Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 12:30 AM
Study NCT ID:
NCT04545060
Status:
COMPLETED
Last Update Posted:
2022-11-07
First Post:
2020-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
VIR-7831 for the Early Treatment of COVID-19 in Outpatients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Chile', 'France'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], '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': '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': 'C000711967', 'term': 'sotrovimab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@vir.bio', 'phone': '415-654-5281', 'title': 'Study Inquiry', 'organization': 'Vir Biotechnology, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline Up to 24 Weeks', 'description': 'All participants who received at least one dose of study intervention', 'eventGroups': [{'id': 'EG000', 'title': 'Sotrovimab (500 mg IV)', 'description': 'Participants received 500 mg sotrovimab administered intravenously (IV)', 'otherNumAtRisk': 523, 'deathsNumAtRisk': 523, 'otherNumAffected': 26, 'seriousNumAtRisk': 523, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received Placebo administered intravenously (IV)', 'otherNumAtRisk': 526, 'deathsNumAtRisk': 526, 'otherNumAffected': 31, 'seriousNumAtRisk': 526, 'deathsNumAffected': 5, 'seriousNumAffected': 35}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Obstructive pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adenocarcinoma pancreas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 526, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Had Progression of COVID-19 Through Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'OG000'}, {'value': '529', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab (500 mg IV)', 'description': 'Participants received 500 mg sotrovimab administered intravenously (IV)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'adjusted relative risk ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '0.09', 'ciUpperLimit': '0.50', 'pValueComment': 'two-sided, alpha=0.05', 'statisticalMethod': 'poisson regression model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Day 29', 'description': 'COVID-19 progression defined as hospitalization \\>24 hours or death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (All participants who were randomly assigned to study intervention)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '523', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab (500 mg IV)', 'description': 'Participants received 500 mg sotrovimab administered intravenously (IV)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study intervention'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '523', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab (500 mg IV)', 'description': 'Participants received 500 mg sotrovimab administered intravenously (IV)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study intervention'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Infusion-related Reactions (IRR) Including Hypersensitivity Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '523', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab (500 mg IV)', 'description': 'Participants received 500 mg sotrovimab administered intravenously (IV)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study intervention'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiac Events of Special Interest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '523', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab (500 mg IV)', 'description': 'Participants received 500 mg sotrovimab administered intravenously (IV)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study intervention'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serum Anti-drug Antibody (ADA) to Sotrovimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '513', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab (500 mg IV)', 'description': 'Participants received 500 mg sotrovimab administered intravenously (IV)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects with any post-baseline ADA result'}, {'type': 'SECONDARY', 'title': 'Titers of Serum Anti-drug Antibody (ADA) to Sotrovimab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '513', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab (500 mg IV)', 'description': 'Participants received 500 mg sotrovimab administered intravenously (IV)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo administered intravenously (IV)'}], 'classes': [{'title': 'Treatment-induced', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '1280'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Treatment-boosted', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '5120'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Treatment-unaffected', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '80'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24 Weeks', 'description': 'Titers defined as the reciprocal of the highest dilution of the sample (including minimum required dilution) that yields a positive result.', 'unitOfMeasure': 'Titer', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety (subjects with any post-baseline ADA)'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV (Lead-In Phase)', 'description': 'Participants in the Lead-in phase received 500 mg sotrovimab administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '245.6', 'spread': '39.44', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Lead-in phase (n=10) who received 500 mg sotrovimab administered intravenously (IV). One subject was excluded from summary due to insufficient data (no data before study Day 5).'