Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2025-12-29 @ 6:53 PM
Study NCT ID:
NCT04828161
Status:
TERMINATED
Last Update Posted:
2023-01-18
First Post:
2021-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Dose Finding, Efficacy and Safety Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Poland'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-12-13', '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': 'C000715987', 'term': 'ensovibep'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@Novartis.com', 'phone': '+1 862 778 8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': "Part B was not initiated based on regulatory feedback indicating that with evolving treatment options, a placebo controlled design was no longer considered to be appropriate. 2 patients randomized to ensovibep 225 mg didn't receive treatment they were randomized to: 1 patient received no active drug as infusion was not prepared correctly; 1 patient received lower dose (\\<75 mg) as infusion was interrupted. For Safety set, these 2 were reported in placebo and ensovibep 75 mg arms, respectively."}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Ensovibep 600 mg', 'description': 'Participants received single IV infusion of ensovibep 600 mg on Day 1.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 51, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ensovibep 225 mg', 'description': 'Participants received single IV infusion of ensovibep 225 mg on Day 1.', 'otherNumAtRisk': 98, 'deathsNumAtRisk': 98, 'otherNumAffected': 40, 'seriousNumAtRisk': 98, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Ensovibep 75 mg', 'description': 'Participants received single IV infusion of ensovibep 75 mg on Day 1.', 'otherNumAtRisk': 102, 'deathsNumAtRisk': 102, 'otherNumAffected': 40, 'seriousNumAtRisk': 102, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Ensovibep Total', 'description': 'Participants received single IV infusion of ensovibep on Day 1.', 'otherNumAtRisk': 300, 'deathsNumAtRisk': 300, 'otherNumAffected': 131, 'seriousNumAtRisk': 300, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Placebo', 'description': 'Participants received single IV infusion of placebo matching with ensovibep on Day 1.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 53, 'seriousNumAtRisk': 100, 'deathsNumAffected': 2, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Haemorrhagic diathesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Lymphocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Abnormal sensation in eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Disorder of globe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Infusion site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Infusion site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Vessel puncture site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Nonalcoholic fatty liver disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Allergy to chemicals', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Eye infection 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'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Phlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Cor pulmonale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Paranasal sinus inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part A: Time-Weighted Change From Baseline in Log10 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Through Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ensovibep 600 mg', 'description': 'Participants received single IV infusion of ensovibep 600 mg on Day 1.'}, {'id': 'OG001', 'title': 'Ensovibep 225 mg', 'description': 'Participants received single IV infusion of ensovibep 225 mg on Day 1.'}, {'id': 'OG002', 'title': 'Ensovibep 75 mg', 'description': 'Participants received single IV infusion of ensovibep 75 mg on Day 1.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received single IV infusion of placebo matching with ensovibep on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.99', 'spread': '0.097', 'groupId': 'OG000'}, {'value': '-1.73', 'spread': '0.093', 'groupId': 'OG001'}, {'value': '-1.81', 'spread': '0.093', 'groupId': 'OG002'}, {'value': '-1.40', 'spread': '0.098', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '-0.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.138', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.014', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '-0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.135', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.002', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '-0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.135', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) and Days 3, 5 and 8', 'description': 'The SARS-CoV-2 viral load was measured by means of a nasopharyngeal swab, followed by quantitative reverse transcription-polymerase chain reaction assay at a central laboratory. The multiple comparison procedure-modeling methodology was used. Time-weighted change from baseline was used as viral loads were measured at multiple time points.', 'unitOfMeasure': 'log10 copies/milliliter (mL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants in the randomized set for whom IV infusion of study treatment was administered. Only participants included in the analysis are reported.'}, {'type': 'SECONDARY', 'title': 'Part A: Percentage of Participants With Hospitalizations and/or ER Visits Related to COVID-19 or Death From Any Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ensovibep 600 mg', 'description': 'Participants received single IV infusion of ensovibep 600 mg on Day 1.'}, {'id': 'OG001', 'title': 'Ensovibep 225 mg', 'description': 'Participants received single IV infusion of ensovibep 225 mg on Day 1.'}, {'id': 'OG002', 'title': 'Ensovibep 75 mg', 'description': 'Participants received single IV infusion of ensovibep 75 mg on Day 1.