Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT05438602
Status:
COMPLETED
Last Update Posted:
2024-09-23
First Post:
2022-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Learn About the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older With COVID-19 and a Compromised Immune System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-08-12', '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_Inquires@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer Inc.', 'organization': 'Pfizer ClinicalTrials.gov Call Center'}, '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 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}, 'limitationsAndCaveats': {'description': 'For outcome measure data have not been reported for RP separately, since there was 1 participant each in 2 arms (Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day and Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 day), it could have led to re-identification of RP participants. In other sections of results data for RP and MSP have been combined.'}}, 'adverseEventsModule': {'timeFrame': 'Day 1 of dosing up to Week 24', 'description': 'Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \\>=30 to less than (\\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\\^2) or estimated creatinine clearance (eCrCl) \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 5 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 10 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 12, 'seriousNumAtRisk': 54, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 5 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 19, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Nirmatrelvir + Ritonavir 15 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 19, 'seriousNumAtRisk': 51, 'deathsNumAffected': 1, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pseudomonas infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Follicular lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Sustained Nasopharyngeal (NP) Swab Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribonucleic Acid (RNA) < Lower Limit of Quantitation (LLOQ) From Day 15 to Day 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \\>=30 to less than (\\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\\^2) or estimated creatinine clearance (eCrCl) \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 5 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 10 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG001', 'title': 'Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 5 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG002', 'title': 'Nirmatrelvir + Ritonavir 15 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.54', 'spread': '0.483', 'groupId': 'OG000', 'lowerLimit': '0.483', 'upperLimit': '0.748'}, {'value': '70.83', 'spread': '0.580', 'groupId': 'OG001', 'lowerLimit': '0.580', 'upperLimit': '0.837'}, {'value': '66.00', 'spread': '0.529', 'groupId': 'OG002', 'lowerLimit': '0.529', 'upperLimit': '0.791'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 15 to Day 44', 'description': "NP swab was collected by healthcare professional (HCP) from participants and were sent to the central laboratory for viral RNA level testing real-time reverse transcriptase-polymerase chain reaction(RT-PCR). Sustained was defined as NP swab SARS-CoV-2 RNA level not \\>=2.0 log10 per milliliter (copies/mL) at any study visit (through Day 44) following the first study visit where the participant's NP swab SARS-CoV-2 RNA level \\<LLOQ (\\<2.0 log10 copies/mL).", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to First NP Swab SARS-Cov-2 RNA <LLOQ for Participants With NP Swab SARS-CoV-2 RNA >= LLOQ at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \\>=30 to less than (\\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\\^2) or estimated creatinine clearance (eCrCl) \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 5 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 10 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG001', 'title': 'Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 5 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG002', 'title': 'Nirmatrelvir + Ritonavir 15 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.500', 'spread': '6.000', 'groupId': 'OG000', 'lowerLimit': '6.000', 'upperLimit': '15.000'}, {'value': '11.000', 'spread': '10.000', 'groupId': 'OG001', 'lowerLimit': '10.000', 'upperLimit': '15.000'}, {'value': '9.000', 'spread': '6.000', 'groupId': 'OG002', 'lowerLimit': '6.000', 'upperLimit': '11.000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 44', 'description': 'An NP swab was collected by HCP from participants and were sent to the central laboratory for viral RNA level testing RT-PCR. The LLOQ is \\<2.0 log10 copies/mL. Kaplan-Meier method was used for analysis. Time (days) to first NP swab SARS-CoV-2 RNA\\<LLOQ (event) was calculated as (First Event Date) - (First Dose Date) +1.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure with non-missing data in the analysis set."}, {'type': 'SECONDARY', 'title': 'Time to First Sustained NP Swab SARS-CoV-2 RNA < LLOQ for Participants Through Day 44 With NP Swab SARS-CoV-2 RNA >= LLOQ at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \\>=30 to less than (\\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\\^2) or estimated creatinine clearance (eCrCl) \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 5 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 10 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG001', 'title': 'Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 5 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG002', 'title': 'Nirmatrelvir + Ritonavir 15 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.000', 'spread': '9.000', 'groupId': 'OG000', 'lowerLimit': '9.000', 'upperLimit': '16.000'}, {'value': '11.000', 'spread': '10.000', 'groupId': 'OG001', 'lowerLimit': '10.000', 'upperLimit': '15.000'}, {'value': '10.000', 'spread': '9.000', 'groupId': 'OG002', 'lowerLimit': '9.000', 'upperLimit': '16.000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 44', 'description': "An NP swab was collected by HCP from participants and were sent to the central laboratory for viral RNA level testing RT-PCR. Sustained was defined as NP swab SARS-CoV-2 RNA level not \\>=2.0 log10 copies/mL at any study visit (through Day 44) following the first study visit where the participant's NP swab SARS-CoV-2 RNA level \\< LLOQ. The LLOQ is \\<2.0 log10 copies/mL. Time (days) to first sustained NP swab SARS-CoV-2 RNA\\<LLOQ (event) was calculated as (First Event Date) - (First Dose Date) +1.", 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure with non-missing data in the analysis set."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \\>=30 to less than (\\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\\^2) or estimated creatinine clearance (eCrCl) \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 5 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 10 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG001', 'title': 'Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 5 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG002', 'title': 'Nirmatrelvir + Ritonavir 15 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '98.08', 'spread': '0.930', 'groupId': 'OG000', 'lowerLimit': '0.930', 'upperLimit': '1.000'}, {'value': '97.92', 'spread': '0.925', 'groupId': 'OG001', 'lowerLimit': '0.925', 'upperLimit': '1.000'}, {'value': '92.00', 'spread': '0.923', 'groupId': 'OG002', 'lowerLimit': '0.923', 'upperLimit': '1.000'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '90.38', 'spread': '0.925', 'groupId': 'OG000', 'lowerLimit': '0.925', 'upperLimit': '1.000'}, {'value': '93.75', 'spread': '0.921', 'groupId': 'OG001', 'lowerLimit': '0.921', 'upperLimit': '1.000'}, {'value': '92.00', 'spread': '0.923', 'groupId': 'OG002', 'lowerLimit': '0.923', 'upperLimit': '1.000'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '92.31', 'spread': '0.926', 'groupId': 'OG000', 'lowerLimit': '0.926', 'upperLimit': '1.000'}, {'value': '95.83', 'spread': '0.923', 'groupId': 