COVID-19
Conditions
Keywords
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Brief summary
The purpose of this study is to determine whether PF-07321332/ritonavir is safe and effective for the treatment of adults who are ill with COVID-19 and do not need to be in the hospital, but are at an increased risk of developing severe illness. Throughout the study period, provision will be made to allow study visits to be conducted at a participant's home or another non-clinic location if available. The total study duration is up to 24 weeks.
Interventions
DRUGPF-07321332
PF-07321332 (tablet)
DRUGRitonavir
Ritonavir (capsule)
DRUGPlacebo
Placebo (tablet or capsule)
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Eligible participants with a confirmed diagnosis of SARS-CoV-2 infection will be randomized (1:1) to receive PF-07321332/ritonavir or placebo orally every 12 hours for 5 days (10 doses total).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed SARS-CoV-2 infection within 5 days prior to randomization * Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of randomization and at least 1 of the specified COVID-19 signs/symptoms present on the day of randomization * Fertile participants must agree to use a highly effective method of contraception * Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19
Exclusion criteria
* History of or need for hospitalization for the medical treatment of COVID-19 * Prior to current disease episode, any confirmed SARS-CoV-2 infection * Known medical history of active liver disease * Receiving dialysis or have known moderate to severe renal impairment * Known human immunodeficiency virus (HIV) infection with a viral load greater than 400 copies/mL or taking prohibited medications for HIV treatment * Suspected or confirmed concurrent active systemic infection other than COVID-19 * History of hypersensitivity or other contraindication to any of the components of the study intervention * Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance or are strong inducers of CYP3A4 * Has received or is expected to receive convalescent COVID-19 plasma * Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day 34 visit * Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 through the long-term follow-up visit * Known prior participation in this trial or other trial involving PF-07321332 * Oxygen saturation of \<92% on room air, or on their standard home oxygen supplementation for those who regularly receive chronic supplementary oxygen for an underlying lung condition * Females who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population | From Day 1 to Day 28 | Percentage of participants with COVID-19 related hospitalization or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier (KM) method. Using KM method, survival probability for each time interval was calculated as the number of participants surviving divided by the number of participants at risk. Participants who had the event, dropped out, or moved out were not counted as at risk i.e., participants who were lost were considered censored and were not counted in the denominator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs) | From start of study intervention (Day 1) up to end of safety follow-up (Day 34) | An AE was any untoward medical occurrence in a participant, temporarily associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical events. |
| Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population | From Day 1 to Day 28 | Percentage of participants with COVID-19 related hospitalization or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier method. |
| Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population | From Day 1 (baseline) to Day 28 | Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. |
| Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population | From Day 1 (baseline) to Day 28 | Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. |
| Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- Modified Intent-to-Treat 2 (mITT2) Population | From Day 1 (baseline) to Day 28 | Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. |
| Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT Population | From Day 1 to Day 28 | Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported. |
| Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 Population | From Day 1 to Day 28 | Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported. |
| Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 Population | From Day 1 to Day 28 | Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported. |
| Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population | From Day 1 (baseline) to Day 28 | Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. |
| Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population | From Day 1 (baseline) to Day 28 | Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. |
| Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population | From Day 1 (baseline) to Day 28 | Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. |
| Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | From Day 1 (baseline) to Day 28 | Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. |
| Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | From Day 1 (baseline) to Day 28 | Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. |
| Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | From Day 1 (baseline) to Day 28 | Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. |
| Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | From Day 1 (baseline) to Day 28 | Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. |
| Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population | Baseline, Day 3, 5, 10 and 14 | The viral load was measured in nasal or nasopharyngeal samples using RT-PCR. |
| Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | From Day 1 (baseline) to Day 28 | Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. |
| Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | From Day 1 (baseline) to Day 28 | Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From start of study intervention (Day 1) up to end of safety follow-up (Day 34) | An adverse event (AE) was any untoward medical occurrence in a participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. Serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical events. AEs included both SAEs and all non-SAEs. An AE was considered as TEAE if the event started on or after start date of study intervention. |
| Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT1 Population | From Day 1 (baseline) to Day 28 | Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= no occurrence, 1= mild for 1 to 2 times, 2= moderate for 3 to 4 times, and 3= severe for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline). |
| Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT2 Population | From Day 1 (baseline) to Day 28 | Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= no occurrence, 1= mild for 1 to 2 times, 2= moderate for 3 to 4 times, and 3= severe for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline). |
| Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT Population | Day 1, 5 | In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation \>=95% were reported. |
| Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 Population | Day 1, 5 | In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation \>=95% were reported. |
| Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 Population | Day 1, 5 | In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation \>=95% were reported. |
| Percentage of Participants Who Died Through Week 24- mITT Population | From Day 1 up to Week 24 | In this outcome measure, percentage of participants with death due to any cause was presented. |
| Percentage of Participants Who Died Through Week 24- mITT1 Population | From Day 1 up to Week 24 | In this outcome measure, percentage of participants with death due to any cause was presented. |
| Percentage of Participants Who Died Through Week 24- mITT2 Population | From Day 1 up to Week 24 | In this outcome measure, percentage of participants with death due to any cause was presented. |
| Plasma Concentration Versus Time Summary of PF-07321332 | 1 Hour post-dose on Day 1 and pre-dose on Day 5 | — |
| Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population | Baseline, Day 3, 5, 10 and 14 | The viral load was measured in nasal or nasopharyngeal samples using reverse transcription polymerase chain reaction (RT-PCR). |
| Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population | Baseline, Day 3, 5, 10 and 14 | The viral load was measured in nasal or nasopharyngeal samples using RT-PCR. |
| Number of COVID-19 Related Medical Visits- mITT Population | From Day 1 up to Day 34 | Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (intensive care unit \[ICU\] and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported. |
| Number of COVID-19 Related Medical Visits- mITT1 Population | From Day 1 up to Day 34 | Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (ICU and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported. |
| Number of COVID-19 Related Medical Visits- mITT2 Population | From Day 1 up to Day 34 | Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (ICU and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported. |
| Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population | From Day 1 up to Day 34 | — |
| Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population | From Day 1 up to Day 34 | — |
| Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population | From Day 1 up to Day 34 | — |
| Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT Population | From Day 1 (baseline) to Day 28 | Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= no occurrence, 1= mild for 1 to 2 times, 2= moderate for 3 to 4 times, and 3= severe for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline). |
Countries
Argentina, Brazil, Bulgaria, Colombia, Czechia, Hungary, India, Japan, Malaysia, Mexico, Poland, Puerto Rico, Russia, South Africa, South Korea, Spain, Thailand, Turkey (Türkiye), Ukraine, United States
Participant flow
Pre-assignment details
2256 participants signed the informed consent form (ICF). Out of these 2256 participants, 130 were screen failures who did not meet the study criteria and were not enrolled. There were 13 participants who were not screen failure but not randomized due to withdrew consent or other reasons. Of the 2113 randomized subjects, only 2091 received study treatment.
Participants by arm
| Arm | Count |
|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received 300 milligrams (mg) PF-07321332 coadministered with 100 mg ritonavir orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24. | 1,038 |
| Placebo Participants with SARS-CoV-2 infection received placebo orally, q12h for 5 days. Participants were followed up for safety up to Day 34 and long-term safety follow up was up to Week 24. | 1,053 |
| Total | 2,091 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 15 |
| Overall Study | Lost to Follow-up | 20 | 16 |
| Overall Study | Other | 5 | 0 |
| Overall Study | Withdrawal by Subject | 37 | 43 |
Baseline characteristics
| Characteristic | Placebo | Total | PF-07321332 300 mg + Ritonavir 100 mg |
|---|---|---|---|
| Age, Continuous | 45.96 Years STANDARD_DEVIATION 15.56 | 45.84 Years STANDARD_DEVIATION 15.46 | 44.86 Years STANDARD_DEVIATION 15.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 439 Participants | 864 Participants | 425 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 607 Participants | 1215 Participants | 608 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 12 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 94 Participants | 189 Participants | 95 Participants |
| Race (NIH/OMB) Asian | 156 Participants | 309 Participants | 153 Participants |
| Race (NIH/OMB) Black or African American | 35 Participants | 87 Participants | 52 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 19 Participants | 9 Participants |
| Race (NIH/OMB) White | 756 Participants | 1484 Participants | 728 Participants |
| Sex: Female, Male Female | 515 Participants | 1037 Participants | 522 Participants |
| Sex: Female, Male Male | 538 Participants | 1054 Participants | 516 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,038 | 15 / 1,053 |
| other Total, other adverse events | 234 / 1,038 | 228 / 1,053 |
| serious Total, serious adverse events | 19 / 1,038 | 72 / 1,053 |
Outcome results
Primary
Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population
Percentage of participants with COVID-19 related hospitalization or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier (KM) method. Using KM method, survival probability for each time interval was calculated as the number of participants surviving divided by the number of participants at risk. Participants who had the event, dropped out, or moved out were not counted as at risk i.e., participants who were lost were considered censored and were not counted in the denominator.
Time frame: From Day 1 to Day 28
Population: mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic monoclonal antibody (mAb) treatment and were treated \<=3 days of COVID-19 onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population | 0.752 Percentage of participants |
| Placebo | Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population | 6.888 Percentage of participants |
Comparison: The difference of the percentage in the 2 treatment groups and its 95% confidence interval, and p-value based on Normal approximation of the data are presented.p-value: <0.000195% CI: [-8.208, -4.066]Normal approximation
Secondary
Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population
The viral load was measured in nasal or nasopharyngeal samples using RT-PCR.
