Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:55 PM
Study NCT ID:
NCT04723394
Status:
COMPLETED
Last Update Posted:
2023-07-05
First Post:
2021-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase III Study of AZD7442 for Treatment of COVID-19 in Outpatient Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Bulgaria'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000714168', 'term': 'cilgavimab and tixagevimab drug combination'}, {'id': 'C000714167', 'term': 'tixagevimab'}, {'id': 'C000714149', 'term': 'cilgavimab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'Global Clinical Lead', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'Publication of any part or entirely of study results requires prior written approval from sponsor, with no timeframe for sponsor to review.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug until end of study, with an average of 436 days.', 'description': 'AEs are reported for the Safety Analysis Set, defined as all participants randomized and dosed with IMP.', 'eventGroups': [{'id': 'EG000', 'title': 'AZD7442', 'description': 'Single dose of 600 mg of AZD7442 (2 separate IM injections) on Day 1', 'otherNumAtRisk': 452, 'deathsNumAtRisk': 452, 'otherNumAffected': 230, 'seriousNumAtRisk': 452, 'deathsNumAffected': 8, 'seriousNumAffected': 46}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Single dose of Placebo (2 separate IM injections) on Day 1', 'otherNumAtRisk': 451, 'deathsNumAtRisk': 451, 'otherNumAffected': 224, 'seriousNumAtRisk': 451, 'deathsNumAffected': 8, 'seriousNumAffected': 65}], 'otherEvents': [{'term': 'Normochromic normocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Decreased activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Energy increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injection site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Suprapubic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vaccination site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vaccination site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hepatitis toxic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Non-alcoholic steatohepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Allergy to arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Asymptomatic COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bed bug infestation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bronchitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bronchitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 49, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 44, 'numAffected': 43}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cervicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chlamydial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Enterobacter pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gonococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gonorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'H3N2 influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Helicobacter gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 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'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood loss anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oesophageal varices haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Varices oesophageal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 452, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 451, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'A Composite of Either Severe COVID-19 or Death From Any Cause Through Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7442', 'description': 'Single dose of 600 mg of AZD7442 (2 separate IM injections) on Day 1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single dose of Placebo (2 separate IM injections) on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk Reduction (100*[1-RR])', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '50.38', 'ciLowerLimit': '14.38', 'ciUpperLimit': '71.25', 'groupDescription': 'AZD7442 vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'CMH was stratified by randomization factors'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1) and Day 29', 'description': 'Severe COVID-19 is characterized by a minimum of either pneumonia (fever, cough, tachypnea, or dyspnea, and lung infiltrates) or hypoxemia (SpO2 \\< 90% in room air and/or severe respiratory distress) and a WHO Clinical Progression Scale score of 5 or higher.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Full Analysis Set (mFAS) - All randomized participants who received IMP ≤ 7 days from symptom onset and were not hospitalized at baseline (≤ Day 1) for isolation purpose. For AZD7442, N = 413; Placebo, N = 421. For the analysis of the primary endpoint, only participants within this population who were assessed for the primary endpoint were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'A Composite of Death From Any Cause or Hospitalization for COVID-19 Complications or Sequelae Through Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '404', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7442', 'description': 'Single dose of 600 mg of AZD7442 (2 separate IM injections) on Day 1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single dose of Placebo (2 separate IM injections) on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk Reduction (100*[1-RR])', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '49.24', 'ciLowerLimit': '14.72', 