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Ignite Creation Date: 2025-12-25 @ 3:53 AM

Ignite Modification Date: 2025-12-26 @ 2:42 AM

Study NCT ID: NCT04960202

Status: COMPLETED

Last Update Posted: 2025-07-10

First Post: 2021-07-10

Is NOT Gene Therapy: False

Has Adverse Events: True

Brief Title: EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Taiwan'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-12-20', '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': 'C000718217', 'term': 'nirmatrelvir'}, {'id': 'D019438', 'term': 'Ritonavir'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from the study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of study intervention at Day 1 up to end of long-term safety follow-up (Week 24)', 'description': 'Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. SAS population included all participants who were randomized and took at least one dose of investigational product.', 'eventGroups': [{'id': 'EG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.', 'otherNumAtRisk': 1038, 'deathsNumAtRisk': 1038, 'otherNumAffected': 234, 'seriousNumAtRisk': 1038, 'deathsNumAffected': 0, 'seriousNumAffected': 19}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.', 'otherNumAtRisk': 1053, 'deathsNumAtRisk': 1053, 'otherNumAffected': 228, 'seriousNumAtRisk': 1053, 'deathsNumAffected': 15, 'seriousNumAffected': 72}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Lymphadenopathy mediastinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hyperacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Thyroiditis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Faeces soft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hyperchlorhydria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Oedema due to cardiac disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hepatitis toxic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Steatohepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Mycotic allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Bronchopulmonary aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hepatitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Mumps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Oropharyngeal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pyelonephritis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Blood fibrinogen decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Blood lactate 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2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Blood thyroid stimulating hormone decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Breath sounds abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'C-reactive protein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Coagulation time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Creatinine renal clearance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Creatinine renal clearance increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Differential white blood cell count abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Neutrophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Prothrombin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Red blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Serum ferritin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Serum ferritin increased', 'stats': [{'groupId': 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thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Skin oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Disease risk factor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Vein collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Atypical pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Eye injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Creatinine renal clearance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Fibrin D dimer increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Brain stem stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Facial paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Abortion threatened', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Nasal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1038, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1053, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '647', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.752', 'groupId': 'OG000', 'lowerLimit': '0.313', 'upperLimit': '1.796'}, {'value': '6.888', 'groupId': 'OG001', 'lowerLimit': '5.172', 'upperLimit': '9.146'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.137', 'ciLowerLimit': '-8.208', 'ciUpperLimit': '-4.066', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.057', 'groupDescription': 'The difference of the percentage in the 2 treatment groups and its 95% confidence interval, and p-value based on Normal approximation of the data are presented.', 'statisticalMethod': 'Normal approximation', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to Day 28', 'description': 'Percentage of participants with COVID-19 related hospitalization or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier (KM) method. Using KM method, survival probability for each time interval was calculated as the number of participants surviving divided by the number of participants at risk. Participants who had the event, dropped out, or moved out were not counted as "at risk" i.e., participants who were lost were considered "censored" and were not counted in the denominator.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic monoclonal antibody (mAb) treatment and were treated \\<=3 days of COVID-19 onset.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}, {'value': '1053', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '228', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study intervention (Day 1) up to end of safety follow-up (Day 34)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. Serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical events. AEs included both SAEs and all non-SAEs. An AE was considered as TEAE if the event started on or after start date of study intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAS) included all participants who received at least one dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}, {'value': '1053', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'title': 'AEs leading to study discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study intervention (Day 1) up to end of safety follow-up (Day 34)', 'description': 'An AE was any untoward medical occurrence in a participant, temporarily associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS population included all participants who were randomized and took at least one dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '977', 'groupId': 'OG000'}, {'value': '989', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.933', 'groupId': 'OG000', 'lowerLimit': '0.487', 'upperLimit': '1.786'}, {'value': '6.571', 'groupId': 'OG001', 'lowerLimit': '5.180', 'upperLimit': '8.318'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.638', 'ciLowerLimit': '-7.308', 'ciUpperLimit': '-3.967', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.852', 'groupDescription': 'The difference of the percentage in the 2 treatment groups and its 95% confidence interval, and p-value based on Normal approximation of the data are presented.', 'statisticalMethod': 'Normal approximation', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to Day 28', 'description': 'Percentage of participants with COVID-19 related hospitalization or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment.'}, {'type': 'SECONDARY', 'title': 'Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '666', 'groupId': 'OG000'}, {'value': '645', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.00', 'groupId': 'OG000', 'lowerLimit': '12.00', 'upperLimit': '13.00'}, {'value': '15.00', 'groupId': 'OG001', 'lowerLimit': '13.00', 'upperLimit': '16.00'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.294', 'ciLowerLimit': '1.136', 'ciUpperLimit': '1.476', 'groupDescription': 'Analysis of treatment effect on time to sustained alleviation is based on Cox proportional hazard (PH) model with treatment and geographic region effects as independent variables, and baseline SARS-CoV-2 serology status and baseline viral load (\\<4 logarithm to base 10 \\[log10\\] copies/milliliter \\[mL\\], \\>=4 log10 copies/mL) as covariates.', 'statisticalMethod': 'Cox Proportional Hazard Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \\<=3 days of COVID-19 onset. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '970', 'groupId': 'OG000'}, {'value': '986', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.00', 'groupId': 'OG000', 'lowerLimit': '12.00', 'upperLimit': '13.00'}, {'value': '15.00', 'groupId': 'OG001', 'lowerLimit': '14.00', 'upperLimit': '16.00'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.266', 'ciLowerLimit': '1.134', 'ciUpperLimit': '1.412', 'groupDescription': 'Analysis of treatment effect on time to sustained alleviation is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\\<=3, \\>3), baseline SARS-CoV-2 serology status and baseline viral load (\\<4 log10 copies/mL, \\>=4 log10 copies/mL) as covariates.', 'statisticalMethod': 'Cox Proportional Hazard Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- Modified Intent-to-Treat 2 (mITT2) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1031', 'groupId': 'OG000'}, {'value': '1050', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.00', 'groupId': 'OG000', 'lowerLimit': '12.00', 'upperLimit': '13.00'}, {'value': '16.00', 'groupId': 'OG001', 'lowerLimit': '15.00', 'upperLimit': '17.00'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.258', 'ciLowerLimit': '1.131', 'ciUpperLimit': '1.400', 'groupDescription': 'Analysis of treatment effect on time to sustained alleviation is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\\<=3, \\>3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (\\<4 log10 copies/mL, \\>=4 log10 copies/mL) as covariates.', 'statisticalMethod': 'Cox Proportional Hazard Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '666', 'groupId': 'OG000'}, {'value': '645', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.168', 'groupId': 'OG000'}, {'value': '20.775', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3473', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.871', 'ciLowerLimit': '0.652', 'ciUpperLimit': '1.162', 'groupDescription': 'Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, baseline SARS-CoV-2 serology status and baseline viral load (\\< 4 log10 copies/mL, \\>= 4 log10 copies/mL).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to Day 28', 'description': 'Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \\<=3 days of COVID-19 onset. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '970', 'groupId': 'OG000'}, {'value': '986', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.691', 'groupId': 'OG000'}, {'value': '21.298', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5762', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.936', 'ciLowerLimit': '0.740', 'ciUpperLimit': '1.182', 'groupDescription': 'Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\\<=3, \\>3), baseline SARS-CoV-2 serology status and baseline viral load (\\< 4 log10 copies/mL, \\>= 4 log10 copies/mL).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to Day 28', 'description': 'Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1031', 'groupId': 'OG000'}, {'value': '1050', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.660', 'groupId': 'OG000'}, {'value': '21.810', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7807', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.969', 'ciLowerLimit': '0.773', 'ciUpperLimit': '1.213', 'groupDescription': 'Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\\<=3, \\>3), COVID-19 mAb treatment (Yes/No),baseline SARS-CoV-2 serology status and baseline viral load (\\< 4 log10 copies/mL, \\>= 4 log10 copies/mL).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to Day 28', 'description': 'Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '647', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.00', 'groupId': 'OG000', 'lowerLimit': '15.00', 'upperLimit': '17.00'}, {'value': '18.00', 'groupId': 'OG001', 'lowerLimit': '17.00', 'upperLimit': '20.00'}]}]}], 'analyses': [{'pValue': '0.0053', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.219', 'ciLowerLimit': '1.061', 'ciUpperLimit': '1.401', 'groupDescription': 'Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and baseline SARS-CoV-2 serology status and baseline viral load (\\<4 log10 copies/mL, \\>=4 log10 copies/mL) as covariates.', 'statisticalMethod': 'Cox Proportional Hazard Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \\<=3 days of COVID-19 onset. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '977', 'groupId': 'OG000'}, {'value': '989', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.00', 'groupId': 'OG000', 'lowerLimit': '15.00', 'upperLimit': '18.00'}, {'value': '19.00', 'groupId': 'OG001', 'lowerLimit': '18.00', 'upperLimit': '20.00'}]}]}], 'analyses': [{'pValue': '0.0022', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.200', 'ciLowerLimit': '1.068', 'ciUpperLimit': '1.348', 'groupDescription': 'Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\\<=3, \\>3), baseline SARS-CoV-2 serology status and baseline viral load (\\<4 log10 copies/mL, \\>=4 log10 copies/mL) as covariates.', 'statisticalMethod': 'Cox Proportional Hazard Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}, {'value': '1053', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.00', 'groupId': 'OG000', 'lowerLimit': '15.00', 'upperLimit': '18.00'}, {'value': '19.00', 'groupId': 'OG001', 'lowerLimit': '18.00', 'upperLimit': '20.00'}]}]}], 'analyses': [{'pValue': '0.0021', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.194', 'ciLowerLimit': '1.066', 'ciUpperLimit': '1.337', 'groupDescription': 'Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\\<=3, \\>3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (\\<4 log10 copies/mL, \\>=4 log10 copies/mL) as covariates.', 'statisticalMethod': 'Cox Proportional Hazard Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '647', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'title': 'Muscle or body aches', 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.000', 'groupId': 'OG000', 'lowerLimit': '5.000', 'upperLimit': '7.000'}, {'value': '7.000', 'groupId': 'OG001', 'lowerLimit': '6.000', 'upperLimit': '8.000'}]}]}, {'title': 'Shortness of breath or difficulty breathing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.000', 'groupId': 'OG000', 'lowerLimit': '5.000', 'upperLimit': '7.000'}, {'value': '8.000', 'groupId': 'OG001', 'lowerLimit': '6.000', 'upperLimit': '9.000'}]}]}, {'title': 'Chills or shivering', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.000', 'groupId': 'OG000', 'lowerLimit': '3.000', 'upperLimit': '4.000'}, {'value': '5.000', 'groupId': 'OG001', 'lowerLimit': '4.000', 'upperLimit': '5.000'}]}]}, {'title': 'Cough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}, {'value': '525', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.000', 'groupId': 'OG000', 'lowerLimit': '8.000', 'upperLimit': '9.000'}, {'value': '10.000', 'groupId': 'OG001', 'lowerLimit': '9.000', 'upperLimit': '11.000'}]}]}, {'title': 'Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.000', 'groupId': 'OG000', 'lowerLimit': '3.000', 'upperLimit': '6.000'}, {'value': '4.000', 'groupId': 'OG001', 'lowerLimit': '3.000', 'upperLimit': '6.000'}]}]}, {'title': 'Feeling hot or feverish', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.000', 'groupId': 'OG000', 'lowerLimit': '3.000', 'upperLimit': '4.000'}, {'value': '5.000', 'groupId': 'OG001', 'lowerLimit': '4.000', 'upperLimit': '5.000'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.000', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': '5.000'}, {'value': '7.000', 'groupId': 'OG001', 'lowerLimit': '6.000', 'upperLimit': '8.000'}]}]}, {'title': 'Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.000', 'groupId': 'OG000', 'lowerLimit': '3.000', 'upperLimit': '5.000'}, {'value': '5.000', 'groupId': 'OG001', 'lowerLimit': '4.000', 'upperLimit': '7.000'}]}]}, {'title': 'Stuffy or runny nose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'OG000'}, {'value': '440', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.000', 'groupId': 'OG000', 'lowerLimit': '5.000', 'upperLimit': '7.000'}, {'value': '7.000', 'groupId': 'OG001', 'lowerLimit': '7.000', 'upperLimit': '8.000'}]}]}, {'title': 'Sore throat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.000', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': '5.000'}, {'value': '6.000', 'groupId': 'OG001', 'lowerLimit': '5.000', 'upperLimit': '7.000'}]}]}, {'title': 'Vomit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.000', 'groupId': 'OG000', 'lowerLimit': '2.000', 'upperLimit': '4.000'}, {'value': '3.000', 'groupId': 'OG001', 'lowerLimit': '2.000', 'upperLimit': '5.000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \\<=3 days of COVID-19 onset. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for each specified category.'