'OG001', 'lowerLimit': '0.923', 'upperLimit': '1.000'}, {'value': '92.00', 'spread': '0.923', 'groupId': 'OG002', 'lowerLimit': '0.923', 'upperLimit': '1.000'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '88.46', 'spread': '0.923', 'groupId': 'OG000', 'lowerLimit': '0.923', 'upperLimit': '1.000'}, {'value': '91.67', 'spread': '0.920', 'groupId': 'OG001', 'lowerLimit': '0.920', 'upperLimit': '1.000'}, {'value': '88.00', 'spread': '0.920', 'groupId': 'OG002', 'lowerLimit': '0.920', 'upperLimit': '1.000'}]}]}, {'title': 'Day 21', 'categories': [{'measurements': [{'value': '86.54', 'spread': '0.921', 'groupId': 'OG000', 'lowerLimit': '0.921', 'upperLimit': '1.000'}, {'value': '93.75', 'spread': '0.921', 'groupId': 'OG001', 'lowerLimit': '0.921', 'upperLimit': '1.000'}, {'value': '88.00', 'spread': '0.920', 'groupId': 'OG002', 'lowerLimit': '0.920', 'upperLimit': '1.000'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '84.62', 'spread': '0.920', 'groupId': 'OG000', 'lowerLimit': '0.920', 'upperLimit': '1.000'}, {'value': '95.83', 'spread': '0.923', 'groupId': 'OG001', 'lowerLimit': '0.923', 'upperLimit': '1.000'}, {'value': '78.00', 'spread': '0.910', 'groupId': 'OG002', 'lowerLimit': '0.910', 'upperLimit': '1.000'}]}]}, {'title': 'Day 35', 'categories': [{'measurements': [{'value': '82.69', 'spread': '0.918', 'groupId': 'OG000', 'lowerLimit': '0.918', 'upperLimit': '1.000'}, {'value': '93.75', 'spread': '0.921', 'groupId': 'OG001', 'lowerLimit': '0.921', 'upperLimit': '1.000'}, {'value': '84.00', 'spread': '0.916', 'groupId': 'OG002', 'lowerLimit': '0.916', 'upperLimit': '1.000'}]}]}, {'title': 'Day 44', 'categories': [{'measurements': [{'value': '86.54', 'spread': '0.921', 'groupId': 'OG000', 'lowerLimit': '0.921', 'upperLimit': '1.000'}, {'value': '91.67', 'spread': '0.920', 'groupId': 'OG001', 'lowerLimit': '0.920', 'upperLimit': '1.000'}, {'value': '88.00', 'spread': '0.920', 'groupId': 'OG002', 'lowerLimit': '0.920', 'upperLimit': '1.000'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '73.08', 'groupId': 'OG000'}, {'value': '87.50', 'groupId': 'OG001'}, {'value': '78.00', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '69.23', 'groupId': 'OG000'}, {'value': '85.42', 'groupId': 'OG001'}, {'value': '84.00', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Days 5, 10, 15, 21, 28, 35, and 44; Weeks 12 and 24', 'description': 'A 6-mL blood sample was collected for adult and pediatric participants and was analyzed to measure SARS-CoV-2 RNA \\<LLOQ in Plasma by RT-PCR. The LLOQ is \\<2.0 log10 copies/mL.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \\>=30 to less than (\\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\\^2) or estimated creatinine clearance (eCrCl) \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 5 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 10 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG001', 'title': 'Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 5 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG002', 'title': 'Nirmatrelvir + Ritonavir 15 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.77', 'spread': '0.292', 'groupId': 'OG000', 'lowerLimit': '0.292', 'upperLimit': '1.000'}, {'value': '8.33', 'spread': '0.398', 'groupId': 'OG001', 'lowerLimit': '0.398', 'upperLimit': '1.000'}, {'value': '4.00', 'spread': '0.158', 'groupId': 'OG002', 'lowerLimit': '0.158', 'upperLimit': '1.000'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '38.46', 'spread': '0.832', 'groupId': 'OG000', 'lowerLimit': '0.832', 'upperLimit': '1.000'}, {'value': '29.17', 'spread': '0.768', 'groupId': 'OG001', 'lowerLimit': '0.768', 'upperLimit': '1.000'}, {'value': '38.00', 'spread': '0.824', 'groupId': 'OG002', 'lowerLimit': '0.824', 'upperLimit': '1.000'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '51.92', 'spread': '0.872', 'groupId': 'OG000', 'lowerLimit': '0.872', 'upperLimit': '1.000'}, {'value': '64.58', 'spread': '0.888', 'groupId': 'OG001', 'lowerLimit': '0.888', 'upperLimit': '1.000'}, {'value': '58.00', 'spread': '0.881', 'groupId': 'OG002', 'lowerLimit': '0.881', 'upperLimit': '1.000'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '69.23', 'spread': '0.903', 'groupId': 'OG000', 'lowerLimit': '0.903', 'upperLimit': '1.000'}, {'value': '77.08', 'spread': '0.905', 'groupId': 'OG001', 'lowerLimit': '0.905', 'upperLimit': '1.000'}, {'value': '72.00', 'spread': '0.903', 'groupId': 'OG002', 'lowerLimit': '0.903', 'upperLimit': '1.000'}]}]}, {'title': 'Day 21', 'categories': [{'measurements': [{'value': '71.15', 'spread': '0.905', 'groupId': 'OG000', 'lowerLimit': '0.905', 'upperLimit': '1.000'}, {'value': '91.67', 'spread': '0.920', 'groupId': 'OG001', 'lowerLimit': '0.920', 'upperLimit': '1.000'}, {'value': '78.00', 'spread': '0.910', 'groupId': 'OG002', 'lowerLimit': '0.910', 'upperLimit': '1.000'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '80.77', 'spread': '0.916', 'groupId': 'OG000', 'lowerLimit': '0.916', 'upperLimit': '1.000'}, {'value': '93.75', 'spread': '0.921', 'groupId': 'OG001', 'lowerLimit': '0.921', 'upperLimit': '1.000'}, {'value': '76.00', 'spread': '0.907', 'groupId': 'OG002', 'lowerLimit': '0.907', 'upperLimit': '1.000'}]}]}, {'title': 'Day 35', 'categories': [{'measurements': [{'value': '80.77', 'spread': '0.916', 'groupId': 'OG000', 'lowerLimit': '0.916', 'upperLimit': '1.000'}, {'value': '91.67', 'spread': '0.920', 'groupId': 'OG001', 'lowerLimit': '0.920', 'upperLimit': '1.000'}, {'value': '84.00', 'spread': '0.916', 'groupId': 'OG002', 'lowerLimit': '0.916', 'upperLimit': '1.000'}]}]}, {'title': 'Day 44', 'categories': [{'measurements': [{'value': '78.85', 'spread': '0.914', 'groupId': 'OG000', 'lowerLimit': '0.914', 'upperLimit': '1.000'}, {'value': '91.67', 'spread': '0.920', 'groupId': 'OG001', 'lowerLimit': '0.920', 'upperLimit': '1.000'}, {'value': '88.00', 'spread': '0.920', 'groupId': 'OG002', 'lowerLimit': '0.920', 'upperLimit': '1.000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Days 5, 10, 15, 21, 28, 35 and 44', 'description': 'An NP swab was collected by HCP from adult and pediatric participants and were sent to the central laboratory for viral RNA level testing RT-PCR. The LLOQ is \\<2.0 log10 copies/mL.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \\>=30 to less than (\\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\\^2) or estimated creatinine clearance (eCrCl) \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 5 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 10 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG001', 'title': 'Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 5 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG002', 'title': 'Nirmatrelvir + Ritonavir 15 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}], 'classes': [{'title': 'Change at Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.449', 'spread': '1.730', 'groupId': 'OG000'}, {'value': '-3.621', 'spread': '1.521', 'groupId': 'OG001'}, {'value': '-3.746', 'spread': '1.687', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.167', 'spread': '2.292', 'groupId': 'OG000'}, {'value': '-4.931', 'spread': '1.899', 'groupId': 'OG001'}, {'value': '-5.002', 'spread': '1.942', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.827', 'spread': '2.476', 'groupId': 'OG000'}, {'value': '-5.773', 'spread': '1.473', 'groupId': 'OG001'}, {'value': '-6.009', 'spread': '2.093', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.472', 'spread': '2.028', 'groupId': 'OG000'}, {'value': '-6.328', 'spread': '1.472', 'groupId': 'OG001'}, {'value': '-6.319', 'spread': '1.967', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.938', 'spread': '2.138', 'groupId': 'OG000'}, {'value': '-6.509', 'spread': '1.571', 'groupId': 'OG001'}, {'value': '-6.530', 'spread': '1.770', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.237', 'spread': '1.746', 'groupId': 'OG000'}, {'value': '-6.596', 'spread': '1.453', 'groupId': 'OG001'}, {'value': '-6.633', 'spread': '1.816', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.916', 'spread': '1.865', 'groupId': 'OG000'}, {'value': '-6.597', 'spread': '1.445', 'groupId': 'OG001'}, {'value': '-6.707', 'spread': '1.922', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Days 5, 10, 15, 21, 28, 35 and 44', 'description': 'An NP swab was collected by HCP from adult and pediatric participants and were sent to the central laboratory for viral RNA level testing RT-PCR.