Viewing Study NCT04452318

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Ignite Creation Date: 2025-12-25 @ 5:01 AM
Ignite Modification Date: 2025-12-26 @ 4:02 AM
Study NCT ID: NCT04452318
Status: COMPLETED
Last Update Posted: 2023-05-15
First Post: 2020-06-26
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711487', 'term': 'casirivimab'}, {'id': 'C000711488', 'term': 'imdevimab'}, {'id': 'C000711751', 'term': 'casirivimab and imdevimab drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@regeneron.com', 'phone': '8447346643', 'title': 'Clinical Trials Administrator', 'organization': 'Regeneron Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': "The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to day 226', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort A Placebo', 'description': 'Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline', 'otherNumAtRisk': 1428, 'deathsNumAtRisk': 1428, 'otherNumAffected': 247, 'seriousNumAtRisk': 1428, 'deathsNumAffected': 2, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Cohort A R10933+R10987', 'description': 'Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline', 'otherNumAtRisk': 1439, 'deathsNumAtRisk': 1439, 'otherNumAffected': 96, 'seriousNumAtRisk': 1439, 'deathsNumAffected': 3, 'seriousNumAffected': 24}, {'id': 'EG002', 'title': 'Cohort A1 Placebo', 'description': 'Cohort A1: Placebo of R10933 + R10987 Pediatric Subjects (\\<12 years) with SARS-CoV-2 RT-qPCR Negative', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort B Placebo', 'description': 'Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive', 'otherNumAtRisk': 170, 'deathsNumAtRisk': 170, 'otherNumAffected': 63, 'seriousNumAtRisk': 170, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'Cohort B R10933+R10987', 'description': 'Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive', 'otherNumAtRisk': 165, 'deathsNumAtRisk': 165, 'otherNumAffected': 41, 'seriousNumAtRisk': 165, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Undetermined Placebo', 'description': 'Undetermined: Placebo of R10933 + R10987 Adult and Adolescent subjects (≥12 years) whose baseline RT-qPCR status was inconclusive or missing', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 10, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Undetermined R10933+R10987', 'description': 'Undetermined: R10933 + R10987 Adult and Adolescent subjects (≥12 years) whose baseline RT-qPCR status was inconclusive or missing', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 2, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 149, 'numAffected': 148}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 32, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 59, 'numAffected': 58}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Asymptomatic COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 119, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 73, 'numAffected': 71}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}], 'seriousEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Scrotal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, 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[{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Soft tissue injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Burns second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Post procedural inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Traumatic lung injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 0, 'numAffected': 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'numAtRisk': 1428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 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{'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cervix carcinoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Breast haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) During the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '753', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Placebo of R10933 + R10987', 'description': 'Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG001', 'title': 'Cohort A: R10933 + R10987', 'description': 'Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '0.090', 'ciUpperLimit': '0.332', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 month', 'description': 'Symptomatic SARS-CoV-2 infection (broad-term) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Seronegative modified full analysis set in Cohort A includes randomized subjects aged 12 years and older who are laboratory confirmed negative for SARS-CoV-2 and negative serostatus for SAS-CoV-2 antibodies at baseline'}, {'type': 'PRIMARY', 'title': 'Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Broad-Term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Placebo of R10933 + R10987', 'description': 'Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive'}, {'id': 'OG001', 'title': 'Cohort B: R10933 + R10987', 'description': 'Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive'}], 'classes': [{'categories': [{'measurements': [{'value': '42.5', 'groupId': 'OG000'}, {'value': '28.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.0380', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '0.298', 'ciUpperLimit': '0.966', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 Days', 'description': 'The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\\>=12 to=50), and region (US vs ex-US).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Estimate of percent of participants meeting the criteria based on fixed categories'}, {'type': 'PRIMARY', 'title': 'Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1428', 'groupId': 'OG000'}, {'value': '1439', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '165', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Placebo of R10933 + R10987', 'description': 'Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG001', 'title': 'Cohort A: R10933 + R10987', 'description': 'Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG002', 'title': 'Cohort B: Placebo of R10933 + R10987', 'description': 'Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive'}, {'id': 'OG003', 'title': 'Cohort B: R10933 + R10987', 'description': 'Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive'}], 'classes': [{'title': '# of participants with at least one TEAE', 'categories': [{'measurements': [{'value': '512', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}]}, {'title': '# of participants with at least one Grade 1 TEAE', 'categories': [{'measurements': [{'value': '384', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}]}, {'title': '# of participants with at least one Grade 2 TEAE', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': '# of participants with at least one Grade 3 TEAE', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': '# of participants with at least one Grade 4 TEAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '# of participants with at least one Grade 5 TEAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort A and Cohort B: Percentage of Participants With High Viral Load in Nasopharyngeal (NP) Swab Samples During the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '749', 'groupId': 'OG000'}, {'value': '745', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Placebo of R10933 + R10987', 'description': 'Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG001', 'title': 'Cohort A: R10933 + R10987', 'description': 'Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG002', 'title': 'Cohort B: Placebo of R10933 + R10987', 'description': 'Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive'}, {'id': 'OG003', 'title': 'Cohort B: R10933 + R10987', 'description': 'Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive'}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}, {'value': '62.6', 'groupId': 'OG002'}, {'value': '40.