Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT04350593
Status:
COMPLETED
Last Update Posted:
2022-06-10
First Post:
2020-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dapagliflozin in Respiratory Failure in Patients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DARE-19@saint-lukes.org', 'phone': '816-932-9858', 'title': 'DARE-19 Global Project Manager', 'organization': "Saint Luke's Hospital of Kansas City"}, 'certainAgreement': {'otherDetails': 'The sponsor can review results communications prior to public release and can embargo communications regarding results for a period that is less than or equal to 45 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication with the exception of requiring the removal of confidential information. The embargo can be extended to 90 days if there would be any patent applications to be filed by the sponsor related to the proposed publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.', 'description': 'All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Dapagliflozin 10mg', 'description': 'Dapagliflozin 10 mg daily\n\nDapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg', 'otherNumAtRisk': 613, 'deathsNumAtRisk': 625, 'otherNumAffected': 2, 'seriousNumAtRisk': 613, 'deathsNumAffected': 41, 'seriousNumAffected': 70}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Dapagliflozin matching placebo 10 mg daily\n\nPlacebo: Placebo Comparator', 'otherNumAtRisk': 616, 'deathsNumAtRisk': 625, 'otherNumAffected': 2, 'seriousNumAtRisk': 616, 'deathsNumAffected': 54, 'seriousNumAffected': 87}], 'otherEvents': [{'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}], 'seriousEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Severe acute respiratory syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Device related sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Emphysematous pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Herpes virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Meningoencephalitis herpetic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Labyrinthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Pulmonary sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Urinary tract infection enterococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Lactic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Diabetic metabolic decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Euglycemic diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Ischemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Myasthenia gravis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Cerebral disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Presnycope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Arterial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Hypovolemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Respiration abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 32}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Renal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Blood electrolytes abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Cardiac Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}, {'term': 'Upper gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Prevention of COVID-19 Complications or Death: During the 30-day Treatment Period, Time to First Occurrence of New/Worsened Organ Dysfunction During Index Hospitalization or Death From Any Cause.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin 10mg', 'description': 'Dapagliflozin 10 mg daily\n\nDapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Dapagliflozin matching placebo 10 mg daily\n\nPlacebo: Placebo Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000'}, {'value': '15.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization through Day 30', 'description': 'Time to first occurrence of new/worsened organ dysfunction during index hospitalization or death from any cause.\n\nEvent rates are presented as the number of subjects with event per 100 patient month (30 days) of follow-up.\n\nUnit of Measure: Patients with events per 100 patient-months (pt-mos) at risk.\n\nNew/worsened organ dysfunction is defined as at least one of the following:\n\n* Respiratory decompensation requiring initiation of mechanical ventilation (includes invasive or non-invasive ventilation, CPAP, or BiPAP), and/or initiation of extracorporeal membrane oxygenation (ECMO)\n* New or worsening congestive heart failure\n* Requirement for vasopressor therapy and/or inotropic or mechanical circulatory support\n* Ventricular tachycardia or fibrillation lasting at least 30 seconds and/or associated with hemodynamic instability or pulseless electrical activity, or resuscitated cardiac arrest\n* Doubling of s-Creatinine or initiation of renal replacement therapy', 'unitOfMeasure': 'Patients with events/100 pt-mos at risk', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Improving Clinical Recovery: Hierarchical Composite Outcome Measure Including Death From Any Cause Through Day 30, New/Worsened Organ Dysfunction, Clinical Status at Day 30 and Hospital Discharge Before Day 30 and Alive at Day 30.