Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-28 @ 3:36 PM
Study NCT ID:
NCT04417257
Status:
TERMINATED
Last Update Posted:
2025-11-13
First Post:
2020-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of LAU-7b for the Treatment of Coronavirus Disease 2019 (COVID-19) Disease in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017313', 'term': 'Fenretinide'}], 'ancestors': [{'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jmhoule@laurentpharma.com', 'phone': '514-941-2313', 'title': 'Vice president Clinical Development', 'organization': 'Laurent Pharmaceuticals Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The Pilot Phase 2 was conducted prior to the Omicron variants and completed normally. Participants with Health Status 3 + 4 grouped together were further studied in a Phase 3 extension, conducted with Omicron variants and vaccination. The Phase 3 was terminated early for futility due to lack of aggravation events (primary efficacy endpoint). The Phase 3 SAP pre-specified the efficacy analyses performed under such a scenario.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the time of informed consent until the End-of-Study follow-up on Day 60, or until early termination or death, whichever occurred first.', 'description': 'Any AE that occurred from the first dose of study treatment until the End-of-Study follow-up, on Day 60, or until early termination or death, whichever occurred first, was considered treatment-emergent (TEAE). Since participants are already hospitalized, other hospitalization for routine or planned clinical procedures, prolongation of hospitalization for any COVID-19-related adverse change in the subject\'s condition, or for "social" reasons, were not considered as a serious AE.', 'eventGroups': [{'id': 'EG000', 'title': 'LAU-7b Phase 2', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 300 mg per day for the first 3 days, followed by 200 mg per day', 'otherNumAtRisk': 117, 'deathsNumAtRisk': 117, 'otherNumAffected': 97, 'seriousNumAtRisk': 117, 'deathsNumAffected': 14, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Placebo Phase 2', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 3 capsules per day for the first 3 days, and 2 capsules per day for the following days.', 'otherNumAtRisk': 115, 'deathsNumAtRisk': 115, 'otherNumAffected': 94, 'seriousNumAtRisk': 115, 'deathsNumAffected': 11, 'seriousNumAffected': 22}, {'id': 'EG002', 'title': 'LAU-7b Phase 3', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 300 mg per day for the first 3 days, followed by 200 mg per day', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 45, 'seriousNumAtRisk': 57, 'deathsNumAffected': 3, 'seriousNumAffected': 12}, {'id': 'EG003', 'title': 'Placebo Phase 3', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 3 capsules per day for the first 3 days, and 2 capsules per day for the following days.', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 54, 'seriousNumAtRisk': 62, 'deathsNumAffected': 1, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Hyperglicaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Taste disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}], 'seriousEvents': [{'term': 'Idiopathic neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Cor pulmonale acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Pulseless electrical activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Obstruction gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Subdural hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Ischaemic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Paranoia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Asthma-chronic obstructive pulmonary disease overlap syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Organizing pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Arterial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Outcome for Phase 2: Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 2', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b: LAU-7b will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 300 mg per day for the first 3 days, followed by 200 mg per day'}, {'id': 'OG001', 'title': 'Placebo Phase 2', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo oral capsule: Placebo will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 3 capsules per day for the first 3 days, and 2 capsules per day for the following days.'}], 'classes': [{'title': 'ITT population, alive and free of respiratory failure. Missing data as failure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}, {'title': 'Per-Protocol Population, alive and free of respiratory failure, no imputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'Health Status 3 + 4 at baseline alive and free of respiratory failure. Missing data as failure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Health Status 5 at baseline alive and free of respiratory failure. Missing data as failure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Health Status 3 + 4 at baseline with Day 29 data (no imputation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7377', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.9', 'ciLowerLimit': '-15', 'ciUpperLimit': '9', 'pValueComment': 'one-sided (right tailed)', 'estimateComment': 'A positive difference favours LAU-7b, a negative difference favours placebo.', 'groupDescription': 'Participants with health status data missing on Day 29 were treated as non-responders, where a non-responder was defined as not reaching a health status of 1-4.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.0', 'ciLowerLimit': '-10.0', 'ciUpperLimit': '2.8', 'pValueComment': 'one-sided (right tailed)', 'estimateComment': 'A positive difference favours LAU-7b, a negative difference favours placebo.', 'groupDescription': 'Participants from Per-Protocol population and with available Day 29 health status data', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0177', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.570', 'ciLowerLimit': '0.359', 'ciUpperLimit': '0.907', 'pValueComment': 'À priori threshold for statistical significance is set at 0.1', 'groupDescription': 'Multivariable logistic regression was constructed for the proportion of participants alive and free of respiratory failure on Day 29 as the outcome variable by screening baseline covariates using stepwise technique with an alpha of 0.1 as the entry and stay criterion, and treatment group was forced to remain in the model. Health status at baseline was used as a continuous variable', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'This P-value is for the baseline factor "Health Status at baseline". Other baseline factors not significant.'}, {'pValue': '0.3537', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.9', 'ciLowerLimit': '-10.2', 'ciUpperLimit': '18.2', 'pValueComment': 'One-sided (right tailed)', 'estimateComment': 'A positive difference favours LAU-7b, a negative difference favours placebo.', 'groupDescription': 'Participants in the ITT population with baseline Health Status of 3 + 4 grouped together with imputation of failure for missing Day 29 data', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9590', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.2', 'ciLowerLimit': '-36.6', 'ciUpperLimit': '5.4', 'pValueComment': 'one-sided (right tailed)', 'estimateComment': 'A positive difference favours LAU-7b, a negative difference favours placebo.', 'groupDescription': 'Participants in the ITT population with baseline Health Status of 5 and imputation of failure for missing Day 29 data', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0553', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.9', 'ciLowerLimit': '0.4', 'ciUpperLimit': '17.1', 'pValueComment': 'one-sided (right tailed)', 'estimateComment': 'A positive difference favours LAU-7b, a negative difference favours placebo.', 'groupDescription': 'Participants in the ITT population with baseline Health Status of 3 + 4 and available Day 29 health status data (no imputation)', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'On Day 29', 'description': 'This will be assessed through health status scoring using the WHO 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (received a minimum of one study treatment dose), per-protocol (PP) population (received a minimum of 12 days of study treatment and no major protocol deviation)'}, {'type': 'PRIMARY', 'title': 'Primary Outcome for Phase 3: Proportion of Participants Requiring Mechanical Ventilation (Includes Extra-corporeal Membrane Oxygenation - ECMO) AND/OR Deceased (All Causes) by Day 60 (Ordinal Scale Scores 1-4, Inclusively)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 3', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b: LAU-7b will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 300 mg per day for the first 3 days, followed by 200 mg per day'}, {'id': 'OG001', 'title': 'Placebo Phase 3', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo oral capsule: Placebo will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 3 capsules per day for the first 3 days, and 2 capsules per day for the following days.'