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '0.069', 'ciUpperLimit': '0.236', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0024', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.41', 'ciLowerLimit': '0.228', 'ciUpperLimit': '0.728', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 month', 'description': 'High viral load (\\> 4 log 10 copies/ml)', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad Term) During the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '753', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Placebo of R10933 + R10987', 'description': 'Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG001', 'title': 'Cohort A: R10933 + R10987', 'description': 'Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'spread': '1.135', 'groupId': 'OG000', 'lowerLimit': '1.135'}, {'value': '0.02', 'spread': '0.181', 'groupId': 'OG001', 'lowerLimit': '0.181'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Stratified Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 month', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort A and Cohort B: Number of Weeks of High Viral Load in NP Swab Samples During the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '749', 'groupId': 'OG000'}, {'value': '745', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Placebo of R10933 + R10987', 'description': 'Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG001', 'title': 'Cohort A: R10933 + R10987', 'description': 'Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG002', 'title': 'Cohort B: Placebo of R10933 + R10987', 'description': 'Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive'}, {'id': 'OG003', 'title': 'Cohort B: R10933 + R10987', 'description': 'Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive'}], 'classes': [{'categories': [{'measurements': [{'value': '0.18', 'spread': '0.554', 'groupId': 'OG000', 'lowerLimit': '0.554'}, {'value': '0.02', 'spread': '0.154', 'groupId': 'OG001', 'lowerLimit': '0.154'}, {'value': '0.81', 'spread': '0.758', 'groupId': 'OG002', 'lowerLimit': '0.758'}, {'value': '0.49', 'spread': '0.677', 'groupId': 'OG003', 'lowerLimit': '0.677'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Stratified Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0010', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Stratified Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 month', 'description': 'High viral load (\\> 4 log 10 copies/ml)', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort A: Number of Weeks of RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '753', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Placebo of R10933 + R10987', 'description': 'Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG001', 'title': 'Cohort A: R10933 + R10987', 'description': 'Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': '0.31', 'spread': '0.854', 'groupId': 'OG000', 'lowerLimit': '0.854'}, {'value': '0.05', 'spread': '0.260', 'groupId': 'OG001', 'lowerLimit': '0.260'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'Stratified Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 month', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '753', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Placebo of R10933 + R10987', 'description': 'Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG001', 'title': 'Cohort A: R10933 + R10987', 'description': 'Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': '14.56', 'groupId': 'OG000'}, {'value': '5.00', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '0.208', 'ciUpperLimit': '0.456', 'statisticalMethod': 'Multiple Imputation, Logistic Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 month', 'description': 'The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\\>=12 to=50), and region (US vs ex-US)', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Estimate of percentage of participants meeting the criteria based on fixed categories'}, {'type': 'SECONDARY', 'title': 'Cohort A: Percentage of Participants in Placebo Group With a RT-qPCR Confirmed SARS-CoV-2 Infection During the EAP With an Index Case Participating in Study R10933-10987-COV-2067 (NCT04425629)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Placebo of R10933 + R10987', 'description': 'Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}], 'classes': [{'title': '% with index case receiving R10933+R10987 in 2067', 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000'}]}]}, {'title': '% with index case receiving placebo in 2067', 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000'}]}]}, {'title': '% with index case treatment in 2067 not available', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 month', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort A: Percentage of Participants With a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '753', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Placebo of R10933 + R10987', 'description': 'Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG001', 'title': 'Cohort A: R10933 + R10987', 'description': 'Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '0.051', 'ciUpperLimit': '0.286', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 month', 'description': 'Symptomatic SARS-CoV-2 infection (CDC definition) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort A: Number of Weeks of Symptomatic RT-qPCR-confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '753', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Placebo of R10933 + R10987', 'description': 'Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG001', 'title': 'Cohort A: R10933 + R10987', 'description': 'Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': '0.21', 'spread': '1.042', 'groupId': 'OG000', 'lowerLimit': '1.042'}, {'value': '0.01', 'spread': '0.128', 'groupId': 'OG001', 'lowerLimit': '0.128'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'Stratified Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 month', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '753', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Placebo of R10933 + R10987', 'description': 'Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG001', 'title': 'Cohort A: R10933 + R10987', 'description': 'Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '0.