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received single IV infusion of placebo matching with ensovibep on Day 1.'}], 'classes': [{'title': 'Any event', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '3.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '6.1', 'groupId': 'OG003'}]}]}, {'title': 'Hospitalizations (≥ 24 h of acute care)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '5.1', 'groupId': 'OG003'}]}]}, {'title': 'Emergency room visits related to COVID-19', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '5.1', 'groupId': 'OG003'}]}]}, {'title': 'Death from any cause', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '2.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 29', 'description': 'Percentage of participants experiencing hospitalizations (\\>= 24 h of acute care) and/or ER visits related to COVID-19 or death from any cause up to Day 29 were presented along with relative risk to placebo.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants in the randomized set for whom IV infusion of study treatment was administered.'}, {'type': 'SECONDARY', 'title': 'Part A: Time to Sustained Clinical Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ensovibep 600 mg', 'description': 'Participants received single IV infusion of ensovibep 600 mg on Day 1.'}, {'id': 'OG001', 'title': 'Ensovibep 225 mg', 'description': 'Participants received single IV infusion of ensovibep 225 mg on Day 1.'}, {'id': 'OG002', 'title': 'Ensovibep 75 mg', 'description': 'Participants received single IV infusion of ensovibep 75 mg on Day 1.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received single IV infusion of placebo matching with ensovibep on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000', 'lowerLimit': '14.0', 'upperLimit': '29.0'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '13.0', 'upperLimit': '21.0'}, {'value': '14.0', 'groupId': 'OG002', 'lowerLimit': '11.0', 'upperLimit': '28.0'}, {'value': '29.0', 'groupId': 'OG003', 'lowerLimit': '21.0', 'upperLimit': '32.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Day 29', 'description': 'Sustained clinical recovery was defined as follows;\n\n1. All symptoms from the modified Food and Drug Administration (FDA) COVID-19 questionnaire scored as moderate or severe at baseline were subsequently scored as mild or absent, and\n2. All symptoms from the modified FDA COVID-19 questionnaire scored as mild or absent at baseline were subsequently scored as absent, with no subsequent worsening, up to Day 29.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants in the randomized set for whom IV infusion of study treatment was administered. Only participants included in the analysis are reported.'}, {'type': 'SECONDARY', 'title': 'Part A: Observed Maximum Serum Concentration (Cmax) of Total and Free Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ensovibep 600 mg', 'description': 'Participants received single IV infusion of ensovibep 600 mg on Day 1.'}, {'id': 'OG001', 'title': 'Ensovibep 225 mg', 'description': 'Participants received single IV infusion of ensovibep 225 mg on Day 1.'}, {'id': 'OG002', 'title': 'Ensovibep 75 mg', 'description': 'Participants received single IV infusion of ensovibep 75 mg on Day 1.'}], 'classes': [{'title': 'Total Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '187', 'spread': '25.3', 'groupId': 'OG000'}, {'value': '70.4', 'spread': '27.5', 'groupId': 'OG001'}, {'value': '25.1', 'spread': '38.4', 'groupId': 'OG002'}]}]}, {'title': 'Free Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '210', 'spread': '26.3', 'groupId': 'OG000'}, {'value': '78.1', 'spread': '31.5', 'groupId': 'OG001'}, {'value': '29.3', 'spread': '46.4', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91', 'description': 'Blood samples were collected to determine the Cmax of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.', 'unitOfMeasure': 'microgram (mcg) per mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic (PK) analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.'}, {'type': 'SECONDARY', 'title': 'Part A: Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Total and Free Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ensovibep 600 mg', 'description': 'Participants received single IV infusion of ensovibep 600 mg on Day 1.'}, {'id': 'OG001', 'title': 'Ensovibep 225 mg', 'description': 'Participants received single IV infusion of ensovibep 225 mg on Day 1.'}, {'id': 'OG002', 'title': 'Ensovibep 75 mg', 'description': 'Participants received single IV infusion of ensovibep 75 mg on Day 1.'}], 'classes': [{'title': 'Total Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '63300', 'spread': '87.6', 'groupId': 'OG000'}, {'value': '21100', 'spread': '122.0', 'groupId': 'OG001'}, {'value': '7950', 'spread': '67.1', 'groupId': 'OG002'}]}]}, {'title': 'Free Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '68200', 'spread': '84.4', 'groupId': 'OG000'}, {'value': '22500', 'spread': '126.9', 'groupId': 'OG001'}, {'value': '8380', 'spread': '67.9', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91', 'description': 'Blood samples were collected to determine the AUClast of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.', 'unitOfMeasure': 'h*mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.'}, {'type': 'SECONDARY', 'title': 'Part A: Area Under the Concentration-Time Curve From Time Zero to 48 Hours (AUC 0-48h) of Total and Free Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ensovibep 600 mg', 'description': 'Participants received single IV infusion of ensovibep 600 mg on Day 1.'}, {'id': 'OG001', 'title': 'Ensovibep 225 mg', 'description': 'Participants received single IV infusion of ensovibep 225 mg on Day 1.'}, {'id': 'OG002', 'title': 'Ensovibep 75 mg', 'description': 'Participants received single IV infusion of ensovibep 75 mg on Day 1.'