}, {'type': 'SECONDARY', 'title': 'Concentration at the Last Quantifiable Time Point (Clast) of VIR-7831 After IV Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV (Lead-In Phase)', 'description': 'Participants in the Lead-in phase received 500 mg sotrovimab administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '44.41', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Lead-in phase (n=10) who received 500 mg sotrovimab administered intravenously (IV). One subject was excluded from summary due to insufficient data (no data past study Day 2).'}, {'type': 'SECONDARY', 'title': 'Time to Reach the Maximum Concentration (Tmax) of VIR-7831 After IV Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV (Lead-In Phase)', 'description': 'Participants in the Lead-in phase received 500 mg sotrovimab administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.05'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169', 'unitOfMeasure': 'day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Lead-in phase (n=10) who received 500 mg sotrovimab administered intravenously (IV). One subject was excluded from summary due to insufficient data (no data before study Day 5).'}, {'type': 'SECONDARY', 'title': 'Time of the Last Quantifiable Concentration (Tlast) of VIR-7831 After IV Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV (Lead-In Phase)', 'description': 'Participants in the Lead-in phase received 500 mg sotrovimab administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000', 'lowerLimit': '160', 'upperLimit': '167'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169', 'unitOfMeasure': 'day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Lead-in phase (n=10) who received 500 mg sotrovimab administered intravenously (IV). One subject was excluded from summary due to insufficient data (no data past study Day 2).'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUCinf) of VIR-7831 After IV Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV (Lead-In Phase)', 'description': 'Participants in the Lead-in phase received 500 mg sotrovimab administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '5536.9', 'spread': '25.18', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169', 'unitOfMeasure': 'day*μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Lead-in phase (n=10) who received 500 mg sotrovimab administered intravenously (IV). One subject was excluded from summary due to insufficient data (no data past study Day 2).'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration-time Curve From the Time of Dosing to the Time of the Last Measurable (Positive) Concentration (AUClast) of VIR-7831 After IV Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV (Lead-In Phase)', 'description': 'Participants in the Lead-in phase received 500 mg sotrovimab administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '4777.7', 'spread': '20.15', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169', 'unitOfMeasure': 'day*μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Lead-in phase (n=10) who received 500 mg sotrovimab administered intravenously (IV). One subject was excluded from summary due to insufficient data (no data past study Day 2).'}, {'type': 'SECONDARY', 'title': 'Percentage of AUCinf Obtained by Extrapolation (%AUCexp) for VIR-7831 After IV Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV (Lead-In Phase)', 'description': 'Participants in the Lead-in phase received 500 mg sotrovimab administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'spread': '41.26', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169', 'unitOfMeasure': 'percentage', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Lead-in phase (n=10) who received 500 mg sotrovimab administered intravenously (IV). One subject was excluded from summary due to insufficient data (no data past study Day 2).'}, {'type': 'SECONDARY', 'title': 'Terminal Elimination Half-life (t1/2) of VIR-7831 After IV Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV (Lead-In Phase)', 'description': 'Participants in the Lead-in phase received 500 mg sotrovimab administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '56.5', 'groupId': 'OG000', 'lowerLimit': '42.4', 'upperLimit': '77.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169', 'unitOfMeasure': 'day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Lead-in phase (n=10) who received 500 mg sotrovimab administered intravenously (IV). One subject was excluded from summary due to insufficient data (no data past study Day 2).'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution During the Elimination Phase (Vz) of VIR-7831 Following IV Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV (Lead-In Phase)', 'description': 'Participants in the Lead-in phase received 500 mg sotrovimab administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '7.52', 'spread': '13.77', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169', 'unitOfMeasure': 'Liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Lead-in phase (n=10) who received 500 mg sotrovimab administered intravenously (IV). One subject was excluded from summary due to insufficient data (no data past study Day 2).'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution at Steady State (Vss) of VIR-7831 Following IV Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV (Lead-In Phase)', 'description': 'Participants in the Lead-in phase received 500 mg sotrovimab administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '6.93', 'spread': '11.59', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169', 'unitOfMeasure': 'Liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Lead-in phase (n=10) who received 500 mg sotrovimab administered intravenously (IV). One subject was excluded from summary due to insufficient data (no data past study Day 2).'