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.0010', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '0.020', 'ciUpperLimit': '0.370', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 month', 'description': 'The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\\>=12 to=50), and region (US vs ex-US)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Estimate of percentage of participants meeting the criteria based on fixed categories'}, {'type': 'SECONDARY', 'title': 'Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '753', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Placebo of R10933 + R10987', 'description': 'Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG001', 'title': 'Cohort A: R10933 + R10987', 'description': 'Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'spread': '0.843', 'groupId': 'OG000', 'lowerLimit': '0.843'}, {'value': '0.00', 'spread': '0.084', 'groupId': 'OG001', 'lowerLimit': '0.084'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'Stratified Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 month', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '753', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Placebo of R10933 + R10987', 'description': 'Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG001', 'title': 'Cohort A: R10933 + R10987', 'description': 'Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1, Week 2, Week 3, Week 4', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '752', 'groupId': 'OG000'}, {'value': '753', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Placebo of R10933 + R10987', 'description': 'Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG001', 'title': 'Cohort A: R10933 + R10987', 'description': 'Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1, Week 2, Week 3, Week 4', 'description': 'The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\\>=12 to=50), and region (US vs ex-US)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Estimate of percentage of participants meeting the criteria based on fixed categories'}, {'type': 'SECONDARY', 'title': 'Cohort A: Time-weighted Average of Viral Load From the First Positive SARS CoV-2 RT-qPCR in NP Swab Samples (That Has an Onset During the EAP) Until the Third Weekly Visit After the First Positive Test During the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Placebo of R10933 + R10987', 'description': 'Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG001', 'title': 'Cohort A: R10933 + R10987', 'description': 'Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': '3.065', 'spread': '0.243', 'groupId': 'OG000', 'lowerLimit': '0.243'}, {'value': '0.942', 'spread': '0.317', 'groupId': 'OG001', 'lowerLimit': '0.317'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.123', 'ciLowerLimit': '-2.707', 'ciUpperLimit': '-1.539', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.295', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 1 month', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort A: Time-weighted Average of Viral Load From the First Positive SARS-CoV-2 RT-qPCR in NP Swab Samples (That Has an Onset During the EAP) Until the Second Weekly Visit After the First Positive Test During the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Placebo of R10933 + R10987', 'description': 'Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG001', 'title': 'Cohort A: R10933 + R10987', 'description': 'Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': '3.689', 'spread': '0.281', 'groupId': 'OG000', 'lowerLimit': '0.281'}, {'value': '1.205', 'spread': '0.368', 'groupId': 'OG001', 'lowerLimit': '0.368'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.483', 'ciLowerLimit': '-3.161', 'ciUpperLimit': 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{'value': '1028', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Placebo of R10933 + R10987', 'description': 'Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG001', 'title': 'Cohort A: R10933 + R10987', 'description': 'Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG002', 'title': 'Cohort B: Placebo of R10933 + R10987', 'description': 'Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive'}, {'id': 'OG003', 'title': 'Cohort B: R10933 + R10987', 'description': 'Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive'}], 'classes': [{'title': 'Total Symptomatic COVID-19', 'categories': [{'measurements': [{'value': 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{'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Grade 5 Symptomatic COVID-19', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30 Up to Day 225 (Approximately 8 months)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Placebo of R10933 + R10987', 'description': 'Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG001', 'title': 'Cohort A: R10933 + R10987', 'description': 'Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG002', 'title': 'Cohort B: Placebo of R10933 + R10987', 'description': 'Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive'}, {'id': 'OG003', 'title': 'Cohort B: R10933 + R10987', 'description': 'Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive'}], 'classes': [{'title': 'Total Symptomatic COVID-19', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Grade 1 Symptomatic COVID-19', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Grade 2 Symptomatic COVID-19', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Symptomatic COVID-19', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Grade 4 Symptomatic COVID-19', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Grade 5 Symptomatic COVID-19', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 29', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Placebo of R10933 + R10987', 'description': 'Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG001', 'title': 'Cohort A: R10933 + R10987', 'description': 'Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG002', 'title': 'Cohort B: Placebo of R10933 + R10987', 'description': 'Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive'}, {'id': 'OG003', 'title': 'Cohort B: R10933 + R10987', 'description': 'Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive'}], 'classes': [{'title': 'Total Symptomatic COVID-19', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Grade 1 Symptomatic COVID-19', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Grade 2 Symptomatic COVID-19', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3Symptomatic COVID-19', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Grade 4 Symptomatic COVID-19', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Grade 5 Symptomatic COVID-19', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30 Up to Day 225 (Approximately 8 months)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (Broad-term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Placebo of R10933 + R10987', 'description': 'Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive'}, {'id': 'OG001', 'title': 'Cohort B: R10933 + R10987', 'description': 'Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive'}], 'classes': [{'categories': [{'measurements': [{'value': '1.64', 'spread': '3.493', 'groupId': 'OG000', 'lowerLimit': '3.493'}, {'value': '0.90', 'spread': '2.586', 'groupId': 'OG001', 'lowerLimit': '2.586'}]}]}], 'analyses': [{'pValue': '= 0.0273', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Stratified Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 14 Days', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort B: Percentage of Participants With Asymptomatic Infection Who Develop Signs and Symptoms (CDC Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Placebo of R10933 + R10987', 'description': 'Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive'}, {'id': 'OG001', 'title': 'Cohort B: R10933 + R10987', 'description': 'Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive'}], 'classes': [{'categories': [{'measurements': [{'value': '39.7', 'groupId': 'OG000'}, {'value': '26.