}], 'classes': [{'title': 'ITT population with Day 60 data (no imputation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Per-Protocol Population, alive and free of respiratory failure, no imputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6600', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.7', 'ciLowerLimit': '-6.9', 'ciUpperLimit': '13.9', 'pValueComment': 'Two-sided test', 'estimateComment': 'A negative difference favours LAU-7b, a positive difference favours placebo.', 'groupDescription': 'ITT population with Day 60 health status/survival data', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-10.6', 'ciUpperLimit': '12.6', 'pValueComment': 'Two-sided test', 'estimateComment': 'A negative difference favours LAU-7b, a positive difference favours placebo.', 'groupDescription': 'Per-Protocol population with Day 60 health status/survival data', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'By Day 60', 'description': 'This will be assessed through health status scoring using the WHO 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (received a minimum of one study treatment dose), per-protocol (PP) population (received a minimum of 12 days of study treatment and no major protocol deviation)'}, {'type': 'SECONDARY', 'title': 'The Safety of LAU-7b Therapy, Overview.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 2', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 300 mg per day for the first 3 days, followed by 200 mg per day'}, {'id': 'OG001', 'title': 'Placebo Phase 2', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 3 capsules per day for the first 3 days, and 2 capsules per day for the following days.'}, {'id': 'OG002', 'title': 'LAU-7b Phase 3', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 300 mg per day for the first 3 days, followed by 200 mg per day'}, {'id': 'OG003', 'title': 'Placebo Phase 3', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 3 capsules per day for the first 3 days, and 2 capsules per day for the following days.'}], 'classes': [{'title': 'Participants with TEAEs', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}]}, {'title': 'Participants with serious TEAEs', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Participants with at least possibly-related serious TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Participants with TEAEs with fatal outcome', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Participants with TEAEs leading to treatment discontinuation', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Participants with AE related to COVID-19', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}]}, {'title': 'Participants with suspected unexpected serious adverse reaction (SUSAR)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to Day 60', 'description': 'This will be assessed through monitoring of treatment emergent adverse events and serious adverse events, vital signs including oxygen saturation and body temperature, symptom-directed physical examinations and safety laboratory tests.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population = ITT population'}, {'type': 'SECONDARY', 'title': 'The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 2', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 300 mg per day for the first 3 days, followed by 200 mg per day'}, {'id': 'OG001', 'title': 'Placebo Phase 2', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 3 capsules per day for the first 3 days, and 2 capsules per day for the following days.'}, {'id': 'OG002', 'title': 'LAU-7b Phase 3', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 300 mg per day for the first 3 days, followed by 200 mg per day'}, {'id': 'OG003', 'title': 'Placebo Phase 3', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 3 capsules per day for the first 3 days, and 2 capsules per day for the following days.'}], 'classes': [{'title': 'Dry skin', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'Vision blurred', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Dyspnea', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Insomnia', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to Day 60', 'description': 'This will be assessed through monitoring of treatment emergent adverse events and serious adverse events, vital signs including oxygen saturation and body temperature, symptom-directed physical examinations and safety laboratory tests.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population = ITT'}, {'type': 'SECONDARY', 'title': 'Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 2', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG001', 'title': 'Placebo Phase2', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG002', 'title': 'LAU-7b Phase 3', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG003', 'title': 'Placebo Phase 3', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}], 'classes': [{'title': 'Health Status on Day 14', 'categories': [{'title': 'Health Status = 1', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Health Status = 2', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Health Status = 3', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}, {'title': 'Health Status = 4', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}, {'title': 'Health Status = 5', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Health Status = 6', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Health Status = 7', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Missing Health Status data', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Health Status on Day 29', 'categories': [{'title': 'Health Status = 1', 'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}, {'title': 'Health Status = 2', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}, {'title': 'Health Status = 3', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Health Status = 4', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Health Status = 5', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Health Status = 6', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Health Status = 7', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Missing Health Status data', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.5459', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'two-sided test', 'groupDescription': 'ITT population, Day 14. The proportional odds assumption of the ordinal logistic regression was not met (P-value of Score test = 0.0180) and a Wilcoxon two sample test was performed.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6229', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'two-sided test', 'groupDescription': 'ITT population, Day 29. The proportional odds assumption of the ordinal logistic regression was not met (P-value \\<.0001) and a Wilcoxon two sample test was performed.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'On Days 14 and 29', 'description': 'The health status was graded using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; this endpoint was not statistically analyzed for Phase 3, terminated early for futility.'}, {'type': 'SECONDARY', 'title': 'For Phase 2 Portion: Rate of All-causes Death by Day 29, Depicted by a Change From Baseline in the Ordinal Scale Score to Category 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 2', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG001', 'title': 'Placebo Phase 2', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}], 'classes': [{'title': 'Overall ITT population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Rate of all-cause death by Day 29', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'All other Health Status including missing data', 'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Health Status 3 + 4 at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Rate of all-cause death by Day 29', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'All other Health Status including missing data', 'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Health Status 5 at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Rate of all-cause death by Day 29', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'All other Health Status including missing data', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8222', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'two-sided test', 'groupDescription': 'Total number of participants in the overall ITT population who had the event prior to or with Day 29 assessment available.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0536', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'two-sided test', 'groupDescription': 'Total number of participants with Health Status 3 + 4 at baseline who had the event prior to or with Day 29 assessment available.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1131', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'two-sided test', 'groupDescription': 'Total number of participants with Health Status 5 at baseline who had the event prior to or with Day 29 assessment available.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'On Day 29', 'description': 'This was assessed with Day 29 (and Day 60, presented separately) Health Status grading using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; In this portion of study, participants with Health Status 3,4 and 5 were enrolled.'}, {'type': 'SECONDARY', 'title': 'For Phase 3 Portion: Rate of All-causes Death by Day 29, Depicted by a Change From Baseline in the Ordinal Scale Score to Category 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 3', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG001', 'title': 'Placebo Phase 3', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}], 'classes': [{'title': 'Rate of all-cause death by Day 29', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'All other Health Status including missing data', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'On Day 29', 'description': 'This was assessed with Day 29 (and Day 60, presented separately) Health Status grading using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; in this study portion all participants except one (Health Status of 5) had a Health Status of 3 or 4 at baseline, the participant with Health Status of 5 is grouped with the other participants. This endpoint was not statistically analyzed for Phase 3, terminated early for futility.'