19 (NCT06729593)', 'detailedDescription': 'This is a master protocol to evaluate the safety and efficacy of investigational agents aimed at improving outcomes for patients with acute respiratory failure related to COVID-19.\n\nTrials within this protocol will be adaptive, randomized, blinded and initially placebo-controlled. Participants will receive standard of care (SOC) treatment as part of the protocol. If an investigational agent shows superiority over placebo, SOC for the study of future investigational agents may be modified accordingly.\n\nThe international trials within this protocol will be conducted in up to several hundred clinical sites. Participating sites are affiliated with networks funded by the United States National Institutes of Health (NIH) and the US Department of Veterans Affairs.\n\nThe protocol is for a Phase 3 platform study that allows investigational agents to be added and dropped during the course of the study. This allows for efficient testing of new agents against control within the same trial infrastructure. When more than one agent is being tested concurrently, participants may be randomly allocated across agents (as well as between the agent and its placebo) so the same control group can be shared, when feasible. In some situations, a factorial design may be used to study multiple agents.\n\nParticipants will be followed for 90 days following randomization for the primary endpoint and most secondary endpoints. Selected secondary endpoints will be measured at 180 days.\n\nThis study is planned to provide 80% power to detect an odds ratio of 1.5 for improvement in recovery status at Day 90 for an investigational agent versus placebo with use of the ordinal outcome. The planned sample size is 640 participants (320 per group) for each investigational agent/placebo. Sample size may be re-estimated before enrollment is complete based on an assessment of whether the pooled proportions of the outcome are still consistent with adequate power for the hypothesized difference measured by the odds ratio.\n\nRandomization will be stratified by study site pharmacy and by receipt of invasive mechanical ventilation, or ECMO (extracorporeal membrane oxygenation) at enrollment. Other agent-specific stratification factors may be considered.\n\nInvestigational agents suitable for testing in the inpatient setting will be prioritized based on in vitro data, preclinical data, Phase 1 pharmacokinetic and safety data, and clinical data from completed and ongoing trials. In some cases, a vanguard cohort/initial pilot phase may be incorporated into the trial.\n\nAn independent Data and Safety Monitoring Board (DSMB) will review interim safety and efficacy data at least monthly. Pre-specified guidelines will be established to recommend early stopping of the trial for evidence of harm or substantial efficacy. The DSMB may recommend discontinuation of an investigational agent if the risks are judged to outweigh the benefits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent.\n* Requiring admission for inpatient hospital acute medical care for clinical manifestations of COVID-19 (not for purely public health or quarantine purposes).\n* Current respiratory failure (i.e. receipt of high-flow nasal cannula, non-invasive ventilation, invasive mechanical ventilation, or ECMO used to treat acute hypoxemic respiratory failure).\n* SARS-CoV-2 (COVID-19) infection, documented by a nucleic acid test (NAT) or equivalent testing with most recent rest within 14 days prior to randomization.\n* Respiratory failure is believed to be due to SARS-CoV-2 pneumonia.\n\nExclusion Criteria:\n\n* Known allergy to investigational agent or vehicle.\n* More than 4 days since initiation of support for respiratory failure.\n* Chronic/home mechanical ventilation (invasive or non-invasive) for chronic lung or neuromuscular disease (non-invasive ventilation used solely for sleep-disordered breathing is not an exclusion).\n* Moribund patient (i.e. not expected to survive 24 hours).\n* Active use of "comfort care" or other hospice-equivalent SOC.\n* Expected inability to participate in study procedures.\n* In the opinion of the investigator, any condition for which, participation would not be in the best interest of the participant or that could limit protocol-specified assessments.\n* Previous enrollment in TESICO\n\nAdditional agent-specific criteria also apply, and are listed in the substudy records Substudy H1: Aviptadil for Severely Ill Inpatients With COVID-19 (NCT06729606) Substudy H2: Remdesivir for Severely Ill Inpatients With COVID-19 (NCT06729593)'}, 'identificationModule': {'nctId': 'NCT04843761', 'acronym': 'TESICO', 'briefTitle': 'ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With Acute Respiratory Distress Syndrome Associated With COVID-19', 'orgStudyIdInfo': {'id': '015 / ACTIV-3b'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stratum 1 - Aviptadil + Remdesivir + SOC', 'description': 'Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir\n\nParticipants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)', 'interventionNames': ['Biological: Remdesivir', 'Biological: Aviptadil', 