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.0460', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '0.299', 'ciUpperLimit': '0.989', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 month', 'description': 'The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\\>=12 to=50), and region (US vs ex-US)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Estimate of percentage of participants meeting the criteria based on fixed categories'}, {'type': 'SECONDARY', 'title': 'Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Strict-term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Placebo of R10933 + R10987', 'description': 'Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive'}, {'id': 'OG001', 'title': 'Cohort B: R10933 + R10987', 'description': 'Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive'}], 'classes': [{'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000'}, {'value': '9.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.0721', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '0.207', 'ciUpperLimit': '1.070', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 Days', 'description': 'The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\\>=12 to=50), and region (US vs ex-US)', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Estimate of percentage of participants meeting the criteria based on fixed categories'}, {'type': 'SECONDARY', 'title': 'Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (CDC Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Placebo of R10933 + R10987', 'description': 'Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive'}, {'id': 'OG001', 'title': 'Cohort B: R10933 + R10987', 'description': 'Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive'}], 'classes': [{'categories': [{'measurements': [{'value': '1.71', 'spread': '3.569', 'groupId': 'OG000', 'lowerLimit': '3.569'}, {'value': '0.88', 'spread': '2.584', 'groupId': 'OG001', 'lowerLimit': '2.584'}]}]}], 'analyses': [{'pValue': '= 0.0260', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Stratified Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 14 Days', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (Strict-term Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Placebo of R10933 + R10987', 'description': 'Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive'}, {'id': 'OG001', 'title': 'Cohort B: R10933 + R10987', 'description': 'Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive'}], 'classes': [{'categories': [{'measurements': [{'value': '0.68', 'spread': '1.889', 'groupId': 'OG000', 'lowerLimit': '1.889'}, {'value': '0.40', 'spread': '1.876', 'groupId': 'OG001', 'lowerLimit': '1.876'}]}]}], 'analyses': [{'pValue': '= 0.0614', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Stratified Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 14 Days', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort B: Change in Viral Load From Baseline to Day 8 Visit in NP Swab Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Placebo of R10933 + R10987', 'description': 'Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive'}, {'id': 'OG001', 'title': 'Cohort B: R10933 + R10987', 'description': 'Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.543', 'spread': '0.238', 'groupId': 'OG000', 'lowerLimit': '0.238'}, {'value': '-3.004', 'spread': '0.239', 'groupId': 'OG001', 'lowerLimit': '0.239'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.461', 'ciLowerLimit': '-2.127', 'ciUpperLimit': '-0.795', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.337', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to day 8 visit', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort B: Change in Viral Load From Baseline to Day 15 Visit in NP Swab Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Placebo of R10933 + R10987', 'description': 'Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive'}, {'id': 'OG001', 'title': 'Cohort B: R10933 + R10987', 'description': 'Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.014', 'spread': '0.195', 'groupId': 'OG000', 'lowerLimit': '0.195'}, {'value': '-4.864', 'spread': '0.199', 'groupId': 'OG001', 'lowerLimit': '0.199'}]}]}], 'analyses': [{'pValue': '= 0.0026', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.850', 'ciLowerLimit': '-1.400', 'ciUpperLimit': '-0.300', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.279', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to day 15 visit', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort B: Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) in NP Swab Samples Until the Day 22 Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Placebo of R10933 + R10987', 'description': 'Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive'}, {'id': 'OG001', 'title': 'Cohort B: R10933 + R10987', 'description': 'Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.639', 'spread': '0.136', 'groupId': 'OG000', 'lowerLimit': '0.136'}, {'value': '-3.580', 'spread': '0.137', 'groupId': 'OG001', 'lowerLimit': '0.137'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.940', 'ciLowerLimit': '-1.321', 'ciUpperLimit': '-0.559', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.193', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 22', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort B: AUC in Viral Load From the First Positive SARS-CoV-2 RT-qPCR NP Swab Samples Detected During the EAP to the First Confirmed Negative Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Placebo of R10933 + R10987', 'description': 'Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive'}, {'id': 'OG001', 'title': 'Cohort B: R10933 + R10987', 'description': 'Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive'}], 'classes': [{'categories': [{'measurements': [{'value': '82.008', 'spread': '4.328', 'groupId': 'OG000', 'lowerLimit': '4.328'}, {'value': '55.964', 'spread': '4.201', 'groupId': 'OG001', 'lowerLimit': '4.201'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-26.045', 'ciLowerLimit': '-37.973', 'ciUpperLimit': '-14.117', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.041', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 14 Days', 'unitOfMeasure': 'log10 copies/milliLiter*days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort B: Maximum SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples in Participants With 1 or More