Trial Outcomes & Findings for A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection (NCT NCT05047601)
NCT ID: NCT05047601
Last Updated: 2023-05-06
Results Overview
Percentage of participants who developed symptomatic Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) or Rapid Antigen Test (RAT) confirmed SARS-Cov-2 infection were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
2954 participants
Primary outcome timeframe
From Day 1 to Day 14
Results posted on
2023-05-06
Participant Flow
Participants who had a negative screening severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) rapid antigen test result and were asymptomatic household contacts of individuals who were symptomatic and recently tested positive for SARS-CoV-2, were included in the study.
A total of 2880 participants were screened. Out of which, 122 participants were screen failures. 22 participants were not screen failures and were not randomized. 2736 participants were randomized and 2721 participants received study drug.
Participant milestones
| Measure |
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
Participants were randomized to receive nirmatrelvir 300 milligrams (mg) and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
|
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
|
Placebo
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
|
|---|---|---|---|
|
Overall Study
STARTED
|
921
|
917
|
898
|
|
Overall Study
Treated
|
913
|
911
|
897
|
|
Overall Study
COMPLETED
|
877
|
864
|
863
|
|
Overall Study
NOT COMPLETED
|
44
|
53
|
35
|
Reasons for withdrawal
| Measure |
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
Participants were randomized to receive nirmatrelvir 300 milligrams (mg) and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
|
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
|
Placebo
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
11
|
7
|
|
Overall Study
Withdrawal by Subject
|
25
|
36
|
23
|
|
Overall Study
Other
|
10
|
6
|
5
|
Baseline Characteristics
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
Baseline characteristics by cohort
| Measure |
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
n=921 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
|
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
n=917 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
|
Placebo
n=898 Participants
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
|
Total
n=2736 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.92 Years
STANDARD_DEVIATION 14.88 • n=39 Participants
|
42.85 Years
STANDARD_DEVIATION 15.02 • n=41 Participants
|
42.39 Years
STANDARD_DEVIATION 14.36 • n=35 Participants
|
43.06 Years
STANDARD_DEVIATION 14.77 • n=31 Participants
|
|
Sex: Female, Male
Female
|
502 Participants
n=39 Participants
|
479 Participants
n=41 Participants
|
474 Participants
n=35 Participants
|
1455 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
419 Participants
n=39 Participants
|
438 Participants
n=41 Participants
|
424 Participants
n=35 Participants
|
1281 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
664 Participants
n=39 Participants
|
642 Participants
n=41 Participants
|
643 Participants
n=35 Participants
|
1949 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
257 Participants
n=39 Participants
|
275 Participants
n=41 Participants
|
255 Participants
n=35 Participants
|
787 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
58 Participants
n=39 Participants
|
52 Participants
n=41 Participants
|
49 Participants
n=35 Participants
|
159 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
34 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
139 Participants
n=39 Participants
|
136 Participants
n=41 Participants
|
132 Participants
n=35 Participants
|
407 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
714 Participants
n=39 Participants
|
711 Participants
n=41 Participants
|
704 Participants
n=35 Participants
|
2129 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 14Population: Modified Intent-To-Treat (mITT) population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.
Percentage of participants who developed symptomatic Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) or Rapid Antigen Test (RAT) confirmed SARS-Cov-2 infection were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.
Outcome measures
| Measure |
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
n=844 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
|
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
n=830 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
|
Placebo
n=840 Participants
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
|
|---|---|---|---|
|
Percentage of Participants Who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline
|
2.607 Percentage of participants
|
2.410 Percentage of participants
|
3.929 Percentage of participants
|
SECONDARY outcome
Timeframe: From start of study intervention (Day 1) up to end of safety follow-up (Day 38)Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening ; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity ; congenital anomaly/birth defect; or that was considered as an important medical event. TEAEs were defined as events that started on or after the study medication start date and time. AEs included both serious and all non-serious adverse events. AEs that led to study discontinuation and AEs that led to discontinuation of study intervention and then continued study were also reported in this outcome measure.
