COVID-19
Conditions
Keywords
Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2)
Brief summary
The purpose of this clinical trial is to learn whether the study medicine prevent symptoms of COVID-19 in adults who have been exposed to household member(s) with a confirmed symptomatic COVID-19 infection. All participants in the study will receive treatment for COVID-19 as needed, based on their regular doctor's recommendation. Two-thirds of participants will also receive two study medicines (PF-07321332 and ritonavir) by mouth twice a day for either five or ten days. We will compare the experiences of people receiving the study medicines to those of the people who do not. This will help us determine if the study medicines are safe and effective
Interventions
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double Blind Double Dummy
Intervention model description
Eligible participants who are asymptomatic household contacts of an individual with symptomatic COVID-19 will be randomized (1:1:1) to receive orally every 12 hours: PF-07321332/ritonavir for 5 days followed by placebo for 5 days or PF-07321332/ritonavir for 10 days or Placebo for 10 days
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants who have a negative screening SARS-CoV-2 rapid antigen test result and who are asymptomatic household contacts with exposure within 96 hours to an individual who is symptomatic and recently tested positive for SARS CoV-2. * Fertile participants must agree to use a highly effective method of contraception
Exclusion criteria
* History of SARS-CoV-2 infection in the past 6 months * Experiencing measured fever (documented temperature \>38˚C or 100.4˚F) or other signs or symptoms consistent with COVID-19 * Known medical history of active liver disease * Chronic Kidney Disease or have known moderate to severe renal impairment. * Known Human Immunodeficiency Virus (HIV) infection with viral load \> 400 copies/ml within the last 6 months or taking prohibited medications for HIV treatment * Suspected or confirmed concurrent active systemic infection * Active cancer requiring treatment with prohibited medication. * Current or expected use of any medications or substances that are highly dependent on Cytochrome P450 3A4 (CYP3A4) for clearance or are strong inducers of CYP3A4 * Has received approved, authorized, or investigational anti-SARS-CoV-2 mAb, convalescent plasma, other drugs for treatment of COVID-19, or other anti-SARS-CoV-2 biologic products within 6 months of screening * Has received any SARS-CoV-2 vaccine within 6 months prior to screening or is expected to receive a SARS-CoV-2 vaccine or other approved, authorized, or investigational postexposure prophylaxis treatments through Day 38. * Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 * Known or prior participation in this trial or another trial involving PF-07321332. * Females who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From Day 1 to Day 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From Day 1 to Day 14 | 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. |
| 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 | From Day 1 to Day 28 | 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. |
| 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 | From Day 1 to Day 14 | 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. |
| Time to RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline | From Day 1 to Day 14 | 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. |
| 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 | From Day 1 to Day 14 | 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. |
| 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 | From Day 1 to Day 14 | 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. |
| Percentage of Participants With Death Event Through Day 38: Among Participants With Negative RT-PCR at Baseline | From Day 1 to Day 38 | Percentage of participants with death (all-cause) event were reported in this outcome measure. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | From start of study intervention (Day 1) up to end of safety follow-up (Day 38) | 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. |
| 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 | From Day 1 to Day 28 | This outcome measure has been reported in terms of number of participants according to days of symptomatic SARS-CoV-2 infection through Day 28. |
| Plasma Concentration Versus Time Summary of Nirmatrelvir (PF-07321332) | Day 1: 1 hour post dose; Day 5: 2 hours pre-dose | — |
| Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | From Day 1 to Day 14 | 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. |
| Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | From Day 1 to Day 14 | 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. |
| Number of Days of Hospitalization and Intensive Care Unit (ICU) Stay: Among Participants With Negative RT-PCR at Baseline | From Day 1 to Day 28 | 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. |
| Number of COVID-19 Related Medical Visits Through Day 28: Among Participants With Negative RT-PCR at Baseline | From Day 1 to Day 28 | 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. |
| 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 | From Day 1 to Day 28 | 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. |
Countries
Argentina, Brazil, Bulgaria, Colombia, Czechia, Hungary, Japan, Malaysia, Mexico, Poland, Russia, South Africa, Spain, Thailand, Turkey (Türkiye), Ukraine, United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days 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. | 921 |
| 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. | 917 |
| Placebo Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 days from Day 1 through Day 10. | 898 |
| Total | 2,736 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 11 | 7 |
| Overall Study | Other | 10 | 6 | 5 |
| Overall Study | Withdrawal by Subject | 25 | 36 | 23 |
Baseline characteristics
| Characteristic | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 43.92 Years STANDARD_DEVIATION 14.88 | 42.85 Years STANDARD_DEVIATION 15.02 | 42.39 Years STANDARD_DEVIATION 14.36 | 43.06 Years STANDARD_DEVIATION 14.77 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 664 Participants | 642 Participants | 643 Participants | 1949 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 257 Participants | 275 Participants | 255 Participants | 787 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 58 Participants | 52 Participants | 49 Participants | 159 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 15 Participants | 11 Participants | 34 Participants |
| Race (NIH/OMB) Black or African American | 139 Participants | 136 Participants | 132 Participants | 407 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 714 Participants | 711 Participants | 704 Participants | 2129 Participants |
| Sex: Female, Male Female | 502 Participants | 479 Participants | 474 Participants | 1455 Participants |
| Sex: Female, Male Male | 419 Participants | 438 Participants | 424 Participants | 1281 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 912 | 0 / 911 | 0 / 898 |
| other Total, other adverse events | 176 / 912 | 173 / 911 | 152 / 898 |
| serious Total, serious adverse events | 3 / 912 | 1 / 911 | 2 / 898 |
Outcome results
Primary
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
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.