}, {'type': 'SECONDARY', 'title': 'For Phase 2 Portion: Rate of All-causes Death By Day 60, Depicted by a Change From Baseline in the Ordinal Scale Score to Category 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 2', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG001', 'title': 'Placebo Phase 2', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}], 'classes': [{'title': 'Overall ITT population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Rate of all-cause death by Day 60', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'All other Health Status including missing data', 'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Health Status 3 + 4 at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Rate of all-cause death by Day 60', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'All other Health Status including missing data', 'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Health Status 5 at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Rate of all-cause death by Day 60', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'All other Health Status including missing data', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6689', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'two-sided test', 'groupDescription': 'Total number of participants in the overall ITT population who had the event prior to or with Day 60 assessment available.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0536', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'two-sided test', 'groupDescription': 'Total number of participants with Health Status 3 + 4 at baseline who had the event prior to or with Day 60 assessment available.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0786', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'two-sided test', 'groupDescription': 'Total number of participants with Health Status 5 at baseline who had the event prior to or with Day 60 assessment available.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'On Day 60', 'description': 'This was assessed with Day 60 (and Day 29, presented separately) Health Status grading using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; in this portion of study, participants with Health Status 3,4 and 5 were enrolled.'}, {'type': 'SECONDARY', 'title': 'For Phase 3 Portion: Rate of All-causes Death By Day 60, Depicted by a Change From Baseline in the Ordinal Scale Score to Category 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 3', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG001', 'title': 'Placebo Phase 3', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}], 'classes': [{'title': 'Rate of all-cause death by Day 60', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'All other Health Status including missing data', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'On Day 60', 'description': 'This was assessed with Day 60 (and Day 29, presented separately) Health Status grading using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; in this portion of study, all except one (Health Status of 5) had a Health Status of 3 or 4 at baseline, the participant with Health Status of 5 is grouped with the other participants. This endpoint was not statistically analyzed for Phase 3, terminated early for futility.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 3', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG001', 'title': 'Placebo Phase 3', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Two-sided test'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 29', 'description': 'This will be assessed through health status scoring using the WHO 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with Day 29 health status/survival data (no imputation); this is a secondary endpoint for Phase 3, terminated early for futility.'}, {'type': 'SECONDARY', 'title': 'For Phase 2 Portion: Rate of COVID-19 Disease-related Aggravation, Depicted by a Change From Baseline in the Ordinal Scale Score of at Least One Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 2', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG001', 'title': 'Placebo Phase 2', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}], 'classes': [{'title': 'Overall ITT population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Rate of COVID-19 disease-related aggravation by Day 60', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'title': 'No aggravation by Day 60', 'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Health Status 3 + 4 at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Rate of COVID-19 disease-related aggravation by Day 60', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'No aggravation by Day 60', 'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Health Status 5 at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Rate of COVID-19 disease-related aggravation by Day 60', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'No aggravation by Day 60', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'two-sided test', 'groupDescription': 'Calculated based on the total number of participants who had the event prior to or with Day 60 assessment available within each group', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0680', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'two-sided test', 'groupDescription': 'Calculated based on the total number of participants with health status 3 + 4 at baseline who had the event prior to or with Day 60 assessment available within each group.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0534', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'two-sided test', 'groupDescription': 'Calculated based on the total number of participants with health status 5 at baseline who had the event prior to or with Day 60 assessment available within each group.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to Day 60', 'description': 'This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; in this portion of study, participants with Health Status of 3, 4 and 5 were enrolled.'}, {'type': 'SECONDARY', 'title': 'For Phase 3 Portion: Rate of COVID-19 Disease-related Aggravation, Depicted by a Change From Baseline in the Ordinal Scale Score of at Least One Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 3', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG001', 'title': 'Placebo Phase 3', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}], 'classes': [{'title': 'Rate of COVID-19 disease-related aggravation by Day 60', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'No aggravation by Day 60', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7923', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided test', 'groupDescription': 'Calculated based on the total number of participants who had the event prior to or with Day 60 assessment available within each group', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to Day 60', 'description': 'This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; in this portion of study, all except one (Health Status of 5) had a Health Status of 3 or 4 at baseline, the participant with Health Status of 5 is grouped with the other participants.'}, {'type': 'SECONDARY', 'title': 'For Phase 2 Only: Rate of COVID-19 Disease-related Transfer to Intensive Care Unit, Depicted by a Change From Baseline in the Ordinal Scale Score to Categories 5 or 6.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 2', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG001', 'title': 'Placebo Phase 2', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}], 'classes': [{'title': 'Overall ITT population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Rate of COVID-19 disease-related transfer to ICU', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}, {'title': 'No transfer to ICU', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Health Status 3 + 4 at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Rate of COVID-19 disease-related transfer to ICU', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'No transfer to ICU', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Health Status 5 at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Rate of COVID-19 disease-related transfer to ICU', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': 'No transfer to ICU', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8886', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'two-sided test', 'groupDescription': 'Calculated based on the total number of participants who had the event prior to or with Day 60 assessment available within each group.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2735', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'two-sided test', 'groupDescription': 'Calculated based on the total number of participants with Health Status 3 + 4 at baseline who had the event prior to or with Day 60 assessment available within each group.