}, {'type': 'SECONDARY', 'title': 'Clearance (CL) of VIR-7831 After IV Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab 500 mg IV (Lead-In Phase)', 'description': 'Participants in the Lead-in phase received 500 mg sotrovimab administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '90.3', 'spread': '25.18', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169', 'unitOfMeasure': 'mL/day', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Lead-in phase (n=10) who received 500 mg sotrovimab administered intravenously (IV). One subject was excluded from summary due to insufficient data (no data past study Day 2).'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had Progression of COVID-19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'OG000'}, {'value': '529', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab (500 mg IV)', 'description': 'Participants received 500 mg sotrovimab administered intravenously (IV)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'relative risk ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '0.19', 'ciUpperLimit': '0.63', 'pValueComment': 'two-sided, alpha=0.05', 'statisticalMethod': 'poisson regression model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Day 29', 'description': 'COVID-19 progression defined as a visit to a hospital emergency room for management of illness or hospitalization for acute management of illness or death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (All participants who were randomly assigned to study intervention)'}, {'type': 'SECONDARY', 'title': 'Mean Change in FLU PRO Plus Total Score (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab (500 mg IV)', 'description': 'Participants received 500 mg sotrovimab administered intravenously (IV)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.05', 'groupId': 'OG000', 'lowerLimit': '-3.27', 'upperLimit': '-2.83'}, {'value': '-1.98', 'groupId': 'OG001', 'lowerLimit': '-2.20', 'upperLimit': '-1.76'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.07', 'ciLowerLimit': '-1.38', 'ciUpperLimit': '-0.76', 'pValueComment': 'two-sided, alpha=0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Through Day 7', 'description': 'Mean change in InFLUenza Patient-Reported Outcome (FLU-PRO Plus) questionnaire total score.\n\nThe FLU-PRO is a 32-item daily diary assessing influenza symptoms and severity across 6 body systems (nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic). The FLU-PRO Plus includes the 32-item FLU-PRO with 2 additional items for loss of smell and taste. The mean total score can range from 0 (symptom free) to 4 (very severe symptoms) and was calculated as the arithmetic mean of the 32 items within FLU-PRO. Missing total score at day 7 was imputed using a modified last observation carried forward approach.', 'unitOfMeasure': 'Total symptom score x days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (All participants who were randomly assigned to study intervention) with available FLU-PRO Plus total scores to calculate AUC through Day 7.'}, {'type': 'SECONDARY', 'title': 'Time to Symptom Alleviation Using FLU-PRO Plus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'OG000'}, {'value': '529', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab (500 mg IV)', 'description': 'Participants received 500 mg sotrovimab administered intravenously (IV)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'It was not possible to calculate the median time to sustained symptom alleviation due to the high proportion of missing data', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'It was not possible to calculate the median time to sustained symptom alleviation due to the high proportion of missing data', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through Day 21', 'description': "Symptom alleviation is defined as absence of the majority of core symptoms of COVID-19 (except for cough or fatigue, where scoring no more than 'somewhat' in severity, and loss of smell or taste were allowed) as measured by FLU-PRO Plus, sustained for \\>=48 hours. Participants could only achieve sustained symptom alleviation following \\>=2 non-missing consecutively scored questionnaires that showed symptom alleviation. Participants who did not achieve sustained symptom alleviation were censored at Day 21, the day of death, or the day of withdrawal, whichever was earliest. Days where symptom alleviation could not be assessed to a missing/incomplete questionnaire were imputed as no symptom alleviation.