}], 'classes': [{'title': 'Total Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7520', 'spread': '35.3', 'groupId': 'OG000'}, {'value': '2830', 'spread': '35.7', 'groupId': 'OG001'}, {'value': '999', 'spread': '34.4', 'groupId': 'OG002'}]}]}, {'title': 'Free Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8290', 'spread': '32.1', 'groupId': 'OG000'}, {'value': '2800', 'spread': '156.2', 'groupId': 'OG001'}, {'value': '1120', 'spread': '36.7', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Day 3', 'description': 'Blood samples were collected to determine the AUC 0-48h of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.', 'unitOfMeasure': 'h*mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.'}, {'type': 'SECONDARY', 'title': 'Part A: Area Under the Concentration-Time Curve From Time Zero to 168 Hours (AUC 0-168h) of Total and Free Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ensovibep 600 mg', 'description': 'Participants received single IV infusion of ensovibep 600 mg on Day 1.'}, {'id': 'OG001', 'title': 'Ensovibep 225 mg', 'description': 'Participants received single IV infusion of ensovibep 225 mg on Day 1.'}, {'id': 'OG002', 'title': 'Ensovibep 75 mg', 'description': 'Participants received single IV infusion of ensovibep 75 mg on Day 1.'}], 'classes': [{'title': 'Total Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23000', 'spread': '23.7', 'groupId': 'OG000'}, {'value': '8570', 'spread': '33.1', 'groupId': 'OG001'}, {'value': '3020', 'spread': '31.4', 'groupId': 'OG002'}]}]}, {'title': 'Free Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25200', 'spread': '23.2', 'groupId': 'OG000'}, {'value': '8940', 'spread': '73.2', 'groupId': 'OG001'}, {'value': '3390', 'spread': '35.3', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3 and 8', 'description': 'Blood samples were collected to determine the AUC 0-168h of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.', 'unitOfMeasure': 'h*mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.'}, {'type': 'SECONDARY', 'title': 'Part A: Area Under the Concentration-Time Curve From Time Zero to 336 Hours (AUC 0-336h) of Total and Free Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ensovibep 600 mg', 'description': 'Participants received single IV infusion of ensovibep 600 mg on Day 1.'}, {'id': 'OG001', 'title': 'Ensovibep 225 mg', 'description': 'Participants received single IV infusion of ensovibep 225 mg on Day 1.'}, {'id': 'OG002', 'title': 'Ensovibep 75 mg', 'description': 'Participants received single IV infusion of ensovibep 75 mg on Day 1.'}], 'classes': [{'title': 'Total Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '38200', 'spread': '23.2', 'groupId': 'OG000'}, {'value': '13800', 'spread': '37.6', 'groupId': 'OG001'}, {'value': '5040', 'spread': '31.9', 'groupId': 'OG002'}]}]}, {'title': 'Free Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41800', 'spread': '23.5', 'groupId': 'OG000'}, {'value': '15300', 'spread': '41.6', 'groupId': 'OG001'}, {'value': '5620', 'spread': '39.1', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8 and 15', 'description': 'Blood samples were collected to determine the AUC 0-336h of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.', 'unitOfMeasure': 'h*mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.'}, {'type': 'SECONDARY', 'title': 'Part A: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinfinity) of Total and Free Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ensovibep 600 mg', 'description': 'Participants received single IV infusion of ensovibep 600 mg on Day 1.'}, {'id': 'OG001', 'title': 'Ensovibep 225 mg', 'description': 'Participants received single IV infusion of ensovibep 225 mg on Day 1.'}, {'id': 'OG002', 'title': 'Ensovibep 75 mg', 'description': 'Participants received single IV infusion of ensovibep 75 mg on Day 1.'}], 'classes': [{'title': 'Total Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '75400', 'spread': '33.5', 'groupId': 'OG000'}, {'value': '27600', 'spread': '36.3', 'groupId': 'OG001'}, {'value': '9930', 'spread': '41.0', 'groupId': 'OG002'}]}]}, {'title': 'Free Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '80100', 'spread': '40.6', 'groupId': 'OG000'}, {'value': '29400', 'spread': '34.8', 'groupId': 'OG001'}, {'value': '9540', 'spread': '45.8', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91', 'description': 'Blood samples were collected to determine the AUCinfinity of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.', 'unitOfMeasure': 'h*mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.'}, {'type': 'SECONDARY', 'title': 'Part A: Time to Reach the Maximum Concentration (Tmax) of Total and Free Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ensovibep 600 mg', 'description': 'Participants received single IV infusion of ensovibep 600 mg on Day 1.'}, {'id': 'OG001', 'title': 'Ensovibep 225 mg', 'description': 'Participants received single IV infusion of ensovibep 225 mg on Day 1.'}, {'id': 'OG002', 'title': 'Ensovibep 75 mg', 'description': 'Participants received single IV infusion of ensovibep 75 mg on Day 1.'}], 'classes': [{'title': 'Total Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.935', 'spread': '457.5', 'groupId': 'OG000'}, {'value': '1.30', 'spread': '693.5', 'groupId': 'OG001'}, {'value': '1.05', 'spread': '573.6', 'groupId': 'OG002'}]}]}, {'title': 'Free Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.01', 'spread': '473.8', 'groupId': 'OG000'}, {'value': '1.09', 'spread': '516.6', 'groupId': 'OG001'}, {'value': '1.24', 'spread': '810.1', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91', 'description': 'Blood samples were collected to determine the Tmax of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.', 'unitOfMeasure': 'hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.'}, {'type': 'SECONDARY', 'title': 'Part A: Apparent Total Body Clearance (CL) of Total and Free Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ensovibep 600 mg', 'description': 'Participants received single IV infusion of ensovibep 600 mg on Day 1.'