'ciUpperLimit': '69.79', 'groupDescription': 'AZD7442 vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'CMH was stratified by randomization factors'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1) and Day 169', 'description': 'Death from Any Cause or Hospitalization for COVID-19 Complications or Sequelae through Day 169', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Full Analysis Set (mFAS) - All randomized participants who received IMP \\<= 7 days from symptom onset and were not hospitalized at baseline (\\<= Day 1) for isolation purpose. For AZD7442, N = 413; Placebo, N = 421. For the analysis of the Key Secondary Endpoint, only participants within this population who were assessed for the primary endpoint were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZD7442', 'description': 'Single dose of 600 mg of AZD7442 (2 separate IM injections) on Day 1'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Single dose of Placebo (2 separate IM injections) on Day 1'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'All Participants Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '456'}, {'groupId': 'FG001', 'numSubjects': '454'}]}, {'type': 'Dosed', 'comment': 'Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '452'}, {'groupId': 'FG001', 'numSubjects': '451'}]}, {'type': 'Modified Full Analysis Set', 'comment': 'Dosed, randomized \\<=7 days from symptom onset and not hospitalized for isolation purposes at baseline', 'achievements': [{'groupId': 'FG000', 'numSubjects': '413'}, {'groupId': 'FG001', 'numSubjects': '421'}]}, {'type': 'Primary Analysis Population', 'comment': 'Participants who are included in the modified full analysis set excluding those who did not have an assessment for the primary endpoint', 'achievements': [{'groupId': 'FG000', 'numSubjects': '410'}, {'groupId': 'FG001', 'numSubjects': '419'}]}, {'type': 'Key Secondary Analysis Population', 'comment': 'Participants who are included in the modified full analysis set excluding those who did not have an assessment for the key secondary endpoint', 'achievements': [{'groupId': 'FG000', 'numSubjects': '404'}, {'groupId': 'FG001', 'numSubjects': '411'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '407'}, {'groupId': 'FG001', 'numSubjects': '390'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '64'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Participants withdrawn due to eligibility, eligibility, moving, and being randomized in error.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '910 participants were randomized to receive treatment in study D8851C00001 (TACKLE) with AZD7442 (AZD8895 + AZD1061) or placebo. Of the 910 participants randomized, 903 (99.2%) received treatment with study drug. Of the 903 dosed, 452 (50.1%) participants received AZD7442 and 451 (49.9%) participants received placebo.', 'preAssignmentDetails': 'In TACKLE, at the first visit, ie, the enrollment visit 1, participants were evaluated regarding the protocol mandated inclusion and exclusion criteria. After enrolment, eligible participants were randomized at a 1: 1 ratio to receive a single dose of study provided AZD7442 (AZD8895 + AZD1061) or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '452', 'groupId': 'BG000'}, {'value': '451', 'groupId': 'BG001'}, {'value': '903', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AZD7442', 'description': 'Single dose of 600 mg of AZD7442 (2 separate IM injections) on Day 1'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Single dose of Placebo (2 separate IM injections) on Day 1'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.0', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '83.0'}, {'value': '46.0', 'groupId': 'BG001', 'lowerLimit': '18.0', 'upperLimit': '86.0'}, {'value': '46.0', 'groupId': 'BG002', 'lowerLimit': '18.0', 'upperLimit': '86.0'}]}]}], 'paramType': 'MEDIAN', 'description': 'Full Analysis Set', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.3', 'spread': '15.42', 'groupId': 'BG000'}, {'value': '45.9', 'spread': '14.99', 'groupId': 'BG001'}, {'value': '46.1', 'spread': '15.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Full Analysis Set', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '239', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '455', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '213', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '448', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Full Analysis Set'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '238', 'groupId': 'BG001'}, {'value': '468', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '222', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '435', 'groupId': 'BG002'}]}]}, {'title': 'Not reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants', 'populationDescription': 'Full Analysis Set'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Not reported', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '285', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '559', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants', 'populationDescription': 'Full Analysis Set'}, {'title': 'BMI (kg/m^2)', 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'spread': '5.46', 'groupId': 'BG000'}, {'value': '29.2', 'spread': '6.56', 'groupId': 'BG001'}, {'value': '29.0', 'spread': '6.03', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Full Analysis Set', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Risk of Progression to Severe COVID-19', 'classes': [{'categories': [{'title': 'High', 'measurements': [{'value': '405', 