Time frame: From Day 1 to Day 14
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 2.410 Percentage of participants |
| Placebo | 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 | 3.929 Percentage of participants |
p-value: 0.172295% CI: [0.422, 1.167]Generalized estimating equation (GEE)
p-value: 0.116395% CI: [0.373, 1.115]GEE
Secondary
Number of COVID-19 Related Medical Visits Through Day 28: Among Participants With Negative RT-PCR 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.
Time frame: From Day 1 to Day 28
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 0.02 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Number of COVID-19 Related Medical Visits Through Day 28: Among Participants With Negative RT-PCR at Baseline | 0.0057 Medical visits per day | Standard Deviation 0.0201 |
| Placebo | Number of COVID-19 Related Medical Visits Through Day 28: Among Participants With Negative RT-PCR at Baseline | 0.0066 Medical visits per day | Standard Deviation 0.0182 |
p-value: 0.799195% CI: [0.758, 1.238]Negative binomial regression model
p-value: 0.198595% CI: [0.657, 1.091]Negative binomial regression model
Secondary
Number of Days of Hospitalization and Intensive Care Unit (ICU) Stay: Among Participants With Negative RT-PCR 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.
Time frame: From Day 1 to Day 28
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Number of Days of Hospitalization and Intensive Care Unit (ICU) Stay: Among Participants With Negative RT-PCR at Baseline | ICU Visits: 0 Day | 830 Participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Number of Days of Hospitalization and Intensive Care Unit (ICU) Stay: Among Participants With Negative RT-PCR at Baseline | Hospitalization Visits: 0 Day | 830 Participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 |
| Placebo | 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 | 1 Participants |
| Placebo | 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 |
| Placebo | Number of Days of Hospitalization and Intensive Care Unit (ICU) Stay: Among Participants With Negative RT-PCR at Baseline | Hospitalization Visits: 0 Day | 839 Participants |
| Placebo | Number of Days of Hospitalization and Intensive Care Unit (ICU) Stay: Among Participants With Negative RT-PCR at Baseline | ICU Visits: 0 Day | 840 Participants |
Secondary
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
This outcome measure has been reported in terms of number of participants according to days of symptomatic SARS-CoV-2 infection through Day 28.
Time frame: From Day 1 to Day 28
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 1 Participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 7 Participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 0 Participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 1 Participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 0 Participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 3 Participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 1 Participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 4 Participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 0 Participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 1 Participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 0 Participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 0 Participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 0 Participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 0 Participants |
| Placebo | 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 | 1 Participants |
| Placebo | 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 | 4 Participants |
| Placebo | 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 | 3 Participants |
| Placebo | 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 | 0 Participants |
| Placebo | 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 | 2 Participants |
| Placebo | 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 | 2 Participants |
| Placebo | 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 | 0 Participants |
| Placebo | 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 | 0 Participants |
| Placebo | 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 | 4 Participants |
| Placebo | 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 | 2 Participants |
| Placebo | 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 | 1 Participants |
| Placebo | 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 | 0 Participants |
| Placebo | 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 | 1 Participants |
| Placebo | 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 | 5 Participants |
| Placebo | 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 | 4 Participants |
| Placebo | 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 | 1 Participants |
| Placebo | 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 | 3 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | TEAEs | 218 Participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | SAEs | 3 Participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 11 Participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | TEAEs | 212 Participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | SAEs | 1 Participants |
| Placebo | 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 | 14 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | SAEs | 2 Participants |
| Placebo | 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 |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | TEAEs | 195 Participants |
Secondary
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
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.