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3604', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'two-sided test', 'groupDescription': 'Calculated based on the total number of participants with Health Status 5 at baseline who had the event prior to or with Day 60 assessment available within each group.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to Day 60', 'description': 'This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; this endpoint was analyzed for Phase 2 only. Due to early termination of Phase 3, this endpoint was planned not to be analyzed.'}, {'type': 'SECONDARY', 'title': 'For Phase 2 Only: Rate of COVID-19 Disease-related Transfer to Mechanical Ventilation, Depicted by a Change From Baseline in the Ordinal Scale Score to Category 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 2', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG001', 'title': 'Placebo Phase 2', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}], 'classes': [{'title': 'Overall ITT population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Rate of COVID-19 disease-related transfer to mechanical ventilation', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'No transfer to mechanical ventilation', 'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Health Status 3 + 4 at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Rate of COVID-19 disease-related transfer to mechanical ventilation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'No transfer to mechanical ventilation', 'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Health Status 5 at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Rate of COVID-19 disease-related transfer to mechanical ventilation', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'No transfer to mechanical ventilation', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'two-sided test', 'groupDescription': 'Calculated based on the total number of participants who had the event prior to or with Day 60 assessment available within each group.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0253', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'two-sided test', 'groupDescription': 'Calculated based on the total number of participants with Health Status 3 + 4 at baseline who had the event prior to or with Day 60 assessment available within each group.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2729', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'two-sided test', 'groupDescription': 'Calculated based on the total number of participants with Health Status 5 at baseline who had the event prior to or with Day 60 assessment available within each group.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to Day 60', 'description': 'This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; this endpoint was analyzed for Phase 2 only. Due to early termination of Phase 3, this endpoint was planned not to be analyzed.'}, {'type': 'SECONDARY', 'title': 'For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 2', 'description': 'Active drug as LAU-7b capsules LAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG001', 'title': 'Placebo Phase 2', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm) Placebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}], 'classes': [{'title': 'Change from baseline on Day 14/end of hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Change of -4 categories', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Change of -3 categories', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Change of -2 categories', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Change of -1 category', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'title': 'No change', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': 'Change of +1 category', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Change of +2 categories', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline on Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Change of -4 categories', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Change of -3 categories', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'title': 'Change of -2 categories', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'title': 'Change of -1 category', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'No change', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Change of +1 category', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Change of +2 categories', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline on Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Change of -4 categories', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Change of -3 categories', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'title': 'Change of -2 categories', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Change of -1 category', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'No change', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Change of +1 category', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Change of +2 categories', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline on Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Change of -4 categories', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}, {'title': 'Change of -3 categories', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'title': 'Change of -2 categories', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Change of -1 category', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'No change', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Change of +1 category', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Change of +2 categories', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6460', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Alpha set at 0.05', 'groupDescription': 'Null hypothesis of no difference', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to Day 60', 'description': 'This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score.\n\nOutcome measure data are counts of participants with a given change from baseline in number of categories, by treatment group.\n\nThe mean change from baseline is compared between treatment groups.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; this endpoint was analyzed for Phase 2 only. Due to early termination of Phase 3, this endpoint was planned not to be analyzed.'}, {'type': 'SECONDARY', 'title': "For Phase 2 Only: Time to a Participant's Improvement of at Least One Category on the Ordinal Scale Health Status.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 2', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG001', 'title': 'Placebo Phase 2', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}], 'classes': [{'title': 'Overall ITT population, 75% percentile value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '15'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '14'}]}]}, {'title': 'Participants with Health Status 3 + 4 at baseline, 75% percentile value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '11'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '14'}]}]}, {'title': 'Participants with Health Status 5 at baseline, 75% percentile value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '26'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '15'}]}]}], 'analyses': [{'pValue': '0.8722', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'If health status was not improved (remains stable or aggravates) by Day 60, it was censored at Day 60. Overall ITT population.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5390', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'If health status was not improved (remains stable or aggravates) by Day 60, it was censored at Day 60. Participants with Health Status 3 + 4 at baseline.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2319', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'If health status was not improved (remains stable or aggravates) by Day 60, it was censored at Day 60. Participants with Health Status 5 at baseline.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 60', 'description': 'This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score.\n\nIf health status was not improved (remains stable or aggravates) by Day 60, it was censored at Day 60.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; this endpoint was analyzed for Phase 2 only. Due to early termination of Phase 3, this endpoint was planned not to be analyzed.'}, {'type': 'SECONDARY', 'title': 'For Phase 2 Portion: Time to Recovery, Defined as the Time to Reach Categories 2 or 1 on the Ordinal Scale Participant Health Status (First Occurrence if More Than Once).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 2', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG001', 'title': 'Placebo Phase 2', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}], 'classes': [{'title': 'Overall ITT population, 75% percentile value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '19'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '15'}]}]}, {'title': 'Participants with Health Status 3 + 4 at baseline, 75% percentile value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '14'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '14'}]}]}, {'title': 'Participants with Health Status 5 at baseline, 75% percentile value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '29'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '22'}]}]}], 'analyses': [{'pValue': '0.9358', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'If health status did not reach categories 2 or 1 by Day 60, it was censored at Day 60. Overall ITT population.