}, {'type': 'SECONDARY', 'title': 'Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '977', 'groupId': 'OG000'}, {'value': '989', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'title': 'Muscle or body aches', 'denoms': [{'units': 'Participants', 'counts': [{'value': '772', 'groupId': 'OG000'}, {'value': '778', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.000', 'groupId': 'OG000', 'lowerLimit': '5.000', 'upperLimit': '7.000'}, {'value': '7.000', 'groupId': 'OG001', 'lowerLimit': '7.000', 'upperLimit': '8.000'}]}]}, {'title': 'Shortness of breath or difficulty breathing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}, {'value': '451', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.000', 'groupId': 'OG000', 'lowerLimit': '5.000', 'upperLimit': '7.000'}, {'value': '8.000', 'groupId': 'OG001', 'lowerLimit': '7.000', 'upperLimit': '10.000'}]}]}, {'title': 'Chills or shivering', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}, {'value': '578', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.000', 'groupId': 'OG000', 'lowerLimit': '3.000', 'upperLimit': '4.000'}, {'value': '5.000', 'groupId': 'OG001', 'lowerLimit': '4.000', 'upperLimit': '5.000'}]}]}, {'title': 'Cough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '791', 'groupId': 'OG000'}, {'value': '816', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.000', 'groupId': 'OG000', 'lowerLimit': '8.000', 'upperLimit': '9.000'}, {'value': '10.000', 'groupId': 'OG001', 'lowerLimit': '9.000', 'upperLimit': '11.000'}]}]}, {'title': 'Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.000', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': '6.000'}, {'value': '4.000', 'groupId': 'OG001', 'lowerLimit': '3.000', 'upperLimit': '5.000'}]}]}, {'title': 'Feeling hot or feverish', 'denoms': [{'units': 'Participants', 'counts': [{'value': '603', 'groupId': 'OG000'}, {'value': '613', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.000', 'groupId': 'OG000', 'lowerLimit': '3.000', 'upperLimit': '4.000'}, {'value': '5.000', 'groupId': 'OG001', 'lowerLimit': '4.000', 'upperLimit': '6.000'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '709', 'groupId': 'OG000'}, {'value': '709', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.000', 'groupId': 'OG000', 'lowerLimit': '5.000', 'upperLimit': '6.000'}, {'value': '7.000', 'groupId': 'OG001', 'lowerLimit': '7.000', 'upperLimit': '8.000'}]}]}, {'title': 'Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.000', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': '6.000'}, {'value': '6.000', 'groupId': 'OG001', 'lowerLimit': '5.000', 'upperLimit': '7.000'}]}]}, {'title': 'Stuffy or runny nose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}, {'value': '684', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.000', 'groupId': 'OG000', 'lowerLimit': '5.000', 'upperLimit': '7.000'}, {'value': '7.000', 'groupId': 'OG001', 'lowerLimit': '7.000', 'upperLimit': '8.000'}]}]}, {'title': 'Sore throat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '548', 'groupId': 'OG000'}, {'value': '560', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.000', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': '5.000'}, {'value': '6.000', 'groupId': 'OG001', 'lowerLimit': '5.000', 'upperLimit': '7.000'}]}]}, {'title': 'Vomit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.000', 'groupId': 'OG000', 'lowerLimit': '2.000', 'upperLimit': '4.000'}, {'value': '3.000', 'groupId': 'OG001', 'lowerLimit': '2.000', 'upperLimit': '5.000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for each specified category.'}, {'type': 'SECONDARY', 'title': 'Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}, {'value': '1053', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'title': 'Muscle or body aches', 'denoms': [{'units': 'Participants', 'counts': [{'value': '821', 'groupId': 'OG000'}, {'value': '830', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.000', 'groupId': 'OG000', 'lowerLimit': '6.000', 'upperLimit': '7.000'}, {'value': '8.000', 'groupId': 'OG001', 'lowerLimit': '7.000', 'upperLimit': '9.000'}]}]}, {'title': 'Shortness of breath or difficulty breathing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'OG000'}, {'value': '487', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.000', 'groupId': 'OG000', 'lowerLimit': '5.000', 'upperLimit': '7.000'}, {'value': '9.000', 'groupId': 'OG001', 'lowerLimit': '8.000', 'upperLimit': '10.000'}]}]}, {'title': 'Chills or shivering', 'denoms': [{'units': 'Participants', 'counts': [{'value': '627', 'groupId': 'OG000'}, {'value': '620', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.000', 'groupId': 'OG000', 'lowerLimit': '3.000', 'upperLimit': '4.000'}, {'value': '5.000', 'groupId': 'OG001', 'lowerLimit': '4.000', 'upperLimit': '5.000'}]}]}, {'title': 'Cough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '874', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.000', 'groupId': 'OG000', 'lowerLimit': '8.000', 'upperLimit': '9.000'}, {'value': '10.000', 'groupId': 'OG001', 'lowerLimit': '9.000', 'upperLimit': '11.000'}]}]}, {'title': 'Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.000', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': '6.000'}, {'value': '4.000', 'groupId': 'OG001', 'lowerLimit': '3.000', 'upperLimit': '5.000'}]}]}, {'title': 'Feeling hot or feverish', 'denoms': [{'units': 'Participants', 'counts': [{'value': '649', 'groupId': 'OG000'}, {'value': '656', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.000', 'groupId': 'OG000', 'lowerLimit': '3.000', 'upperLimit': '4.000'}, {'value': '5.000', 'groupId': 'OG001', 'lowerLimit': '4.000', 'upperLimit': '5.000'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '759', 'groupId': 'OG000'}, {'value': '760', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.000', 'groupId': 'OG000', 'lowerLimit': '5.000', 'upperLimit': '6.000'}, {'value': '7.000', 'groupId': 'OG001', 'lowerLimit': '7.000', 'upperLimit': '8.000'}]}]}, {'title': 'Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.000', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': '6.000'}, {'value': '6.000', 'groupId': 'OG001', 'lowerLimit': '5.000', 'upperLimit': '7.000'}]}]}, {'title': 'Stuffy or runny nose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '739', 'groupId': 'OG000'}, {'value': '738', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.000', 'groupId': 'OG000', 'lowerLimit': '5.000', 'upperLimit': '7.000'}, {'value': '7.000', 'groupId': 'OG001', 'lowerLimit': '7.000', 'upperLimit': '8.000'}]}]}, {'title': 'Sore throat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '582', 'groupId': 'OG000'}, {'value': '607', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.000', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': '5.000'}, {'value': '6.000', 'groupId': 'OG001', 'lowerLimit': '5.000', 'upperLimit': '7.000'}]}]}, {'title': 'Vomit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.000', 'groupId': 'OG000', 'lowerLimit': '3.000', 'upperLimit': '4.000'}, {'value': '3.000', 'groupId': 'OG001', 'lowerLimit': '2.000', 'upperLimit': '5.000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for each specified category.'}, {'type': 'SECONDARY', 'title': 'Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '647', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'title': 'Muscle or body aches', 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.000', 'groupId': 'OG000', 'lowerLimit': '8.000', 'upperLimit': '11.000'}, {'value': '12.000', 'groupId': 'OG001', 'lowerLimit': '11.000', 'upperLimit': '13.000'}]}]}, {'title': 'Shortness of breath or difficulty breathing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.000', 'groupId': 'OG000', 'lowerLimit': '7.000', 'upperLimit': '9.000'}, {'value': '11.000', 'groupId': 'OG001', 'lowerLimit': '10.000', 'upperLimit': '14.000'}]}]}, {'title': 'Chills or shivering', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.000', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': '5.000'}, {'value': '7.000', 'groupId': 'OG001', 'lowerLimit': '6.000', 'upperLimit': '8.000'}]}]}, {'title': 'Cough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '539', 'groupId': 'OG000'}, {'value': '525', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.000', 'groupId': 'OG000', 'lowerLimit': '12.000', 'upperLimit': '13.000'}, {'value': '15.000', 'groupId': 'OG001', 'lowerLimit': '14.000', 'upperLimit': '16.000'}]}]}, {'title': 'Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.000', 'groupId': 'OG000', 'lowerLimit': '5.000', 'upperLimit': '8.000'}, {'value': '6.000', 'groupId': 'OG001', 'lowerLimit': '4.000', 'upperLimit': '9.000'}]}]}, {'title': 'Feeling hot or feverish', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.000', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': '5.000'}, {'value': '7.000', 'groupId': 'OG001', 'lowerLimit': '6.000', 'upperLimit': '8.000'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.000', 'groupId': 'OG000', 'lowerLimit': '8.000', 'upperLimit': '9.000'}, {'value': '11.000', 'groupId': 'OG001', 'lowerLimit': '9.000', 'upperLimit': '12.000'}]}]}, {'title': 'Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.000', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': '7.000'}, {'value': '7.000', 'groupId': 'OG001', 'lowerLimit': '6.000', 'upperLimit': '10.000'}]}]}, {'title': 'Stuffy or runny nose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'OG000'}, {'value': '440', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.000', 'groupId': 'OG000', 'lowerLimit': '9.000', 'upperLimit': '10.000'}, {'value': '10.000', 'groupId': 'OG001', 'lowerLimit': '9.000', 'upperLimit': '11.000'}]}]}, {'title': 'Sore throat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.000', 'groupId': 'OG000', 'lowerLimit': '6.000', 'upperLimit': '7.000'}, {'value': '9.000', 'groupId': 'OG001', 'lowerLimit': '8.000', 'upperLimit': '10.000'}]}]}, {'title': 'Vomit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.000', 'groupId': 'OG000', 'lowerLimit': '2.000', 'upperLimit': '5.000'}, {'value': '3.000', 'groupId': 'OG001', 'lowerLimit': '2.000', 'upperLimit': '5.000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \\<=3 days of COVID-19 onset. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for each specified category.'}, {'type': 'SECONDARY', 'title': 'Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '977', 'groupId': 'OG000'}, {'value': '989', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'title': 'Muscle or body aches', 'denoms': [{'units': 'Participants', 'counts': [{'value': '772', 'groupId': 'OG000'}, {'value': '778', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.000', 'groupId': 'OG000', 'lowerLimit': '8.000', 'upperLimit': '10.000'}, {'value': '12.000', 'groupId': 'OG001', 'lowerLimit': '11.000', 'upperLimit': '13.000'}]}]}, {'title': 'Shortness of breath or difficulty breathing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}, {'value': '451', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.000', 'groupId': 'OG000', 'lowerLimit': '8.000', 'upperLimit': '10.000'}, {'value': '12.000', 'groupId': 'OG001', 'lowerLimit': '11.000', 'upperLimit': '15.000'}]}]}, {'title': 'Chills or shivering', 'denoms': [{'units': 'Participants', 'counts': [{'value': '548', 'groupId': 'OG000'}, {'value': '578', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.000', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': '5.000'}, {'value': '7.000', 'groupId': 'OG001', 'lowerLimit': '6.000', 'upperLimit': '8.000'}]}]}, {'title': 'Cough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '791', 'groupId': 'OG000'}, {'value': '816', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.000', 'groupId': 'OG000', 'lowerLimit': '12.000', 'upperLimit': '14.000'}, {'value': '15.000', 'groupId': 'OG001', 'lowerLimit': '14.000', 'upperLimit': '17.000'}]}]}, {'title': 'Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.000', 'groupId': 'OG000', 'lowerLimit': '6.000', 'upperLimit': '8.000'}, {'value': '6.000', 'groupId': 'OG001', 'lowerLimit': '5.000', 'upperLimit': '8.000'}]}]}, {'title': 'Feeling hot or feverish', 'denoms': [{'units': 'Participants', 'counts': [{'value': '603', 'groupId': 'OG000'}, {'value': '613', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.000', 'comment': 'Due to variability of data, the number of participants with events available was not sufficient for the calculation of the limits using KM.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '7.000', 'groupId': 'OG001', 'lowerLimit': '6.000', 'upperLimit': '8.000'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '709', 'groupId': 'OG000'}, {'value': '709', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.000', 'groupId': 'OG000', 'lowerLimit': '8.000', 'upperLimit': '10.000'}, {'value': '11.000', 'groupId': 'OG001', 'lowerLimit': '10.000', 'upperLimit': '13.000'}]}]}, {'title': 'Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.000', 'groupId': 'OG000', 'lowerLimit': '6.000', 'upperLimit': '8.000'}, {'value': '7.000', 'groupId': 'OG001', 'lowerLimit': '6.000', 'upperLimit': '9.000'}]}]}, {'title': 'Stuffy or runny nose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}, {'value': '684', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.000', 'groupId': 'OG000', 'lowerLimit': '9.000', 'upperLimit': '10.000'}, {'value': '10.000', 'groupId': 'OG001', 'lowerLimit': '9.000', 'upperLimit': '11.000'}]}]}, {'title': 'Sore throat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '548', 'groupId': 'OG000'}, {'value': '560', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.000', 'groupId': 'OG000', 'lowerLimit': '6.000', 'upperLimit': '8.000'}, {'value': '9.000', 'groupId': 'OG001', 'lowerLimit': '8.000', 'upperLimit': '10.000'}]}]}, {'title': 'Vomit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.000', 'groupId': 'OG000', 'lowerLimit': '3.000', 'upperLimit': '5.000'}, {'value': '3.000', 'groupId': 'OG001', 'lowerLimit': '2.000', 'upperLimit': '5.000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for each specified category.'}, {'type': 'SECONDARY', 'title': 'Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}, {'value': '1053', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'title': 'Muscle or body aches', 'denoms': [{'units': 'Participants', 'counts': [{'value': '821', 'groupId': 'OG000'}, {'value': '830', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.000', 'groupId': 'OG000', 'lowerLimit': '8.000', 'upperLimit': '10.000'}, {'value': '12.000', 'groupId': 'OG001', 'lowerLimit': '11.000', 'upperLimit': '13.000'}]}]}, {'title': 'Shortness of breath or difficulty breathing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'OG000'}, {'value': '487', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.000', 'groupId': 'OG000', 'lowerLimit': '8.000', 'upperLimit': '10.000'}, {'value': '13.000', 'groupId': 'OG001', 'lowerLimit': '11.000', 'upperLimit': '15.000'}]}]}, {'title': 'Chills or shivering', 'denoms': [{'units': 'Participants', 'counts': [{'value': '627', 'groupId': 'OG000'}, {'value': '620', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.000', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': '5.000'}, {'value': '7.000', 'groupId': 'OG001', 'lowerLimit': '6.000', 'upperLimit': '8.000'}]}]}, {'title': 'Cough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '872', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.000', 'groupId': 'OG000', 'lowerLimit': '12.000', 'upperLimit': '14.000'}, {'value': '15.000', 'groupId': 'OG001', 'lowerLimit': '14.000', 'upperLimit': '17.000'}]}]}, {'title': 'Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.000', 'groupId': 'OG000', 'lowerLimit': '6.000', 'upperLimit': '8.000'}, {'value': '6.000', 'groupId': 'OG001', 'lowerLimit': '5.000', 'upperLimit': '8.000'}]}]}, {'title': 'Feeling hot or feverish', 'denoms': [{'units': 'Participants', 'counts': [{'value': '649', 'groupId': 'OG000'}, {'value': '656', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.000', 'groupId': 'OG000', 'lowerLimit': '5.000', 'upperLimit': '6.000'}, {'value': '7.000', 'groupId': 'OG001', 'lowerLimit': '6.000', 'upperLimit': '8.000'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '759', 'groupId': 'OG000'}, {'value': '760', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.000', 'groupId': 'OG000', 'lowerLimit': '9.000', 'upperLimit': '10.000'}, {'value': '11.000', 'groupId': 'OG001', 'lowerLimit': '10.000', 'upperLimit': '13.000'}]}]}, {'title': 'Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.000', 'groupId': 'OG000', 'lowerLimit': '6.000', 'upperLimit': '8.000'}, {'value': '7.000', 'groupId': 'OG001', 'lowerLimit': '6.000', 'upperLimit': '9.000'}]}]}, {'title': 'Stuffy or runny nose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '739', 'groupId': 'OG000'}, {'value': '738', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.000', 'groupId': 'OG000', 'lowerLimit': '9.000', 'upperLimit': '10.000'}, {'value': '11.000', 'groupId': 'OG001', 'lowerLimit': '10.000', 'upperLimit': '12.000'}]}]}, {'title': 'Sore throat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '584', 'groupId': 'OG000'}, {'value': '607', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.000', 'groupId': 'OG000', 'lowerLimit': '6.000', 'upperLimit': '8.000'}, {'value': '9.000', 'groupId': 'OG001', 'lowerLimit': '8.000', 'upperLimit': '10.000'}]}]}, {'title': 'Vomit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.000', 'groupId': 'OG000', 'lowerLimit': '3.000', 'upperLimit': '5.000'}, {'value': '4.000', 'groupId': 'OG001', 'lowerLimit': '3.000', 'upperLimit': '5.000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for each specified category.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '666', 'groupId': 'OG000'}, {'value': '645', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '507', 'groupId': 'OG000'}, {'value': '483', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5293', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.088', 'ciLowerLimit': '0.836', 'ciUpperLimit': '1.416', 'groupDescription': 'Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, baseline SARS-CoV-2 serology status and baseline viral load (\\< 4 log10 copies/mL, \\>= 4 log10 copies/mL).