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here "Number of Participants Analyzed" were participants evaluable for this outcome measure. All participants reported under "Number of Participants Analyzed" contributed data to table but may not have evaluable data for every row. Here, "number analyzed" signifies participants with non-missing data in the analysis set and evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \\>=30 to less than (\\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\\^2) or estimated creatinine clearance (eCrCl) \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 5 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 10 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG001', 'title': 'Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 5 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG002', 'title': 'Nirmatrelvir + Ritonavir 15 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}], 'classes': [{'title': 'Change at Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.457', 'spread': '0.643', 'groupId': 'OG000'}, {'value': '-1.360', 'spread': '0.717', 'groupId': 'OG001'}, {'value': '-1.528', 'spread': '0.626', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.487', 'spread': '0.601', 'groupId': 'OG000'}, {'value': '-1.700', 'spread': '0.000', 'groupId': 'OG001'}, {'value': '-1.880', 'spread': '0.380', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.700', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '-1.700', 'spread': '0.000', 'groupId': 'OG001'}, {'value': '-1.880', 'spread': '0.380', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.700', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '-1.700', 'spread': '0.000', 'groupId': 'OG001'}, {'value': '-1.880', 'spread': '0.380', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.700', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '-1.700', 'spread': '0.000', 'groupId': 'OG001'}, {'value': '-1.910', 'spread': '0.405', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.700', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '-1.700', 'spread': '0.000', 'groupId': 'OG001'}, {'value': '-1.894', 'spread': '0.392', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.700', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '-1.700', 'spread': '0.000', 'groupId': 'OG001'}, {'value': '-1.880', 'spread': '0.380', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Days 5, 10, 15, 21, 28, 35 and 44', 'description': 'A 6-mL blood sample was collected for adult and pediatric participants and was analyzed to measure SARS-CoV-2 RNA by RT-PCR.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants with non-missing data in the analysis set and evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Rebound in SARS-CoV-2 RNA Level in NP Swabs at Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \\>=30 to less than (\\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\\^2) or estimated creatinine clearance (eCrCl) \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 5 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 10 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG001', 'title': 'Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 5 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG002', 'title': 'Nirmatrelvir + Ritonavir 15 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 16 through Day 44', 'description': 'Rebound in SARS-CoV-2 RNA level in NP swabs at follow up (ie, any study visit after end of treatment through Day 44) was defined as a half (0.5) log10 copies/mL increase or greater in SARS-CoV-2 RNA level relative to end of treatment SARS-CoV-2 RNA level based on treatment regimen, with a follow-up viral RNA level \\>= 2.5 log10 copies/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Treatment Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \\>=30 to less than (\\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\\^2) or estimated creatinine clearance (eCrCl) \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 5 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 10 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG001', 'title': 'Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 5 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG002', 'title': 'Nirmatrelvir + Ritonavir 15 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'AEs Leading to Study Treatment Discontinuation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 of dosing up to Week 24', 'description': 'An adverse event (AE) was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. TEAE was an AE that occurred after initiation of study treatment that was not present at the time of treatment start or an AE that increased in severity after the initiation of medication, if the event was present at the time of treatment start emerges. SAE was an AE resulting in any of the following outcomes or considered medically significant: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or birth defect.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomized participants who received at least 1 dose of the study intervention.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With COVID-19-Related Hospitalization >24 Hours (h) or Death Through Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \\>=30 to less than (\\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\\^2) or estimated creatinine clearance (eCrCl) \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 5 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 10 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG001', 'title': 'Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 5 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG002', 'title': 'Nirmatrelvir + Ritonavir 15 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}], 'classes': [{'title': 'Hospitalization', 'categories': [{'measurements': [{'value': '3.846', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 28', 'description': 'Hospitalization \\>24 h is defined as \\>24h of acute care in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. This included specialized acute medical care unit within an assisted living facility or nursing home. This did not include hospitalization for the purposes of public health and/or clinical trial execution.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Death Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \\>=30 to less than (\\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\\^2) or estimated creatinine clearance (eCrCl) \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 5 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 10 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG001', 'title': 'Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 5 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG002', 'title': 'Nirmatrelvir + Ritonavir 15 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.923', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Week 24', 'description': 'Death due to any cause through week 24 was considered. Kaplan-Meier method was used for evaluation.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With COVID-19-Related Hospitalization Through Day 44 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \\>=30 to less than (\\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\\^2) or estimated creatinine clearance (eCrCl) \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 5 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 10 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG001', 'title': 'Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 5 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG002', 'title': 'Nirmatrelvir + Ritonavir 15 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}], 'classes': [{'title': 'Through Day 44', 'categories': [{'measurements': [{'value': '3.846', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Through Week 24', 'categories': [{'measurements': [{'value': '3.846', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 44 and Day 1 through Week 24', 'description': 'COVID-19 related hospitalization is defined as \\>24h of acute care in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. This included specialized acute medical care unit within an assisted living facility or nursing home. This did not include hospitalization for the purposes of public health and/or clinical trial execution.