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6300', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'If health status did not reach categories 2 or 1 by Day 60, it was censored at Day 60. Participants with Health Status 3 + 4 at baseline.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6550', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'If health status did not reach categories 2 or 1 by Day 60, it was censored at Day 60. Participants with Health Status 5 at baseline.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 60', 'description': 'This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score.\n\nIf health status did not reach categories 2 or 1 by Day 60, it was censored at Day 60.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, in this portion of study, participants with Health Status 3, 4 or 5 were enrolled.'}, {'type': 'SECONDARY', 'title': 'For Phase 3 Portion: Time to Recovery, Defined as the Time to Reach Categories 2 or 1 on the Ordinal Scale Participant Health Status (First Occurrence if More Than Once).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 3', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG001', 'title': 'Placebo Phase 3', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '9'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '9'}]}]}], 'analyses': [{'pValue': '0.9101', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided test', 'groupDescription': 'If health status did not reach categories 2 or 1 by Day 60, it was censored at Day 60. Overall ITT population.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 60', 'description': 'This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score.\n\nIf health status did not reach categories 2 or 1 by Day 60, it was censored at Day 60.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; in this portion of study, all except one (Health Status of 5) had a Health Status of 3 or 4 at baseline, the participant with Health Status of 5 is grouped with the other participants.'}, {'type': 'SECONDARY', 'title': 'For Phase 2 Only: Time to Mechanical Ventilation, Defined Here as Time to Reach Category 6 on the Ordinal Scale Participant Health Status.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 2', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG001', 'title': 'Placebo Phase 2', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable, insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable, insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 60', 'description': 'This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score.\n\nIf category 6 was skipped and the subject died (category 7), it was considered an event.\n\nSubjects with missing observations were censored at their last available assessment if they did not need mechanical ventilation while on study.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; this endpoint was analyzed for Phase 2 only. Due to early termination of Phase 3, this endpoint was planned not to be analyzed.'}, {'type': 'SECONDARY', 'title': 'For Phase 2 Only: Time to Death, Defined Here as a Time to Reach Category 7 on the Ordinal Scale Participant Health Status, Censored to Day 60 if it Happens Later Than Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 2', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG001', 'title': 'Placebo Phase 2', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable, insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable, insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 60', 'description': 'This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score.\n\nIt was censored to Day 60 if it happened later than Day 60, or at the last available visit where the subject was alive if no further ordinal scale health status.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; this endpoint was analyzed for Phase 2 only. Due to early termination of Phase 3, this endpoint was planned not to be analyzed.'}, {'type': 'SECONDARY', 'title': 'For Phase 2 Portion: Duration of Hospitalization (Days) Within the Study Period Days 1-60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 2', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG001', 'title': 'Placebo Phase 2', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}], 'classes': [{'title': 'Overall ITT population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.04', 'spread': '10.51', 'groupId': 'OG000'}, {'value': '8.23', 'spread': '6.91', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Health Status 3 + 4 at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.33', 'spread': '8.39', 'groupId': 'OG000'}, {'value': '6.50', 'spread': '5.78', 'groupId': 'OG001'}]}]}, {'title': 'Participants with Health Status 5 at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.07', 'spread': '12.18', 'groupId': 'OG000'}, {'value': '11.14', 'spread': '7.69', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2706', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'two-sided test', 'groupDescription': 'Overall ITT population. The Kolmogorov-Smirnov test and visual check indicated the normality assumption was rejected, and two-sided Wilcoxon rank sum test was used to obtain the P-value.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0974', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'two-sided test', 'groupDescription': 'Participants with Health Status 3 + 4 at baseline. The Kolmogorov-Smirnov test and visual check indicated the normality assumption was rejected, and two-sided Wilcoxon rank sum test was used to obtain the P-value.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5549', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'two-sided test', 'groupDescription': 'Participants with Health Status 5 at baseline. The Kolmogorov-Smirnov test and visual check indicated the normality assumption was rejected, and two-sided Wilcoxon rank sum test was used to obtain the P-value.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 60', 'description': 'Monitoring of the hospitalization. In case of re-hospitalization within Day 60 for a given participant, the additional hospitalization time was included. Hospitalization for more than 60 days was considered 60 days in the calculation.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, in this portion of study, participants with Health Status 3, 4 or 5 were enrolled.'}, {'type': 'SECONDARY', 'title': 'For Phase 3 Portion: Duration of Hospitalization (Days) Within the Study Period Days 1-60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 3', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG001', 'title': 'Placebo Phase 3', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.81', 'spread': '6.95', 'groupId': 'OG000'}, {'value': '6.77', 'spread': '6.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4787', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Two-sided test', 'groupDescription': 'Overall ITT population. The Kolmogorov-Smirnov test and visual check indicated the normality assumption was rejected, and two-sided Wilcoxon rank sum test was used to obtain the P-value', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 60', 'description': 'Monitoring of the hospitalization. In case of re-hospitalization within Day 60 for a given participant, the additional hospitalization time was included. Hospitalization for more than 60 days was considered 60 days in the calculation.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; in this portion of study, all except one (Health Status of 5) had a Health Status of 3 or 4 at baseline, the participant with Health Status of 5 is grouped with the other participants.'}, {'type': 'SECONDARY', 'title': 'For Phase 2 Only: Time to Attain an Undetectable Viral Load in Oropharyngeal Swabs.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 2', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG001', 'title': 'Placebo Phase 2', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}], 'classes': [{'title': 'Positive SARS-CoV-2 result on Day 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Positive SARS-CoV-2 result on Day 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Positive SARS-CoV-2 result on Day 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Positive SARS-CoV-2 result on Day 14 or End-of-Hospitalization', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until discharge of participants, up to Day 60', 'description': 'Intent was to compare median time to undetectable viral load between treatment groups, through oropharyngeal swabs done at specified times while hospitalized. However, almost all sites were unable to obtain serial samples until discharge of participants. Therefore, with only a handful of results (reported herein), it was not possible to estimate the time to undetectable viral load.