}, {'id': 'OG001', 'title': 'Ensovibep 225 mg', 'description': 'Participants received single IV infusion of ensovibep 225 mg on Day 1.'}, {'id': 'OG002', 'title': 'Ensovibep 75 mg', 'description': 'Participants received single IV infusion of ensovibep 75 mg on Day 1.'}], 'classes': [{'title': 'Total Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.07', 'spread': '35.4', 'groupId': 'OG000'}, {'value': '8.11', 'spread': '36.1', 'groupId': 'OG001'}, {'value': '7.48', 'spread': '42.1', 'groupId': 'OG002'}]}]}, {'title': 'Free Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.55', 'spread': '37.3', 'groupId': 'OG000'}, {'value': '7.64', 'spread': '35.3', 'groupId': 'OG001'}, {'value': '7.78', 'spread': '43.0', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91', 'description': 'Blood samples were collected to determine the CL of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.', 'unitOfMeasure': 'mL/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.'}, {'type': 'SECONDARY', 'title': 'Part A: Terminal Elimination Rate Constant (Lambda z) of Total and Free Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ensovibep 600 mg', 'description': 'Participants received single IV infusion of ensovibep 600 mg on Day 1.'}, {'id': 'OG001', 'title': 'Ensovibep 225 mg', 'description': 'Participants received single IV infusion of ensovibep 225 mg on Day 1.'}, {'id': 'OG002', 'title': 'Ensovibep 75 mg', 'description': 'Participants received single IV infusion of ensovibep 75 mg on Day 1.'}], 'classes': [{'title': 'Total Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.003', 'spread': '52.1', 'groupId': 'OG000'}, {'value': '0.002', 'spread': '50.6', 'groupId': 'OG001'}, {'value': '0.002', 'spread': '39.5', 'groupId': 'OG002'}]}]}, {'title': 'Free Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.003', 'spread': '69.6', 'groupId': 'OG000'}, {'value': '0.003', 'spread': '48.3', 'groupId': 'OG001'}, {'value': '0.003', 'spread': '61.2', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91', 'description': 'Blood samples were collected to determine the lambda z of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.', 'unitOfMeasure': 'per hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.'}, {'type': 'SECONDARY', 'title': 'Part A: Terminal Elimination Half-Life (T1/2) of Total and Free Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ensovibep 600 mg', 'description': 'Participants received single IV infusion of ensovibep 600 mg on Day 1.'}, {'id': 'OG001', 'title': 'Ensovibep 225 mg', 'description': 'Participants received single IV infusion of ensovibep 225 mg on Day 1.'}, {'id': 'OG002', 'title': 'Ensovibep 75 mg', 'description': 'Participants received single IV infusion of ensovibep 75 mg on Day 1.'}], 'classes': [{'title': 'Total Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '274', 'spread': '54.0', 'groupId': 'OG000'}, {'value': '290', 'spread': '53.8', 'groupId': 'OG001'}, {'value': '309', 'spread': '39.8', 'groupId': 'OG002'}]}]}, {'title': 'Free Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '262', 'spread': '67.7', 'groupId': 'OG000'}, {'value': '234', 'spread': '48.3', 'groupId': 'OG001'}, {'value': '215', 'spread': '60.6', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91', 'description': 'Blood samples were collected to determine the T1/2 of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.', 'unitOfMeasure': 'hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.'}, {'type': 'SECONDARY', 'title': 'Part A: Apparent Volume of Distribution (Vz) of Total and Free Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ensovibep 600 mg', 'description': 'Participants received single IV infusion of ensovibep 600 mg on Day 1.'}, {'id': 'OG001', 'title': 'Ensovibep 225 mg', 'description': 'Participants received single IV infusion of ensovibep 225 mg on Day 1.'}, {'id': 'OG002', 'title': 'Ensovibep 75 mg', 'description': 'Participants received single IV infusion of ensovibep 75 mg on Day 1.'}], 'classes': [{'title': 'Total Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3230', 'spread': '35.0', 'groupId': 'OG000'}, {'value': '3310', 'spread': '37.5', 'groupId': 'OG001'}, {'value': '3330', 'spread': '38.7', 'groupId': 'OG002'}]}]}, {'title': 'Free Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2760', 'spread': '46.1', 'groupId': 'OG000'}, {'value': '2590', 'spread': '36.4', 'groupId': 'OG001'}, {'value': '2470', 'spread': '45.6', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91', 'description': 'Blood samples were collected to determine the Vz of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.', 'unitOfMeasure': 'mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.'}, {'type': 'PRIMARY', 'title': 'Part B: Percentage of Participants With Hospitalizations and/or Emergency Room (ER) Visits Related to COVID-19 or Death From Any Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3/Part B: Ensovibep 75 mg', 'description': 'Phase 3/Part B: ensovibep active treatment. Part B was not initiated.'}, {'id': 'OG001', 'title': 'Phase 3/Part B: Placebo', 'description': 'Phase 3/Part B: Placebo. Part B was not initiated.'}], 'classes': [{'title': 'Any event'}, {'title': 'Hospitalizations (≥ 24 h of acute care)'}, {'title': 'Emergency room visits related to COVID-19'}, {'title': 'Death from any cause'}], 'timeFrame': 'Up to Day 29', 'description': 'Percentage of participants experiencing hospitalizations \\[\\>= 24 hour (h) of acute care\\] and/or ER visits related to COVID-19 or death from any cause up to Day 29.', 'reportingStatus': 'POSTED', 'populationDescription': 'The Part B of the study was not initiated based on regulatory feedback indicating that with evolving treatment options, a placebo controlled design was no longer considered to be appropriate.'}, {'type': 'SECONDARY', 'title': 'Part B: Change From Baseline in Log10 SARS-CoV-2 Viral Load Through Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3/Part B: Ensovibep 75 mg', 'description': 'Phase 3/Part B: ensovibep active treatment. Part B was not initiated.'