Positive Test That Has an Onset During the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Placebo of R10933 + R10987', 'description': 'Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive'}, {'id': 'OG001', 'title': 'Cohort B: R10933 + R10987', 'description': 'Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive'}], 'classes': [{'categories': [{'measurements': [{'value': '4.731', 'spread': '0.238', 'groupId': 'OG000', 'lowerLimit': '0.238'}, {'value': '3.336', 'spread': '0.240', 'groupId': 'OG001', 'lowerLimit': '0.240'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.395', 'ciLowerLimit': '-2.063', 'ciUpperLimit': '-0.727', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.338', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 1 month', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort B: Number of Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Placebo of R10933 + R10987', 'description': 'Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive'}, {'id': 'OG001', 'title': 'Cohort B: R10933 + R10987', 'description': 'Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'spread': '0.234', 'groupId': 'OG000', 'lowerLimit': '0.234'}, {'value': '0.00', 'spread': '0.000', 'groupId': 'OG001', 'lowerLimit': '0.000'}]}]}], 'analyses': [{'pValue': '= 0.0138', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Stratified Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 month', 'unitOfMeasure': 'Medically attended visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cohort B: Percentage of Participants Requiring Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS CoV-2 Infection That Has an Onset at Baseline or During the EAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Placebo of R10933 + R10987', 'description': 'Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive'}, {'id': 'OG001', 'title': 'Cohort B: R10933 + R10987', 'description': 'Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.0292', 'groupIds': ['OG000', 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'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort B: Placebo of R10933 + R10987', 'description': 'Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive'}, {'id': 'OG001', 'title': 'Cohort B: R10933 + R10987', 'description': 'Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive'}], 'classes': [{'categories': [{'measurements': [{'value': '0.38', 'spread': '2.671', 'groupId': 'OG000', 'lowerLimit': '2.671'}, {'value': '0.00', 'spread': '0.000', 'groupId': 'OG001', 'lowerLimit': '0.000'}]}]}], 'analyses': [{'pValue': '= 0.0842', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Stratified Wilcoxon Rank Sum test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 month', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Estimate of proportion of participants meeting the criteria'}, {'type': 'SECONDARY', 'title': 'Concentrations of REGN10987 in Serum Over Time (Cohort A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: R10933 + R10987', 'description': 'Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}], 'classes': [{'title': '0 Days Post-Dose (n=107)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0233', 'spread': '0.145', 'groupId': 'OG000'}]}]}, {'title': '28 Days Post-Dose (n=74)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.6', 'spread': '9.78', 'groupId': 'OG000'}]}]}, {'title': '56 Days Post-Dose (n=105)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.4', 'spread': '5.88', 'groupId': 'OG000'}]}]}, {'title': '112 Days Post-Dose (n=88)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.10', 'spread': '1.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose', 'unitOfMeasure': 'milligrams per Liter (mg/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants in Cohort A with reportable concentrations obtained from baseline to day 112 of study for REGN10987 only. 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The PK analysis safety subset is based on the actual treatment received (as treated) rather than as randomized'}, {'type': 'SECONDARY', 'title': 'Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1606', 'groupId': 'OG000'}, {'value': '1595', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Overall Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'OG001', 'title': 'R10933 + R10987', 'description': 'Participants received a single 1200mg intravenous dose of REGN10933+REGN10987'}], 'classes': [{'categories': [{'measurements': [{'value': '1544', 'groupId': 'OG000'}, {'value': '1319', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This ADA analysis set (AAS) includes all treated subjects who received study drug and had at least 1 non-missing ADA result after study drug administration. 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'reasons': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': 'Of 3375 participants screened, 3298 participants were randomized and 3270 participants were treated. 77 participants were screen failures and 28 participants were randomized but not treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1430', 'groupId': 'BG000'}, {'value': '1441', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '173', 'groupId': 'BG003'}, {'value': '166', 'groupId': 'BG004'}, {'value': '53', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}, {'value': '3298', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort A: Placebo of R10933 + R10987', 'description': 'Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'BG001', 'title': 'R10933 + R10987', 'description': 'R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline'}, {'id': 'BG002', 'title': 'Cohort A1: Placebo of R10933 + R10987', 'description': 'Cohort A1: Placebo of R10933 + R10987 Pediatric Subjects (\\<12 years) with SARS-CoV-2 RT-qPCR Negative'}, {'id': 'BG003', 'title': 'Cohort B: Placebo of R10933 + R10987', 'description': 'Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive'}, {'id': 'BG004', 'title': 'Cohort B: R10933 + R10987', 'description': 'Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive'}, {'id': 'BG005', 'title': 'Undetermined: Placebo of R10933 + R10987', 'description': 'Undetermined: Placebo of R10933 + R10987 Adult and Adolescent subjects (≥12 years) whose baseline RT-qPCR status was inconclusive or missing'}, {'id': 'BG006', 'title': 'Undetermined: R10933 + R10987', 'description': 'Undetermined: R10933 + R10987 Adult and Adolescent subjects (≥12 years) whose baseline RT-qPCR status was inconclusive or missing'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.4', 'spread': '15.70', 'groupId': 'BG000'}, {'value': '42.1', 'spread': '16.00', 'groupId': 'BG001'}, {'value': '10.0', 'spread': '0.0', 'groupId': 'BG002'}, {'value': '41.8', 'spread': '18.1', 'groupId': 'BG003'}, {'value': '39.5', 'spread': '17.81', 'groupId': 'BG004'}, {'value': '43.0', 'spread': '16.73', 'groupId': 'BG005'}, {'value': '39.0', 'spread': '15.3', 'groupId': 'BG006'}, {'value': '42.0', 'spread': '16.10', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': 'In utero', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Preterm newborn infants (gestational age < 37 wks)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Newborns (0-27 days)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Infants and toddlers (28 days-23 months)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Children (2-11 years)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}, {'title': 'Adolescents (12-17 years)', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '145', 'groupId': 'BG007'}]}, {'title': 'Adults (18-64 years)', 'measurements': [{'value': '1272', 'groupId': 'BG000'}, {'value': '1263', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '130', 'groupId': 'BG003'}, {'value': '127', 'groupId': 'BG004'}, {'value': '45', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '2867', 'groupId': 'BG007'}]}, {'title': 'From 65-84 years', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '274', 'groupId': 'BG007'}]}, {'title': '85 years and over', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '738', 'groupId': 'BG000'}, {'value': '780', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}, {'value': '1736', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '692', 'groupId': 'BG000'}, {'value': '661', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}, {'value': '86', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}, {'value': '1562', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '707', 'groupId': 'BG000'}, {'value': '698', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '1573', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '711', 'groupId': 'BG000'}, {'value': '735', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '25', 'groupId': 'BG006'}, {'value': '1702', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '23', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '1193', 'groupId': 'BG000'}, {'value': '1196', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '149', 'groupId': 'BG003'}, {'value': '140', 'groupId': 'BG004'}, {'value': '46', 'groupId': 'BG005'}, {'value': '29', 'groupId': 'BG006'}, {'value': '2754', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '350', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '103', 'groupId': 'BG007'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}]}, {'title': 'Other', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '75', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-25', 'size': 1645688, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-09-28T14:01', 'hasProtocol': True}, {'date': '2021-03-26', 'size': 1074999, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-09-28T13:58', 'hasProtocol': False}, {'date': '2021-01-22', 'size': 344710, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-04-02T14:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3303}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-20', 'studyFirstSubmitDate': '2020-06-26', 'resultsFirstSubmitDate': '2022-09-29', 'studyFirstSubmitQcDate': '2020-06-26', 'lastUpdatePostDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-20', 'studyFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) During the EAP', 'timeFrame': 'Up to 1 month', 'description': 'Symptomatic SARS-CoV-2 infection (broad-term) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression.'}, {'measure': 'Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Broad-Term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP', 'timeFrame': 'Up to 14 Days', 'description': 'The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\\>=12 to=50), and region (US vs ex-US).'}, {'measure': 'Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs', 'timeFrame': 'Up to 8 months'}], 'secondaryOutcomes': [{'measure': 'Cohort A and Cohort B: Percentage of Participants With High Viral Load in Nasopharyngeal (NP) Swab Samples During the EAP', 'timeFrame': 'Up to 1 month', 'description': 'High viral load (\\> 4 log 10 copies/ml)'}, {'measure': 'Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad Term) During the EAP', 'timeFrame': 'Up to 1 month'}, {'measure': 'Cohort A and Cohort B: Number of Weeks of High Viral Load in NP Swab Samples During the EAP', 'timeFrame': 'Up to 1 month', 'description': 'High viral load (\\> 4 log 10 copies/ml)'}, {'measure': 'Cohort A: Number of Weeks of RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP', 'timeFrame': 'Up to 1 month'}, {'measure': 'Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP', 'timeFrame': 'Up to 1 month', 'description': 'The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\\>=12 to=50), and region (US vs ex-US)'}, {'measure': 'Cohort A: Percentage of Participants in Placebo Group With a RT-qPCR Confirmed SARS-CoV-2 Infection During the EAP With an Index Case Participating in Study R10933-10987-COV-2067 (NCT04425629)', 'timeFrame': 'Up to 1 month'}, {'measure': 'Cohort A: Percentage of Participants With a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP', 'timeFrame': 'Up to 1 month', 'description': 'Symptomatic SARS-CoV-2 infection (CDC definition) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression.'}, {'measure': 'Cohort A: Number of Weeks of Symptomatic RT-qPCR-confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP', 'timeFrame': 'Up to 1 month'}, {'measure': 'Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP', 'timeFrame': 'Up to 1 month', 'description': 'The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\\>=12 to=50), and region (US vs ex-US)'}, {'measure': 'Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP', 'timeFrame': 'Up to 1 month'}, {'measure': 'Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP', 'timeFrame': 'Week 1, Week 2, Week 3, Week 4'}, {'measure': 'Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP', 'timeFrame': 'Week 1, Week 2, Week 3, Week 4', 'description': 'The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\\>=12 to=50), and region (US vs ex-US)'}, {'measure': 'Cohort A: Time-weighted Average of Viral Load From the First Positive SARS CoV-2 RT-qPCR in NP Swab Samples (That Has an Onset During the EAP) Until the Third Weekly Visit After the First Positive Test During the EAP', 'timeFrame': 'Up to 1 month'}, {'measure': 'Cohort A: Time-weighted Average of Viral Load From the First Positive SARS-CoV-2 RT-qPCR in NP Swab Samples (That Has an Onset During the EAP) Until the Second Weekly Visit After the First Positive Test During the EAP', 'timeFrame': 'Up to 1 month'}, {'measure': 'Cohort A: Maximum SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples Among Individuals With ≥1 RT-qPCR Positive That Has an Onset During the EAP', 'timeFrame': 'Up to 1 month'}, {'measure': 'Cohort A: SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples Corresponding to the Onset of First Positive RT-qPCR During the EAP', 'timeFrame': 'Up to 1 month'}, {'measure': 'Cohort A: Area Under the Curve (AUC) in Viral Load From the First Positive SARS-CoV-2 RT-qPCR NP Swab Samples Detected During the EAP Until the First Confirmed Negative Test', 'timeFrame': 'Up to 1 month'}, {'measure': 'Cohort A: Total Number of Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP', 'timeFrame': 'Up to 1 month', 'description': 'Medically attended visits referred to hospitalizations, Emergency Room visits, or visits at an Urgent Care center.'