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin 10mg', 'description': 'Dapagliflozin 10 mg daily\n\nDapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Dapagliflozin matching placebo 10 mg daily\n\nPlacebo: Placebo Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '547', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization through Day 30', 'description': 'The number of patients experiencing improvement by day 30 compared with baseline (discharged from hospital without a worsening event and alive, or still in hospital without a worsening event and without oxygen support) in the hierarchical composite endpoint analysis.\n\nHierarchical composite outcome measure includes:\n\n* Death from any cause through Day 30\n* New/worsened organ dysfunction\n* Clinical status at Day 30 for patients still hospitalized and without any worsening organ dysfunction\n* Hospital discharge before Day 30 and alive at Day 30', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin 10mg', 'description': 'Dapagliflozin 10 mg daily\n\nDapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Dapagliflozin matching placebo 10 mg daily\n\nPlacebo: Placebo Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '6.0'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization through Day 30', 'description': 'Time to hospital discharge (refers to index hospitalization only).\n\nMedian time to hospital discharge is presented in days.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Number of Days Alive and Free From Respiratory Decompensation Requiring Initiation of Mechanical Ventilation (Includes Invasive or Non-invasive Ventilation, CPAP, or BiPAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin 10mg', 'description': 'Dapagliflozin 10 mg daily\n\nDapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Dapagliflozin matching placebo 10 mg daily\n\nPlacebo: Placebo Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '27.8', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '27.4', 'spread': '7.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Randomization through Day 30', 'description': 'Total number of days alive and free from mechanical ventilation (includes invasive or non-invasive ventilation, CPAP, or BiPAP) is calculated for each patient as total follow-up time (30 days) substracted days in hospital with mechanical ventilation and days dead.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Number of Days Alive, Not in the ICU, and Free From Respiratory Decompensation Requiring Initiation of Mechanical Ventilation (Includes Invasive or Non-invasive Ventilation, CPAP, or BiPAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin 10mg', 'description': 'Dapagliflozin 10 mg daily\n\nDapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Dapagliflozin matching placebo 10 mg daily\n\nPlacebo: Placebo Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '27.5', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '27.1', 'spread': '7.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Randomization through Day 30', 'description': 'Total number of days alive, not in the ICU and free from mechanical ventilation (includes invasive or non-invasive ventilation, CPAP, or BiPAP) is calculated for each patient as total follow-up time (30 days) substracted days in ICU and days dead.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Composite of Acute Kidney Injury or Initiation of Renal Replacement Therapy, or Death From Any Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin 10mg', 'description': 'Dapagliflozin 10 mg daily\n\nDapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Dapagliflozin matching placebo 10 mg daily\n\nPlacebo: Placebo Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '11.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization through Day 30', 'description': 'Acute kidney injury is defined as an episode of doubling s-creatinine compared to baseline during index hospitalization or SAE. Initiation of renal replacement therapy is defined as initiation of renal replacement therapy during index hospitalization or SAE.\n\nEvent rates are presented as the number of subjects with event per 100 patient month (30 days) of follow-up.\n\nUnit of Measure: Patients with events per 100 patient-months (pt-mos) at risk.', 'unitOfMeasure': 'Patients with events/100 pt-mos at risk', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Death From Any Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin 10mg', 'description': 'Dapagliflozin 10 mg daily\n\nDapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Dapagliflozin matching placebo 10 mg daily\n\nPlacebo: Placebo Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}, {'value': '9.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization through Day 30', 'description': 'Time to death from any cause.