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With COVID-19-Related Intensive Care Unit (ICU) Admission Through Day 44 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \\>=30 to less than (\\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\\^2) or estimated creatinine clearance (eCrCl) \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 5 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 10 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG001', 'title': 'Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 5 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG002', 'title': 'Nirmatrelvir + Ritonavir 15 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}], 'classes': [{'title': 'Through Day 44', 'categories': [{'measurements': [{'value': '1.923', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Through Week 24', 'categories': [{'measurements': [{'value': '1.923', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 44 and Day 1 through Week 24', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Through Day 44 and Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \\>=30 to less than (\\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\\^2) or estimated creatinine clearance (eCrCl) \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 5 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 10 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG001', 'title': 'Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 5 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG002', 'title': 'Nirmatrelvir + Ritonavir 15 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}], 'classes': [{'title': 'Through Day 44', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Through Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 44 and Day 1 through Week 24', 'description': 'Invasive mechanical ventilation or ECMO were types of oxygen support received in hospital.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Mean Number of Days in Hospital and ICU Stay Through Day 44 and Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \\>=30 to less than (\\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\\^2) or estimated creatinine clearance (eCrCl) \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 5 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 10 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG001', 'title': 'Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 5 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG002', 'title': 'Nirmatrelvir + Ritonavir 15 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}], 'classes': [{'title': 'Hospital Stay: Up to Day 44', 'categories': [{'measurements': [{'value': '0.635', 'spread': '3.453', 'groupId': 'OG000', 'lowerLimit': '3.453'}, {'value': '0.000', 'spread': '0.000', 'groupId': 'OG001', 'lowerLimit': '0.000'}, {'value': '0.000', 'spread': '0.000', 'groupId': 'OG002', 'lowerLimit': '0.000'}]}]}, {'title': 'Hospital Stay: Up to Week 24', 'categories': [{'measurements': [{'value': '0.635', 'spread': '3.453', 'groupId': 'OG000', 'lowerLimit': '3.453'}, {'value': '0.000', 'spread': '0.000', 'groupId': 'OG001', 'lowerLimit': '0.000'}, {'value': '0.000', 'spread': '0.000', 'groupId': 'OG002', 'lowerLimit': '0.000'}]}]}, {'title': 'ICU Stay: Up to Day 44', 'categories': [{'measurements': [{'value': '0.442', 'spread': '3.190', 'groupId': 'OG000', 'lowerLimit': '3.190'}, {'value': '0.000', 'spread': '0.000', 'groupId': 'OG001', 'lowerLimit': '0.000'}, {'value': '0.000', 'spread': '0.000', 'groupId': 'OG002', 'lowerLimit': '0.000'}]}]}, {'title': 'ICU Stay: Up to Week 24', 'categories': [{'measurements': [{'value': '0.442', 'spread': '3.190', 'groupId': 'OG000', 'lowerLimit': '3.190'}, {'value': '0.000', 'spread': '0.000', 'groupId': 'OG001', 'lowerLimit': '0.000'}, {'value': '0.000', 'spread': '0.000', 'groupId': 'OG002', 'lowerLimit': '0.000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 through Day 44 and Day 1 through Week 24', 'description': 'Hospitalization \\>24 hours is defined as \\>24h of acute care in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with severe COVID-19.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Mean Number of COVID-19-Related Medical Visits Through Day 44 and Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \\>=30 to less than (\\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\\^2) or estimated creatinine clearance (eCrCl) \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 5 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 10 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG001', 'title': 'Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 5 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG002', 'title': 'Nirmatrelvir + Ritonavir 15 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}], 'classes': [{'title': 'Through Day 44', 'categories': [{'measurements': [{'value': '0.115', 'spread': '0.615', 'groupId': 'OG000', 'lowerLimit': '0.615'}, {'value': '0.000', 'spread': '0.000', 'groupId': 'OG001', 'lowerLimit': '0.000'}, {'value': '0.000', 'spread': '0.000', 'groupId': 'OG002', 'lowerLimit': '0.000'}]}]}, {'title': 'Through Week 24', 'categories': [{'measurements': [{'value': '0.115', 'spread': '0.615', 'groupId': 'OG000', 'lowerLimit': '0.615'}, {'value': '0.000', 'spread': '0.000', 'groupId': 'OG001', 'lowerLimit': '0.000'}, {'value': '0.020', 'spread': '0.141', 'groupId': 'OG002', 'lowerLimit': '0.141'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 through Day 44 and Day 1 through Week 24', 'unitOfMeasure': 'Medical visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \\>=30 to less than (\\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\\^2) or estimated creatinine clearance (eCrCl) \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 5 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 10 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG001', 'title': 'Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 5 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG002', 'title': 'Nirmatrelvir + Ritonavir 15 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}], 'classes': [{'title': 'Muscle or body aches', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.000', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': '9.000'}, {'value': '9.000', 'groupId': 'OG001', 'lowerLimit': '4.000', 'upperLimit': '9.000'}, {'value': '9.000', 'groupId': 'OG002', 'lowerLimit': '5.000', 'upperLimit': '13.000'}]}]}, {'title': 'SOB or difficulty breathing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.000', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': '9.000'}, {'value': '9.000', 'groupId': 'OG001', 'lowerLimit': '4.000', 'upperLimit': '9.000'}, {'value': '6.000', 'groupId': 'OG002', 'lowerLimit': '4.000', 'upperLimit': '13.000'}]}]}, {'title': 'Chills or shivering', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.000', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': '6.000'}, {'value': '4.000', 'groupId': 'OG001', 'lowerLimit': '4.000', 'upperLimit': '5.000'}, {'value': '5.000', 'groupId': 'OG002', 'lowerLimit': '4.000', 'upperLimit': '5.000'}]}]}, {'title': 'Cough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.000', 'groupId': 'OG000', 'lowerLimit': '5.000', 'upperLimit': '9.000'}, {'value': '9.000', 'groupId': 'OG001', 'lowerLimit': '6.000', 'upperLimit': '9.000'}, {'value': '10.000', 'groupId': 'OG002', 'lowerLimit': '5.000', 'upperLimit': '13.000'}]}]}, {'title': 'Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.000', 'groupId': 'OG000', 'lowerLimit': '5.000', 'upperLimit': '10.000'}, {'value': '5.000', 'groupId': 'OG001', 'lowerLimit': '4.000', 'upperLimit': '9.000'}, {'value': '9.000', 'groupId': 'OG002', 