Outcome measures
| Measure |
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
n=912 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
|
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
n=911 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
|
Placebo
n=898 Participants
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation
SAEs
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation
TEAEs
|
218 Participants
|
212 Participants
|
195 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation
AEs led to discontinuation of study
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation
AEs led to discontinue study intervention and continued study
|
10 Participants
|
11 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 14Population: Modified Intent-To-Treat (mITT2) population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline and were at increased risk of severe COVID-19 illness.
Percentage of participants who had a symptomatic RT-PCR or RAT confirmed SARS-Cov-2 infection were reported in this outcome measure. The risk factors associated with severe covid-19 illness included age greater than or equal to 60 years, body mass index greater than 25, social history of smoking and presence of comorbidities. Index case was defined as participants with symptomatic COVID-19.
Outcome measures
| Measure |
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
n=627 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
|
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
n=605 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
|
Placebo
n=606 Participants
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
|
|---|---|---|---|
|
Percentage of Participants Who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline With Increased Risk of Severe COVID-19 Illness
|
2.871 Percentage of participants
|
2.645 Percentage of participants
|
3.465 Percentage of participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 28Population: mITT2 population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline and were at increased risk of severe COVID-19 illness.
The risk factors associated with severe covid-19 illness included age greater than or equal to 60 years, body mass index greater than 25, social history of smoking and presence of comorbidities.
Outcome measures
| Measure |
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
n=627 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
|
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
n=605 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
|
Placebo
n=606 Participants
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
|
|---|---|---|---|
|
Percentage of Participants With COVID-19 Related Hospitalization or Death From Any Cause Through Day 28: Among Participants With Negative RT-PCR at Baseline With Increased Risk of Severe COVID-19 Illness
|
0 Percentage of participants
|
0 Percentage of participants
|
0.165 Percentage of participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 14Population: mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.
Percentage of participants who had asymptomatic RT-PCR or RAT confirmed SARS-CoV-2 infection through day 14 among participants with negative RT-PCR at baseline were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.
Outcome measures
| Measure |
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
n=844 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
|
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
n=830 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
|
Placebo
n=840 Participants
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
|
|---|---|---|---|
|
Percentage of Participants With Asymptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline
|
2.014 Percentage of participants
|
1.928 Percentage of participants
|
3.095 Percentage of participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 14Population: mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.
Number of days between first dose and confirmation of the SARS-CoV-2 infection by RT-PCR or RAT was reported in this outcome measure.
Outcome measures
| Measure |
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
n=844 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
|
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
n=830 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
|
Placebo
n=840 Participants
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
|
|---|---|---|---|
|
Time to RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline
|
NA Days
Median and the corresponding 95% CI could not be calculated as the proportion of participants who achieved the event were low.
|
NA Days
Median and the corresponding 95% CI could not be calculated as the proportion of participants who achieved the event were low.
|
NA Days
Median and the corresponding 95% CI could not be calculated as the proportion of participants who achieved the event were low.
|
SECONDARY outcome
Timeframe: From Day 1 to Day 14Population: mITT1 population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a positive RT-PCR result at baseline.
Percentage of participants with a positive RT-PCR result at baseline who had a symptomatic SARS-CoV-2 infection confirmed by RAT or RT-PCR through Day 14 were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.
Outcome measures
| Measure |
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
n=38 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
|
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
n=48 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
|
Placebo
n=29 Participants
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
|
|---|---|---|---|
|
Percentage of Participants With Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Positive RT-PCR at Baseline
|
28.947 Percentage of participants
|
45.833 Percentage of participants
|
37.931 Percentage of participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 14Population: Modified Intent-To-Treat (mITT3) population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative, positive or missing RT-PCR result at baseline.
Percentage of participants with a negative, positive, or missing RT-PCR result at baseline, who had a symptomatic SARS-CoV-2 infection confirmed by RAT or RT-PCR through Day 14 were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.
Outcome measures
| Measure |
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
n=889 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
|
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
n=887 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
|
Placebo
n=873 Participants
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
|
|---|---|---|---|
|
Percentage of Participants With Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative, Positive or Missing RT-PCR at Baseline
|
3.712 Percentage of Participants
|
4.848 Percentage of Participants
|
5.269 Percentage of Participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 28Population: mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.