'groupId': 'BG000'}, {'value': '406', 'groupId': 'BG001'}, {'value': '811', 'groupId': 'BG002'}]}, {'title': 'Low', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Risk of Progression to Severe COVID-19 is assessed based on participant's medical history - based on FDA/CDC guidelines. Summarized in the Full Analysis Set", 'unitOfMeasure': 'Participants'}, {'title': 'Country', 'classes': [{'categories': [{'title': 'Argentina', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Brazil', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Czech Republic', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Germany', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'Hungary', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Italy', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'Japan', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Mexico', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '305', 'groupId': 'BG002'}]}, {'title': 'Poland', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Russian Federation', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Spain', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Ukraine', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'United Kingdom', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'United States', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set - All participants randomized and dosed with IMP'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-30', 'size': 15993121, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_006.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-17T09:57', 'hasProtocol': True}, {'date': '2021-09-20', 'size': 9419078, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_007.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-17T09:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 910}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-30', 'studyFirstSubmitDate': '2021-01-14', 'resultsFirstSubmitDate': '2022-08-17', 'studyFirstSubmitQcDate': '2021-01-22', 'lastUpdatePostDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-28', 'studyFirstPostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A Composite of Either Severe COVID-19 or Death From Any Cause Through Day 29', 'timeFrame': 'Baseline (Day 1) and Day 29', 'description': 'Severe COVID-19 is characterized by a minimum of either pneumonia (fever, cough, tachypnea, or dyspnea, and lung infiltrates) or hypoxemia (SpO2 \\< 90% in room air and/or severe respiratory distress) and a WHO Clinical Progression Scale score of 5 or higher.'}], 'secondaryOutcomes': [{'measure': 'A Composite of Death From Any Cause or Hospitalization for COVID-19 Complications or Sequelae Through Day 169', 'timeFrame': 'Baseline (Day 1) and Day 169', 'description': 'Death from Any Cause or Hospitalization for COVID-19 Complications or Sequelae through Day 169'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Treatment of COVID-19'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Ashraf-Kashani and Kumar 2017 Ashraf-Kashani N, Kumar R. 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Phase 3 trial shows Regen-Cov™ (casirivimab with imdevimab) antibody cocktail reduced hospitalization or death by 70% in non-hospitalized Covid-19 patients. Published online 23 March 2021. Accessed 31 March 2021. https://investor.regeneron.com/news-releases/news-release-details/phase-3-trial-shows-regen-covtm-casirivimab-imdevimab-antibody#:~:text=This%20definitive%20Phase%203%20outcomes,71%25%20(2%2C400%20mg%20IV)'}, {'pmid': '38403865', 'type': 'DERIVED', 'citation': 'Hobbs FDR, Montgomery H, Padilla F, Simon-Campos JA, Arbetter D, Seegobin S, Kiazand A, Streicher K, Martinez-Alier N, Cohen TS, Esser MT. Safety, Efficacy and Pharmacokinetics of AZD7442 (Tixagevimab/Cilgavimab) for Treatment of Mild-to-Moderate COVID-19: 15-Month Final Analysis of the TACKLE Trial. Infect Dis Ther. 2024 Mar;13(3):521-533. doi: 10.1007/s40121-024-00931-4. 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Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D8851C00001&attachmentIdentifier=dd6cb212-7d2d-40c2-a4b9-39d661461486&fileName=Clinical_Study_Protocol_Redacted.pdf&versionIdentifier=', 'label': 'Redacted CSP'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D8851C00001&attachmentIdentifier=7e4b7190-a3a8-49b7-8cce-8d5b0c3da7ae&fileName=Statistical_Analysis_Plan__Redacted.pdf&versionIdentifier=', 'label': 'Redacted SAP'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D8851C00001&attachmentIdentifier=a1495ac4-8d00-4c45-b026-1f0084417cb8&fileName=CSR_Synopsis_Redacted.pdf&versionIdentifier=', 'label': 'Redacted CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'This Phase III study will assess whether AZD7442 (a combination of 2 mAbs) can safely treat outpatient adults with COVID-19 and prevent either severe COVID-19 or death.', 'detailedDescription': "A novel coronavirus, SARS-CoV-2, first emerged in China in November 2019 causing cases of atypical pneumonia. As of 6 October 2020, the virus has spread to all corners of the globe, with over 35 million confirmed cases reported and more than one million associated deaths according to the WHO. The COVID-19 pandemic is causing major disruption to global healthcare systems with significant socioeconomic impacts. Effective interventions to prevent or treat COVID-19 remain few in number and clinical experience is limited.\n\nThere is an urgent need to rapidly evaluate treatments in the non-hospitalized setting to prevent progression and reduce serious complications of COVID-19, as well as its transmission.