\n\nEvent rates are presented as the number of subjects with event per 100 patient month (30 days) of follow-up.\n\nUnit of Measure: Patients with events per 100 patient-months (pt-mos) at risk.', 'unitOfMeasure': 'Patients with events/100 pt-mos at risk', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dapagliflozin 10mg', 'description': 'Dapagliflozin 10 mg daily\n\nDapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Dapagliflozin matching placebo 10 mg daily\n\nPlacebo: Placebo Comparator'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '625'}, {'groupId': 'FG001', 'numSubjects': '625'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '617'}, {'groupId': 'FG001', 'numSubjects': '620'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dapagliflozin 10mg', 'description': 'Dapagliflozin 10 mg daily\n\nDapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Dapagliflozin matching placebo 10 mg daily\n\nPlacebo: Placebo Comparator'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '61.0', 'spread': '13.4', 'groupId': 'BG000'}, {'value': '61.8', 'spread': '13.5', 'groupId': 'BG001'}, {'value': '61.4', 'spread': '13.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '260', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '533', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '365', 'groupId': 'BG000'}, {'value': '352', 'groupId': 'BG001'}, {'value': '717', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '621', 'groupId': 'BG000'}, {'value': '619', 'groupId': 'BG001'}, {'value': '1240', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '394', 'groupId': 'BG000'}, {'value': '362', 'groupId': 'BG001'}, {'value': '756', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '343', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'N numbers might differ for some parameters based on data availability.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'BG000'}, {'value': '618', 'groupId': 'BG001'}, {'value': '1241', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '452', 'groupId': 'BG000'}, {'value': '459', 'groupId': 'BG001'}, {'value': '911', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '79', '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', 'populationDescription': 'N numbers might differ for some parameters based on data availability.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Argentina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '382', 'groupId': 'BG000'}, {'value': '380', 'groupId': 'BG001'}, {'value': '762', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}, {'title': 'India', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Type 2 diabetes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '312', 'groupId': 'BG000'}, {'value': '324', 'groupId': 'BG001'}, {'value': '636', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Heart failure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '526', 'groupId': 'BG000'}, {'value': '534', 'groupId': 'BG001'}, {'value': '1060', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Atherosclerotic cardiovascular disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chronic kidney disease, estimated glomerular filtration rate (eGFR) 25-60 mL/min per 1.73 m^2', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Patients with two or more inclusion risk factors', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '292', 'groupId': 'BG000'}, {'value': '319', 'groupId': 'BG001'}, {'value': '611', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age >/= 60 years', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '339', 'groupId': 'BG000'}, {'value': '360', 'groupId': 'BG001'}, {'value': '699', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index >/= 30', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '296', 'groupId': 'BG000'}, {'value': '305', 'groupId': 'BG001'}, {'value': '601', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chronic obstructive pulmonary disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current smoker', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Heart rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '79.3', 'spread': '13.7', 'groupId': 'BG000'}, {'value': '79.7', 'spread': '13.7', 'groupId': 'BG001'}, {'value': '79.5', 'spread': '13.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Blood pressure - systolic', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '126.6', 'spread': '16.0', 'groupId': 'BG000'}, {'value': '127.0', 'spread': '16.3', 'groupId': 'BG001'}, {'value': '126.8', 'spread': '16.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Blood pressure - diastolic', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '76.6', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '76.2', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '76.4', 'spread': '10.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Temperature', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36.4', 'spread': '0.6', 'groupId': 'BG000'}, {'value': '36.4', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '36.4', 'spread': '0.