}, {'id': 'OG001', 'title': 'Phase 3/Part B: Placebo', 'description': 'Phase 3/Part B: Placebo. Part B was not initiated.'}], 'timeFrame': 'Baseline (Day 1) and Days 3, 5 and 8', 'description': 'The SARS-CoV-2 viral load was measured by means of a nasopharyngeal swab, followed by quantitative reverse transcription-polymerase chain reaction assay at a central laboratory. The multiple comparison procedure-modeling methodology was used.', 'reportingStatus': 'POSTED', 'populationDescription': 'The Part B of the study was not initiated based on regulatory feedback indicating that with evolving treatment options, a placebo controlled design was no longer considered to be appropriate.'}, {'type': 'SECONDARY', 'title': 'Part B: Time to Sustained Clinical Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3/Part B: Ensovibep 75 mg', 'description': 'Phase 3/Part B: ensovibep active treatment. Part B was not initiated.'}, {'id': 'OG001', 'title': 'Phase 3/Part B: Placebo', 'description': 'Phase 3/Part B: Placebo. Part B was not initiated.'}], 'timeFrame': 'Up to Day 29', 'description': 'Sustained clinical recovery was defined as follows;\n\n1. All symptoms from the modified FDA COVID-19 questionnaire scored as moderate or severe at baseline were subsequently scored as mild or absent, and\n2. All symptoms from the modified FDA COVID-19 questionnaire scored as mild or absent at baseline were subsequently scored as absent, with no subsequent worsening, up to Day 29.', 'reportingStatus': 'POSTED', 'populationDescription': 'The Part B of the study was not initiated based on regulatory feedback indicating that with evolving treatment options, a placebo controlled design was no longer considered to be appropriate.'}, {'type': 'SECONDARY', 'title': 'Part B: Percentage of Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Response to Ensovibep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3/Part B: Ensovibep 75 mg', 'description': 'Phase 3/Part B: ensovibep active treatment. Part B was not initiated.'}, {'id': 'OG001', 'title': 'Phase 3/Part B: Placebo', 'description': 'Phase 3/Part B: Placebo. Part B was not initiated.'}], 'timeFrame': 'Pre-dose on Day 1 and Days 15, 29, 61 and 91 postdose of Ensovibep', 'description': 'Treatment-emergent ADA is defined as any participant with a\n\n1. 2-fold (1 dilution) increase in titer than the minimum required dilution if no ADAs were detected at baseline (treatment-induced ADA); or,\n2. 4-fold (2 dilutions) increase in titer compared with baseline if ADAs were detected at baseline (treatment-boosted ADA).', 'reportingStatus': 'POSTED', 'populationDescription': 'The Part B of the study was not initiated based on regulatory feedback indicating that with evolving treatment options, a placebo controlled design was no longer considered to be appropriate.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ensovibep 600 mg', 'description': 'Participants received single intravenous (IV) infusion of ensovibep 600 milligram (mg) on Day 1.'}, {'id': 'FG001', 'title': 'Ensovibep 225 mg', 'description': 'Participants received single IV infusion of ensovibep 225 mg on Day 1.'}, {'id': 'FG002', 'title': 'Ensovibep 75 mg', 'description': 'Participants received single IV infusion of ensovibep 75 mg on Day 1.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Participants received single IV infusion of placebo matching with ensovibep on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '102'}, {'groupId': 'FG002', 'numSubjects': '103'}, {'groupId': 'FG003', 'numSubjects': '102'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '95'}, {'groupId': 'FG002', 'numSubjects': '96'}, {'groupId': 'FG003', 'numSubjects': '94'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This study consisted of 2 parts, Part A and Part B. The Part A was Phase II proof of efficacy study conducted in ambulatory adult participants with symptomatic coronavirus disease 2019 (COVID-19) at 45 centers across 5 countries (Hungary, India, Netherlands, South Africa, and USA) between 10 May 2021 and 27 Jan 2022. The Part B was to be a Phase III confirmatory study. Only Part A analysis is reported since Part B of the study was not initiated.', 'preAssignmentDetails': 'The Part A of the study consisted of a screening period (up to 3 days) followed by study treatment on Day 1. Participants were randomized in 1:1:1:1 ratio, stratified by risk for COVID-19 disease progression, to receive 1 of 4 study treatments (Ensovibep 600 mg or Ensovibep 225 mg or Ensovibep 75 mg or Placebo). A total of 407 participants were randomized in the study, of which 400 were treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}, {'value': '400', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Ensovibep 600 mg', 'description': 'Participants received single IV infusion of ensovibep 600 mg on Day 1.'}, {'id': 'BG001', 'title': 'Ensovibep 225 mg', 'description': 'Participants received single IV infusion of ensovibep 225 mg on Day 1.'}, {'id': 'BG002', 'title': 'Ensovibep 75 mg', 'description': 'Participants received single IV infusion of ensovibep 75 mg on Day 1.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Participants received single IV infusion of placebo matching with ensovibep on Day 1.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.6', 'spread': '11.50', 'groupId': 'BG000'}, {'value': '40.2', 'spread': '12.90', 'groupId': 'BG001'}, {'value': '41.5', 'spread': '12.84', 'groupId': 'BG002'}, {'value': '42.3', 'spread': '13.75', 'groupId': 'BG003'}, {'value': '41.1', 'spread': '12.75', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}, {'value': '218', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '182', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '247', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}, {'title': 'Multiple', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}, {'title': 'Not reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all participants in the randomized set for whom IV infusion of study treatment was initiated during the treatment period.