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= no occurrence, 1= mild for 1 to 2 times, 2= moderate for 3 to 4 times, and 3= severe for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \\<=3 days of COVID-19 onset. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT1 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '970', 'groupId': 'OG000'}, {'value': '986', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '735', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6379', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.053', 'ciLowerLimit': '0.850', 'ciUpperLimit': '1.303', 'groupDescription': 'Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\\<=3, \\>3), baseline SARS-CoV-2 serology status and baseline viral load (\\< 4 log10 copies/mL, \\>= 4 log10 copies/mL).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= no occurrence, 1= mild for 1 to 2 times, 2= moderate for 3 to 4 times, and 3= severe for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT2 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1031', 'groupId': 'OG000'}, {'value': '1050', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '787', 'groupId': 'OG000'}, {'value': '790', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6760', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.046', 'ciLowerLimit': '0.848', 'ciUpperLimit': '1.290', 'groupDescription': 'Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\\<=3, \\>3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (\\< 4 log10 copies/mL, \\>= 4 log10 copies/mL).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= no occurrence, 1= mild for 1 to 2 times, 2= moderate for 3 to 4 times, and 3= severe for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '647', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '647', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.443', 'groupId': 'OG000'}, {'value': '91.963', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '627', 'groupId': 'OG000'}, {'value': '595', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92.823', 'groupId': 'OG000'}, {'value': '89.076', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1997', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '19.400', 'ciLowerLimit': '7.788', 'ciUpperLimit': '48.328', 'estimateComment': 'Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg', 'statisticalMethod': 'Breslow-Day test', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.948', 'ciLowerLimit': '4.159', 'ciUpperLimit': '19.253', 'estimateComment': 'Odds ratio for Day 5 vs Day 1: Placebo', 'statisticalMethod': 'Breslow-Day test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, 5', 'description': 'In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation \\>=95% were reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \\<=3 days of COVID-19 onset. Here, "Number Analyzed" signifies participants evaluable for each specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '977', 'groupId': 'OG000'}, {'value': '989', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '977', 'groupId': 'OG000'}, {'value': '989', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.347', 'groupId': 'OG000'}, {'value': '92.214', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '912', 'groupId': 'OG000'}, {'value': '912', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.577', 'groupId': 'OG000'}, {'value': '87.610', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2810', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.875', 'ciLowerLimit': '10.097', 'ciUpperLimit': '43.156', 'estimateComment': 'Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg', 'statisticalMethod': 'Breslow-Day test', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.452', 'ciLowerLimit': '6.823', 'ciUpperLimit': '22.725', 'estimateComment': 'Odds ratio for Day 5 vs Day 1: Placebo', 'statisticalMethod': 'Breslow Day test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, 5', 'description': 'In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation \\>=95% were reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here, "Number Analyzed" signifies participants evaluable for each specified time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}, {'value': '1053', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}, {'value': '1053', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.353', 'groupId': 'OG000'}, {'value': '91.738', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '969', 'groupId': 'OG000'}, {'value': '966', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.538', 'groupId': 'OG000'}, {'value': '87.681', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2226', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.119', 'ciLowerLimit': '10.412', 'ciUpperLimit': '42.837', 'estimateComment': 'Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg', 'statisticalMethod': 'Breslow-Day test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2342', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.036', 'ciLowerLimit': '6.808', 'ciUpperLimit': '21.280', 'estimateComment': 'Odds ratio for Day 5 vs Day 1: Placebo', 'statisticalMethod': 'Breslow-Day test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, 5', 'description': 'In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation \\>=95% were reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here, "Number Analyzed" signifies participants evaluable for each specified time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Died Through Week 24- mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '647', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 up to Week 24', 'description': 'In this outcome measure, percentage of participants with death due to any cause was presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \\<=3 days of COVID-19 onset.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Died Through Week 24- mITT1 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '977', 'groupId': 'OG000'}, {'value': '989', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 up to Week 24', 'description': 'In this outcome measure, percentage of participants with death due to any cause was presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Died Through Week 24- mITT2 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}, {'value': '1053', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 up to Week 24', 'description': 'In this outcome measure, percentage of participants with death due to any cause was presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT2 population included all participants who were randomized and took at least one dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration Versus Time Summary of PF-07321332', 'denoms': [{'units': 'Participants', 'counts': [{'value': '772', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'title': 'Day 1 (1 Hour post dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2201', 'spread': '2130.7', 'groupId': 'OG000'}]}]}, {'title': 'Day 5 (Pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '505', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3087', 'spread': '2884.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Hour post-dose on Day 1 and pre-dose on Day 5', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS population included all participants who were randomized and took at least one dose of study intervention. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here "Number Analyzed" signifies participants evaluable for the specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '647', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '509', 'groupId': 'OG000'}, {'value': '498', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.829', 'spread': '1.805', 'groupId': 'OG000'}, {'value': '-1.203', 'spread': '1.697', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}, {'value': '478', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.244', 'spread': '1.697', 'groupId': 'OG000'}, {'value': '-2.923', 'spread': '1.787', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}, {'value': '447', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.522', 'spread': '2.105', 'groupId': 'OG000'}, {'value': '-3.964', 'spread': '2.1115', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '486', 'groupId': 'OG000'}, {'value': '472', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.108', 'spread': '2.141', 'groupId': 'OG000'}, {'value': '-4.862', 'spread': '2.121', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 3, 5, 10 and 14', 'description': 'The viral load was measured in nasal or nasopharyngeal samples using reverse transcription polymerase chain reaction (RT-PCR).', 'unitOfMeasure': 'Log10 copies per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \\<=3 days of COVID-19 onset. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for each specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '977', 'groupId': 'OG000'}, {'value': '989', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '733', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.790', 'spread': '1.727', 'groupId': 'OG000'}, {'value': '-1.182', 'spread': '1.689', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '688', 'groupId': 'OG000'}, {'value': '694', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.064', 'spread': '1.708', 'groupId': 'OG000'}, {'value': '-2.213', 'spread': '1.754', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'OG000'}, {'value': '663', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.309', 'spread': '2.108', 'groupId': 'OG000'}, {'value': '-3.772', 'spread': '2.058', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '691', 'groupId': 'OG000'}, {'value': '698', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.878', 'spread': '2.144', 'groupId': 'OG000'}, {'value': '-4.556', 'spread': '2.146', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 3, 5, 10 and 14', 'description': 'The viral load was measured in nasal or nasopharyngeal samples using RT-PCR.', 'unitOfMeasure': 'Log10 copies per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for each specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}, {'value': '1053', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '766', 'groupId': 'OG000'}, {'value': '781', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.828', 'spread': '1.715', 'groupId': 'OG000'}, {'value': '-1.178', 'spread': '1.663', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}, {'value': '743', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.097', 'spread': '1.692', 'groupId': 'OG000'}, {'value': '-2.239', 'spread': '1.741', 'groupId': 'OG001'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '728', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.322', 'spread': '2.109', 'groupId': 'OG000'}, {'value': '-3.777', 'spread': '2.041', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '739', 'groupId': 'OG000'}, {'value': '752', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.882', 'spread': '2.142', 'groupId': 'OG000'}, {'value': '-4.547', 'spread': '2.146', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 3, 5, 10 and 14', 'description': 'The viral load was measured in nasal or nasopharyngeal samples using RT-PCR.', 'unitOfMeasure': 'Log10 copies per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here \'Overall Number of Participants Analyzed\' signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for each specified time point.'}, {'type': 'SECONDARY', 'title': 'Number of COVID-19 Related Medical Visits- mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '647', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 up to Day 34', 'description': "Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (intensive care unit \\[ICU\\] and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported.", 'unitOfMeasure': 'Visits', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \\<=3 days of COVID-19 onset.'}, {'type': 'SECONDARY', 'title': 'Number of COVID-19 Related Medical Visits- mITT1 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '977', 'groupId': 'OG000'}, {'value': '989', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 up to Day 34', 'description': "Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (ICU and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported.", 'unitOfMeasure': 'Visits', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment.'}, {'type': 'SECONDARY', 'title': 'Number of COVID-19 Related Medical Visits- mITT2 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}, {'value': '1053', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 up to Day 34', 'description': "Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (ICU and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported.", 'unitOfMeasure': 'Visits', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT2 population included all participants who were randomized and took at least one dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '647', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'title': 'Duration of hospitalization visits', 'categories': [{'measurements': [{'value': '0.088', 'spread': '1.049', 'groupId': 'OG000'}, {'value': '0.844', 'spread': '4.535', 'groupId': 'OG001'}]}]}, {'title': 'Duration of ICU visits', 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '0.179', 'spread': '2.389', 'groupId': 'OG001'}]}]}, {'title': 'Duration of non-ICU visits', 'categories': [{'measurements': [{'value': '0.088', 'spread': '1.049', 'groupId': 'OG000'}, {'value': '0.666', 'spread': '3.710', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 up to Day 34', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \\<=3 days of COVID-19 onset. The analysis was performed on all participants (i.e. hospitalized and non-hospitalized participants were included).'}, {'type': 'SECONDARY', 'title': 'Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '977', 'groupId': 'OG000'}, {'value': '989', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'title': 'Duration of hospitalization visits', 'categories': [{'measurements': [{'value': '0.087', 'spread': '0.968', 'groupId': 'OG000'}, {'value': '0.766', 'spread': '4.055', 'groupId': 'OG001'}]}]}, {'title': 'Duration of ICU visits', 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '0.128', 'spread': '1.964', 'groupId': 'OG001'}]}]}, {'title': 'Duration of non-ICU visits', 'categories': [{'measurements': [{'value': '0.087', 'spread': '0.968', 'groupId': 'OG000'}, {'value': '0.639', 'spread': '3.446', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 up to Day 34', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. The analysis was performed on all participants (i.e. hospitalized and non-hospitalized participants were included).'}, {'type': 'SECONDARY', 'title': 'Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}, {'value': '1053', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'classes': [{'title': 'Duration of hospitalization visits', 'categories': [{'measurements': [{'value': '0.092', 'spread': '0.988', 'groupId': 'OG000'}, {'value': '0.729', 'spread': '3.940', 'groupId': 'OG001'}]}]}, {'title': 'Duration of ICU visits', 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '0.121', 'spread': '1.904', 'groupId': 'OG001'}]}]}, {'title': 'Duration of non-ICU visits', 'categories': [{'measurements': [{'value': '0.092', 'spread': '0.988', 'groupId': 'OG000'}, {'value': '0.610', 'spread': '3.350', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 up to Day 34', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT2 population included all participants who were randomized and took at least one dose of study intervention. The analysis was performed on all participants (i.e. hospitalized and non-hospitalized participants were included).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1038'}, {'groupId': 'FG001', 'numSubjects': '1053'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '976'}, {'groupId': 'FG001', 'numSubjects': '979'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '74'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}], 'preAssignmentDetails': '2256 participants signed the informed consent form (ICF). Out of these 2256 participants, 130 were screen failures who did not meet the study criteria and were not enrolled. There were 13 participants who were not screen failure but not randomized due to withdrew consent or other reasons. Of the 2113 randomized subjects, only 2091 received study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'BG000'}, {'value': '1053', 'groupId': 'BG001'}, {'value': '2091', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.86', 'spread': '15.37', 'groupId': 'BG000'}, {'value': '45.96', 'spread': '15.56', 'groupId': 'BG001'}, {'value': '45.84', 'spread': '15.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '522', 'groupId': 'BG000'}, {'value': '515', 'groupId': 'BG001'}, {'value': '1037', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '516', 'groupId': 'BG000'}, {'value': '538', 'groupId': 'BG001'}, {'value': '1054', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '425', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '864', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '608', 'groupId': 'BG000'}, {'value': '607', 'groupId': 'BG001'}, {'value': '1215', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '309', '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': '52', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '728', 'groupId': 'BG000'}, {'value': '756', 'groupId': 'BG001'}, {'value': '1484', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis set included all participants randomly assigned to study intervention, whether or not administered the study intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-20', 'size': 4092885, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-11-22T16:17', 'hasProtocol': True}, {'date': '2022-04-28', 'size': 3780719, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-11-22T16:17', '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', 'interventionModelDescription': 'Eligible participants with a confirmed diagnosis of SARS-CoV-2 infection will be randomized (1:1) to receive PF-07321332/ritonavir or placebo orally every 12 hours for 5 days (10 doses total).