\n\nThe FLU-PRO is a 32-item daily diary assessing influenza symptoms and severity across 6 body systems (nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic). The FLU-PRO Plus includes the 32-item FLU-PRO with 2 additional items for loss of smell and taste.", 'unitOfMeasure': 'Days', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (All participants who were randomly assigned to study intervention)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Viral Load in Nasal Secretions by qRT-PCR at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab (500 mg IV)', 'description': 'Participants received 500 mg sotrovimab administered intravenously (IV)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.589', 'spread': '0.0606', 'groupId': 'OG000'}, {'value': '-2.357', 'spread': '0.0598', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.232', 'ciLowerLimit': '-0.399', 'ciUpperLimit': '-0.065', 'pValueComment': 'two-sided, alpha=0.05', 'statisticalMethod': 'Mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 8', 'unitOfMeasure': 'Log 10 copies/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Virology analysis population (all participants who were randomly assigned to study intervention with a central lab confirmed quantifiable baseline nasopharyngeal swab) with analyzable data at Day 8'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'OG000'}, {'value': '529', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab (500 mg IV)', 'description': 'Participants received 500 mg sotrovimab administered intravenously (IV)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Day 8', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (All participants who were randomly assigned to study intervention)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'OG000'}, {'value': '529', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab (500 mg IV)', 'description': 'Participants received 500 mg sotrovimab administered intravenously (IV)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Day 15', 'description': 'Participants were defined as progression to severe respiratory COVID-19 if they required supplemental oxygen either by nasal cannula, face mask, high-flow oxygen devices, or non-invasive ventilation. Participants were defined as progression to critical respiratory COVID-19 if they required invasive mechanical ventilation or ECMO.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (All participants who were randomly assigned to study intervention)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'OG000'}, {'value': '529', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab (500 mg IV)', 'description': 'Participants received 500 mg sotrovimab administered intravenously (IV)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Day 22', 'description': 'Participants were defined as progression to severe respiratory COVID-19 if they required supplemental oxygen either by nasal cannula, face mask, high-flow oxygen devices, or non-invasive ventilation. Participants were defined as progression to critical respiratory COVID-19 if they required invasive mechanical ventilation or ECMO.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (All participants who were randomly assigned to study intervention)'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'OG000'}, {'value': '529', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab (500 mg IV)', 'description': 'Participants received 500 mg sotrovimab administered intravenously (IV)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'relative risk ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '0.12', 'ciUpperLimit': '0.59', 'pValueComment': 'two-sided, alpha=0.05', 'statisticalMethod': 'poisson regression model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Day 29', 'description': 'Participants were defined as progression to severe respiratory COVID-19 if they required supplemental oxygen either by nasal cannula, face mask, high-flow oxygen devices, or non-invasive ventilation. Participants were defined as progression to critical respiratory COVID-19 if they required invasive mechanical ventilation or ECMO.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (All participants who were randomly assigned to study intervention)'}, {'type': 'SECONDARY', 'title': '29-day All-cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'OG000'}, {'value': '529', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab (500 mg IV)', 'description': 'Participants received 500 mg sotrovimab administered intravenously (IV)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Day 29', 'description': 'Participants alive at the respective follow-up timepoint were censored at that timepoint; participants who withdrew prior to the respective timepoint were censored at the time of study withdrawal', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '60-day All-cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'OG000'}, {'value': '529', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab (500 mg IV)', 'description': 'Participants received 500 mg sotrovimab administered intravenously (IV)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Day 60', 'description': 'Participants alive at the respective follow-up timepoint were censored at that timepoint; participants who withdrew prior to the respective timepoint were censored at the time of study withdrawal', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (All participants who were randomly assigned to study intervention)'}, {'type': 'SECONDARY', 'title': '90-day All-cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'OG000'}, {'value': '529', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sotrovimab (500 mg IV)', 'description': 'Participants received 500 mg sotrovimab administered intravenously (IV)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received Placebo administered intravenously (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Day 90', 'description': 'Participants alive at the respective follow-up timepoint were censored at that timepoint; participants who withdrew prior to the respective timepoint were censored at the time of study withdrawal', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (All participants who were randomly assigned to study intervention)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sotrovimab (500 mg IV)', 'description': 'Participants received 500 mg sotrovimab administered intravenously (IV)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received Placebo administered intravenously (IV)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '528'}, {'groupId': 'FG001', 'numSubjects': '529'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '498'}, {'groupId': 'FG001', 'numSubjects': '488'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '41'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '22'}]}]}], 'preAssignmentDetails': 'The study comprised two parts: lead-in phase and expansion phase'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'BG000'}, {'value': '529', 'groupId': 'BG001'}, {'value': '1057', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sotrovimab (500 mg IV)', 'description': 'Participants received 500 mg sotrovimab administered intravenously (IV)'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received placebo administered intravenously (IV)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '421', 'groupId': 'BG000'}, {'value': '417', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.6', 'spread': '15.07', 'groupId': 'BG000'}, {'value': '52.6', 'spread': '14.76', 'groupId': 'BG001'}, {'value': '52.1', 'spread': '14.92', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '96'}, {'value': '53', 'groupId': 'BG001', 'lowerLimit': '17', 'upperLimit': '88'}, {'value': '53', 'groupId': 'BG002', 'lowerLimit': '17', 'upperLimit': '96'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': 'Randomized Age Group Strata, Categorical', 'categories': [{'title': '<=70 years', 'measurements': [{'value': '472', 'groupId': 'BG000'}, {'value': '473', 'groupId': 'BG001'}, {'value': '945', 'groupId': 'BG002'}]}, {'title': '>70 years', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '299', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '572', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '229', 'groupId': 'BG000'}, {'value': '256', 'groupId': 'BG001'}, {'value': '485', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '345', 'groupId': 'BG000'}, {'value': '346', 'groupId': 'BG001'}, {'value': '691', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '366', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '458', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '921', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '479', 'groupId': 'BG000'}, {'value': '474', 'groupId': 'BG001'}, {'value': '953', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Peru', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '89.5', 'spread': '21.5', 'groupId': 'BG000'}, {'value': '90.05', 'spread': '21.3', 'groupId': 'BG001'}, {'value': '89.8', 'spread': '21.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Weight at Screening', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '32.3', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '32.2', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '32.3', 'spread': '6.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index at Screening', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All participants who were randomly assigned to study intervention in the study ( irrespective of whether they have been dosed)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-17', 'size': 1517482, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-09-02T16:25', 'hasProtocol': True}, {'date': '2021-01-29', 'size': 919203, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-08-22T15:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1057}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-12', 'studyFirstSubmitDate': '2020-09-04', 'resultsFirstSubmitDate': '2022-09-06', 'studyFirstSubmitQcDate': '2020-09-09', 'lastUpdatePostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-12', 'studyFirstPostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Had Progression of COVID-19 Through Day 29', 'timeFrame': 'Through Day 29', 'description': 'COVID-19 progression defined as hospitalization \\>24 hours or death'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Number of Participants With Infusion-related Reactions (IRR) Including Hypersensitivity Reactions', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Number of Participants With Cardiac Events of Special Interest', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Number of Participants With Serum Anti-drug Antibody (ADA) to Sotrovimab', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Titers of Serum Anti-drug Antibody (ADA) to Sotrovimab', 'timeFrame': 'Up to 24 Weeks', 'description': 'Titers defined as the reciprocal of the highest dilution of the sample (including minimum required dilution) that yields a positive result.'}, {'measure': 'Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration', 'timeFrame': 'Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169'}, {'measure': 'Concentration at the Last Quantifiable Time Point (Clast) of VIR-7831 After IV Administration', 'timeFrame': 'Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169'}, {'measure': 'Time to Reach the Maximum Concentration (Tmax) of VIR-7831 After IV Administration', 'timeFrame': 'Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169'}, {'measure': 'Time of the Last Quantifiable Concentration (Tlast) of VIR-7831 After IV Administration', 'timeFrame': 'Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169'}, {'measure': 'Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUCinf) of VIR-7831 After IV Administration', 'timeFrame': 'Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169'}, {'measure': 'Area Under the Serum Concentration-time Curve From the Time of Dosing to the Time of the Last Measurable (Positive) Concentration (AUClast) of