\n\nAs a response to the ongoing pandemic, AstraZeneca is developing mAbs to the SARS-CoV-2 spike protein. The SARS-CoV-2 spike protein contains the virus's RBD, which enables the virus to bind to receptors on human cells. By targeting this region of the virus's spike protein, antibodies can block the virus's attachment to human cells, and, therefore, is expected to block infection. Amino acid substitutions have been introduced into the antibodies to both extend their half-lives, which should prolong their potential prophylactic benefit, and decrease Fc effector function in order to decrease the potential risk of antibody-dependent enhancement of disease.\n\nAZD7442, a combination of 2 of these mAbs (AZD8895 and AZD1061), is being evaluated for administration to treat or prevent COVID-19. There are currently one ongoing Phase I study and two ongoing Phase III studies with AZD7442, in addition to this treatment study.\n\nEnrollment of up to approximately 1700 participants is planned."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participant has a documented laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular test (antigen or nucleic acid) from any respiratory tract specimen (eg, oropharyngeal, NP, or nasal swab, or saliva) collected ≤ 3 days prior to Day 1.\n2. WHO Clinical Progression Scale score \\> 1 and \\< 4.\n3. Participant must be dosed with IMP no more than 7 days from self-reported onset of COVID-19-related symptoms (mild to moderate COVID-19) or measured fever, defined as the self-reported date of first reported sign/symptom.\n4. One or more of the following signs/symptoms must be present within 24 hours prior to Day1: Cough, Sore throat, Shortness of breath or difficulty breathing at rest or with activity, Body pain or muscle pain/aches, Fatigue, Headache, Chills, Nasal obstruction or congestion, Nasal discharge, Nausea or vomiting, Diarrhea, New loss of taste or smell.\n5. Oxygenation saturation of ≥ 92% obtained at rest by study staff within 24 hours prior to Day 1 (unless participant regularly receives chronic supplementary oxygen for an underlying lung condition).\n6. Participant agrees not to participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until reaching hospitalization or 28 days after entry into the study (whichever is earliest).\n7. Participant must be ≥ 18 years of age, provide informed consent and is able to comply with study requirements/procedures.\n8. Male participants: Contraception for male participants is not required; however, to avoid the transfer of any fluids, all male participants must use a condom from Day 1 and agree to continue through 90 days following administration of IMP.\n9. Women of childbearing potential must use one highly effective form of birth control.\n\nExclusion Criteria:\n\n1. History or current hospitalization for COVID-19.\n2. Current need for hospitalization/immediate medical attention in a clinic/emergency room service\n3. Previous hypersensitivity, infusion related reaction, or adverse reaction to any monoclonal antibodies or known allergy to components of the IMP or placebo.\n4. Receipt of any investigational or licensed vaccine for prevention of COVID-19 at any time prior to entry into this study or expected administration immediately after enrollment.\n5. Current requirement or anticipated impending need for mechanical ventilation.\n6. Any significant disease, disorder or finding that may increase risk to the participant that might affect his/her ability to participate in this study.\n7. Received convalescent COVID-19 plasma treatment any time prior to entry into this study.\n8. Receipt of systemic steroids (e.g., prednisone, dexamethasone) or inhaled steroids within 30 days prior to study entry, unless a stable dose is used for a chronic condition.\n9. Receipt of any IMP in the previous 90 days or 5 half lives (whichever is longer), or expected receipt of IMP during the study follow-up period, or concurrent participation in another interventional study.\n10. Pregnant or breastfeeding women.'}, 'identificationModule': {'nctId': 'NCT04723394', 'acronym': 'TACKLE', 'briefTitle': 'Phase III Study of AZD7442 for Treatment of COVID-19 in Outpatient Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Safety and Efficacy of AZD7442 for the Treatment of COVID-19 in Non-hospitalized Adults', 'orgStudyIdInfo': {'id': 'D8851C00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZD7442', 'description': 'Up to approximately 1700 participants will be randomized in a 1:1 ratio. Arm 1 (n=up to approximately 850) will receive a single dose (× 2 IM injections) of 600 mg of AZD7442.', 'interventionNames': ['Drug: AZD7442']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Up to approximately 1700 participants will be randomized in a 1:1 ratio. Arm 2 (n=up to approximately 850) will receive saline placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD7442', 'type': 'DRUG', 'otherNames': ['Combination of 2 mAbs (AZD8895 and AZD1061)'], 'description': 'Single dose (× 2 separate IM injections) of 600 mg of AZD7442 or saline placebo on Day 1.', 'armGroupLabels': ['AZD7442']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Single dose (× 2 separate IM injections) of 600 mg of AZD7442 or saline placebo on Day 1.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35501', 'city': 'Jasper', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.83122, 'lon': -87.27751}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 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