Participants were categorized according to severity of signs and symptoms as no, mild, moderate, severe in this outcome measure. The 12 signs and symptoms included stuffy or runny nose, sore throat, shortness of breath or difficulty breathing, cough, low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea. Participants recorded their daily severity rating of their symptoms over the past 24 hours based on a 4-point scale in which 0 was reported if no symptoms were present; 1 if mild; 2 if moderate; and 3 if severe.
Outcome measures
| Measure |
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
n=844 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
|
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
n=830 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
|
Placebo
n=840 Participants
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
|
|---|---|---|---|
|
Percentage of Participants With no, Mild, Moderate, or Severe Signs and Symptoms Attributed to COVID-19 Through Day 28: Among Participants With Negative RT-PCR at Baseline
Severe
|
2.133 Percentage of participants
|
2.048 Percentage of participants
|
2.738 Percentage of participants
|
|
Percentage of Participants With no, Mild, Moderate, or Severe Signs and Symptoms Attributed to COVID-19 Through Day 28: Among Participants With Negative RT-PCR at Baseline
Moderate
|
6.872 Percentage of participants
|
5.060 Percentage of participants
|
7.143 Percentage of participants
|
|
Percentage of Participants With no, Mild, Moderate, or Severe Signs and Symptoms Attributed to COVID-19 Through Day 28: Among Participants With Negative RT-PCR at Baseline
No
|
81.517 Percentage of participants
|
83.373 Percentage of participants
|
81.667 Percentage of participants
|
|
Percentage of Participants With no, Mild, Moderate, or Severe Signs and Symptoms Attributed to COVID-19 Through Day 28: Among Participants With Negative RT-PCR at Baseline
Mild
|
7.820 Percentage of participants
|
8.193 Percentage of participants
|
7.619 Percentage of participants
|
|
Percentage of Participants With no, Mild, Moderate, or Severe Signs and Symptoms Attributed to COVID-19 Through Day 28: Among Participants With Negative RT-PCR at Baseline
Missing
|
1.659 Percentage of participants
|
1.325 Percentage of participants
|
0.833 Percentage of participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 28Population: mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
This outcome measure has been reported in terms of number of participants according to days of symptomatic SARS-CoV-2 infection through Day 28.
Outcome measures
| Measure |
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
n=22 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
|
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
n=20 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
|
Placebo
n=33 Participants
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
|
|---|---|---|---|
|
Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline
1 Day of Symptoms
|
1 Participants
|
7 Participants
|
2 Participants
|
|
Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline
2 Days of Symptoms
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline
3 Days of Symptoms
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline
4 Days of Symptoms
|
5 Participants
|
0 Participants
|
2 Participants
|
|
Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline
5 Days of Symptoms
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline
6 Days of Symptoms
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline
7 Days of Symptoms
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline
8 Days of Symptoms
|
2 Participants
|
0 Participants
|
5 Participants
|
|
Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline
9 Days of Symptoms
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline
10 Days of Symptoms
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline
11 Days of Symptoms
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline
12 Days of Symptoms
|
2 Participants
|
0 Participants
|
4 Participants
|
|
Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline
13 Days of Symptoms
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline
14 Days of Symptoms
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline
18 Days of Symptoms
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline
20 Days of Symptoms
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline
26 Days of Symptoms
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1: 1 hour post dose; Day 5: 2 hours pre-dosePopulation: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. This outcome measure was not planned to be analyzed for placebo arm. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and ''Number Analyzed'' signifies participants evaluable at specific time points.
Outcome measures
| Measure |
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
n=476 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
|
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
n=476 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
|
Placebo
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
|
|---|---|---|---|
|
Plasma Concentration Versus Time Summary of Nirmatrelvir (PF-07321332)
Day 1 (1 hour post-dose)
|
1489 Nanograms per milliliter
Standard Deviation 1481.4
|
1472 Nanograms per milliliter
Standard Deviation 1488.2
|
—
|
|
Plasma Concentration Versus Time Summary of Nirmatrelvir (PF-07321332)
Day 5 (2 hours pre-dose)
|
1688 Nanograms per milliliter
Standard Deviation 2093.3
|
1657 Nanograms per milliliter
Standard Deviation 2068.2
|
—
|
SECONDARY outcome
Timeframe: From Day 1 to Day 38Population: mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.