'lowerLimit': '4.000', 'upperLimit': '22.000'}]}]}, {'title': 'Feeling hot or feverish', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.000', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': '6.000'}, {'value': '4.000', 'groupId': 'OG001', 'lowerLimit': '4.000', 'upperLimit': '5.000'}, {'value': '5.000', 'groupId': 'OG002', 'lowerLimit': '4.000', 'upperLimit': '5.000'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.000', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': '15.000'}, {'value': '5.000', 'groupId': 'OG001', 'lowerLimit': '4.000', 'upperLimit': '9.000'}, {'value': '5.000', 'groupId': 'OG002', 'lowerLimit': '4.000', 'upperLimit': '9.000'}]}]}, {'title': 'Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.000', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': '13.000'}, {'value': '4.000', 'groupId': 'OG001', 'lowerLimit': '4.000', 'upperLimit': '5.000'}, {'value': '6.000', 'groupId': 'OG002', 'lowerLimit': '4.000', 'upperLimit': '13.000'}]}]}, {'title': 'Stuffy or runny nose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.000', 'groupId': 'OG000', 'lowerLimit': '6.000', 'upperLimit': '11.000'}, {'value': '9.000', 'groupId': 'OG001', 'lowerLimit': '5.000', 'upperLimit': '9.000'}, {'value': '9.000', 'groupId': 'OG002', 'lowerLimit': '5.000', 'upperLimit': '10.000'}]}]}, {'title': 'Sense of smell', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.000', 'groupId': 'OG000', 'lowerLimit': '6.000', 'upperLimit': '10.000'}, {'value': '9.000', 'groupId': 'OG001', 'lowerLimit': '4.000', 'upperLimit': '10.000'}, {'value': '9.000', 'groupId': 'OG002', 'lowerLimit': '5.000', 'upperLimit': '10.000'}]}]}, {'title': 'Sense of taste', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.000', 'groupId': 'OG000', 'lowerLimit': '5.000', 'upperLimit': '10.000'}, {'value': '9.000', 'groupId': 'OG001', 'lowerLimit': '4.000', 'upperLimit': '10.000'}, {'value': '9.000', 'groupId': 'OG002', 'lowerLimit': '6.000', 'upperLimit': '13.000'}]}]}, {'title': 'Sore throat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.000', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': '6.000'}, {'value': '5.000', 'groupId': 'OG001', 'lowerLimit': '4.000', 'upperLimit': '9.000'}, {'value': '5.000', 'groupId': 'OG002', 'lowerLimit': '4.000', 'upperLimit': '9.000'}]}]}, {'title': 'Low energy or tiredness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.000', 'groupId': 'OG000', 'lowerLimit': '6.000', 'upperLimit': '13.000'}, {'value': '9.000', 'groupId': 'OG001', 'lowerLimit': '5.000', 'upperLimit': '10.000'}, {'value': '9.000', 'groupId': 'OG002', 'lowerLimit': '5.000', 'upperLimit': '14.000'}]}]}, {'title': 'Vomit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.000', 'comment': 'The upper limit of CI could not be estimated due to insufficient number of participants with event.', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': 'NA'}, {'value': '4.000', 'comment': "The number of participants response in the participant's diary and participants with events available were not sufficient for calculation of the limits using Kaplan-Meier method", 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.500', 'comment': 'The upper limit of CI could not be estimated due to insufficient number of participants with event.', 'groupId': 'OG002', 'lowerLimit': '4.000', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 44', 'description': 'Symptoms alleviation through day44 of each targeted COVID-19 sign/symptom was defined as first time when each targeted symptom scored as moderate/severe at study entry are scored as mild or absent and a targeted symptom scored mild or absent at study entry are scored as absent.COVID-19 targeted signs/symptoms were muscle or body aches,shortness of breath(SOB)or difficulty breathing,chills or shivering, cough,diarrhea,feeling hot or feverish,headache,nausea,stuffy or runny nose,sense of smell,sense of taste,sore throat,low energy or tiredness, vomit.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable analysis set analyzed. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. All participants reported under "Number of Participants Analyzed"\' contributed data to table but may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants with non-missing data and with baseline severity of mild, moderate and severe of targeted signs/symptoms.'}, {'type': 'SECONDARY', 'title': 'Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \\>=30 to less than (\\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\\^2) or estimated creatinine clearance (eCrCl) \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 5 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 10 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG001', 'title': 'Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 5 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG002', 'title': 'Nirmatrelvir + Ritonavir 15 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}], 'classes': [{'title': 'Muscle or body aches', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.500', 'groupId': 'OG000', 'lowerLimit': '10.000', 'upperLimit': '19.000'}, {'value': '11.000', 'groupId': 'OG001', 'lowerLimit': '9.000', 'upperLimit': '21.000'}, {'value': '10.000', 'groupId': 'OG002', 'lowerLimit': '6.000', 'upperLimit': '20.000'}]}]}, {'title': 'SOB or difficulty breathing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.000', 'groupId': 'OG000', 'lowerLimit': '5.000', 'upperLimit': '13.000'}, {'value': '9.500', 'groupId': 'OG001', 'lowerLimit': '9.000', 'upperLimit': '19.000'}, {'value': '12.000', 'groupId': 'OG002', 'lowerLimit': '6.000', 'upperLimit': '19.000'}]}]}, {'title': 'Chills or shivering', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.000', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': '9.000'}, {'value': '4.000', 'groupId': 'OG001', 'lowerLimit': '4.000', 'upperLimit': '9.000'}, {'value': '5.000', 'groupId': 'OG002', 'lowerLimit': '4.000', 'upperLimit': '6.000'}]}]}, {'title': 'Cough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.000', 'groupId': 'OG000', 'lowerLimit': '10.000', 'upperLimit': '20.000'}, {'value': '12.000', 'groupId': 'OG001', 'lowerLimit': '9.000', 'upperLimit': '21.000'}, {'value': '19.500', 'groupId': 'OG002', 'lowerLimit': '11.000', 'upperLimit': '22.000'}]}]}, {'title': 'Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.000', 'groupId': 'OG000', 'lowerLimit': '6.000', 'upperLimit': '10.000'}, {'value': '9.000', 'groupId': 'OG001', 'lowerLimit': '4.000', 'upperLimit': '13.000'}, {'value': '16.500', 'groupId': 'OG002', 'lowerLimit': '4.000', 'upperLimit': '26.000'}]}]}, {'title': 'Feeling hot or feverish', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.000', 'groupId': 'OG000', 'lowerLimit': '5.000', 'upperLimit': '9.000'}, {'value': '7.000', 'groupId': 'OG001', 'lowerLimit': '4.000', 'upperLimit': '9.000'}, {'value': '5.000', 'groupId': 'OG002', 'lowerLimit': '4.000', 'upperLimit': '6.000'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.000', 'groupId': 'OG000', 'lowerLimit': '9.000', 'upperLimit': '15.000'}, {'value': '10.000', 'groupId': 'OG001', 'lowerLimit': '9.000', 'upperLimit': '15.000'}, {'value': '9.000', 'groupId': 'OG002', 'lowerLimit': '5.000', 'upperLimit': '11.000'}]}]}, {'title': 'Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.000', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': '14.000'}, {'value': '4.000', 'groupId': 'OG001', 'lowerLimit': '4.000', 'upperLimit': '9.000'}, {'value': '9.000', 'groupId': 'OG002', 'lowerLimit': '4.000', 'upperLimit': '13.000'}]}]}, {'title': 'Stuffy or runny nose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.000', 'groupId': 'OG000', 'lowerLimit': '10.000', 'upperLimit': '22.000'}, {'value': '13.000', 'groupId': 'OG001', 'lowerLimit': '9.000', 'upperLimit': '15.000'}, {'value': '13.000', 'groupId': 'OG002', 'lowerLimit': '9.000', 'upperLimit': '16.000'}]}]}, {'title': 'Sense of smell', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.000', 'groupId': 'OG000', 'lowerLimit': '9.000', 'upperLimit': '15.000'}, {'value': '9.000', 'groupId': 'OG001', 'lowerLimit': '5.000', 'upperLimit': '11.000'}, {'value': '9.000', 'groupId': 'OG002', 'lowerLimit': '5.000', 