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2091}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2021-07-10', 'resultsFirstSubmitDate': '2022-11-22', 'studyFirstSubmitQcDate': '2021-07-10', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-13', 'studyFirstPostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population', 'timeFrame': 'From Day 1 to Day 28', 'description': 'Percentage of participants with COVID-19 related hospitalization or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier (KM) method. Using KM method, survival probability for each time interval was calculated as the number of participants surviving divided by the number of participants at risk. Participants who had the event, dropped out, or moved out were not counted as "at risk" i.e., participants who were lost were considered "censored" and were not counted in the denominator.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'From start of study intervention (Day 1) up to end of safety follow-up (Day 34)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. Serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical events. AEs included both SAEs and all non-SAEs. An AE was considered as TEAE if the event started on or after start date of study intervention.'}, {'measure': 'Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs)', 'timeFrame': 'From start of study intervention (Day 1) up to end of safety follow-up (Day 34)', 'description': 'An AE was any untoward medical occurrence in a participant, temporarily associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical events.'}, {'measure': 'Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population', 'timeFrame': 'From Day 1 to Day 28', 'description': 'Percentage of participants with COVID-19 related hospitalization or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier method.'}, {'measure': 'Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.'}, {'measure': 'Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.'}, {'measure': 'Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- Modified Intent-to-Treat 2 (mITT2) Population', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.'}, {'measure': 'Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT Population', 'timeFrame': 'From Day 1 to Day 28', 'description': 'Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported.'}, {'measure': 'Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 Population', 'timeFrame': 'From Day 1 to Day 28', 'description': 'Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported.'}, {'measure': 'Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 Population', 'timeFrame': 'From Day 1 to Day 28', 'description': 'Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported.'}, {'measure': 'Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.'}, {'measure': 'Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.'}, {'measure': 'Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.'}, {'measure': 'Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.'}, {'measure': 'Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.'}, {'measure': 'Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.'}, {'measure': 'Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.'}, {'measure': 'Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.'}, {'measure': 'Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.'}, {'measure': 'Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT Population', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= no occurrence, 1= mild for 1 to 2 times, 2= moderate for 3 to 4 times, and 3= severe for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline).'}, {'measure': 'Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT1 Population', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= no occurrence, 1= mild for 1 to 2 times, 2= moderate for 3 to 4 times, and 3= severe for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline).'}, {'measure': 'Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT2 Population', 'timeFrame': 'From Day 1 (baseline) to Day 28', 'description': 'Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= no occurrence, 1= mild for 1 to 2 times, 2= moderate for 3 to 4 times, and 3= severe for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline).'}, {'measure': 'Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT Population', 'timeFrame': 'Day 1, 5', 'description': 'In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation \\>=95% were reported.'}, {'measure': 'Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 Population', 'timeFrame': 'Day 1, 5', 'description': 'In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation \\>=95% were reported.'}, {'measure': 'Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 Population', 'timeFrame': 'Day 1, 5', 'description': 'In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation \\>=95% were reported.'}, {'measure': 'Percentage of Participants Who Died Through Week 24- mITT Population', 'timeFrame': 'From Day 1 up to Week 24', 'description': 'In this outcome measure, percentage of participants with death due to any cause was presented.'}, {'measure': 'Percentage of Participants Who Died Through Week 24- mITT1 Population', 'timeFrame': 'From Day 1 up to Week 24', 'description': 'In this outcome measure, percentage of participants with death due to any cause was presented.'}, {'measure': 'Percentage of Participants Who Died Through Week 24- mITT2 Population', 'timeFrame': 'From Day 1 up to Week 24', 'description': 'In this outcome measure, percentage of participants with death due to any cause was presented.'}, {'measure': 'Plasma Concentration Versus Time Summary of PF-07321332', 'timeFrame': '1 Hour post-dose on Day 1 and pre-dose on Day 5'}, {'measure': 'Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population', 'timeFrame': 'Baseline, Day 3, 5, 10 and 14', 'description': 'The viral load was measured in nasal or nasopharyngeal samples using reverse transcription polymerase chain reaction (RT-PCR).'}, {'measure': 'Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population', 'timeFrame': 'Baseline, Day 3, 5, 10 and 14', 'description': 'The viral load was measured in nasal or nasopharyngeal samples using RT-PCR.'}, {'measure': 'Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population', 'timeFrame': 'Baseline, Day 3, 5, 10 and 14', 'description': 'The viral load was measured in nasal or nasopharyngeal samples using RT-PCR.'}, {'measure': 'Number of COVID-19 Related Medical Visits- mITT Population', 'timeFrame': 'From Day 1 up to Day 34', 'description': "Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (intensive care unit \\[ICU\\] and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported."}, {'measure': 'Number of COVID-19 Related Medical Visits- mITT1 Population', 'timeFrame': 'From Day 1 up to Day 34', 'description': "Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (ICU and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported."}, {'measure': 'Number of COVID-19 Related Medical Visits- mITT2 Population', 'timeFrame': 'From Day 1 up to Day 34', 'description': "Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (ICU and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported."}, {'measure': 'Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population', 'timeFrame': 'From Day 1 up to Day 34'}, {'measure': 'Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population', 'timeFrame': 'From Day 1 up to Day 34'}, {'measure': 'Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population', 'timeFrame': 'From Day 1 up to Day 34'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '40809391', 'type': 'DERIVED', 'citation': 'Ansari W, Coetzer H, Gebo KA, Ren J, Scott A, Cappelleri JC, Cha-Silva AS, Leister-Tebbe H. Patient-Reported Outcomes of Nirmatrelvir Treatment for High-Risk, Nonhospitalized Adults With Symptomatic COVID-19. Open Forum Infect Dis. 2025 Aug 1;12(8):ofaf449. doi: 10.1093/ofid/ofaf449. eCollection 2025 Aug.'