'Drug: Corticosteroid']}, {'type': 'EXPERIMENTAL', 'label': 'Stratum 1 - Aviptadil + Remdesivir Placebo + SOC', 'description': 'Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir\n\nParticipants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)', 'interventionNames': ['Drug: Remdesivir Placebo', 'Biological: Aviptadil', 'Drug: Corticosteroid']}, {'type': 'EXPERIMENTAL', 'label': 'Stratum 1 - Aviptadil Placebo + Remdesivir + SOC', 'description': 'Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir\n\nParticipants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)', 'interventionNames': ['Biological: Remdesivir', 'Drug: Aviptadil Placebo', 'Drug: Corticosteroid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Stratum 1 - Aviptadil Placebo + Remdesivir Placebo + SOC', 'description': 'Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir\n\nParticipants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)', 'interventionNames': ['Drug: Remdesivir Placebo', 'Drug: Aviptadil Placebo', 'Drug: Corticosteroid']}, {'type': 'EXPERIMENTAL', 'label': 'Stratum 2 - Aviptadil + SOC', 'description': 'Eligible for Aviptadil and Remdesivir contraindicated\n\n* Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal\n\nParticipants enrolled in this arm were analyzed in substudy H1 (NCT06729606)', 'interventionNames': ['Biological: Aviptadil', 'Drug: Corticosteroid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Stratum 2 - Aviptadil Placebo + SOC', 'description': 'Eligible for Aviptadil and Remdesivir contraindicated\n\n* Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal\n\nParticipants enrolled in this arm were analyzed in substudy H1 (NCT06729606)', 'interventionNames': ['Drug: Aviptadil Placebo', 'Drug: Corticosteroid']}, {'type': 'EXPERIMENTAL', 'label': 'Stratum 3 - Remdesivir + SOC', 'description': 'Eligible for Remdesivir and Aviptadil contraindicated\n\n* Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection\n\nParticipants enrolled in this arm were analyzed in substudy H2 (NCT06729593)', 'interventionNames': ['Biological: Remdesivir', 'Drug: Corticosteroid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Stratum 3 - Remdesivir Placebo + SOC', 'description': 'Eligible for Remdesivir and Aviptadil contraindicated\n\n* Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection\n\nParticipants enrolled in this arm were analyzed in substudy H2 (NCT06729593)', 'interventionNames': ['Drug: Remdesivir Placebo', 'Drug: Corticosteroid']}, {'type': 'EXPERIMENTAL', 'label': 'Stratum 4 - Aviptadil + SOC', 'description': 'Eligible for Aviptadil and prior/current use of Remdesivir\n\nParticipants enrolled in this arm were analyzed in substudy H1 (NCT06729606)', 'interventionNames': ['Biological: Aviptadil', 'Drug: Corticosteroid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Stratum 4 - Aviptadil Placebo + SOC', 'description': 'Eligible for Aviptadil and prior/current use of Remdesivir\n\nParticipants enrolled in this arm were analyzed in substudy H1 (NCT06729606)', 'interventionNames': ['Drug: Aviptadil Placebo', 'Drug: Corticosteroid']}], 'interventions': [{'name': 'Remdesivir', 'type': 'BIOLOGICAL', 'description': 'Administered by IV infusion, daily for 10 days. Initial loading dose is 200 mg with all subsequent doses 100 mg.', 'armGroupLabels': ['Stratum 1 - Aviptadil + Remdesivir + SOC', 'Stratum 1 - Aviptadil Placebo + Remdesivir + SOC', 'Stratum 3 - Remdesivir + SOC']}, {'name': 'Remdesivir Placebo', 'type': 'DRUG', 'description': 'Commercially available 0.9% sodium chloride solution. Administered by IV infusion daily for 10 days.', 'armGroupLabels': ['Stratum 1 - Aviptadil + Remdesivir Placebo + SOC', 'Stratum 1 - Aviptadil Placebo + Remdesivir Placebo + SOC', 'Stratum 3 - Remdesivir Placebo + SOC']}, {'name': 'Aviptadil', 'type': 'BIOLOGICAL', 'otherNames': ['Vasoactive Intestinal Peptide', 'VIP'], 'description': 'Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr.', 'armGroupLabels': ['Stratum 1 - Aviptadil + Remdesivir + SOC', 'Stratum 1 - Aviptadil + Remdesivir Placebo + SOC', 'Stratum 2 - Aviptadil + SOC', 'Stratum 4 - Aviptadil + SOC']}, {'name': 'Aviptadil Placebo', 'type': 'DRUG', 'description': 'Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days.', 'armGroupLabels': ['Stratum 1 - Aviptadil Placebo + Remdesivir + SOC', 'Stratum 1 - Aviptadil Placebo + Remdesivir Placebo + SOC', 'Stratum 2 - Aviptadil Placebo + SOC', 'Stratum 4 - Aviptadil Placebo + SOC']}, {'name': 'Corticosteroid', 'type': 'DRUG', 'description': 'In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.', 'armGroupLabels': ['Stratum 1 - Aviptadil + Remdesivir + SOC', 'Stratum 1 - Aviptadil + Remdesivir Placebo + SOC', 'Stratum 1 - Aviptadil Placebo + Remdesivir + SOC', 'Stratum 1 - Aviptadil Placebo + Remdesivir Placebo + SOC', 'Stratum 2 - Aviptadil + SOC', 'Stratum 2 - Aviptadil Placebo + SOC', 'Stratum 3 - Remdesivir + SOC', 'Stratum 3 - Remdesivir Placebo + SOC', 'Stratum 4 - Aviptadil + SOC', 'Stratum 4 - Aviptadil Placebo + SOC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center Tucson (Site 206-004), 1625 N. 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