'upperLimit': '10.000'}]}]}, {'title': 'Sense of taste', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.000', 'groupId': 'OG000', 'lowerLimit': '9.000', 'upperLimit': '14.000'}, {'value': '10.500', 'groupId': 'OG001', 'lowerLimit': '9.000', 'upperLimit': '21.000'}, {'value': '10.000', 'groupId': 'OG002', 'lowerLimit': '6.000', 'upperLimit': '13.000'}]}]}, {'title': 'Sore throat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.000', 'groupId': 'OG000', 'lowerLimit': '5.000', 'upperLimit': '11.000'}, {'value': '9.500', 'groupId': 'OG001', 'lowerLimit': '9.000', 'upperLimit': '13.000'}, {'value': '9.000', 'groupId': 'OG002', 'lowerLimit': '9.000', 'upperLimit': '10.000'}]}]}, {'title': 'Low energy or tiredness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.000', 'groupId': 'OG000', 'lowerLimit': '13.000', 'upperLimit': '33.000'}, {'value': '20.000', 'groupId': 'OG001', 'lowerLimit': '13.000', 'upperLimit': '35.000'}, {'value': '22.000', 'comment': 'The upper limit of CI could not be estimated due to insufficient number of participants with event.', 'groupId': 'OG002', 'lowerLimit': '15.000', 'upperLimit': 'NA'}]}]}, {'title': 'Vomit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.000', 'comment': 'The upper limit of CI could not be estimated due to insufficient number of participants with event.', 'groupId': 'OG000', 'lowerLimit': '4.000', 'upperLimit': 'NA'}, {'value': '4.000', 'comment': 'The upper limit of CI could not be estimated due to insufficient number of participants with event.', 'groupId': 'OG001', 'lowerLimit': '4.000', 'upperLimit': 'NA'}, {'value': '4.500', 'comment': 'The upper limit of CI could not be estimated due to insufficient number of participants with event.', 'groupId': 'OG002', 'lowerLimit': '4.000', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 44', 'description': 'Symptoms resolution through day 44 of each targeted COVID-19 sign/symptom was defined as the first time when each targeted symptom scored as mild, moderate or severe at study entry are scored as absent. COVID -19 targeted signs/symptoms were muscle or body aches, SOB or difficulty breathing, chills or shivering, cough, diarrhoea, feeling hot or feverish, headache, nausea, stuffy or runny nose, sense of smell, sense of taste, sore throat, low energy or tiredness, vomit.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable analysis set analyzed. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. All participants reported under "Number of Participants Analyzed"\' contributed data to table but may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants with non-missing data and with baseline severity of mild, moderate and severe of targeted signs and symptoms.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Any Severe Targeted Signs and Symptoms Attributed to COVID-19 Through Day 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \\>=30 to less than (\\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\\^2) or estimated creatinine clearance (eCrCl) \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 5 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 10 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG001', 'title': 'Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 5 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'OG002', 'title': 'Nirmatrelvir + Ritonavir 15 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.85', 'groupId': 'OG000'}, {'value': '31.25', 'groupId': 'OG001'}, {'value': '38.00', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 44', 'description': 'COVID-19 targeted signs/symptoms were muscle or body aches, SOB or difficulty breathing, chills or shivering, cough, diarrhea, feeling hot or feverish, headache, nausea, stuffy or runny nose, sense of smell, sense of taste, sore throat, low energy or tiredness, vomit.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \\>=30 to less than (\\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\\^2) or estimated creatinine clearance (eCrCl) \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 5 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 10 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'FG001', 'title': 'Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 5 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'FG002', 'title': 'Nirmatrelvir + Ritonavir 15 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}], 'periods': [{'title': 'Treatment (15 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'No longer met eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}, {'title': 'Follow-up (Through Day 44)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants followed up after discontinuation or completion of treatment.', 'groupId': 'FG000', 'numSubjects': '54'}, {'comment': 'Participants followed up after discontinuation or completion of treatment.', 'groupId': 'FG001', 'numSubjects': '52'}, {'comment': 'Participants followed up after discontinuation or completion of treatment.', 'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}, {'title': 'Long-term Follow-up (Through Week 24)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants followed up after discontinuation or completion of treatment.', 'groupId': 'FG000', 'numSubjects': '54'}, {'comment': 'Participants followed up after discontinuation or completion of treatment.', 'groupId': 'FG001', 'numSubjects': '52'}, {'comment': 'Participants followed up after discontinuation or completion of treatment.', 'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'In this study there were following population enrolled: main study population (MSP) and rebound population (RP). MSP: Non-hospitalized participants aged greater than or equal to (\\>=) 12 years weighing \\>= 40 kilogram(kg) who were immunocompromised and diagnosed with symptomatic Coronavirus disease 2019 (COVID-19) were enrolled. RP: Non-hospitalized participants with documented, symptomatic COVID-19 rebound within 14 days after 5-day treatment with nirmatrelvir/ritonavir were enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '157', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 milligram (mg) and ritonavir 100 mg orally every 12 hours (q12h) for 5 days. Participants with estimated glomerular filtration rate (eGFR) \\>=30 to less than (\\<) 60 milliliters per minute (mL/min)/1.73 square meter (m\\^2) or estimated creatinine clearance (eCrCl) \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 5 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 10 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'BG001', 'title': 'Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 10 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 10 days. Participants then received placebo for nirmatrelvir and placebo for ritonavir q12h for next 5 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'BG002', 'title': 'Nirmatrelvir + Ritonavir 15 Day', 'description': 'Eligible participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally q12h for 5 days. Participants with eGFR \\>=30 to \\<60 mL/min/1.73 m\\^2 or eCrCl \\>=30 to \\<60 mL/min received nirmatrelvir 150 mg and ritonavir 100 mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.09', 'spread': '14.77', 'groupId': 'BG000'}, {'value': '54.77', 'spread': '16.20', 'groupId': 'BG001'}, {'value': '55.63', 'spread': '14.44', 'groupId': 'BG002'}, {'value': '55.85', 'spread': '15.08', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '< 12 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '12 - 17 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': '18 - 44 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}, {'title': '45 - 59 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}, {'title': '60 - 64 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': '65 - 74 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': '>= 75 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all randomised participants who received at least 1 dose of the study intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-13', 'size': 1651317, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-15T11:21', 'hasProtocol': True}, {'date': '2023-08-03', 'size': 254104, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-15T11:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-16', 'studyFirstSubmitDate': '2022-06-28', 'resultsFirstSubmitDate': '2024-07-15', 'studyFirstSubmitQcDate': '2022-06-28', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-16', 'studyFirstPostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Nasopharyngeal (NP) Swab Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribonucleic Acid (RNA) < Lower Limit of Quantitation (LLOQ) From Day 15 to Day 44', 'timeFrame': 'From Day 15 to Day 44', 'description': "NP swab was collected by healthcare professional (HCP) from participants and were sent to the central laboratory for viral RNA level testing real-time reverse transcriptase-polymerase chain reaction(RT-PCR). Sustained was defined as NP swab SARS-CoV-2 RNA level not \\>=2.0 log10 per milliliter (copies/mL) at any study visit (through Day 44) following the first study visit where the participant's NP swab SARS-CoV-2 RNA level \\<LLOQ (\\<2.0 log10 copies/mL)."