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'In Phase 2 portion Only: Participants sampled after randomization during hospitalization. Too few samples collected, intended endpoint not estimable. Not an endpoint for Phase 3'}, {'type': 'SECONDARY', 'title': 'The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LAU-7b Phase 2', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG001', 'title': 'Placebo Phase 2', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG002', 'title': 'LAU-7b Phase 3', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'OG003', 'title': 'Placebo Phase 3', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo was administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.544', 'spread': '0.346', 'groupId': 'OG000'}, {'value': '0.599', 'spread': '0.318', 'groupId': 'OG001'}, {'value': '0.597', 'spread': '0.308', 'groupId': 'OG002'}, {'value': '0.517', 'spread': '0.324', 'groupId': 'OG003'}]}]}, {'title': 'Day 14 or end of hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.747', 'spread': '0.274', 'groupId': 'OG000'}, {'value': '0.783', 'spread': '0.218', 'groupId': 'OG001'}, {'value': '0.745', 'spread': '0.309', 'groupId': 'OG002'}, {'value': '0.660', 'spread': '0.324', 'groupId': 'OG003'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.838', 'spread': '0.238', 'groupId': 'OG000'}, {'value': '0.853', 'spread': '0.185', 'groupId': 'OG001'}, {'value': '0.819', 'spread': '0.263', 'groupId': 'OG002'}, {'value': '0.754', 'spread': '0.264', 'groupId': 'OG003'}]}]}, {'title': 'Day 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.871', 'spread': '0.250', 'groupId': 'OG000'}, {'value': '0.912', 'spread': '0.139', 'groupId': 'OG001'}, {'value': '0.824', 'spread': '0.216', 'groupId': 'OG002'}, {'value': '0.745', 'spread': '0.308', 'groupId': 'OG003'}]}]}, {'title': 'Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.888', 'spread': '0.195', 'groupId': 'OG000'}, {'value': '0.920', 'spread': '0.127', 'groupId': 'OG001'}, {'value': '0.830', 'spread': '0.180', 'groupId': 'OG002'}, {'value': '0.774', 'spread': '0.292', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.4746', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.03', 'estimateComment': 'A negative difference favours LAU-7b, a positive difference favours placebo.', 'groupDescription': 'The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 14 or end of hospitalization data.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7445', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Leat Squares Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.05', 'estimateComment': 'A negative difference favours LAU-7b, a positive difference favours placebo.', 'groupDescription': 'The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 29.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7105', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.05', 'estimateComment': 'A negative difference favours LAU-7b, a positive difference favours placebo.', 'groupDescription': 'The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 45.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6424', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.04', 'estimateComment': 'A negative difference favours LAU-7b, a positive difference favours placebo.', 'groupDescription': 'The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 60.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2789', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Least Square Means difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.14', 'estimateComment': 'A negative difference favours LAU-7b, a positive difference favours placebo.', 'groupDescription': 'The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 14 or end of hospitalization data.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2884', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Least Square Means difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.14', 'estimateComment': 'A negative difference favours LAU-7b, a positive difference favours placebo.', 'groupDescription': 'The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 29', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2058', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Least Square Means difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.15', 'estimateComment': 'A negative difference favours LAU-7b, a positive difference favours placebo.', 'groupDescription': 'The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 45', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5160', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Least Square Means difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.12', 'estimateComment': 'A negative difference favours LAU-7b, a positive difference favours placebo.', 'groupDescription': 'The data were analyzed using the Mixed Model Repeated Measures (MMRM) with change from baseline as the outcome variable. Day 60', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'On Days 1, 14, 29, 45 and 60', 'description': 'This will be assessed in person or remotely, in participants reaching Days 14, 29, 45 and 60 and able to fill the questionnaire. EQ-5D-5L value was calculated based on the EQ-5D-5L user guide, and a higher value indicated better health status. The upper anchor point, full health, was 1.0 and the minimum value was 0.0.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LAU-7b', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b: LAU-7b will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 300 mg per day for the first 3 days, followed by 200 mg per day'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo oral capsule: Placebo will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days, 3 capsules per day for the first 3 days, and 2 capsules per day for the following days.'}], 'periods': [{'title': 'Pilot Phase 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Modified Intention To Treat (ITT), subjects must have received at least one dose of study treatment', 'groupId': 'FG000', 'numSubjects': '117'}, {'comment': 'Modified ITT, subjects must have received at least one dose of study treatment', 'groupId': 'FG001', 'numSubjects': '115'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '91'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Hepatic impairment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Unblinding', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'All other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Phase 3 Extension', 'milestones': [{'type': 'STARTED', 'comment': 'The Phase 3 Extension is distinct from the Pilot Phase 2', 'achievements': [{'comment': 'ITT, all randomized subjects are included whether or not having been dosed with study treatment', 'groupId': 'FG000', 'numSubjects': '57'}, {'comment': 'ITT, all randomized subjects are included whether or not having been dosed with study treatment', 'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Patient withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Study terminated by sponsor due to futility criteria reached', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted in two distinct, sequential parts. The Pilot Phase 2 followed by a Phase 3 extension in a new group of subjects. The Pilot Phase 2 included 232 subjects from August 18, 2020 to July 15, 2021 and the Phase 3 extension included 119 subjects from January 28, 2022 to November 13, 2023.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '351', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'LAU-7b Phase 2', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b: LAU-7b will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'BG001', 'title': 'Placebo Phase 2', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo oral capsule: Placebo will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'BG002', 'title': 'LAU-7b Phase 3', 'description': 'Active drug as LAU-7b capsules\n\nLAU-7b: LAU-7b will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'BG003', 'title': 'Placebo Phase 3', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)\n\nPlacebo oral capsule: Placebo will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.5', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '56.7', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '68.1', 'spread': '12.97', 'groupId': 'BG002'}, {'value': '65.9', 'spread': '15.91', 'groupId': 'BG003'}, {'value': '61.1', 'spread': '15', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '18 to 44 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}]}, {'title': '45 to 69 years', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '187', 'groupId': 'BG004'}]}, {'title': '70 years and older', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '149', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '202', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '311', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '272', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '76', 'groupId': 'BG004'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '275', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Health Status of the Patient on the 7-point Ordinal Scale', 'classes': [{'categories': [{'title': 'Health Status at baseline = 3', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}, {'title': 'Health Status at baseline = 4', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}, {'title': 'Health Status at baseline = 5', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '85', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The main efficacy variable is the 7-point patient health status ordinal scale proposed by the World Health Organization (WHO) for Coronavirus Disease 2019 (COVID-19) clinical trials. The scale is as follows:\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)\n7. Death', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Pilot Phase 2 and the Phase 3 extensions are distinct, sequential portions with different subjects.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-18', 'size': 2547339, 'label': 'Study Protocol: Pilot Phase 2 Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-05T15:04', 'hasProtocol': True}, {'date': '2023-08-04', 'size': 2729848, 'label': 'Study Protocol: Phase 3 Extension Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_003.