Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-31 @ 1:10 PM
Study NCT ID:
NCT06729606
Status:
COMPLETED
Last Update Posted:
2025-10-09
First Post:
2024-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Aviptadil for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-07-28', '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': '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 collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0, 1, and 2 AND any other Adverse Events through Study Day 28.', 'description': 'Adverse events were collected irrespective of mono or dual therapy assignment', 'eventGroups': [{'id': 'EG000', 'title': 'Aviptadil + SOC', 'description': 'Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761)\n\nAviptadil: 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.\n\nCorticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.', 'otherNumAtRisk': 231, 'deathsNumAtRisk': 231, 'otherNumAffected': 200, 'seriousNumAtRisk': 231, 'deathsNumAffected': 90, 'seriousNumAffected': 25}, {'id': 'EG001', 'title': 'Placebo + SOC', 'description': 'Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761)\n\nAviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days.\n\nCorticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.', 'otherNumAtRisk': 230, 'deathsNumAtRisk': 230, 'otherNumAffected': 176, 'seriousNumAtRisk': 230, 'deathsNumAffected': 86, 'seriousNumAffected': 23}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Blood loss anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Heparin-induced thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Acute right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Arrhythmia supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 33, 'numAffected': 22}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pulseless electrical activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Supraventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 21, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Eye oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diverticular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Peptic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Retroperitoneal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Retroperitoneal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Complication associated with device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 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'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Haemofiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Renal replacement therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Distributive shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 61, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 56, 'numAffected': 38}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 709, 'numAffected': 159}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 687, 'numAffected': 140}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 12, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'seriousEvents': [{'term': 'Heparin-induced thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pulseless electrical activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diverticular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Barotrauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Computerised tomogram thorax abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Bronchial obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pneumomediastinum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 231, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aviptadil + SOC', 'description': 'Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761)\n\nAviptadil: 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.\n\nCorticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761)\n\nAviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days.\n\nCorticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.'}], 'classes': [{'categories': [{'title': 'category 1 = at home and off oxygen (recovered) for at least 77 days', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'category 2 = at home and off oxygen for 49-76 days', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'title': 'category 3 = at home and off oxygen for 1-48 days', 'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'category 4 = not hospitalized but either on supplemental oxygen or not at home', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'category 5 = hospitalized or in hospice care', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'category 6 = died', 'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.54', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.55', 'pValueComment': 'Proportional odds model stratified by disease severity (high flow nasal canula \\[HFNC\\]/non-invasive ventilation \\[NIV\\] or invasive mechanical ventiliation \\[IMV\\]/ECMO) at study entry to determine the odds of being in a better category at day 90.', 'estimateComment': 'Summary odds ratio for being in a better category, active/placebo (95% confidence interval); pvalue', 'statisticalMethod': 'Proportional odds model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Status on Day 90', 'description': "The primary outcome was a 6-category ordinal outcome defining the participant's status at Day 90: (1) at home (defined as the type of residence before hospitalization) and off oxygen (recovered) for at least 77 days, (2) at home and off oxygen for 49-76 days, (3) at home and off oxygen for 1-48 days, (4) not hospitalized but either on supplemental oxygen or not at home, (5) hospitalized or in hospice care, or (6) dead.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '6 participants in the Aviptadil+SOC arm and 5 participants in the Placebo+SOC arm did not have the day 90 status available to compute the primary endpoint. These participants were excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died Through Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aviptadil + SOC', 'description': 'Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761)\n\nAviptadil: 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.\n\nCorticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761)\n\nAviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days.\n\nCorticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.'}], 'classes': [{'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.78', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.41', 'estimateComment': 'Hazard ratio for active/placebo (95% confidence interval); pvalue', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Day 90', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Safety Outcome Through Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aviptadil + SOC', 'description': 'Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761)\n\nAviptadil: 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.\n\nCorticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761)\n\nAviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days.\n\nCorticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.'}], 'classes': [{'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.40', 'ciLowerLimit': '0.94', 'ciUpperLimit': '2.08', 'estimateComment': 'Odds ratio for active/placebo (95% confidence interval); pvalue', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Day 5', 'description': 'Composite safety outcome of a serious adverse event, Grade 3/4 adverse event, organ failure/serious infection, or death through Day 5', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Safety Outcome Through Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aviptadil + SOC', 'description': 'Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761)\n\nAviptadil: 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.\n\nCorticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761)\n\nAviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days.\n\nCorticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.'}], 'classes': [{'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.15', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.44', 'estimateComment': 'Hazard ratio for active/placebo (95% confidence interval); pvalue', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Day 28', 'description': 'Composite safety outcome of a serious adverse event, Grade 3/4 adverse event, organ failure/serious infection, or death through Day 28', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died Through Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aviptadil + SOC', 'description': 'Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761)\n\nAviptadil: 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.