Percentage of participants with death (all-cause) event were reported in this outcome measure.
Outcome measures
| Measure |
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
n=844 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
|
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
n=830 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
|
Placebo
n=840 Participants
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
|
|---|---|---|---|
|
Percentage of Participants With Death Event Through Day 38: Among Participants With Negative RT-PCR at Baseline
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 14Population: mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline. Here 'Number Analyzed' signifies participants evaluable for the specific time points.
Nasal samples were collected to estimate the viral load in terms of logarithm to base 10 (log10) copies per milliliter in participants with negative RT-PCR at baseline and were reported in this outcome measure.
Outcome measures
| Measure |
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
n=844 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
|
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
n=830 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
|
Placebo
n=840 Participants
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
|
|---|---|---|---|
|
Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline
Day 1
|
0.042 Log 10 copies per milliliter
Standard Deviation 0.265
|
0.035 Log 10 copies per milliliter
Standard Deviation 0.241
|
0.038 Log 10 copies per milliliter
Standard Deviation 0.253
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline
Day 2
|
0.078 Log 10 copies per milliliter
Standard Deviation 0.523
|
0.053 Log 10 copies per milliliter
Standard Deviation 0.409
|
0.108 Log 10 copies per milliliter
Standard Deviation 0.611
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline
Day 3
|
0.090 Log 10 copies per milliliter
Standard Deviation 0.586
|
0.048 Log 10 copies per milliliter
Standard Deviation 0.374
|
0.147 Log 10 copies per milliliter
Standard Deviation 0.760
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline
Day 4
|
0.081 Log 10 copies per milliliter
Standard Deviation 0.537
|
0.057 Log 10 copies per milliliter
Standard Deviation 0.409
|
0.165 Log 10 copies per milliliter
Standard Deviation 0.859
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline
Day 5
|
0.079 Log 10 copies per milliliter
Standard Deviation 0.528
|
0.074 Log 10 copies per milliliter
Standard Deviation 0.573
|
0.217 Log 10 copies per milliliter
Standard Deviation 1.063
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline
Day 6
|
0.074 Log 10 copies per milliliter
Standard Deviation 0.575
|
0.090 Log 10 copies per milliliter
Standard Deviation 0.670
|
0.189 Log 10 copies per milliliter
Standard Deviation 0.978
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline
Day 7
|
0.088 Log 10 copies per milliliter
Standard Deviation 0.586
|
0.053 Log 10 copies per milliliter
Standard Deviation 0.536
|
0.186 Log 10 copies per milliliter
Standard Deviation 0.883
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline
Day 8
|
0.096 Log 10 copies per milliliter
Standard Deviation 0.627
|
0.081 Log 10 copies per milliliter
Standard Deviation 0.669
|
0.159 Log 10 copies per milliliter
Standard Deviation 0.860
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline
Day 9
|
0.094 Log 10 copies per milliliter
Standard Deviation 0.672
|
0.062 Log 10 copies per milliliter
Standard Deviation 0.596
|
0.135 Log 10 copies per milliliter
Standard Deviation 0.784
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline
Day 10
|
0.080 Log 10 copies per milliliter
Standard Deviation 0.616
|
0.064 Log 10 copies per milliliter
Standard Deviation 0.590
|
0.133 Log 10 copies per milliliter
Standard Deviation 0.725
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline
Day 11
|
0.103 Log 10 copies per milliliter
Standard Deviation 0.673
|
0.053 Log 10 copies per milliliter
Standard Deviation 0.511
|
0.115 Log 10 copies per milliliter
Standard Deviation 0.707
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline
Day 12
|
0.106 Log 10 copies per milliliter
Standard Deviation 0.748
|
0.051 Log 10 copies per milliliter
Standard Deviation 0.447
|
0.103 Log 10 copies per milliliter
Standard Deviation 0.662
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline
Day 13
|
0.085 Log 10 copies per milliliter
Standard Deviation 0.642
|
0.052 Log 10 copies per milliliter
Standard Deviation 0.425
|
0.117 Log 10 copies per milliliter
Standard Deviation 0.714
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline
Day 14
|
0.108 Log 10 copies per milliliter
Standard Deviation 0.717
|
0.035 Log 10 copies per milliliter
Standard Deviation 0.386
|
0.146 Log 10 copies per milliliter
Standard Deviation 0.798
|
SECONDARY outcome
Timeframe: From Day 1 to Day 14Population: mITT1 population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a positive RT-PCR result at baseline. Here 'Number Analyzed' signifies participants evaluable for the specific time points.