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-10-15T20:12', 'hasProtocol': True}, {'date': '2021-08-04', 'size': 678517, 'label': 'Statistical Analysis Plan: Pilot Phase 2 portion Final Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-08-05T15:14', 'hasProtocol': False}, {'date': '2021-02-22', 'size': 265895, 'label': 'Statistical Analysis Plan: Pilot Phase 2 Interim Futility Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-08-05T15:17', 'hasProtocol': False}, {'date': '2023-09-28', 'size': 694408, 'label': 'Statistical Analysis Plan: Phase 3 Extension Final Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_004.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-10-15T20:15', 'hasProtocol': False}, {'date': '2023-10-03', 'size': 240277, 'label': 'Statistical Analysis Plan: Phase 3 Interim sample size re-estimation/futility SAP', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_005.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-10-15T20:17', 'hasProtocol': False}, {'date': '2024-10-29', 'size': 215968, 'label': 'Statistical Analysis Plan: Phase 3 Statistical Analysis Plan Addendum', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_006.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-10-15T20:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients will be randomly assigned to take either the active drug (LAU-7b capsule) or a matching inactive placebo (inactive capsule)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blind, randomized, parallel groups and placebo-controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 351}}, 'statusModule': {'whyStopped': 'Phase 2 completed normally, Phase 3 terminated for futility due to lack of aggravation events.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-29', 'studyFirstSubmitDate': '2020-05-28', 'resultsFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2020-06-03', 'lastUpdatePostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-29', 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcome for Phase 2: Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively)', 'timeFrame': 'On Day 29', 'description': 'This will be assessed through health status scoring using the WHO 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death'}, {'measure': 'Primary Outcome for Phase 3: Proportion of Participants Requiring Mechanical Ventilation (Includes Extra-corporeal Membrane Oxygenation - ECMO) AND/OR Deceased (All Causes) by Day 60 (Ordinal Scale Scores 1-4, Inclusively)', 'timeFrame': 'By Day 60', 'description': 'This will be assessed through health status scoring using the WHO 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death'}], 'secondaryOutcomes': [{'measure': 'The Safety of LAU-7b Therapy, Overview.', 'timeFrame': 'From baseline to Day 60', 'description': 'This will be assessed through monitoring of treatment emergent adverse events and serious adverse events, vital signs including oxygen saturation and body temperature, symptom-directed physical examinations and safety laboratory tests.'}, {'measure': 'The Safety of LAU-7b Therapy, Display of TEAEs With Incidence Equal or Greater Than 10% in Either Treatment Group', 'timeFrame': 'From baseline to Day 60', 'description': 'This will be assessed through monitoring of treatment emergent adverse events and serious adverse events, vital signs including oxygen saturation and body temperature, symptom-directed physical examinations and safety laboratory tests.'}, {'measure': 'Health Status of the Participant on the 7-point Ordinal Scale on Days 14 and 29, Compared Between Active and Placebo Groups.', 'timeFrame': 'On Days 14 and 29', 'description': 'The health status was graded using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death'}, {'measure': 'For Phase 2 Portion: Rate of All-causes Death by Day 29, Depicted by a Change From Baseline in the Ordinal Scale Score to Category 7', 'timeFrame': 'On Day 29', 'description': 'This was assessed with Day 29 (and Day 60, presented separately) Health Status grading using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death'}, {'measure': 'For Phase 3 Portion: Rate of All-causes Death by Day 29, Depicted by a Change From Baseline in the Ordinal Scale Score to Category 7', 'timeFrame': 'On Day 29', 'description': 'This was assessed with Day 29 (and Day 60, presented separately) Health Status grading using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death'}, {'measure': 'For Phase 2 Portion: Rate of All-causes Death By Day 60, Depicted by a Change From Baseline in the Ordinal Scale Score to Category 7', 'timeFrame': 'On Day 60', 'description': 'This was assessed with Day 60 (and Day 29, presented separately) Health Status grading using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death'}, {'measure': 'For Phase 3 Portion: Rate of All-causes Death By Day 60, Depicted by a Change From Baseline in the Ordinal Scale Score to Category 7', 'timeFrame': 'On Day 60', 'description': 'This was assessed with Day 60 (and Day 29, presented separately) Health Status grading using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death'}, {'measure': 'Proportion of Participants Alive and Free of Respiratory Failure by Day 29 (Ordinal Scale Scores 1-4, Inclusively)', 'timeFrame': 'Day 29', 'description': 'This will be assessed through health status scoring using the WHO 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death'}, {'measure': 'For Phase 2 Portion: Rate of COVID-19 Disease-related Aggravation, Depicted by a Change From Baseline in the Ordinal Scale Score of at Least One Category', 'timeFrame': 'From baseline to Day 60', 'description': 'This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death'}, {'measure': 'For Phase 3 Portion: Rate of COVID-19 Disease-related Aggravation, Depicted by a Change From Baseline in the Ordinal Scale Score of at Least One Category', 'timeFrame': 'From baseline to Day 60', 'description': 'This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death'}, {'measure': 'For Phase 2 Only: Rate of COVID-19 Disease-related Transfer to Intensive Care Unit, Depicted by a Change From Baseline in the Ordinal Scale Score to Categories 5 or 6.', 'timeFrame': 'From baseline to Day 60', 'description': 'This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death'}, {'measure': 'For Phase 2 Only: Rate of COVID-19 Disease-related Transfer to Mechanical Ventilation, Depicted by a Change From Baseline in the Ordinal Scale Score to Category 6', 'timeFrame': 'From baseline to Day 60', 'description': 'This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale, a higher score is worse than a low score.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death'}, {'measure': 'For Phase 2 Only: Mean Change From Baseline of the Ordinal Scale Patient Health Status as a Function of Assessment Time.', 'timeFrame': 'From baseline to Day 60', 'description': 'This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score.\n\nOutcome measure data are counts of participants with a given change from baseline in number of categories, by treatment group.\n\nThe mean change from baseline is compared between treatment groups.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death'}, {'measure': "For Phase 2 Only: Time to a Participant's Improvement of at Least One Category on the Ordinal Scale Health Status.", 'timeFrame': 'From baseline to Day 60', 'description': 'This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score.\n\nIf health status was not improved (remains stable or aggravates) by Day 60, it was censored at Day 60.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death'}, {'measure': 'For Phase 2 Portion: Time to Recovery, Defined as the Time to Reach Categories 2 or 1 on the Ordinal Scale Participant Health Status (First Occurrence if More Than Once).', 'timeFrame': 'From baseline to Day 60', 'description': 'This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score.\n\nIf health status did not reach categories 2 or 1 by Day 60, it was censored at Day 60.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death'}, {'measure': 'For Phase 3 Portion: Time to Recovery, Defined as the Time to Reach Categories 2 or 1 on the Ordinal Scale Participant Health Status (First Occurrence if More Than Once).', 'timeFrame': 'From baseline to Day 60', 'description': 'This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score.\n\nIf health status did not reach categories 2 or 1 by Day 60, it was censored at Day 60.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death'}, {'measure': 'For Phase 2 Only: Time to Mechanical Ventilation, Defined Here as Time to Reach Category 6 on the Ordinal Scale Participant Health Status.', 'timeFrame': 'From baseline to Day 60', 'description': 'This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score.\n\nIf category 6 was skipped and the subject died (category 7), it was considered an event.\n\nSubjects with missing observations were censored at their last available assessment if they did not need mechanical ventilation while on study.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death'}, {'measure': 'For Phase 2 Only: Time to Death, Defined Here as a Time to Reach Category 7 on the Ordinal Scale Participant Health Status, Censored to Day 60 if it Happens Later Than Day 60', 'timeFrame': 'From baseline to Day 60', 'description': 'This was assessed through daily health status scoring using the World Health Organization 7-point Ordinal Scale (below), a higher score is worse than a low score.\n\nIt was censored to Day 60 if it happened later than Day 60, or at the last available visit where the subject was alive if no further ordinal scale health status.\n\n1. Not hospitalized, no limitations on activities\n2. Not hospitalized, limitation on activities\n3. Hospitalized, not requiring supplemental oxygen\n4. Hospitalized, requiring supplemental oxygen\n5. Hospitalized, on non-invasive ventilation or high flow oxygen devices\n6. Hospitalized, on invasive mechanical ventilation or extra-corporeal membrane oxygenation\n7. Death'}, {'measure': 'For Phase 2 Portion: Duration of Hospitalization (Days) Within the Study Period Days 1-60', 'timeFrame': 'From baseline to Day 60', 'description': 'Monitoring of the hospitalization. In case of re-hospitalization within Day 60 for a given participant, the additional hospitalization time was included. Hospitalization for more than 60 days was considered 60 days in the calculation.'}, {'measure': 'For Phase 3 Portion: Duration of Hospitalization (Days) Within the Study Period Days 1-60', 'timeFrame': 'From baseline to Day 60', 'description': 'Monitoring of the hospitalization. In case of re-hospitalization within Day 60 for a given participant, the additional hospitalization time was included. Hospitalization for more than 60 days was considered 60 days in the calculation.'}, {'measure': 'For Phase 2 Only: Time to Attain an Undetectable Viral Load in Oropharyngeal Swabs.', 'timeFrame': 'Until discharge of participants, up to Day 60', 'description': 'Intent was to compare median time to undetectable viral load between treatment groups, through oropharyngeal swabs done at specified times while hospitalized. However, almost all sites were unable to obtain serial samples until discharge of participants. Therefore, with only a handful of results (reported herein), it was not possible to estimate the time to undetectable viral load.'}, {'measure': 'The Change From Baseline in the Score Obtained on the EuroQol Five-dimensions Five-level (EQ-5D-5L) Quality-of-life Survey', 'timeFrame': 'On Days 1, 14, 29, 45 and 60', 'description': 'This will be assessed in person or remotely, in participants reaching Days 14, 29, 45 and 60 and able to fill the questionnaire. EQ-5D-5L value was calculated based on the EQ-5D-5L user guide, and a higher value indicated better health status. The upper anchor point, full health, was 1.0 and the minimum value was 0.0.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inflammation', 'Antiviral', 'Host-directed treatment', 'Docosahexaenoic acid', 'Pro-resolving'], 'conditions': ['COVID-19 Disease']}, 'descriptionModule': {'briefSummary': 'A randomized, double-blind, placebo-controlled Phase 2/3 Study of LAU-7b against confirmed COVID-19 Disease in hospitalized patients at a higher risk of complications.', 'detailedDescription': 'RESOLUTION is a multicenter, randomized, double-blind, placebo-controlled Phase 2/3 study of LAU-7b for the treatment of COVID-19 Disease in participants at a higher risk than the general COVID-19 Disease population to develop complications while hospitalized.\n\nThe goal of the study is to evaluate the efficacy of LAU-7b therapy + standard-of-care relative to placebo + standard-of-care in participants with COVID-19 Disease with confirmed SARS-CoV-2 infection. SARS is "severe acute respiratory syndrome". CoV is " Coronavirus".\n\nThe purpose of the treatment with LAU-7b is to prevent the worsening of the health of hospitalized participants including aggravation such as recourse to mechanical ventilation and death.\n\nThe means are the direct effects of LAU-7b on the resolution of inflammation, interference with viral proliferation and protection from excessive pro-inflammatory response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participant exhibited symptoms \\[Extension Phase 3 study only: (including at least one lower respiratory symptom such as shortness of breath or dyspnea)\\] of COVID-19 disease at screening and/or since the start of their hospitalization (may have included treated symptoms)\n2. Participant was 18 years and older, of either gender\n3. Participant must have had at least one of the following factors/co-morbidities:\n\n 1. Controlled or uncontrolled diabetes\n 2. Pre-existing cardiovascular disease, including hypertension\n 3. Pre-existing respiratory disease such as chronic obstructive pulmonary disease(COPD), asthma, emphysema\n 4. Active \\[Extension Phase 3 study only: or a former smoker\\] with 20 pack-years of smoking history\n 5. Obesity as depicted by BMI ≥30 kg/m2\n 6. Laboratory tests indicative of a higher risk of COVID-19-related complications, such as troponin \\>1.5 the upper limit of normal (ULN), \\[Extension Phase 3 study only: D-dimer \\>3.0 ULN\\] and/or C reactive protein (CRP) \\>1.5 ULN\n 7. Aged 70 years and older who, based on the judgment of the investigator, was at a higher risk of developing complications\n4. Participant had a documented positive test for the SARS-CoV-2 virus \\[Pilot Phase 2 study only: or was suspected to be positive and with a test result pending\\]. \\[Extension Phase 3 study only: Co-infection with other viral respiratory infections was allowed and had to be documented in medical history\\]\n5. Participant was under observation by, or admitted to, a controlled facility or hospital \\[Extension Phase 3 study only: for no more than 48 hours (72 hours from amendment 3 onwards) before screening, including any prior stay in another hospital\\] to receive standard of care (SoC) for COVID-19 disease\n6. \\[Pilot Phase 2 study only: Participant\'s hs was 3, 4, or 5 on the WHO ordinal scale and not previously a "6"\\] \\[Extension Phase 3 study only: 3 or 4 on the World Health Organization (WHO) ordinal scale and not previously a "5 or a 6"\\]\n7. If female, participant was either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who were capable of conception had to be practicing a highly effective method of birth control (acceptable methods included intrauterine device, complete abstinence, spermicide + barrier, male partner surgical sterilization, or hormonal contraception) during the study and through 30 days after the last dose of the study medication. Periodical abstinence was not classified as an effective method of birth control. A pregnancy test had to be negative at the Screening Visit\n8. Participant had the ability to understand and give informed consent, which could have been verbal with a witness, according to local requirements\n9. Participant was deemed capable of adequate compliance including attending scheduled visits for the duration of the study\n10. Participant was able to swallow the study drug capsules\n\nExclusion Criteria:\n\n1. Pregnancy or breastfeeding\n2. Health condition deemed to possibly interfere with the study endpoints and/or the safety of the participants. For example, the following conditions were considered contraindicated for participation in the study, but this was not an exhaustive list. In case of doubt, the investigator was to consult with the Sponsor\'s medical representative:\n\n 1. Presence of inherited retinitis pigmentosa\n 2. Presence or history of liver failure (Child-Pugh B or C)\n 3. Presence or history of stage 4 severe chronic kidney disease or dialysis requirement\n 4. Febrile neutropenia\n 5. \\[Pilot Phase 2 study: Presence of active cancer treated with systemic chemotherapy or radiotherapy\\]\\[Extension Phase 3 study: Presence of end-stage cancer\\]\n3. Known history of a severe allergy or sensitivity to retinoids, or with known allergies to excipients in the oral capsule formulation used in the study\n4. Participation in another drug clinical trial within 30 days (or a minimum of 5 t½) prior to screening, except ongoing participation in non-interventional studies\n5. Calculated creatinine clearance (CrCl), using the Cockroft-Gault equation for example \\[Pilot Phase 2 study: \\<60 mL/min\\] \\[Extension Phase 3 study: \\<30 mL/min)\\]\n6. Presence of total bilirubin \\>1.5 x ULN (in the absence of demonstrated Gilbert\'s syndrome), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \\>2.5 x ULN\n7. \\[Extension Phase 3 study only: Subject expected to be transferred to ICU or die in the next 24 hours\\]'}, 'identificationModule': {'nctId': 'NCT04417257', 'acronym': 'RESOLUTION', 'briefTitle': 'Study of LAU-7b for the Treatment of Coronavirus Disease 2019 (COVID-19) Disease in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laurent Pharmaceuticals Inc.'}, 'officialTitle': 'RESOLUTION: A Double-blind, Randomized, Placebo-controlled, Phase II/III Study of the Efficacy and Safety of LAU-7b in the Treatment of Adult Hospitalized Patients With COVID-19 Disease', 'orgStudyIdInfo': {'id': 'LAU-20-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LAU-7b', 'description': 'Active drug as LAU-7b capsules', 'interventionNames': ['Drug: LAU-7b']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo oral capsule (as inactive capsules identical to active arm)', 'interventionNames': ['Drug: Placebo oral capsule']}], 'interventions': [{'name': 'LAU-7b', 'type': 'DRUG', 'otherNames': ['fenretinide'], 'description': 'LAU-7b will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.', 'armGroupLabels': ['LAU-7b']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'description': 'Placebo will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Chandler Regional Medical Center / Mercy Gilbert Medical Center', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United 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