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'degrees Celcius', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Oxygen saturation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '95.5', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '95.2', 'spread': '1.8', 'groupId': 'BG001'}, {'value': '95.3', 'spread': '1.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '% (measured on supplemental oxygen)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'eGFR', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '84.1', 'spread': '25.0', 'groupId': 'BG000'}, {'value': '83.4', 'spread': '24.6', 'groupId': 'BG001'}, {'value': '83.8', 'spread': '24.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL/min per 1.73 m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'SARS-CoV-2 test result at baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Positive', 'measurements': [{'value': '584', 'groupId': 'BG000'}, {'value': '575', 'groupId': 'BG001'}, {'value': '1159', 'groupId': 'BG002'}]}, {'title': 'Negative', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Test results not known', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '225', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '444', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Beta-blocker', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Calcium blocker', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Loop-diuretic', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Statin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Anti-coagulant', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '527', 'groupId': 'BG000'}, {'value': '527', 'groupId': 'BG001'}, {'value': '1054', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Biguanide', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sulfonylurea', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Dipeptidyl peptidase 4 (DPP-4) inhibitor', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Glucagon-like peptide 1 (GLP-1) receptor agonist', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insulin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '223', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '444', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Remdesivir', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Systemic corticosteroids', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '355', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Dexamethasone', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '269', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Other systemic glucocorticoid', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '625', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-20', 'size': 1140076, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-03-29T12:54', 'hasProtocol': True}, {'date': '2021-03-03', 'size': 2057149, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-03-29T12:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-13', 'studyFirstSubmitDate': '2020-04-14', 'resultsFirstSubmitDate': '2022-03-29', 'studyFirstSubmitQcDate': '2020-04-14', 'lastUpdatePostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-11', 'studyFirstPostDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevention of COVID-19 Complications or Death: During the 30-day Treatment Period, Time to First Occurrence of New/Worsened Organ Dysfunction During Index Hospitalization or Death From Any Cause.', 'timeFrame': 'Randomization through Day 30', 'description': 'Time to first occurrence of new/worsened organ dysfunction during index hospitalization or death from any cause.\n\nEvent rates are presented as the number of subjects with event per 100 patient month (30 days) of follow-up.\n\nUnit of Measure: Patients with events per 100 patient-months (pt-mos) at risk.\n\nNew/worsened organ dysfunction is defined as at least one of the following:\n\n* Respiratory decompensation requiring initiation of mechanical ventilation (includes invasive or non-invasive ventilation, CPAP, or BiPAP), and/or initiation of extracorporeal membrane oxygenation (ECMO)\n* New or worsening congestive heart failure\n* Requirement for vasopressor therapy and/or inotropic or mechanical circulatory support\n* Ventricular tachycardia or fibrillation lasting at least 30 seconds and/or associated with hemodynamic instability or pulseless electrical activity, or resuscitated cardiac arrest\n* Doubling of s-Creatinine or initiation of renal replacement therapy'}, {'measure': 'Improving Clinical Recovery: Hierarchical Composite Outcome Measure Including Death From Any Cause Through Day 30, New/Worsened Organ Dysfunction, Clinical Status at Day 30 and Hospital Discharge Before Day 30 and Alive at Day 30.', 'timeFrame': 'Randomization through Day 30', 'description': 'The number of patients experiencing improvement by day 30 compared with baseline (discharged from hospital without a worsening event and alive, or still in hospital without a worsening event and without oxygen support) in the hierarchical composite endpoint analysis.