}], 'secondaryOutcomes': [{'measure': 'Time to First NP Swab SARS-Cov-2 RNA <LLOQ for Participants With NP Swab SARS-CoV-2 RNA >= LLOQ at Baseline', 'timeFrame': 'Day 1 through Day 44', 'description': 'An NP swab was collected by HCP from participants and were sent to the central laboratory for viral RNA level testing RT-PCR. The LLOQ is \\<2.0 log10 copies/mL. Kaplan-Meier method was used for analysis. Time (days) to first NP swab SARS-CoV-2 RNA\\<LLOQ (event) was calculated as (First Event Date) - (First Dose Date) +1.'}, {'measure': 'Time to First Sustained NP Swab SARS-CoV-2 RNA < LLOQ for Participants Through Day 44 With NP Swab SARS-CoV-2 RNA >= LLOQ at Baseline', 'timeFrame': 'Day 1 through Day 44', 'description': "An NP swab was collected by HCP from participants and were sent to the central laboratory for viral RNA level testing RT-PCR. Sustained was defined as NP swab SARS-CoV-2 RNA level not \\>=2.0 log10 copies/mL at any study visit (through Day 44) following the first study visit where the participant's NP swab SARS-CoV-2 RNA level \\< LLOQ. The LLOQ is \\<2.0 log10 copies/mL. Time (days) to first sustained NP swab SARS-CoV-2 RNA\\<LLOQ (event) was calculated as (First Event Date) - (First Dose Date) +1."}, {'measure': 'Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24', 'timeFrame': 'Baseline; Days 5, 10, 15, 21, 28, 35, and 44; Weeks 12 and 24', 'description': 'A 6-mL blood sample was collected for adult and pediatric participants and was analyzed to measure SARS-CoV-2 RNA \\<LLOQ in Plasma by RT-PCR. The LLOQ is \\<2.0 log10 copies/mL.'}, {'measure': 'Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44', 'timeFrame': 'Baseline; Days 5, 10, 15, 21, 28, 35 and 44', 'description': 'An NP swab was collected by HCP from adult and pediatric participants and were sent to the central laboratory for viral RNA level testing RT-PCR. The LLOQ is \\<2.0 log10 copies/mL.'}, {'measure': 'Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44', 'timeFrame': 'Baseline; Days 5, 10, 15, 21, 28, 35 and 44', 'description': 'An NP swab was collected by HCP from adult and pediatric participants and were sent to the central laboratory for viral RNA level testing RT-PCR.'}, {'measure': 'Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44', 'timeFrame': 'Baseline; Days 5, 10, 15, 21, 28, 35 and 44', 'description': 'A 6-mL blood sample was collected for adult and pediatric participants and was analyzed to measure SARS-CoV-2 RNA by RT-PCR.'}, {'measure': 'Number of Participants With Rebound in SARS-CoV-2 RNA Level in NP Swabs at Follow up', 'timeFrame': 'Day 16 through Day 44', 'description': 'Rebound in SARS-CoV-2 RNA level in NP swabs at follow up (ie, any study visit after end of treatment through Day 44) was defined as a half (0.5) log10 copies/mL increase or greater in SARS-CoV-2 RNA level relative to end of treatment SARS-CoV-2 RNA level based on treatment regimen, with a follow-up viral RNA level \\>= 2.5 log10 copies/mL.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Treatment Discontinuation', 'timeFrame': 'Day 1 of dosing up to Week 24', 'description': 'An adverse event (AE) was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. TEAE was an AE that occurred after initiation of study treatment that was not present at the time of treatment start or an AE that increased in severity after the initiation of medication, if the event was present at the time of treatment start emerges. SAE was an AE resulting in any of the following outcomes or considered medically significant: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or birth defect.'}, {'measure': 'Percentage of Participants With COVID-19-Related Hospitalization >24 Hours (h) or Death Through Day 28', 'timeFrame': 'Day 1 through Day 28', 'description': 'Hospitalization \\>24 h is defined as \\>24h of acute care in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. This included specialized acute medical care unit within an assisted living facility or nursing home. This did not include hospitalization for the purposes of public health and/or clinical trial execution.'}, {'measure': 'Percentage of Participants With Death Through Week 24', 'timeFrame': 'Day 1 through Week 24', 'description': 'Death due to any cause through week 24 was considered. Kaplan-Meier method was used for evaluation.'}, {'measure': 'Percentage of Participants With COVID-19-Related Hospitalization Through Day 44 and Week 24', 'timeFrame': 'Day 1 through Day 44 and Day 1 through Week 24', 'description': 'COVID-19 related hospitalization is defined as \\>24h of acute care in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. This included specialized acute medical care unit within an assisted living facility or nursing home. This did not include hospitalization for the purposes of public health and/or clinical trial execution.'}, {'measure': 'Percentage of Participants With COVID-19-Related Intensive Care Unit (ICU) Admission Through Day 44 and Week 24', 'timeFrame': 'Day 1 through Day 44 and Day 1 through Week 24'}, {'measure': 'Percentage of Participants With Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Through Day 44 and Week 24', 'timeFrame': 'Day 1 through Day 44 and Day 1 through Week 24', 'description': 'Invasive mechanical ventilation or ECMO were types of oxygen support received in hospital.'}, {'measure': 'Mean Number of Days in Hospital and ICU Stay Through Day 44 and Through Week 24', 'timeFrame': 'Day 1 through Day 44 and Day 1 through Week 24', 'description': 'Hospitalization \\>24 hours is defined as \\>24h of acute care in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with severe COVID-19.'}, {'measure': 'Mean Number of COVID-19-Related Medical Visits Through Day 44 and Through Week 24', 'timeFrame': 'Day 1 through Day 44 and Day 1 through Week 24'}, {'measure': 'Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44', 'timeFrame': 'Day 1 through Day 44', 'description': 'Symptoms alleviation through day44 of each targeted COVID-19 sign/symptom was defined as first time when each targeted symptom scored as moderate/severe at study entry are scored as mild or absent and a targeted symptom scored mild or absent at study entry are scored as absent.COVID-19 targeted signs/symptoms were muscle or body aches,shortness of breath(SOB)or difficulty breathing,chills or shivering, cough,diarrhea,feeling hot or feverish,headache,nausea,stuffy or runny nose,sense of smell,sense of taste,sore throat,low energy or tiredness, vomit.'}, {'measure': 'Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44', 'timeFrame': 'Day 1 through Day 44', 'description': 'Symptoms resolution through day 44 of each targeted COVID-19 sign/symptom was defined as the first time when each targeted symptom scored as mild, moderate or severe at study entry are scored as absent. COVID -19 targeted signs/symptoms were muscle or body aches, SOB or difficulty breathing, chills or shivering, cough, diarrhoea, feeling hot or feverish, headache, nausea, stuffy or runny nose, sense of smell, sense of taste, sore throat, low energy or tiredness, vomit.'}, {'measure': 'Percentage of Participants With Any Severe Targeted Signs and Symptoms Attributed to COVID-19 Through Day 44', 'timeFrame': 'Day 1 through Day 44', 'description': 'COVID-19 targeted signs/symptoms were muscle or body aches, SOB or difficulty breathing, chills or shivering, cough, diarrhea, feeling hot or feverish, headache, nausea, stuffy or runny nose, sense of smell, sense of taste, sore throat, low energy or tiredness, vomit.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)', 'Coronavirus disease 2019 (COVID-19)', 'Paxlovid', 'Nirmatrelvir', 'Immunocompromised'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '41085942', 'type': 'DERIVED', 'citation': 'Mokgokong R, Cislo P, Tudone E, Weinstein E, Cappelleri JC. Symptom Alleviation/Resolution and Returns to Usual Health/Activities in Immunocompromised Adults with COVID-19 Treated with Nirmatrelvir-Ritonavir: Results from the EPIC-IC Trial. Infect Dis Ther. 2025 Dec;14(12):2763-2783. doi: 10.1007/s40121-025-01228-w. Epub 2025 Oct 14.'}, {'pmid': '40675169', 'type': 'DERIVED', 'citation': 'Weinstein E, Paredes R, Gardner A, Almas M, Baniecki ML, Guan S, Tudone E, Antonucci S, Gregg K, Garcia-Vidal C, Camacho-Ortiz A, Wisemandle W, Terra SG, Liu S, Aberg JA, Rana MM, Corey L, Ford ES, Hammond J, Rusnak J. Extended nirmatrelvir-ritonavir treatment durations for immunocompromised patients with COVID-19 (EPIC-IC): a placebo-controlled, randomised, double-blind, phase 2 trial. Lancet Infect Dis. 2025 Nov;25(11):1243-1253. doi: 10.1016/S1473-3099(25)00221-X. Epub 2025 Jul 14.'}, {'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.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C4671034', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Nirmatrelvir/Ritonavir) for the possible treatment of COVID-19.\n\nPatients with COVID-19 who have more difficulty in fighting against infections have a higher chance of severe illness. Such patients may benefit from longer treatment durations compared to the standard treatment regimen.\n\nThe study is seeking participants who:\n\n* Have a confirmed COVID-19 infection\n* Are Immunocompromised\n* Experience onset of signs/symptoms attributable to the current COVID-19 infection within 5 days prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization.\n\nIn addition, this study will also evaluate the efficacy and safety of a second treatment course of nirmatrelvir/ritonavir in people who experience that their COVID-19 is flaring up within 14 days of having taken a 5-day treatment course of nirmatrelvir/ritonavir.\n\nFor this group, the study is seeking participants who:\n\n* Have a confirmed COVID-19 infection\n* Experience a worsening of signs/symptoms after completing an initial 5-day course of nirmatrelvir/ritonavir\n* The worsening of COVID-19 symptoms must occur within 14 days after completion of the initial 5-day course of nirmatrelvir/ritonavir\n* Are Immunocompromised\n* Experience onset of signs/symptoms attributable to the current COVID-19 infection within 48 hours prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization.\n\nAll participants will be taking the study medicine for either 5, 10, or 15 days. The study medication will be taken by mouth 2 times a day. Participants will take part in this study for about 24 weeks. The first dose of study medication is taken at the study site and the rest at home. Selected participants will need to visit the study site at least 10 times during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (applicable for both the main population and population with rebound):\n\n* Participants aged 12 years or older and weighing ≥40 kg at screening.\n* Immunocompromised\n* ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization.\n\nParticipants for the main population must have:\n\n\\- Confirmed SARS-CoV-2 infection as determined by RT-PCR or other acceptable test method in any specimen collected within 5 days prior to randomization for the main study population.\n\nParticipants form the rebound population must have:\n\n\\- Confirmed SARS-CoV-2 infection as determined by RT-PCR or rapid antigen testing in any specimen collected within 24h prior to randomization and collected within 14 days after the completion of the initial 5-day treatment course of nirmatrelvir/ritonavir for the population with rebound.\n\nExclusion Criteria:\n\n* Current need for hospitalization or anticipated need for hospitalization within 24 h after randomization\n* Known medical history of active liver disease\n* Known HIV infection with a viral load \\>400 copies/mL or taking prohibited medications for human immunodeficiency virus (HIV)\n* Receiving dialysis or have known age-specific estimated glomerular filtration rate (eGFR) or estimated creatinine clearance (eCrCl) \\<30 mL/min/1.73 m2 at screening as measured by a serum creatinine point of care device\n* Oxygen saturation of \\<92% on room air obtained at rest within 24 hours prior to randomization\n* Current use of any prohibited concomitant medication(s)\n* Females who are pregnant and \\<14 weeks gestation'}, 'identificationModule': {'nctId': 'NCT05438602', 'briefTitle': 'A Study to Learn About the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older With COVID-19 and a Compromised Immune System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2, RANDOMIZED, DOUBLE-BLIND, 3-ARM STUDY TO INVESTIGATE NIRMATRELVIR/RITONAVIR IN NONHOSPITALIZED PARTICIPANTS AT LEAST 12 YEARS OF AGE WITH SYMPTOMATIC COVID-19 WHO ARE IMMUNOCOMPROMISED', 'orgStudyIdInfo': {'id': 'C4671034'}, 'secondaryIdInfos': [{'id': '2022-001362-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nirmatrelvir plus ritonavir for 5 days', 'description': 'Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 5 days followed by placebo for nirmatrelvir (2 tablets) plus placebo for ritonavir (1 capsule) every 12 hours for 10 days', 'interventionNames': ['Drug: Nirmatrelvir', 'Drug: Ritonavir', 'Drug: Placebo for nirmatrelvir', 'Drug: Placebo for ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'Nirmatrelvir plus ritonavir for 10 days', 'description': 'Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 10 days followed by placebo for nirmatrelvir (2 tablets) plus placebo for ritonavir (1 capsule) every 12 hours for 5 days', 'interventionNames': ['Drug: Nirmatrelvir', 'Drug: Ritonavir', 'Drug: Placebo for nirmatrelvir', 'Drug: Placebo for ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'Nirmatrelvir plus ritonavir for 15 days', 'description': 'Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 15 days.', 'interventionNames': ['Drug: Nirmatrelvir', 'Drug: Ritonavir']}], 'interventions': [{'name': 'Nirmatrelvir', 'type': 'DRUG', 'description': 'Participants will receive 2 tablets of nirmatrelvir every 12 hours', 'armGroupLabels': ['Nirmatrelvir plus ritonavir for 10 days', 'Nirmatrelvir plus ritonavir for 15 days', 'Nirmatrelvir plus ritonavir for 5 days']}, {'name': 'Ritonavir', 'type': 'DRUG', 'description': 'Participants will receive 1 capsule of ritonavir every 12 hours', 'armGroupLabels': ['Nirmatrelvir plus ritonavir for 10 days', 'Nirmatrelvir plus ritonavir for 15 days', 'Nirmatrelvir plus ritonavir for 5 days']}, {'name': 'Placebo for nirmatrelvir', 'type': 'DRUG', 'description': 'Participants will receive 2 tablets of placebo for nirmatrelvir every 12 hours. A placebo does not have any medicine in it but looks just like the medicine being studied.', 'armGroupLabels': ['Nirmatrelvir plus ritonavir for 10 days', 'Nirmatrelvir plus ritonavir for 5 days']}, {'name': 'Placebo for ritonavir', 'type': 'DRUG', 'description': 'Participants will receive 1 capsule of placebo for ritonavir every 12 hours. A placebo does not have any medicine in it but looks just like the medicine being studied.', 'armGroupLabels': ['Nirmatrelvir plus ritonavir for 10 days', 'Nirmatrelvir plus ritonavir for 5 days']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'CRS Outpatient Services UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Helen Diller Medical Center at Parnassus Heights', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSf infectious disease Lab', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33126', 'city': 'Doral', 'state': 'Florida', 'country': 'United States', 'facility': 'I.V.A.M. 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