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-19', 'size': 2893832, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-11-01T19:32', 'hasProtocol': True}, {'date': '2021-12-07', 'size': 2049875, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-11-01T19:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '* Double Blind: two or more parties are unaware of the intervention assignment\n* Masked roles are: Subject, Caregiver, Investigator or Outcomes Assessor.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '* Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.\n* 4 Arms under Phase 2 and 2 Arms under Phase 3'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 407}}, 'statusModule': {'whyStopped': 'Phase 2 completed as planned. Due to the evolving landscape of treatments for COVID-19, the placebo-controlled Phase 3 design will not proceed. No patients were actively participating at the time of termination.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'dispFirstSubmitDate': '2022-07-28', 'completionDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-21', 'studyFirstSubmitDate': '2021-03-24', 'dispFirstSubmitQcDate': '2022-12-21', 'resultsFirstSubmitDate': '2022-11-14', 'studyFirstSubmitQcDate': '2021-03-30', 'dispFirstPostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-21', 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A: Time-Weighted Change From Baseline in Log10 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Through Day 8', 'timeFrame': 'Baseline (Day 1) and Days 3, 5 and 8', 'description': 'The SARS-CoV-2 viral load was measured by means of a nasopharyngeal swab, followed by quantitative reverse transcription-polymerase chain reaction assay at a central laboratory. The multiple comparison procedure-modeling methodology was used. Time-weighted change from baseline was used as viral loads were measured at multiple time points.'}, {'measure': 'Part B: Percentage of Participants With Hospitalizations and/or Emergency Room (ER) Visits Related to COVID-19 or Death From Any Cause', 'timeFrame': 'Up to Day 29', 'description': 'Percentage of participants experiencing hospitalizations \\[\\>= 24 hour (h) of acute care\\] and/or ER visits related to COVID-19 or death from any cause up to Day 29.'}], 'secondaryOutcomes': [{'measure': 'Part A: Percentage of Participants With Hospitalizations and/or ER Visits Related to COVID-19 or Death From Any Cause', 'timeFrame': 'Up to Day 29', 'description': 'Percentage of participants experiencing hospitalizations (\\>= 24 h of acute care) and/or ER visits related to COVID-19 or death from any cause up to Day 29 were presented along with relative risk to placebo.'}, {'measure': 'Part A: Time to Sustained Clinical Recovery', 'timeFrame': 'Up to Day 29', 'description': 'Sustained clinical recovery was defined as follows;\n\n1. All symptoms from the modified Food and Drug Administration (FDA) COVID-19 questionnaire scored as moderate or severe at baseline were subsequently scored as mild or absent, and\n2. All symptoms from the modified FDA COVID-19 questionnaire scored as mild or absent at baseline were subsequently scored as absent, with no subsequent worsening, up to Day 29.'}, {'measure': 'Part A: Observed Maximum Serum Concentration (Cmax) of Total and Free Ensovibep', 'timeFrame': 'Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91', 'description': 'Blood samples were collected to determine the Cmax of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.'}, {'measure': 'Part A: Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Total and Free Ensovibep', 'timeFrame': 'Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91', 'description': 'Blood samples were collected to determine the AUClast of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.'}, {'measure': 'Part A: Area Under the Concentration-Time Curve From Time Zero to 48 Hours (AUC 0-48h) of Total and Free Ensovibep', 'timeFrame': 'Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Day 3', 'description': 'Blood samples were collected to determine the AUC 0-48h of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.'}, {'measure': 'Part A: Area Under the Concentration-Time Curve From Time Zero to 168 Hours (AUC 0-168h) of Total and Free Ensovibep', 'timeFrame': 'Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3 and 8', 'description': 'Blood samples were collected to determine the AUC 0-168h of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.'}, {'measure': 'Part A: Area Under the Concentration-Time Curve From Time Zero to 336 Hours (AUC 0-336h) of Total and Free Ensovibep', 'timeFrame': 'Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8 and 15', 'description': 'Blood samples were collected to determine the AUC 0-336h of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.'}, {'measure': 'Part A: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinfinity) of Total and Free Ensovibep', 'timeFrame': 'Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91', 'description': 'Blood samples were collected to determine the AUCinfinity of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.'}, {'measure': 'Part A: Time to Reach the Maximum Concentration (Tmax) of Total and Free Ensovibep', 'timeFrame': 'Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91', 'description': 'Blood samples were collected to determine the Tmax of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.'}, {'measure': 'Part A: Apparent Total Body Clearance (CL) of Total and Free Ensovibep', 'timeFrame': 'Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91', 'description': 'Blood samples were collected to determine the CL of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.'