\n\nHierarchical composite outcome measure includes:\n\n* Death from any cause through Day 30\n* New/worsened organ dysfunction\n* Clinical status at Day 30 for patients still hospitalized and without any worsening organ dysfunction\n* Hospital discharge before Day 30 and alive at Day 30'}], 'secondaryOutcomes': [{'measure': 'Time to Hospital Discharge', 'timeFrame': 'Randomization through Day 30', 'description': 'Time to hospital discharge (refers to index hospitalization only).\n\nMedian time to hospital discharge is presented in days.'}, {'measure': 'Total Number of Days Alive and Free From Respiratory Decompensation Requiring Initiation of Mechanical Ventilation (Includes Invasive or Non-invasive Ventilation, CPAP, or BiPAP)', 'timeFrame': 'Randomization through Day 30', 'description': 'Total number of days alive and free from mechanical ventilation (includes invasive or non-invasive ventilation, CPAP, or BiPAP) is calculated for each patient as total follow-up time (30 days) substracted days in hospital with mechanical ventilation and days dead.'}, {'measure': 'Total Number of Days Alive, Not in the ICU, and Free From Respiratory Decompensation Requiring Initiation of Mechanical Ventilation (Includes Invasive or Non-invasive Ventilation, CPAP, or BiPAP)', 'timeFrame': 'Randomization through Day 30', 'description': 'Total number of days alive, not in the ICU and free from mechanical ventilation (includes invasive or non-invasive ventilation, CPAP, or BiPAP) is calculated for each patient as total follow-up time (30 days) substracted days in ICU and days dead.'}, {'measure': 'Time to Composite of Acute Kidney Injury or Initiation of Renal Replacement Therapy, or Death From Any Cause', 'timeFrame': 'Randomization through Day 30', 'description': 'Acute kidney injury is defined as an episode of doubling s-creatinine compared to baseline during index hospitalization or SAE. Initiation of renal replacement therapy is defined as initiation of renal replacement therapy during index hospitalization or SAE.\n\nEvent rates are presented as the number of subjects with event per 100 patient month (30 days) of follow-up.\n\nUnit of Measure: Patients with events per 100 patient-months (pt-mos) at risk.'}, {'measure': 'Time to Death From Any Cause', 'timeFrame': 'Randomization through Day 30', 'description': 'Time to death from any cause.\n\nEvent rates are presented as the number of subjects with event per 100 patient month (30 days) of follow-up.\n\nUnit of Measure: Patients with events per 100 patient-months (pt-mos) at risk.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sodium-glucose cotransporter-2 inhibitor (SGLT2i)', 'dapagliflozin', 'COVID-19'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '40739638', 'type': 'DERIVED', 'citation': 'Abdel Jawad M, Furtado RHM, Esterline R, Oscarsson J, Gasparyan SB, Koch GG, Martinez F, Mukhtar O, Verma S, Langkilde AM, Ambery P, Patel S, Gosch K, Windsor SL, Soares RVP, Moia DDF, Aboudara M, Javaheri A, Saraiva JFK, Maia LN, Berwanger O, Sauer AJ, Kosiborod MN. Efficacy and safety of dapagliflozin in patients hospitalized with COVID-19 with and without type 2 diabetes: a prespecified analysis of the DARE-19 randomized trial. Cardiovasc Diabetol. 2025 Jul 30;24(1):307. doi: 10.1186/s12933-025-02875-6.'}, {'pmid': '38770818', 'type': 'DERIVED', 'citation': 'Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.'}, {'pmid': '35699910', 'type': 'DERIVED', 'citation': 'Gasparyan SB, Buenconsejo J, Kowalewski EK, Oscarsson J, Bengtsson OF, Esterline R, Koch GG, Berwanger O, Kosiborod MN. Design and Analysis of Studies Based on Hierarchical Composite Endpoints: Insights from the DARE-19 Trial. Ther Innov Regul Sci. 2022 Sep;56(5):785-794. doi: 10.1007/s43441-022-00420-1. Epub 2022 Jun 14.'}, {'pmid': '34302745', 'type': 'DERIVED', 'citation': 'Kosiborod MN, Esterline R, Furtado RHM, Oscarsson J, Gasparyan SB, Koch GG, Martinez F, Mukhtar O, Verma S, Chopra V, Buenconsejo J, Langkilde AM, Ambery P, Tang F, Gosch K, Windsor SL, Akin EE, Soares RVP, Moia DDF, Aboudara M, Hoffmann Filho CR, Feitosa ADM, Fonseca A, Garla V, Gordon RA, Javaheri A, Jaeger CP, Leaes PE, Nassif M, Pursley M, Silveira FS, Barroso WKS, Lazcano Soto JR, Nigro Maia L, Berwanger O. Dapagliflozin in patients with cardiometabolic risk factors hospitalised with COVID-19 (DARE-19): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2021 Sep;9(9):586-594. doi: 10.1016/S2213-8587(21)00180-7. Epub 2021 Jul 21.'}]}, 'descriptionModule': {'briefSummary': 'This is an international, multicenter, parallel-group, randomized, double-blind, placebo controlled, study in hospitalized adult patients with coronavirus disease 2019 (COVID-19) in the United States, Brazil, Mexico, Argentina, India, Canada, and United Kingdom. The study is evaluating the effect of dapagliflozin 10 milligrams versus placebo, given once daily for 30 days in addition to background local standard of care therapy, on reducing complications and all-cause mortality, or improving clinical recovery.', 'detailedDescription': 'COVID-19 can lead to multiorgan failure, especially in high-risk patients. Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i), favorably impacts many processes dysregulated during acute illness such as COVID-19, has significant cardio- and reno-protective benefits in cardiometabolic disease, and may provide similar organ protection in COVID-19.\n\nThe study population will include hospitalized patients with respiratory manifestations of COVID-19 of any duration, but without the need for mechanical ventilation. The eligible patients should have risk factors for developing serious complications of COVID-19, including hypertension, Type 2 diabetes, atherosclerotic cardiovascular disease, heart failure and/or chronic kidney disease stage 3 to 4.\n\nPatients will be treated for 30 days, with either dapagliflozin 10 milligrams daily or placebo, each to be given in addition to the usual standard of care in the participating hospital.\n\nThe study assessments include only those that are absolutely critical for ensuring the safety of the patients, to measure efficacy outcomes, and collect biomarker data, so as not to place too high a burden on the study personnel and to minimize additional risk of exposure to severe acute respiratory syndrome coronavirus 2 (SARS CoV-2).\n\nThe dual primary efficacy endpoints of the study are time to first event of either complications or death from any cause, and improved clinical recovery through 30 days of follow-up. An extended follow-up period of 60 days (after the 30-day treatment period) is included, in order to examine longer-term trajectory of recovery from COVID-19 among trial participants.\n\nThe safety data will be monitored by an Independent Data and Safety Monitoring Committee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of informed consent\n2. Male or female patients aged ≥18 years\n3. Currently hospitalized\n4. Hospital admission no more than 4 days prior to screening\n5. Confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by laboratory testing within 10 days prior to screening, or strongly suspected SARS-CoV-2 infection on presentation\n6. Chest radiography or computerized tomography (CT) findings that, in the opinion of the investigator, are consistent with coronavirus disease 2019 (COVID-19)\n7. Blood oxygen saturation (SpO2) ≥ 94% while receiving low-flow supplemental oxygen (5 liters or less)\n8. Medical history of at least one of the following:\n\n 1. hypertension\n 2. type 2 diabetes\n 3. atherosclerotic cardiovascular disease\n 4. heart failure (with either reduced or preserved left ventricular ejection fraction (LVEF))\n 5. chronic kidney disease stage 3 to 4 (estimated glomerular filtration rate (eGFR) between 25 to 60 mL/min/1.73 m2)\n\nKey Exclusion Criteria:\n\n1. Respiratory decompensation requiring mechanical ventilation (includes invasive or non invasive ventilation, continuous positive airway pressure (CPAP), or bilevel positive airway pressure (BiPAP))\n2. Expected need for mechanical ventilation (includes invasive or non-invasive ventilation, CPAP, or BiPAP) within the next 24 hours\n3. Expected survival of less than 24 hours at the time of presentation, in the judgement of the investigator\n4. eGFR \\<25 mL/min/1.73 m2 or receiving renal replacement therapy/dialysis\n5. Systolic blood pressure \\<95 mmHg and/or requirement for vasopressor treatment and/or inotropic or mechanical circulatory support at Screening\n6. History of type 1 diabetes mellitus\n7. History of diabetic ketoacidosis\n8. Currently receiving or has received in the last 14 days, experimental immune modulators and/or monoclonal antibody therapies for COVID-19\n9. Current treatment with any sodium-glucose cotransporter-2 inhibitor (SGLT2i) (eg, dapagliflozin, canagliflozin, empagliflozin, ertugliflozin) or having received treatment with any SGLT2i within 4 weeks prior to screening\n10. Current participation in another interventional clinical trial (with an investigational drug) that is not an observational registry\n\n * Note that use of rescue therapies including immune modulators, monoclonal antibody therapies, antiviral therapies, and other agents that are approved or being used through open-label compassionate/expanded use programs or in accordance with the local standard of care is permitted during the study.'}, 'identificationModule': {'nctId': 'NCT04350593', 'acronym': 'DARE-19', 'briefTitle': 'Dapagliflozin in Respiratory Failure in Patients With COVID-19', 'organization': {'class': 'OTHER', 'fullName': "Saint Luke's Health System"}, 'officialTitle': 'An International, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Dapagliflozin in Respiratory Failure in Patients With COVID-19', 'orgStudyIdInfo': {'id': 'D1690C00081'}, 'secondaryIdInfos': [{'id': 'ESR-20-20653', 'type': 'OTHER_GRANT', 'domain': 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