Nasal samples were collected to estimate the viral load in terms of logarithm to base 10 (log10) copies per milliliter in participants with positive RT-PCR at baseline and were reported in this outcome measure.
Outcome measures
| Measure |
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
n=38 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
|
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
n=48 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
|
Placebo
n=29 Participants
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
|
|---|---|---|---|
|
Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline
Day 1
|
4.870 Log 10 copies per milliliter
Standard Deviation 2.041
|
4.470 Log 10 copies per milliliter
Standard Deviation 1.542
|
4.837 Log 10 copies per milliliter
Standard Deviation 1.577
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline
Day 2
|
3.286 Log 10 copies per milliliter
Standard Deviation 2.534
|
2.724 Log 10 copies per milliliter
Standard Deviation 2.208
|
3.104 Log 10 copies per milliliter
Standard Deviation 2.909
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline
Day 3
|
2.880 Log 10 copies per milliliter
Standard Deviation 2.641
|
2.051 Log 10 copies per milliliter
Standard Deviation 2.212
|
3.255 Log 10 copies per milliliter
Standard Deviation 2.702
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline
Day 4
|
2.600 Log 10 copies per milliliter
Standard Deviation 2.427
|
1.514 Log 10 copies per milliliter
Standard Deviation 2.064
|
2.721 Log 10 copies per milliliter
Standard Deviation 2.640
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline
Day 5
|
1.470 Log 10 copies per milliliter
Standard Deviation 2.057
|
1.413 Log 10 copies per milliliter
Standard Deviation 1.745
|
2.994 Log 10 copies per milliliter
Standard Deviation 2.677
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline
Day 6
|
1.065 Log 10 copies per milliliter
Standard Deviation 1.656
|
0.997 Log 10 copies per milliliter
Standard Deviation 1.696
|
2.466 Log 10 copies per milliliter
Standard Deviation 2.561
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline
Day 7
|
1.199 Log 10 copies per milliliter
Standard Deviation 1.747
|
0.913 Log 10 copies per milliliter
Standard Deviation 1.762
|
1.478 Log 10 copies per milliliter
Standard Deviation 2.212
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline
Day 8
|
1.212 Log 10 copies per milliliter
Standard Deviation 1.829
|
0.942 Log 10 copies per milliliter
Standard Deviation 1.908
|
1.072 Log 10 copies per milliliter
Standard Deviation 1.663
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline
Day 9
|
1.169 Log 10 copies per milliliter
Standard Deviation 1.852
|
0.766 Log 10 copies per milliliter
Standard Deviation 1.858
|
1.103 Log 10 copies per milliliter
Standard Deviation 1.545
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline
Day 10
|
0.819 Log 10 copies per milliliter
Standard Deviation 1.656
|
0.541 Log 10 copies per milliliter
Standard Deviation 1.605
|
0.965 Log 10 copies per milliliter
Standard Deviation 1.514
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline
Day 11
|
0.623 Log 10 copies per milliliter
Standard Deviation 1.170
|
0.603 Log 10 copies per milliliter
Standard Deviation 1.044
|
0.707 Log 10 copies per milliliter
Standard Deviation 1.116
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline
Day 12
|
0.532 Log 10 copies per milliliter
Standard Deviation 1.136
|
0.670 Log 10 copies per milliliter
Standard Deviation 1.204
|
0.436 Log 10 copies per milliliter
Standard Deviation 0.919
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline
Day 13
|
0.413 Log 10 copies per milliliter
Standard Deviation 1.098
|
0.313 Log 10 copies per milliliter
Standard Deviation 1.018
|
0.361 Log 10 copies per milliliter
Standard Deviation 0.770
|
|
Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline
Day 14
|
0.284 Log 10 copies per milliliter
Standard Deviation 1.040
|
0.345 Log 10 copies per milliliter
Standard Deviation 0.808
|
0.358 Log 10 copies per milliliter
Standard Deviation 0.735
|
SECONDARY outcome
Timeframe: From Day 1 to Day 28Population: mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.