}, {'measure': 'Part A: Terminal Elimination Rate Constant (Lambda z) of Total and Free Ensovibep', 'timeFrame': 'Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91', 'description': 'Blood samples were collected to determine the lambda z of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.'}, {'measure': 'Part A: Terminal Elimination Half-Life (T1/2) of Total and Free Ensovibep', 'timeFrame': 'Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91', 'description': 'Blood samples were collected to determine the T1/2 of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.'}, {'measure': 'Part A: Apparent Volume of Distribution (Vz) of Total and Free Ensovibep', 'timeFrame': 'Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91', 'description': 'Blood samples were collected to determine the Vz of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.'}, {'measure': 'Part B: Change From Baseline in Log10 SARS-CoV-2 Viral Load Through Day 8', 'timeFrame': 'Baseline (Day 1) and Days 3, 5 and 8', 'description': 'The SARS-CoV-2 viral load was measured by means of a nasopharyngeal swab, followed by quantitative reverse transcription-polymerase chain reaction assay at a central laboratory. The multiple comparison procedure-modeling methodology was used.'}, {'measure': 'Part B: Time to Sustained Clinical Recovery', 'timeFrame': 'Up to Day 29', 'description': 'Sustained clinical recovery was defined as follows;\n\n1. All symptoms from the modified FDA COVID-19 questionnaire scored as moderate or severe at baseline were subsequently scored as mild or absent, and\n2. All symptoms from the modified FDA COVID-19 questionnaire scored as mild or absent at baseline were subsequently scored as absent, with no subsequent worsening, up to Day 29.'}, {'measure': 'Part B: Percentage of Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Response to Ensovibep', 'timeFrame': 'Pre-dose on Day 1 and Days 15, 29, 61 and 91 postdose of Ensovibep', 'description': 'Treatment-emergent ADA is defined as any participant with a\n\n1. 2-fold (1 dilution) increase in titer than the minimum required dilution if no ADAs were detected at baseline (treatment-induced ADA); or,\n2. 4-fold (2 dilutions) increase in titer compared with baseline if ADAs were detected at baseline (treatment-boosted ADA).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ensovibep', 'COVID-19 treatment, symptom reduction, viral load reduction,', 'EMPATHY', 'SARS-CoV-2', 'designed ankyrin repeat protein (DARPin®)', 'angiotensin-converting enzyme 2 (ACE2)'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish the antiviral efficacy of ensovibep against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in humans, identify the optimal dose, and demonstrate its clinical value for treating COVID-19 in adult ambulatory patients.', 'detailedDescription': 'Primary objectives:\n\nPart A: The primary objective of this Part is to demonstrate superiority of ensovibep, compared to placebo, in reducing SARS-CoV-2 viral load through Day 8.\n\nPart B: The primary objective of this Part is to demonstrate superiority of ensovibep, compared to placebo, in reducing the occurrence of hospitalizations (≥ 24 hours of acute care) and/or emergency room visits related to COVID-19 or death from any cause up to Day 29.\n\nSecondary objectives:\n\nPart A: The secondary objectives of this Part are:\n\n* To assess the effect of ensovibep, compared to placebo, in reducing the occurrence of hospitalizations (≥ 24 hours of acute care) and/or emergency room visits related to COVID-19 or death from any cause up to Day 29\n* To assess the effect of ensovibep, compared to placebo, in reducing COVID-19 symptoms through Day 29\n* To evaluate safety and tolerability of ensovibep\n* To characterize the pharmacokinetics (PK) of ensovibep\n\nPart B: The secondary objectives of this Part are:\n\n* To assess the effect of ensovibep, compared to placebo, in reducing SARS-CoV-2 viral load through Day 8\n* To assess the effect of ensovibep, compared to placebo, in reducing COVID-19 symptoms up to Day 29\n* To evaluate the immunogenicity of ensovibep during the study and its clinical relevance (PK, efficacy and safety)\n* To evaluate safety and tolerability of ensovibep\n\nAlthough Amendment 2 was created, modifications for this amendment are not reflected as it was never approved or implemented in the US. The study was conducted under Global Protocol Amendment 1, the last active version of the protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Part A Inclusion Criteria:\n\n1. Men and women ≥ 18 years of age on the day of inclusion (no upper limit).\n2. Presence of two or more of the following COVID-19 symptoms with an onset within 7 days of dosing: Feeling hot or feverish, cough, sore throat, low energy, or tiredness, headache, muscle or body aches, chills or shivering, and shortness of breath.\n3. Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing (rapid antigen test).\n4. Understand and agree to comply with the planned study procedures.\n5. The patient or legally authorized representative give signed informed consent.\n\nPart A Exclusion Criteria:\n\n1. Requiring hospitalization at time of screening, or at time of study drug administration.\n2. Oxygen saturation (SpO2) ≤ 93% on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2) \\< 300, respiratory rate ≥ 30 per minute, and heart rate ≥ 125 per minute. In India, patients with a respiratory rate ≥ 24 per minute or with an oxygen saturation ≤ 93% on room air (SpO2) are not eligible.\n3. Known allergies to any of the components used in the formulation of the ensovibep or placebo.\n4. Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides SARS-CoV-2) that in the opinion of the investigator could constitute a risk when taking intervention.\n5. Any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.\n6. Any co-morbidity requiring surgery within 7 days of dosing, or that is considered life-threatening within 29 days of dosing.