}, {'measure': 'Cohort A: Percentage of Participants With at Least 1 COVID-19-related Hospitalization or Emergency Room Visit Associated With a Positive RT-qPCR During the EAP or All-cause Death', 'timeFrame': 'Up to 1 month'}, {'measure': 'Cohort A: Percentage of Participants Requiring Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS CoV-2 Infection That Has an Onset During the EAP', 'timeFrame': 'Up to 1 month'}, {'measure': 'Cohort A: Proportion of Participants Hospitalized Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP', 'timeFrame': 'Up to 14 Days', 'description': 'The proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP'}, {'measure': 'Cohort A: Number of Days of Hospital and Intensive Care Unit (ICU) Stay in Participants Hospitalized for a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP', 'timeFrame': 'Up to Day 29'}, {'measure': 'Cohort A: Number of Days Missed for Daily Responsibilities Due to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP', 'timeFrame': 'Up to 1 month', 'description': 'Daily responsibilities including work (employed adults) or school (students), daycare or family obligations/responsibilities (childcare or eldercare)'}, {'measure': 'Cohort A: Proportion of Baseline Seropositive Participants (Based on Central Lab Test) With TEAEs and Severity of TEAEs', 'timeFrame': 'Up to 8 months'}, {'measure': 'Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP', 'timeFrame': 'Up to Day 29'}, {'measure': 'Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period', 'timeFrame': 'Day 30 Up to Day 225 (Approximately 8 months)'}, {'measure': 'Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP', 'timeFrame': 'Up to Day 29'}, {'measure': 'Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period', 'timeFrame': 'Day 30 Up to Day 225 (Approximately 8 months)'}, {'measure': 'Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP', 'timeFrame': 'Up to Day 29'}, {'measure': 'Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period', 'timeFrame': 'Day 30 Up to Day 225 (Approximately 8 months)'}, {'measure': 'Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (Broad-term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP', 'timeFrame': 'Up to 14 Days'}, {'measure': 'Cohort B: Percentage of Participants With Asymptomatic Infection Who Develop Signs and Symptoms (CDC Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP', 'timeFrame': 'Up to 1 month', 'description': 'The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\\>=12 to=50), and region (US vs ex-US)'}, {'measure': 'Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Strict-term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP', 'timeFrame': 'Up to 14 Days', 'description': 'The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\\>=12 to=50), and region (US vs ex-US)'}, {'measure': 'Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (CDC Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP', 'timeFrame': 'Up to 14 Days'}, {'measure': 'Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (Strict-term Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP', 'timeFrame': 'Up to 14 Days'}, {'measure': 'Cohort B: Change in Viral Load From Baseline to Day 8 Visit in NP Swab Samples', 'timeFrame': 'Up to day 8 visit'}, {'measure': 'Cohort B: Change in Viral Load From Baseline to Day 15 Visit in NP Swab Samples', 'timeFrame': 'Up to day 15 visit'}, {'measure': 'Cohort B: Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) in NP Swab Samples Until the Day 22 Visit', 'timeFrame': 'Day 22'}, {'measure': 'Cohort B: AUC in Viral Load From the First Positive SARS-CoV-2 RT-qPCR NP Swab Samples Detected During the EAP to the First Confirmed Negative Test', 'timeFrame': 'Up to 14 Days'}, {'measure': 'Cohort B: Maximum SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples in Participants With 1 or More Positive Test That Has an Onset During the EAP', 'timeFrame': 'Up to 1 month'}, {'measure': 'Cohort B: Number of Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP', 'timeFrame': 'Up to 1 month'}, {'measure': 'Cohort B: Percentage of Participants Requiring Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS CoV-2 Infection That Has an Onset at Baseline or During the EAP', 'timeFrame': 'Up to 1 month'}, {'measure': 'Cohort B: Percentage of Participants Hospitalized Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP', 'timeFrame': 'Up to 14 Days'}, {'measure': 'Cohort B: Number of Days Missed for Daily Responsibilities (Where Applicable) Due to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP', 'timeFrame': 'Up to 1 month'}, {'measure': 'Cohort B: Number of Days of Hospital and Intensive Care Unit (ICU) Stay in Participants Hospitalized for a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP', 'timeFrame': 'Up to 1 month'}, {'measure': 'Concentrations of REGN10987 in Serum Over Time (Cohort A)', 'timeFrame': '0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose'}, {'measure': 'Concentrations of REGN10987 in Serum Over Time (Cohort B)', 'timeFrame': '0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose'}, {'measure': 'Concentrations of REGN10933 in Serum Over Time (Cohort A)', 'timeFrame': '0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose'}, {'measure': 'Concentrations of REGN10933 in Serum Over Time (Cohort B)', 'timeFrame': '0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose'}, {'measure': 'Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933', 'timeFrame': 'Up to 8 months'}, {'measure': 'Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987', 'timeFrame': 'Up to 8 months'}, {'measure': 'Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933', 'timeFrame': 'Up to 8 months', 'description': '(TE\\&TB+;NAb+) = TE = Treatment-Emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay'}, {'measure': 'Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987', 'timeFrame': 'Up to 8 Months', 'description': '(TE\\&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asymptomatic', 'Individuals at risk of exposure to SARS-CoV-2', 'Household Contacts of a Person Infected with SARS-CoV-2'], 'conditions': ['Healthy Participants']}, 'referencesModule': {'references': [{'pmid': '37330602', 'type': 'DERIVED', 'citation': "Follmann D, O'Brien MP, Fintzi J, Fay MP, Montefiori D, Mateja A, Herman GA, Hooper AT, Turner KC, Chan KC, Forleo-Neto E, Isa F, Baden LR, El Sahly HM, Janes H, Doria-Rose N, Miller J, Zhou H, Dang W, Benkeser D, Fong Y, Gilbert PB, Marovich M, Cohen MS. Examining protective effects of SARS-CoV-2 neutralizing antibodies after vaccination or monoclonal antibody administration. Nat Commun. 2023 Jun 17;14(1):3605. doi: 10.1038/s41467-023-39292-w."}, {'pmid': '35803290', 'type': 'DERIVED', 'citation': "Herman GA, O'Brien MP, Forleo-Neto E, Sarkar N, Isa F, Hou P, Chan KC, Bar KJ, Barnabas RV, Barouch DH, Cohen MS, Hurt CB, Burwen DR, Marovich MA, Musser BJ, Davis JD, Turner KC, Mahmood A, Hooper AT, Hamilton JD, Parrino J, Subramaniam D, Baum A, Kyratsous CA, DiCioccio AT, Stahl N, Braunstein N, Yancopoulos GD, Weinreich DM; COVID-19 Phase 3 Prevention Trial Team. Efficacy and safety of a single dose of casirivimab and imdevimab for the prevention of COVID-19 over an 8-month period: a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2022 Oct;22(10):1444-1454. doi: 10.1016/S1473-3099(22)00416-9. Epub 2022 Jul 5."}, {'pmid': '35713300', 'type': 'DERIVED', 'citation': 'Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.'}, {'pmid': '35029629', 'type': 'DERIVED', 'citation': "O'Brien MP, Forleo-Neto E, Sarkar N, Isa F, Hou P, Chan KC, Musser BJ, Bar KJ, Barnabas RV, Barouch DH, Cohen MS, Hurt CB, Burwen DR, Marovich MA, Brown ER, Heirman I, Davis JD, Turner KC, Ramesh D, Mahmood A, Hooper AT, Hamilton JD, Kim Y, Purcell LA, Baum A, Kyratsous CA, Krainson J, Perez-Perez R, Mohseni R, Kowal B, DiCioccio AT, Geba GP, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD, Weinreich DM; COVID-19 Phase 3 Prevention Trial Team. Effect of Subcutaneous Casirivimab and Imdevimab Antibody Combination vs Placebo on Development of Symptomatic COVID-19 in Early Asymptomatic SARS-CoV-2 Infection: A Randomized Clinical Trial. JAMA. 2022 Feb 1;327(5):432-441. doi: 10.1001/jama.2021.24939."}, {'pmid': '34473343', 'type': 'DERIVED', 'citation': 'Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.'}, {'pmid': '34347950', 'type': 'DERIVED', 'citation': "O'Brien MP, Forleo-Neto E, Musser BJ, Isa F, Chan KC, Sarkar N, Bar KJ, Barnabas RV, Barouch DH, Cohen MS, Hurt CB, Burwen DR, Marovich MA, Hou P, Heirman I, Davis JD, Turner KC, Ramesh D, Mahmood A, Hooper AT, Hamilton JD, Kim Y, Purcell LA, Baum A, Kyratsous CA, Krainson J, Perez-Perez R, Mohseni R, Kowal B, DiCioccio AT, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD, Weinreich DM; Covid-19 Phase 3 Prevention Trial Team. Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19. N Engl J Med. 2021 Sep 23;385(13):1184-1195. doi: 10.1056/NEJMoa2109682. Epub 2021 Aug 4."}, {'pmid': '34159344', 'type': 'DERIVED', 'citation': "O'Brien MP, Forleo-Neto E, Musser BJ, Isa F, Chan KC, Sarkar N, Bar KJ, Barnabas RV, Barouch DH, Cohen MS, Hurt CB, Burwen DR, Marovich MA, Hou P, Heirman I, Davis JD, Turner KC, Ramesh D, Mahmood A, Hooper AT, Hamilton JD, Kim Y, Purcell LA, Baum A, Kyratsous CA, Krainson J, Perez-Perez R, Mohseni R, Kowal B, DiCioccio AT, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD, Weinreich DM. Subcutaneous REGEN-COV Antibody Combination for Covid-19 Prevention. medRxiv [Preprint]. 2021 Jun 17:2021.06.14.21258567. doi: 10.1101/2021.06.14.21258567."}, {'pmid': '34159343', 'type': 'DERIVED', 'citation': "O'Brien MP, Forleo-Neto E, Sarkar N, Isa F, Hou P, Chan KC, Musser BJ, Bar KJ, Barnabas RV, Barouch DH, Cohen MS, Hurt CB, Burwen DR, Marovich MA, Brown ER, Heirman I, Davis JD, Turner KC, Ramesh D, Mahmood A, Hooper AT, Hamilton JD, Kim Y, Purcell LA, Baum A, Kyratsous CA, Krainson J, Perez-Perez R, Mohseni R, Kowal B, DiCioccio AT, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD, Weinreich DM; COVID-19 Phase 3 Prevention Trial Team. Subcutaneous REGEN-COV Antibody Combination in Early Asymptomatic SARS-CoV-2 Infection: A Randomized Clinical Trial. medRxiv [Preprint]. 2021 Sep 18:2021.06.14.21258569. doi: 10.1101/2021.06.14.21258569."}]}, 'descriptionModule': {'briefSummary': 'Primary Objectives:\n\nCohort A:\n\n• To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing symptomatic SARS-CoV-2 infection (broad-term) confirmed by RT-qPCR\n\nCohort A and Cohort A1:\n\n• To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC) administration compared to placebo\n\nCohort B • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing COVID-19 symptoms (broad-term)\n\nCohort B and Cohort B1\n\n• To evaluate the safety and tolerability of REGN10933+REGN10987 following SC administration compared to placebo', 'detailedDescription': 'Cohort A: adult and adolescent subjects (≥12 years) who are SARS -CoV-2 RT-qPCR negative at baseline\n\nCohort A1: pediatric subjects (\\<12 years) who are SARS-CoV-2 RT--qPCR negative at baseline\n\nCohort B: adult and adolescent subjects (≥12 years) who are SARS -CoV-2 RT-qPCR positive at baseline\n\nCohort B1: pediatric subjects (\\<12 years) who are SARS-CoV-2 RT--qPCR positive at baseline'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Adult subjects 18 years of age (irrespective of weight) and above at the signing of informed consent or adolescent participants ≥12 to \\<18 years of age, or pediatric participants \\<12 years of age at the signing of the assent (parent/guardian sign the informed consent)\n2. Asymptomatic household contact with exposure to an individual with a diagnosis of SARS-CoV-2 infection (index case). To be included in the study, participants must be randomized within 96 hours of collection of the index cases' positive SARS-COV-2 diagnostic test sample\n3. Participant anticipates living in the same household with the index case until study day 29\n4. Is judged by the investigator to be in good health based on medical history and physical examination at screening/baseline, including participants who are healthy or have a chronic, stable medical condition\n5. Willing and able to comply with study visits and study-related procedures/assessments.\n6. Provide informed consent signed by study participant or legally acceptable representative.\n\nKey Exclusion Criteria:\n\n1. History of prior positive SARS-CoV-2 RT-PCR test or positive SARS-CoV-2 serology test at any time before the screening\n2. Participant has lived with individuals who have had previous SARS-CoV-2 infection or currently lives with individuals who have SARS-CoV-2 infection, with the exception of the index case(s), the first individual(s) known to be infected in the household\n3. Active respiratory or non-respiratory symptoms consistent with COVID-19\n4. History of respiratory illness with sign/symptoms of SARS-CoV-2 infection, in the opinion of the investigator, within the prior 6 months to screening\n5. Nursing home resident\n6. Any physical examination findings, and/or history of any illness, concomitant medications or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the participant by their participation in the study\n\nNote: Other protocol-defined Inclusion/ Exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT04452318', 'briefTitle': 'COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-CoV-2 Infection in Household Contacts of Individuals Infected With SARS-CoV-2', 'orgStudyIdInfo': {'id': 'R10933-10987-COV-2069'}, 'secondaryIdInfos': [{'id': '2020-003654-71', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'REGN10933 + REGN10987', 'interventionNames': ['Drug: REGN10933 + REGN10987']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'REGN10933 + REGN10987', 'type': 'DRUG', 'otherNames': ['REGN-COV2', 'Casirivimab', 'Imdevimab', 'REGEN-COV™'], 'description': 'Subcutaneous (SC) or Intramuscular (IM) injections', 'armGroupLabels': ['REGN10933 + REGN10987']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'SC or IM injections', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85210', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Regeneron Study Site', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85712', 'city': 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