This outcome measure has been presented in terms of participants according to number of days of hospitalization and in ICU as 0 days and more than or equal to 1 day.
Outcome measures
| Measure |
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
n=844 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
|
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
n=830 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
|
Placebo
n=840 Participants
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
|
|---|---|---|---|
|
Number of Days of Hospitalization and Intensive Care Unit (ICU) Stay: Among Participants With Negative RT-PCR at Baseline
ICU Visits: 0 Day
|
844 Participants
|
830 Participants
|
840 Participants
|
|
Number of Days of Hospitalization and Intensive Care Unit (ICU) Stay: Among Participants With Negative RT-PCR at Baseline
ICU Visits: More than or equal to 1 day
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Days of Hospitalization and Intensive Care Unit (ICU) Stay: Among Participants With Negative RT-PCR at Baseline
Hospitalization Visits: 0 Day
|
844 Participants
|
830 Participants
|
839 Participants
|
|
Number of Days of Hospitalization and Intensive Care Unit (ICU) Stay: Among Participants With Negative RT-PCR at Baseline
Hospitalization Visits: More than or equal to 1 day
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 28Population: mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline.
In this outcome measure number of COVID-19 related medical visits per day were reported. Number of medical visits per day = number of medical visits/number of days follow up through day 28 visit or the last collection date on or before day 28, if day 28 visit was missing.
Outcome measures
| Measure |
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
n=844 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
|
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
n=830 Participants
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
|
Placebo
n=840 Participants
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
|
|---|---|---|---|
|
Number of COVID-19 Related Medical Visits Through Day 28: Among Participants With Negative RT-PCR at Baseline
|
0.0067 Medical visits per day
Standard Deviation 0.0200
|
0.0057 Medical visits per day
Standard Deviation 0.0201
|
0.0066 Medical visits per day
Standard Deviation 0.0182
|
Adverse Events
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
Serious events: 3 serious events
Other events: 176 other events
Deaths: 0 deaths
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
Serious events: 1 serious events
Other events: 173 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 152 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
n=912 participants at risk
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
|
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
n=911 participants at risk
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
|
Placebo
n=898 participants at risk
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
|
|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.11%
1/912 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/911 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/898 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.11%
1/912 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.11%
1/911 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.11%
1/898 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/912 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/911 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.11%
1/898 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.11%
1/912 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/911 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/898 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.11%
1/912 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/911 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.00%
0/898 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
Other adverse events
| Measure |
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days
n=912 participants at risk
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5, followed by matching placebo every 12 hours from Day 6 through Day 10.
|
Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days
n=911 participants at risk
Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 10.
|
Placebo
n=898 participants at risk
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
23/912 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
2.4%
22/911 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.7%
15/898 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
16/912 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.3%
12/911 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.6%
14/898 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
General disorders
Asthenia
|
1.1%
10/912 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.77%
7/911 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.9%
17/898 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
COVID-19
|
3.0%
27/912 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
2.9%
26/911 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
4.0%
36/898 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
13/912 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.99%
9/911 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.67%
6/898 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
20/912 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.9%
17/911 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
2.0%
18/898 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.2%
11/912 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.5%
14/911 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
2.4%
22/898 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.22%
2/912 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.66%
6/911 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.2%
11/898 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.3%
12/912 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.6%
15/911 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.4%
13/898 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
1.2%
11/912 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.88%
8/911 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
10/898 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Investigations
Fibrin D dimer increased
|
2.0%
18/912 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.4%
13/911 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.45%
4/898 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Nervous system disorders
Dysgeusia
|
5.9%
54/912 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
6.8%
62/911 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.67%
6/898 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Nervous system disorders
Headache
|
1.6%
15/912 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.9%
17/911 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
3.2%
29/898 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
10/912 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.22%
2/911 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.3%
12/898 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.44%
4/912 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
0.33%
3/911 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
1.1%
10/898 • From Day 1 to Day 38
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER