Clinical Trial Results:
An Interventional Efficacy and Safety, Phase 2, Randomized, Double-Blind, 3-arm Study to Investigate Nirmatrelvir/Ritonavir in Non-Hospitalized Participants at Least 12 Years of age With Symptomatic COVID-19 who are Immunocompromised
Summary
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EudraCT number |
2022-001362-35 |
Trial protocol |
ES BG HU SK |
Global end of trial date |
13 Nov 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
10 May 2024
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First version publication date |
10 May 2024
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
C4671034
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05438602 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Pfizer Inc.
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Sponsor organisation address |
235E 42nd Street, New York, United States, NY 10017
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Public contact |
Pfizer Inc., Pfizer ClinicalTrials.gov Call Center, 001 8007181021, ClinicalTrials.gov_Inquires@pfizer.com
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Scientific contact |
Pfizer Inc., Pfizer ClinicalTrials.gov Call Center, 001 8007181021, ClinicalTrials.gov_Inquires@pfizer.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
15 Feb 2024
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Nov 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To describe the effect of nirmatrelvir/ritonavir on viral ribonucleic acid (RNA) levels in nasopharyngeal (NP) swabs over time for the treatment of COVID-19 in non-hospitalized symptomatic participants more than or equal to (>=) 12 years of age with COVID-19 who were immunocompromised.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials participants were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Aug 2022
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety | ||
Long term follow-up duration |
6 Months | ||
Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Australia: 3
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Country: Number of subjects enrolled |
Canada: 11
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Country: Number of subjects enrolled |
Brazil: 4
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Country: Number of subjects enrolled |
Spain: 51
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Country: Number of subjects enrolled |
Bulgaria: 1
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Country: Number of subjects enrolled |
Slovakia: 25
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Country: Number of subjects enrolled |
Mexico: 24
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Country: Number of subjects enrolled |
United States: 38
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Worldwide total number of subjects |
157
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EEA total number of subjects |
77
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
1
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Adults (18-64 years) |
107
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From 65 to 84 years |
49
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85 years and over |
0
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Recruitment
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Recruitment details |
Main study population (MSP): Participants aged >= 12 years weighing >= 40 kilogram(kg) who were immunocompromised and diagnosed with symptomatic COVID-19 were enrolled. Rebound population (RP): Participants with documented, symptomatic COVID-19 rebound within 14 days after 5-day treatment with nirmatrelvir/ritonavir were enrolled. | ||||||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
MSP: A total of 156 participants were enrolled and 155 participants were treated. RP: A total of 2 participants were enrolled and treated. | ||||||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Treatment
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Carer, Investigator | ||||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants (MSP + RP) received 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. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Nirmatrelvir
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Investigational medicinal product code |
PF-07321332
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received nirmatrelvir 300 mg every 12 hours for 5 days.
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Investigational medicinal product name |
Placebo for Ritonavir
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received placebo for ritonavir every 12 hours for 10 days.
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Investigational medicinal product name |
Placebo for Nirmatrelvir
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received placebo for nirmatrelvir every 12 hours for 10 days.
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Investigational medicinal product name |
Ritonavir
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received ritonavir 100 mg every 12 hours for 5 days.
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Arm title
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Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants (MSP + RP) received 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. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Nirmatrelvir
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Investigational medicinal product code |
PF-07321332
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received nirmatrelvir 300 mg every 12 hours for 10 days.
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Investigational medicinal product name |
Placebo for Nirmatrelvir
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received placebo for nirmatrelvir every 12 hours for 5 days.
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Investigational medicinal product name |
Placebo for Ritonavir
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received placebo for ritonavir every 12 hours for 5 days.
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Investigational medicinal product name |
Ritonavir
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received ritonavir 100 mg every 12 hours for 10 days.
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Arm title
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Nirmatrelvir + Ritonavir 15 Day | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants (MSP) received 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. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Ritonavir
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received ritonavir 100 mg every 12 hours for 15 days.
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Investigational medicinal product name |
Nirmatrelvir
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Investigational medicinal product code |
PF-07321332
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received nirmatrelvir 300 mg every 12 hours for 15 days.
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Period 2
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Period 2 title |
Follow-up
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Is this the baseline period? |
No | ||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Carer, Investigator | ||||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Nirmatrelvir + Ritonavir 5 day Then Placebo 10 Day | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants (MSP + RP) received 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. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
No intervention | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Nirmatrelvir + Ritonavir 10-day Then Placebo 5 Day | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants (MSP + RP) received 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. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
No intervention | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Nirmatrelvir + Ritonavir 15 Day | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants (MSP) received 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. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
No intervention | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Period 3
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Period 3 title |
Long-term follow-up
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Is this the baseline period? |
No | ||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Carer, Investigator | ||||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Nirmatrelvir + Ritonavir 5 day Then Placebo 10 Day | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants (MSP + RP) received 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. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
No intervention | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Nirmatrelvir + Ritonavir 10-day Then Placebo 5 Day | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants (MSP + RP) received 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. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
No intervention | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Nirmatrelvir + Ritonavir 15 Day | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants (MSP) received 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. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
No intervention | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day
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Reporting group description |
Participants (MSP + RP) received 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day
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Reporting group description |
Participants (MSP + RP) received 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Nirmatrelvir + Ritonavir 15 Day
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Reporting group description |
Participants (MSP) received 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day
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||
Reporting group description |
Participants (MSP + RP) received 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. | ||
Reporting group title |
Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day
|
||
Reporting group description |
Participants (MSP + RP) received 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. | ||
Reporting group title |
Nirmatrelvir + Ritonavir 15 Day
|
||
Reporting group description |
Participants (MSP) received 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. | ||
Reporting group title |
Nirmatrelvir + Ritonavir 5 day Then Placebo 10 Day
|
||
Reporting group description |
Participants (MSP + RP) received 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. | ||
Reporting group title |
Nirmatrelvir + Ritonavir 10-day Then Placebo 5 Day
|
||
Reporting group description |
Participants (MSP + RP) received 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. | ||
Reporting group title |
Nirmatrelvir + Ritonavir 15 Day
|
||
Reporting group description |
Participants (MSP) received 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. | ||
Reporting group title |
Nirmatrelvir + Ritonavir 5 day Then Placebo 10 Day
|
||
Reporting group description |
Participants (MSP + RP) received 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. | ||
Reporting group title |
Nirmatrelvir + Ritonavir 10-day Then Placebo 5 Day
|
||
Reporting group description |
Participants (MSP + RP) received 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. | ||
Reporting group title |
Nirmatrelvir + Ritonavir 15 Day
|
||
Reporting group description |
Participants (MSP) received 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. |
|
|||||||||||||||||
End point 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: MSP [1] | ||||||||||||||||
End point description |
An 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 copies/mL at any study visit (through Day 44) following the first study visit where the participant's NP swab SARS-CoV-2 RNA <LLOQ (<2.0 log10 copies/mL). Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention.
|
||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
From Day 15 to Day 44
|
||||||||||||||||
Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis was planned for this endpoint. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Time to First NP Swab SARS-Cov-2 RNA <LLOQ for Participants with NP Swab SARS-CoV-2 RNA >= LLOQ at Baseline: MSP | ||||||||||||||||
End point 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 was calculated as (First Event Date) - (First Dose Date) +1. Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, ‘Number of Participants Analysed’ signifies with non-missing data in the analysis set.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Day 1 through Day 44
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point 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: MSP | ||||||||||||||||
End point 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 <LLOQ (<2.0 log10 copies/mL). The LLOQ is <2.0 log10 copies/mL. Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, ‘Number of Participants Analysed’ signifies with non-missing data in the analysis set.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Day 1 through Day 44
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24: MSP | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
A 6-mL blood sample was collected for adult and paediatric participants and was analysed to measure SARS-CoV-2 RNA by RT-PCR. The LLOQ is <2.0 log10 copies/mL. Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline; Days 5, 10, 15, 21, 28, 35, and 44; Weeks 12 and 24
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44: MSP | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
An NP swab was collected by HCP from adult and paediatric participants and were sent to the central laboratory for viral RNA level testing RT-PCR. The LLOQ is <2.0 log10 copies/mL. Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention.
|
||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline; Days 5, 10, 15, 21, 28, 35 and 44
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||
End point title |
Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44: MSP | ||||||||||||||||||||||||||||||||||||||||||||
End point description |
An NP swab was collected by HCP from adult and paediatric participants and were sent to the central laboratory for viral RNA level testing RT-PCR. Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, "n" signifies participants with non-missing data in the analysis set and evaluable at specified time points. Here "Number of Participants Analysed" were participants evaluable for this outcome measure. All participants reported under 'Number of Participants Analysed' contributed data to table but may not have evaluable data for every row.
|
||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline; Day 5, 10, 15, 21, 28, 35 and 44
|
||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||
End point title |
Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44 | ||||||||||||||||||||||||||||||||||||||||||||
End point description |
A 6-mL blood sample was collected for adult and paediatric participants and was analysed to measure SARS-CoV-2 RNA by RT-PCR. Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, "n" signifies participants with non-missing data in the analysis set and evaluable at specified time points. Here, ‘Number of Participants Analyzed’ signifies participants evaluable for this outcome measure.