VIR-7831 After IV Administration', 'timeFrame': 'Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169'}, {'measure': 'Percentage of AUCinf Obtained by Extrapolation (%AUCexp) for VIR-7831 After IV Administration', 'timeFrame': 'Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169'}, {'measure': 'Terminal Elimination Half-life (t1/2) of VIR-7831 After IV Administration', 'timeFrame': 'Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169'}, {'measure': 'Apparent Volume of Distribution During the Elimination Phase (Vz) of VIR-7831 Following IV Administration', 'timeFrame': 'Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169'}, {'measure': 'Apparent Volume of Distribution at Steady State (Vss) of VIR-7831 Following IV Administration', 'timeFrame': 'Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169'}, {'measure': 'Clearance (CL) of VIR-7831 After IV Administration', 'timeFrame': 'Day 1: Pre-dose, and end of infusion; Days 2, 5, 8, 15, 29, 43, 57, 85, 141, 169'}, {'measure': 'Number of Participants Who Had Progression of COVID-19', 'timeFrame': 'Through Day 29', 'description': 'COVID-19 progression defined as a visit to a hospital emergency room for management of illness or hospitalization for acute management of illness or death'}, {'measure': 'Mean Change in FLU PRO Plus Total Score (AUC)', 'timeFrame': 'Through Day 7', 'description': 'Mean change in InFLUenza Patient-Reported Outcome (FLU-PRO Plus) questionnaire total score.\n\nThe FLU-PRO is a 32-item daily diary assessing influenza symptoms and severity across 6 body systems (nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic). The FLU-PRO Plus includes the 32-item FLU-PRO with 2 additional items for loss of smell and taste. The mean total score can range from 0 (symptom free) to 4 (very severe symptoms) and was calculated as the arithmetic mean of the 32 items within FLU-PRO. Missing total score at day 7 was imputed using a modified last observation carried forward approach.'}, {'measure': 'Time to Symptom Alleviation Using FLU-PRO Plus', 'timeFrame': 'Through Day 21', 'description': "Symptom alleviation is defined as absence of the majority of core symptoms of COVID-19 (except for cough or fatigue, where scoring no more than 'somewhat' in severity, and loss of smell or taste were allowed) as measured by FLU-PRO Plus, sustained for \\>=48 hours. Participants could only achieve sustained symptom alleviation following \\>=2 non-missing consecutively scored questionnaires that showed symptom alleviation. Participants who did not achieve sustained symptom alleviation were censored at Day 21, the day of death, or the day of withdrawal, whichever was earliest. Days where symptom alleviation could not be assessed to a missing/incomplete questionnaire were imputed as no symptom alleviation.\n\nThe FLU-PRO is a 32-item daily diary assessing influenza symptoms and severity across 6 body systems (nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic). The FLU-PRO Plus includes the 32-item FLU-PRO with 2 additional items for loss of smell and taste."}, {'measure': 'Change From Baseline in Viral Load in Nasal Secretions by qRT-PCR at Day 8', 'timeFrame': 'Baseline and Day 8'}, {'measure': 'Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 8', 'timeFrame': 'Through Day 8'}, {'measure': 'Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 15', 'timeFrame': 'Through Day 15', 'description': 'Participants were defined as progression to severe respiratory COVID-19 if they required supplemental oxygen either by nasal cannula, face mask, high-flow oxygen devices, or non-invasive ventilation. Participants were defined as progression to critical respiratory COVID-19 if they required invasive mechanical ventilation or ECMO.'}, {'measure': 'Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 22', 'timeFrame': 'Through Day 22', 'description': 'Participants were defined as progression to severe respiratory COVID-19 if they required supplemental oxygen either by nasal cannula, face mask, high-flow oxygen devices, or non-invasive ventilation. Participants were defined as progression to critical respiratory COVID-19 if they required invasive mechanical ventilation or ECMO.'}, {'measure': 'Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 29', 'timeFrame': 'Through Day 29', 'description': 'Participants were defined as progression to severe respiratory COVID-19 if they required supplemental oxygen either by nasal cannula, face mask, high-flow oxygen devices, or non-invasive ventilation. Participants were defined as progression to critical respiratory COVID-19 if they required invasive mechanical ventilation or ECMO.'}, {'measure': '29-day All-cause Mortality', 'timeFrame': 'Through Day 29', 'description': 'Participants alive at the respective follow-up timepoint were censored at that timepoint; participants who withdrew prior to the respective timepoint were censored at the time of study withdrawal'}, {'measure': '60-day All-cause Mortality', 'timeFrame': 'Through Day 60', 'description': 'Participants alive at the respective follow-up timepoint were censored at that timepoint; participants who withdrew prior to the respective timepoint were censored at the time of study withdrawal'}, {'measure': '90-day All-cause Mortality', 'timeFrame': 'Through Day 90', 'description': 'Participants alive at the respective follow-up timepoint were censored at that timepoint; participants who withdrew prior to the respective timepoint were censored at the time of study withdrawal'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'coronavirus', 'coronavirus disease 2019', 'COVID-19'], 'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '35977462', 'type': 'RESULT', 'citation': 'Maher MC, Soriaga LB, Gupta A, Chen YP, di Iulio J, Ledoux S, Smithey MJ, Cathcart AL, McKusick K, Sun D, Aldinger M, Alexander E, Purcell L, Ding X, Peppercorn A, Austin D, Mogalian E, Yeh WW, Shapiro AE, Corti D, Virgin HW, Pang PS, Telenti A. Antibody therapy reverses biological signatures of COVID-19 progression. Cell Rep Med. 2022 Aug 16;3(8):100721. doi: 10.1016/j.xcrm.2022.100721.'}, {'pmid': '35285853', 'type': 'RESULT', 'citation': 'Gupta A, Gonzalez-Rojas Y, Juarez E, Crespo Casal M, Moya J, Rodrigues Falci D, Sarkis E, Solis J, Zheng H, Scott N, Cathcart AL, Parra S, Sager JE, Austin D, Peppercorn A, Alexander E, Yeh WW, Brinson C, Aldinger M, Shapiro AE; COMET-ICE Investigators. Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2022 Apr 5;327(13):1236-1246. doi: 10.1001/jama.2022.2832.'}, {'pmid': '34706189', 'type': 'RESULT', 'citation': 'Gupta A, Gonzalez-Rojas Y, Juarez E, Crespo Casal M, Moya J, Falci DR, Sarkis E, Solis J, Zheng H, Scott N, Cathcart AL, Hebner CM, Sager J, Mogalian E, Tipple C, Peppercorn A, Alexander E, Pang PS, Free A, Brinson C, Aldinger M, Shapiro AE; COMET-ICE Investigators. Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab. N Engl J Med. 2021 Nov 18;385(21):1941-1950. doi: 10.1056/NEJMoa2107934. Epub 2021 Oct 27.'}, {'pmid': '38074312', 'type': 'DERIVED', 'citation': 'Subramanian S, Schnell G, Iulio JD, Gupta AK, Shapiro AE, Sarkis EH, Lopuski A, Peppercorn A, Aldinger M, Hebner CM, Cathcart AL. Resistance analysis following sotrovimab treatment in participants with COVID-19 during the phase III COMET-ICE study. Future Virol. 2023 Nov:10.2217/fvl-2023-0146. doi: 10.2217/fvl-2023-0146. Epub 2023 Dec 7.'}, {'pmid': '37702920', 'type': 'DERIVED', 'citation': 'Satram S, Ghafoori P, Reyes CM, Keeley TJH, Birch HJ, Brintziki D, Aldinger M, Alexander E, Lopuski A, Sarkis EH, Gupta A, Shapiro AE, Powers JH 3rd. Assessment of symptoms in COMET-ICE, a phase 2/3 study of sotrovimab for early treatment of non-hospitalized patients with COVID-19. J Patient Rep Outcomes. 2023 Sep 13;7(1):92. doi: 10.1186/s41687-023-00621-8.'}, {'pmid': '36703019', 'type': 'DERIVED', 'citation': 'Keeley TJH, Satram S, Ghafoori P, Reyes C, Birch HJ, Raymond K, Gelhorn HL, Kosinski M, Saucier CD, Mitchell Foster A, Lopuski A, Powers JH 3rd. Content validity and psychometric properties of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus(c)) instrument in patients with COVID-19. Qual Life Res. 2023 Jun;32(6):1645-1657. doi: 10.1007/s11136-022-03336-3. Epub 2023 Jan 27.'}, {'pmid': '35713300', 'type': 'DERIVED', 'citation': 'Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.'}, {'pmid': '34473343', 'type': 'DERIVED', 'citation': 'Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase 2/3 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 or placebo and will be assessed for safety, tolerability, efficacy, and pharmacokinetics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant must be aged 18 years or older AND at high risk of progression of COVID-19 or ≥ 55 years old\n* Participants must have a positive SARS-CoV-2 test result and oxygen saturation ≥94% on room air and have COVID-19 symptoms and be less than or equal to 5 days from onset of symptoms\n\nExclusion Criteria:\n\n* Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours\n* Symptoms consistent with severe COVID-19\n* Participants who, in the judgement of the investigator are likely to die in the next 7 days\n* Severely immunocompromised participants'}, 'identificationModule': {'nctId': 'NCT04545060', 'acronym': 'COMET-ICE', 'briefTitle': 'VIR-7831 for the Early Treatment of COVID-19 in Outpatients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vir Biotechnology, Inc.'}, 'officialTitle': 'A Phase II/III Randomized, Multi-center, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Monoclonal Antibody VIR-7831 for the Early Treatment of Coronavirus Disease 2019 (COVID-19) in Non-hospitalized Patients', 'orgStudyIdInfo': {'id': 'VIR-7831-5001'}, 'secondaryIdInfos': [{'id': 'GSK Study 214367', 'type': 'OTHER', 'domain': 'GlaxoSmithKline'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VIR-7831 (Sotrovimab)', 'description': 'Participants received 500 mg sotrovimab administered intravenously (IV)', 'interventionNames': ['Biological: VIR-7831 (sotrovimab)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo administered intravenously (IV)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'VIR-7831 (sotrovimab)', 'type': 'BIOLOGICAL', 'description': 'VIR-7831 (sotrovimab) given by intravenous infusion (single dose)', 'armGroupLabels': ['VIR-7831 (Sotrovimab)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sterile normal saline (0.9% NaCl) given by intravenous infusion (single dose)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '35055', 'city': 'Cullman', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'zip': '85210', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91325', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '93030', 'city': 'Oxnard', 'state': 'California', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 34.1975, 'lon': -119.17705}}, {'zip': '90274', 'city': 'Rolling Hills Estates', 'state': 'California', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 33.78779, 'lon': -118.35813}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '33166', 'city': 'Doral', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33122', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 25.77427, 'lon': 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