Time frame: From Day 1 to Day 14
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 2.645 Percentage of participants |
| Placebo | 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 | 3.465 Percentage of participants |
p-value: 0.676695% CI: [0.484, 1.602]GEE
p-value: 0.50795% CI: [0.433, 1.512]GEE
Secondary
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
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.
Time frame: From Day 1 to Day 14
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 1.928 Percentage of participants |
| Placebo | 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 | 3.095 Percentage of participants |
p-value: 0.186995% CI: [0.373, 1.213]GEE
p-value: 0.122195% CI: [0.355, 1.13]GEE
Secondary
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
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.
Time frame: From Day 1 to Day 28
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 |
| Placebo | 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 | 0.165 Percentage of participants |
Secondary
Percentage of Participants With Death Event Through Day 38: Among Participants With Negative RT-PCR at Baseline
Percentage of participants with death (all-cause) event were reported in this outcome measure.
Time frame: From Day 1 to Day 38
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | Percentage of Participants With Death Event Through Day 38: Among Participants With Negative RT-PCR at Baseline | 0 Percentage of participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Percentage of Participants With Death Event Through Day 38: Among Participants With Negative RT-PCR at Baseline | 0 Percentage of participants |
| Placebo | Percentage of Participants With Death Event Through Day 38: Among Participants With Negative RT-PCR at Baseline | 0 Percentage of participants |
Secondary
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
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.
Time frame: From Day 1 to Day 28
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 5.060 Percentage of participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 83.373 Percentage of participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 8.193 Percentage of participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 2.048 Percentage of participants |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 1.325 Percentage of participants |
| Placebo | 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 | 0.833 Percentage of participants |
| Placebo | 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 | 2.738 Percentage of participants |
| Placebo | 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 | 81.667 Percentage of participants |
| Placebo | 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 | 7.143 Percentage of participants |
| Placebo | 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 | 7.619 Percentage of participants |
Secondary
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
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.
Time frame: From Day 1 to Day 14
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 4.848 Percentage of Participants |
| Placebo | 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 | 5.269 Percentage of Participants |
p-value: 0.133395% CI: [0.478, 1.103]GEE
p-value: 0.808895% CI: [0.645, 1.408]GEE
Secondary
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
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.
Time frame: From Day 1 to Day 14
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 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 | 45.833 Percentage of participants |
| Placebo | 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 | 37.931 Percentage of participants |
p-value: 0.412695% CI: [0.378, 1.491]GEE
p-value: 0.427395% CI: [0.725, 2.135]GEE
Secondary
Plasma Concentration Versus Time Summary of Nirmatrelvir (PF-07321332)
Time frame: Day 1: 1 hour post dose; Day 5: 2 hours pre-dose
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | Plasma Concentration Versus Time Summary of Nirmatrelvir (PF-07321332) | Day 1 (1 hour post-dose) | 1489 Nanograms per milliliter | Standard Deviation 1481.4 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | Plasma Concentration Versus Time Summary of Nirmatrelvir (PF-07321332) | Day 5 (2 hours pre-dose) | 1688 Nanograms per milliliter | Standard Deviation 2093.3 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Plasma Concentration Versus Time Summary of Nirmatrelvir (PF-07321332) | Day 1 (1 hour post-dose) | 1472 Nanograms per milliliter | Standard Deviation 1488.2 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Plasma Concentration Versus Time Summary of Nirmatrelvir (PF-07321332) | Day 5 (2 hours pre-dose) | 1657 Nanograms per milliliter | Standard Deviation 2068.2 |
Secondary
Time to RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR 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.
Time frame: From Day 1 to Day 14
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | Time to RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline | NA Days |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Time to RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline | NA Days |
| Placebo | Time to RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline | NA Days |
p-value: 0.0368Log Rank
p-value: 0.0186Log Rank
Secondary
Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline
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.