|
||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline; Days 5, 10, 15, 21, 28, 35 and 44
|
||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of Participants With Rebound in SARS-CoV-2 RNA Level in NP Swabs at Follow up: MSP | ||||||||||||
End point 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. Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 16 through Day 44
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Treatment Discontinuation: MSP | ||||||||||||||||||||||||
End point 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. Safety population included all randomised participants who received at least 1 dose of the study intervention.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Day 1 of dosing up to Week 24
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of Participants With COVID-19-Related Hospitalisation >24 Hours (h) or Death Through Day 28: MSP | ||||||||||||||||||||||||
End point description |
Hospitalisation >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 specialised acute medical care unit within an assisted living facility or nursing home. This did not include hospitalisation for the purposes of public health and/or clinical trial execution. Kaplan-Meier method was used for evaluation. Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Day 1 through Day 28
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Percentage of Participants With Death Through Week 24: MSP | ||||||||||||||||
End point description |
Death due to any cause through week 24 was considered. Kaplan-Meier method was used for evaluation. Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Day 1 through Week 24
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of Participants With COVID-19-Related Hospitalisation Through Day 44 and Week 24: MSP | ||||||||||||||||||||||||
End point description |
COVID-19 related hospitalisation 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 specialised acute medical care unit within an assisted living facility or nursing home. This did not include hospitalisation for the purposes of public health and/or clinical trial execution. Kaplan-Meier method was used for evaluation. Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Day 1 through Day 44 and Day 1 through Week 24
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of Participants With COVID-19-Related Intensive Care Unit (ICU) Admission Through Day 44 and Week 24: MSP | ||||||||||||||||||||||||
End point description |
Kaplan-Meier method was used for evaluation. Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Day 1 through Day 44 and Day 1 through Week 24
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of Participants With Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Through Day 44 and Week 24: MSP | ||||||||||||||||||||||||
End point description |
Invasive mechanical ventilation or ECMO were types of oxygen support received in hospital. Kaplan-Meier method was used for evaluation. Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Day 1 through Day 44 and Day 1 through Week 24
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||
End point title |
Number of Days in Hospital and ICU Stay Through Day 44 and Through Week 24: MSP | ||||||||||||||||||||||||||||||||
End point 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. Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention.
|
||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||
End point timeframe |
Day 1 through Day 44 and Day 1 through Week 24
|
||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of COVID-19-Related Medical Visits Through Day 44 and Through Week 24: MSP | ||||||||||||||||||||||||
End point description |
Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Day 1 through Day 44 and Day 1 through Week 24
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44: MSP | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point 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,diarrhoea,feeling hot or feverish,headache,nausea,stuffy or runny nose,sense of smell,sense of taste,sore throat,low energy or tiredness, vomit. KM method was used for analysis.Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention.Here,“n”signifies number of participants with non-missing data and with baseline severity of mild,moderate and severe of targeted signs/symptoms.Here‘99999’suggests that upper limit/lower limit of CI could not be estimated due to insufficient number of participants with event.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 1 through Day 44
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44: MSP | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point 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. KM method was used for analysis. Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Here, “n” signifies number of participants with non-missing data and with baseline severity of mild, moderate and severe of targeted signs and symptoms. Here‘99999’suggests that upper limit of CI could not be estimated due to insufficient number of participants with event.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 1 through Day 44
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Percentage of Participants With Any Severe Targeted Signs and Symptoms Attributed to COVID-19 Through Day 44: MSP | ||||||||||||||||
End point description |
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. Evaluable analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Day 1 through Day 44
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Day 1 of dosing up to Week 24
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
Safety analysis set included all participants randomly assigned to study intervention.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26.1
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Reporting groups
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Reporting group title |
Nirmatrelvir + Ritonavir 5 Day Then Placebo 10 Day
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Reporting group description |
Participants (MSP + RP) received 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 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Nirmatrelvir + Ritonavir 15 Day
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Reporting group description |
Participants (MSP) received 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 150mg and ritonavir 100mg orally q12h for 15 days. Participants had follow-up through Day 44. Participants had long term follow-up through Week 24. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Nirmatrelvir + Ritonavir 10 Day Then Placebo 5 Day
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Reporting group description |
Participants (MSP + RP) received 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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13 Sep 2022 |
This protocol was amended based on regulatory feedback to update the primary analysis and include an additional population of nonhospitalized symptomatic participants who are immunocompromised with a rebound in
COVID-19. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
Primary endpoint data not reported for RP, since there was 1 participant each in 2 arms, it could have led to re-identification of participants. In other sections of results data for RP and MSP have been combined. |