\n\nCorticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.'}, {'id': 'OG001', 'title': 'Placebo + SOC', 'description': 'Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761)\n\nAviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days.\n\nCorticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.71', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.42', 'estimateComment': 'Hazard ratio for active/placebo (95% confidence interval); pvalue', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Day 180', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aviptadil + SOC', 'description': 'Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761).\n\nAviptadil: 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.\n\nCorticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.'}, {'id': 'FG001', 'title': 'Placebo + SOC', 'description': 'Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761).\n\nAviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days.\n\nCorticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '234'}, {'groupId': 'FG001', 'numSubjects': '237'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '231'}, {'groupId': 'FG001', 'numSubjects': '230'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'This substudy presents analysis for Aviptadil vs Aviptadil Placebo. Per protocol, this comparison was conducted among the pooled cohort of participants who were randomized to receive Active Aviptadil or Aviptadil Placebo within randomization strata 1, 2, and 4 of the master protocol.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '461', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aviptadil + SOC', 'description': 'Arm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761)\n\nAviptadil: 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.\n\nCorticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.'}, {'id': 'BG001', 'title': 'Placebo + SOC', 'description': 'Arm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761)\n\nAviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days.\n\nCorticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '317', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'spread': '14.7', 'groupId': 'BG000'}, {'value': '56.2', 'spread': '15.1', 'groupId': 'BG001'}, {'value': '56.4', 'spread': '14.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '341', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '255', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Only ethnicity (race unknown)', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Number of baseline participants only include those that received an infusion.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-08', 'size': 1036611, 'label': 'Study Protocol: Aviptadil (H1)', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_007.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-27T15:23', 'hasProtocol': True}, {'date': '2021-04-01', 'size': 1152045, 'label': 'Study Protocol: Remdesivir (H2)', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_011.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-06T13:00', 'hasProtocol': True}, {'date': '2022-03-08', 'size': 1697302, 'label': 'Study Protocol: Master', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_012.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-06T13:01', 'hasProtocol': True}, {'date': '2025-08-05', 'size': 100160, 'label': 'Study Protocol: Overview of Study Documents', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_013.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-06T13:03', 'hasProtocol': True}, {'date': '2022-05-01', 'size': 898471, 'label': 'Statistical Analysis Plan: Addendum', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_014.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-08-06T13:01', 'hasProtocol': False}, {'date': '2021-08-05', 'size': 1663827, 'label': 'Statistical Analysis Plan: Main', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_015.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-08-06T13:02', 'hasProtocol': False}, {'date': '2022-03-08', 'size': 1079343, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_016.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-08-06T13:02', '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': 471}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2024-12-10', 'resultsFirstSubmitDate': '2025-05-29', 'studyFirstSubmitQcDate': '2024-12-10', 'lastUpdatePostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-23', 'studyFirstPostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90', 'timeFrame': 'Status on Day 90', 'description': "The primary outcome was a 6-category ordinal outcome defining the participant's status at Day 90: (1) at home (defined as the type of residence before hospitalization) and off oxygen (recovered) for at least 77 days, (2) at home and off oxygen for 49-76 days, (3) at home and off oxygen for 1-48 days, (4) not hospitalized but either on supplemental oxygen or not at home, (5) hospitalized or in hospice care, or (6) dead."}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Died Through Day 90', 'timeFrame': 'Through Day 90'}, {'measure': 'Number of Participants With a Safety Outcome Through Day 5', 'timeFrame': 'Through Day 5', 'description': 'Composite safety outcome of a serious adverse event, Grade 3/4 adverse event, organ failure/serious infection, or death through Day 5'}, {'measure': 'Number of Participants With a Safety Outcome Through Day 28', 'timeFrame': 'Through Day 28', 'description': 'Composite safety outcome of a serious adverse event, Grade 3/4 adverse event, organ failure/serious infection, or death through Day 28'}, {'measure': 'Number of Participants Who Died Through Day 180', 'timeFrame': 'Through Day 180'}]}, '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': {'seeAlsoLinks': [{'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}, {'url': 'http://www.cdc.gov/coronavirus/2019-nCoV/index.html', 'label': 'CDC (Centers for Disease Control and Prevention): Coronavirus (COVID-19) website'}, {'url': 'http://www.niaid.nih.gov/clinical-trials/participant-guide', 'label': "A Participant's Guide to Clinical Trials (NIAID)"}, {'url': 'http://www.niaid.nih.gov/clinical-trials/find-a-clinical-trial', 'label': 'Find a Clinical Trial (NIAID)'}, {'url': 'http://www.niaid.nih.gov/clinical-trials', 'label': 'Clinical Trials at NIAID'}, {'url': 'http://www.niaid.nih.gov/', 'label': 'National Institute for Allergy and Infectious Diseases (NIAID)'}, {'url': 'http://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 Aviptadil 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 Aviptadil plus current standard of care (SOC), or with placebo plus current SOC.', 'detailedDescription': 'This is a treatment trial of the ACTIV-3b/TESICO master protocol (NCT04843761) to evaluate the safety and efficacy of Aviptadil at improving outcomes for patients with acute respiratory failure related to COVID-19.\n\nThis protocol will be adaptive, randomized, blinded and initially placebo-controlled. Participants will receive standard of care (SOC) treatment as part of the protocol.\n\nThis 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 study.\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 Aviptadil versus placebo with use of the ordinal outcome. The planned sample size is 320 participants. 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\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\nRefer to the master protocol (NCT04843761)\n\nExclusion Criteria:\n\nRefer to the master protocol (NCT04843761)\n\nAdditional Exclusion Criteria:\n\n* Refractory hypotension\n* Severe diarrhea\n* Current C. difficile infection\n* Pregnancy or current breast-feeding\n* End-stage liver disease'}, 'identificationModule': {'nctId': 'NCT06729606', 'briefTitle': 'Aviptadil for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial)', '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 (Trial H1: Aviptadil)', 'orgStudyIdInfo': {'id': '015/ACTIV-3b/H1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aviptadil + SOC', 'interventionNames': ['Biological: Aviptadil', 'Drug: Corticosteroid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + SOC', 'interventionNames': ['Biological: Aviptadil Placebo', 'Drug: Corticosteroid']}], 'interventions': [{'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': ['Aviptadil + SOC']}, {'name': 'Aviptadil Placebo', 'type': 'BIOLOGICAL', 'description': 'Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days.', 'armGroupLabels': ['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': ['Aviptadil + SOC', 'Placebo + SOC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '93701', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Fresno (Site 203-005), 155 N. 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