Time frame: From Day 1 to Day 14
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 11 | 0.053 Log 10 copies per milliliter | Standard Deviation 0.511 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 1 | 0.035 Log 10 copies per milliliter | Standard Deviation 0.241 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 2 | 0.053 Log 10 copies per milliliter | Standard Deviation 0.409 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 3 | 0.048 Log 10 copies per milliliter | Standard Deviation 0.374 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 4 | 0.057 Log 10 copies per milliliter | Standard Deviation 0.409 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 5 | 0.074 Log 10 copies per milliliter | Standard Deviation 0.573 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 6 | 0.090 Log 10 copies per milliliter | Standard Deviation 0.67 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 7 | 0.053 Log 10 copies per milliliter | Standard Deviation 0.536 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 8 | 0.081 Log 10 copies per milliliter | Standard Deviation 0.669 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 9 | 0.062 Log 10 copies per milliliter | Standard Deviation 0.596 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 10 | 0.064 Log 10 copies per milliliter | Standard Deviation 0.59 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 12 | 0.051 Log 10 copies per milliliter | Standard Deviation 0.447 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 13 | 0.052 Log 10 copies per milliliter | Standard Deviation 0.425 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 14 | 0.035 Log 10 copies per milliliter | Standard Deviation 0.386 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 13 | 0.117 Log 10 copies per milliliter | Standard Deviation 0.714 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 10 | 0.133 Log 10 copies per milliliter | Standard Deviation 0.725 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 5 | 0.217 Log 10 copies per milliliter | Standard Deviation 1.063 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 4 | 0.165 Log 10 copies per milliliter | Standard Deviation 0.859 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 11 | 0.115 Log 10 copies per milliliter | Standard Deviation 0.707 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 3 | 0.147 Log 10 copies per milliliter | Standard Deviation 0.76 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 1 | 0.038 Log 10 copies per milliliter | Standard Deviation 0.253 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 12 | 0.103 Log 10 copies per milliliter | Standard Deviation 0.662 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 2 | 0.108 Log 10 copies per milliliter | Standard Deviation 0.611 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 8 | 0.159 Log 10 copies per milliliter | Standard Deviation 0.86 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 7 | 0.186 Log 10 copies per milliliter | Standard Deviation 0.883 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 14 | 0.146 Log 10 copies per milliliter | Standard Deviation 0.798 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 9 | 0.135 Log 10 copies per milliliter | Standard Deviation 0.784 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | Day 6 | 0.189 Log 10 copies per milliliter | Standard Deviation 0.978 |
Secondary
Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline
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.
Time frame: From Day 1 to Day 14
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 1.17 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 1.04 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 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 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 11 | 0.603 Log 10 copies per milliliter | Standard Deviation 1.044 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 1 | 4.470 Log 10 copies per milliliter | Standard Deviation 1.542 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 2 | 2.724 Log 10 copies per milliliter | Standard Deviation 2.208 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 3 | 2.051 Log 10 copies per milliliter | Standard Deviation 2.212 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 4 | 1.514 Log 10 copies per milliliter | Standard Deviation 2.064 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 5 | 1.413 Log 10 copies per milliliter | Standard Deviation 1.745 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 6 | 0.997 Log 10 copies per milliliter | Standard Deviation 1.696 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 7 | 0.913 Log 10 copies per milliliter | Standard Deviation 1.762 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 8 | 0.942 Log 10 copies per milliliter | Standard Deviation 1.908 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 9 | 0.766 Log 10 copies per milliliter | Standard Deviation 1.858 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 10 | 0.541 Log 10 copies per milliliter | Standard Deviation 1.605 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 12 | 0.670 Log 10 copies per milliliter | Standard Deviation 1.204 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 13 | 0.313 Log 10 copies per milliliter | Standard Deviation 1.018 |
| Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 14 | 0.345 Log 10 copies per milliliter | Standard Deviation 0.808 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 13 | 0.361 Log 10 copies per milliliter | Standard Deviation 0.77 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 10 | 0.965 Log 10 copies per milliliter | Standard Deviation 1.514 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 5 | 2.994 Log 10 copies per milliliter | Standard Deviation 2.677 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 4 | 2.721 Log 10 copies per milliliter | Standard Deviation 2.64 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 11 | 0.707 Log 10 copies per milliliter | Standard Deviation 1.116 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 3 | 3.255 Log 10 copies per milliliter | Standard Deviation 2.702 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 1 | 4.837 Log 10 copies per milliliter | Standard Deviation 1.577 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 12 | 0.436 Log 10 copies per milliliter | Standard Deviation 0.919 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 2 | 3.104 Log 10 copies per milliliter | Standard Deviation 2.909 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 8 | 1.072 Log 10 copies per milliliter | Standard Deviation 1.663 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 7 | 1.478 Log 10 copies per milliliter | Standard Deviation 2.212 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 14 | 0.358 Log 10 copies per milliliter | Standard Deviation 0.735 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 9 | 1.103 Log 10 copies per milliliter | Standard Deviation 1.545 |
| Placebo | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | Day 6 | 2.466 Log 10 copies per milliliter | Standard Deviation 2.561 |