}, {'pmid': '40592258', 'type': 'DERIVED', 'citation': 'Baniecki ML, Guan S, Rai DK, Yang Q, Lee JT, Hao L, Weinstein E, Hyde C, Cardin RD, Soares H, Hammond J. Integrated virologic analysis of resistance to nirmatrelvir/ritonavir in individuals across four phase 2/3 clinical studies for the treatment of COVID-19. EBioMedicine. 2025 Aug;118:105819. doi: 10.1016/j.ebiom.2025.105819. Epub 2025 Jun 30.'}, {'pmid': '39523543', 'type': 'DERIVED', 'citation': 'Hammond J, Leister-Tebbe H, Gardner A, Abreu P, Bao W, Wisemandle W, Ansari W, Harrington MA, Simon-Campos A, Chew KW, Pypstra R, Rusnak JM. Alleviation of COVID-19 Symptoms and Reduction in Healthcare Utilization Among High-risk Patients Treated With Nirmatrelvir/Ritonavir (NMV/R): A Phase 3 Randomized Trial. Clin Infect Dis. 2025 Feb 24;80(2):323-330. doi: 10.1093/cid/ciae551.'}, {'pmid': '35172054', 'type': 'DERIVED', 'citation': 'Hammond J, Leister-Tebbe H, Gardner A, Abreu P, Bao W, Wisemandle W, Baniecki M, Hendrick VM, Damle B, Simon-Campos A, Pypstra R, Rusnak JM; EPIC-HR Investigators. Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19. N Engl J Med. 2022 Apr 14;386(15):1397-1408. doi: 10.1056/NEJMoa2118542. Epub 2022 Feb 16.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C4671005', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether PF-07321332/ritonavir is safe and effective for the treatment of adults who are ill with COVID-19 and do not need to be in the hospital, but are at an increased risk of developing severe illness. Throughout the study period, provision will be made to allow study visits to be conducted at a participant's home or another non-clinic location if available. The total study duration is up to 24 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed SARS-CoV-2 infection within 5 days prior to randomization\n* Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of randomization and at least 1 of the specified COVID-19 signs/symptoms present on the day of randomization\n* Fertile participants must agree to use a highly effective method of contraception\n* Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19\n\nExclusion Criteria:\n\n* History of or need for hospitalization for the medical treatment of COVID-19\n* Prior to current disease episode, any confirmed SARS-CoV-2 infection\n* Known medical history of active liver disease\n* Receiving dialysis or have known moderate to severe renal impairment\n* Known human immunodeficiency virus (HIV) infection with a viral load greater than 400 copies/mL or taking prohibited medications for HIV treatment\n* Suspected or confirmed concurrent active systemic infection other than COVID-19\n* History of hypersensitivity or other contraindication to any of the components of the study intervention\n* Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance or are strong inducers of CYP3A4\n* Has received or is expected to receive convalescent COVID-19 plasma\n* Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day 34 visit\n* Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 through the long-term follow-up visit\n* Known prior participation in this trial or other trial involving PF-07321332\n* Oxygen saturation of \\<92% on room air, or on their standard home oxygen supplementation for those who regularly receive chronic supplementary oxygen for an underlying lung condition\n* Females who are pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT04960202', 'briefTitle': 'EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2/3, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332/RITONAVIR COMPARED WITH PLACEBO IN NONHOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19 WHO ARE AT INCREASED RISK OF PROGRESSING TO SEVERE ILLNESS', 'orgStudyIdInfo': {'id': 'C4671005'}, 'secondaryIdInfos': [{'id': '2021-002895-38', 'type': 'EUDRACT_NUMBER'}, {'id': 'EPIC-HR', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-07321332/ritonavir', 'description': 'Orally administered PF-07321332+ritonavir', 'interventionNames': ['Drug: PF-07321332', 'Drug: Ritonavir']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Orally administered placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PF-07321332', 'type': 'DRUG', 'description': 'PF-07321332 (tablet)', 'armGroupLabels': ['PF-07321332/ritonavir']}, {'name': 'Ritonavir', 'type': 'DRUG', 'description': 'Ritonavir (capsule)', 'armGroupLabels': ['PF-07321332/ritonavir']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo (tablet or capsule)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35124', 'city': 'Pelham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cahaba Research Inc', 'geoPoint': {'lat': 33.28567, 'lon': -86.80999}}, {'zip': '85210', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'The Institute for Liver Health dba Arizona Clinical Trials', 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States', 'facility': 'MOORE Clinical Research, Inc.', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Innovative Research of West Florida, Inc.', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Herco Medical and Research Center Inc', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33157', 'city': 'Cutler Bay', 'state': 'Florida', 'country': 'United States', 'facility': 'Advance Clinical Research Group', 'geoPoint': {'lat': 25.5783, 'lon': -80.3377}}, {'zip': '33157', 'city': 'Cutler Bay', 'state': 'Florida', 'country': 'United States', 'facility': 'Beautiful Minds Clinical Research Center', 'geoPoint': {'lat': 25.5783, 'lon': -80.3377}}, {'zip': '33010', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Qway Research', 'geoPoint': {'lat': 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'United States', 'facility': 'Advanced Pulmonary Research Institute', 'geoPoint': {'lat': 26.68368, 'lon': -80.27977}}, {'zip': '33122', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Angels Clinical Research Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'LCC Medical Research Institute, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Premium Medical Research Corp', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Global Health Clinical Trials Corp', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'South Florida Research Center, Inc.', 'geoPoint': {'lat': 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'Florida', 'country': 'United States', 'facility': 'Clinical Site Partners, Inc d/b/a CSP Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33186', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Coral Research Clinic Corp', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Savin Medical Group, LLC', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '32808', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Omega Research Orlando, LLC', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33064', 'city': 'Pompano Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'NAPA Research LLC', 'geoPoint': {'lat': 26.23786, 'lon': -80.12477}}, {'zip': '34952', 'city': 'Port Saint Lucie', 'state': 'Florida', 'country': 'United States', 'facility': 'CDC Research Institute', 'geoPoint': {'lat': 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'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research by Design, LLC', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70072', 'city': 'Marrero', 'state': 'Louisiana', 'country': 'United States', 'facility': 'New Orleans Sinus Center (COVID-19 Testing)', 'geoPoint': {'lat': 29.89937, 'lon': -90.10035}}, {'zip': '70072', 'city': 'Marrero', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tandem Clinical Research GI, LLC', 'geoPoint': {'lat': 29.89937, 'lon': -90.10035}}, {'zip': '59701', 'city': 'Butte', 'state': 'Montana', 'country': 'United States', 'facility': 'Mercury Street Medical Group, PLLC', 'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'zip': '89109', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Excel Clinical research', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '13760', 'city': 'Endwell', 'state': 'New York', 'country': 'United States', 'facility': 'Meridian Clinical Research, LLC', 'geoPoint': {'lat': 42.11285, 'lon': -76.02103}}, {'zip': '28112', 'city': 'Monroe', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Monroe Biomedical Research', 'geoPoint': {'lat': 34.98543, 'lon': -80.54951}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Accellacare', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '37040', 'city': 'Clarksville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Premier Medical Group', 'geoPoint': {'lat': 36.52977, 'lon': -87.35945}}, {'zip': '79109', 'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'facility': 'PharmaTex Research, LLC', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'zip': '78745', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'ARC Clinical Research at William Cannon', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77401', 'city': 'Bellaire', 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