\n7. Prior or concurrent use of any medication for treatment of COVID-19, including antiviral agents, convalescent serum, or anti-viral antibodies. Purely symptomatic therapies (e.g., over-the-counter \\[OTC\\] cough medications, acetaminophen, and nonsteroidal anti-inflammatory drugs \\[NSAIDs\\]) are permitted. Prior vaccination for COVID-19 is permitted.\n8. Are concurrently enrolled or were enrolled within the last 30 days or within 5 half-lives (whichever is longer) in any other type of medical research judged not to be scientifically or medically compatible with this study.\n9. Are pregnant or breast feeding.\n10. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception at the time of dosing and for 11 weeks after dosing of study drug. Highly effective contraception methods include:\n\n 1. Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (i.e., calendar, ovulation, symptothermal, and postovulation methods) and withdrawal are not acceptable methods of contraception.\n 2. Female sterilization (have had bilateral surgical oophorectomy \\[with or without hysterectomy\\], total hysterectomy, or bilateral tubal ligation at least 6 weeks before taking study treatment). In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.\n 3. Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that patient.\n 4. Use of oral, injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate \\< 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the informed consent form (ICF).\n11. Patients in the USA who are at high risk of progression to severe COVID-19 illness or hospitalization must not be enrolled in Part A of this study as a placebo-controlled study may not be appropriate in this patient population due to the availability of anti-viral mAbs under EUA in the USA.'}, 'identificationModule': {'nctId': 'NCT04828161', 'acronym': 'EMPATHY', 'briefTitle': 'A Dose Finding, Efficacy and Safety Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19 - The "EMPATHY" Trial', 'orgStudyIdInfo': {'id': 'MP0420-CP302'}, 'secondaryIdInfos': [{'id': '2021-000890-10', 'type': 'EUDRACT_NUMBER'}, {'id': 'CSKO136A12201J', 'type': 'OTHER', 'domain': 'Novartis Pharmaceuticals'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 2 / Part A, ensovibep active treatment arm 1', 'description': 'Phase 2 / Part A: ensovibep active treatment arm 1', 'interventionNames': ['Drug: ensovibep']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 / Part A, ensovibep active treatment arm 2', 'description': 'Phase 2 / Part A: ensovibep active treatment arm 2', 'interventionNames': ['Drug: ensovibep']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 / Part A, ensovibep active treatment arm 3', 'description': 'Phase 2 / Part A: ensovibep active treatment arm 3', 'interventionNames': ['Drug: ensovibep']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase 2 / Part A, Placebo', 'description': 'Phase 2 / Part A: Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 3/ Part B, ensovibep active treatment arm 4', 'description': 'Phase 3/ Part B: ensovibep active treatment. Part B was not initiated.', 'interventionNames': ['Drug: ensovibep']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase 3/ Part B, Placebo arm', 'description': 'Phase 3/ Part B: Placebo. Part B was not initiated.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ensovibep', 'type': 'DRUG', 'otherNames': ['MP0420'], 'description': 'IV on day 1 only.', 'armGroupLabels': ['Phase 2 / Part A, ensovibep active treatment arm 1', 'Phase 2 / Part A, ensovibep active treatment arm 2', 'Phase 2 / Part A, ensovibep active treatment arm 3', 'Phase 3/ Part B, ensovibep active treatment arm 4']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'IV on day 1 only.', 'armGroupLabels': ['Phase 2 / Part A, Placebo', 'Phase 3/ Part B, Placebo arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35501', 'city': 'Jasper', 'state': 'Alabama', 'country': 'United States', 'facility': 'Jasper Summit Research, LLC', 'geoPoint': {'lat': 33.83122, 'lon': -87.27751}}, {'zip': '92324', 'city': 'Colton', 'state': 'California', 'country': 'United States', 'facility': 'Benchmark Southern California', 'geoPoint': {'lat': 34.0739, 'lon': -117.31365}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Ascada Research', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '92691', 'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Neuropsychiatric Specialists', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'zip': '90277', 'city': 'Redondo Beach', 'state': 'California', 'country': 'United States', 'facility': 'Providence Family Medical Center', 'geoPoint': {'lat': 33.84918, 'lon': -118.38841}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Future Innovative Treatments', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '33063', 'city': 'Margate', 'state': 'Florida', 'country': 'United States', 'facility': 'Boward Infectious Disease and Primary Care', 'geoPoint': {'lat': 26.24453, 'lon': -80.20644}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Suncoast Research Group, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Life Spring Research Foundation', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33184', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Bio-Medical Research, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Panax Clinical Research, LLC', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth Tampa', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Palm Beach Research Center', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30519', 'city': 'Buford', 'state': 'Georgia', 'country': 'United States', 'facility': 'Gwinnett Research Institute', 'geoPoint': {'lat': 34.12066, 'lon': -84.00435}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'IACT Health', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Great Lakes Clinical Trials', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21075', 'city': 'Elkridge', 'state': 'Maryland', 'country': 'United States', 'facility': 'Centennial Medical Group - 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