Time frame: Baseline, Day 3, 5, 10 and 14
Population: mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. Here, Number Analyzed signifies participants evaluable for each specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population | Day 3 | -1.790 Log10 copies per milliliter | Standard Deviation 1.727 |
| PF-07321332 300 mg + Ritonavir 100 mg | Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population | Day 5 | -3.064 Log10 copies per milliliter | Standard Deviation 1.708 |
| PF-07321332 300 mg + Ritonavir 100 mg | Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population | Day 10 | -4.309 Log10 copies per milliliter | Standard Deviation 2.108 |
| PF-07321332 300 mg + Ritonavir 100 mg | Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population | Day 14 | -4.878 Log10 copies per milliliter | Standard Deviation 2.144 |
| Placebo | Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population | Day 14 | -4.556 Log10 copies per milliliter | Standard Deviation 2.146 |
| Placebo | Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population | Day 3 | -1.182 Log10 copies per milliliter | Standard Deviation 1.689 |
| Placebo | Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population | Day 10 | -3.772 Log10 copies per milliliter | Standard Deviation 2.058 |
| Placebo | Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population | Day 5 | -2.213 Log10 copies per milliliter | Standard Deviation 1.754 |
Secondary
Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population
The viral load was measured in nasal or nasopharyngeal samples using RT-PCR.
Time frame: Baseline, Day 3, 5, 10 and 14
Population: mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, Number Analyzed signifies participants evaluable for each specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population | Day 5 | -3.097 Log10 copies per milliliter | Standard Deviation 1.692 |
| PF-07321332 300 mg + Ritonavir 100 mg | Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population | Day 3 | -1.828 Log10 copies per milliliter | Standard Deviation 1.715 |
| PF-07321332 300 mg + Ritonavir 100 mg | Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population | Day 10 | -4.322 Log10 copies per milliliter | Standard Deviation 2.109 |
| PF-07321332 300 mg + Ritonavir 100 mg | Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population | Day 14 | -4.882 Log10 copies per milliliter | Standard Deviation 2.142 |
| Placebo | Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population | Day 14 | -4.547 Log10 copies per milliliter | Standard Deviation 2.146 |
| Placebo | Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population | Day 5 | -2.239 Log10 copies per milliliter | Standard Deviation 1.741 |
| Placebo | Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population | Day 10 | -3.777 Log10 copies per milliliter | Standard Deviation 2.041 |
| Placebo | Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population | Day 3 | -1.178 Log10 copies per milliliter | Standard Deviation 1.663 |
Secondary
Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population
The viral load was measured in nasal or nasopharyngeal samples using reverse transcription polymerase chain reaction (RT-PCR).
Time frame: Baseline, Day 3, 5, 10 and 14
Population: mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \<=3 days of COVID-19 onset. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. Here, Number Analyzed signifies participants evaluable for each specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population | Day 3 | -1.829 Log10 copies per milliliter | Standard Deviation 1.805 |
| PF-07321332 300 mg + Ritonavir 100 mg | Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population | Day 5 | -3.244 Log10 copies per milliliter | Standard Deviation 1.697 |
| PF-07321332 300 mg + Ritonavir 100 mg | Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population | Day 10 | -4.522 Log10 copies per milliliter | Standard Deviation 2.105 |
| PF-07321332 300 mg + Ritonavir 100 mg | Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population | Day 14 | -5.108 Log10 copies per milliliter | Standard Deviation 2.141 |
| Placebo | Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population | Day 14 | -4.862 Log10 copies per milliliter | Standard Deviation 2.121 |
| Placebo | Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population | Day 3 | -1.203 Log10 copies per milliliter | Standard Deviation 1.697 |
| Placebo | Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population | Day 10 | -3.964 Log10 copies per milliliter | Standard Deviation 2.1115 |
| Placebo | Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population | Day 5 | -2.923 Log10 copies per milliliter | Standard Deviation 1.787 |
Secondary
Number of COVID-19 Related Medical Visits- mITT1 Population
Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (ICU and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported.
Time frame: From Day 1 up to Day 34
Population: mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Number of COVID-19 Related Medical Visits- mITT1 Population | 40 Visits |
| Placebo | Number of COVID-19 Related Medical Visits- mITT1 Population | 128 Visits |
Secondary
Number of COVID-19 Related Medical Visits- mITT2 Population
Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (ICU and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported.
Time frame: From Day 1 up to Day 34
Population: mITT2 population included all participants who were randomized and took at least one dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Number of COVID-19 Related Medical Visits- mITT2 Population | 45 Visits |
| Placebo | Number of COVID-19 Related Medical Visits- mITT2 Population | 144 Visits |
Secondary
Number of COVID-19 Related Medical Visits- mITT Population
Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (intensive care unit \[ICU\] and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported.
Time frame: From Day 1 up to Day 34
Population: mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \<=3 days of COVID-19 onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Number of COVID-19 Related Medical Visits- mITT Population | 22 Visits |
| Placebo | Number of COVID-19 Related Medical Visits- mITT Population | 81 Visits |
Secondary
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population
Time frame: From Day 1 up to Day 34
Population: mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. The analysis was performed on all participants (i.e. hospitalized and non-hospitalized participants were included).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population | Duration of hospitalization visits | 0.087 Days | Standard Deviation 0.968 |
| PF-07321332 300 mg + Ritonavir 100 mg | Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population | Duration of ICU visits | 0.000 Days | Standard Deviation 0 |
| PF-07321332 300 mg + Ritonavir 100 mg | Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population | Duration of non-ICU visits | 0.087 Days | Standard Deviation 0.968 |
| Placebo | Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population | Duration of hospitalization visits | 0.766 Days | Standard Deviation 4.055 |
| Placebo | Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population | Duration of ICU visits | 0.128 Days | Standard Deviation 1.964 |
| Placebo | Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population | Duration of non-ICU visits | 0.639 Days | Standard Deviation 3.446 |
Secondary
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population
Time frame: From Day 1 up to Day 34
Population: mITT2 population included all participants who were randomized and took at least one dose of study intervention. The analysis was performed on all participants (i.e. hospitalized and non-hospitalized participants were included).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population | Duration of non-ICU visits | 0.092 Days | Standard Deviation 0.988 |
| PF-07321332 300 mg + Ritonavir 100 mg | Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population | Duration of hospitalization visits | 0.092 Days | Standard Deviation 0.988 |
| PF-07321332 300 mg + Ritonavir 100 mg | Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population | Duration of ICU visits | 0.000 Days | Standard Deviation 0 |
| Placebo | Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population | Duration of hospitalization visits | 0.729 Days | Standard Deviation 3.94 |
| Placebo | Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population | Duration of ICU visits | 0.121 Days | Standard Deviation 1.904 |
| Placebo | Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population | Duration of non-ICU visits | 0.610 Days | Standard Deviation 3.35 |
Secondary
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population
Time frame: From Day 1 up to Day 34
Population: mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \<=3 days of COVID-19 onset. The analysis was performed on all participants (i.e. hospitalized and non-hospitalized participants were included).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population | Duration of hospitalization visits | 0.088 Days | Standard Deviation 1.049 |
| PF-07321332 300 mg + Ritonavir 100 mg | Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population | Duration of ICU visits | 0.000 Days | Standard Deviation 0 |
| PF-07321332 300 mg + Ritonavir 100 mg | Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population | Duration of non-ICU visits | 0.088 Days | Standard Deviation 1.049 |
| Placebo | Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population | Duration of hospitalization visits | 0.844 Days | Standard Deviation 4.535 |
| Placebo | Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population | Duration of ICU visits | 0.179 Days | Standard Deviation 2.389 |
| Placebo | Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population | Duration of non-ICU visits | 0.666 Days | Standard Deviation 3.71 |
Secondary
Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant, temporarily associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical events.
Time frame: From start of study intervention (Day 1) up to end of safety follow-up (Day 34)
Population: SAS population included all participants who were randomized and took at least one dose of investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs) | AEs leading to study discontinuation | 0 Participants |
| PF-07321332 300 mg + Ritonavir 100 mg | Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs) | SAEs | 18 Participants |
| Placebo | Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs) | AEs leading to study discontinuation | 13 Participants |
| Placebo | Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs) | SAEs | 71 Participants |
Secondary
Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT1 Population
Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= no occurrence, 1= mild for 1 to 2 times, 2= moderate for 3 to 4 times, and 3= severe for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline).
Time frame: From Day 1 (baseline) to Day 28
Population: mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT1 Population | 735 Participants |
| Placebo | Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT1 Population | 737 Participants |
Comparison: Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).p-value: 0.637995% CI: [0.85, 1.303]Regression, Logistic
Secondary
Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT2 Population
Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= no occurrence, 1= mild for 1 to 2 times, 2= moderate for 3 to 4 times, and 3= severe for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline).
Time frame: From Day 1 (baseline) to Day 28
Population: mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT2 Population | 787 Participants |
| Placebo | Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT2 Population | 790 Participants |
Comparison: Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).p-value: 0.67695% CI: [0.848, 1.29]Regression, Logistic
Secondary
Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT Population
Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= no occurrence, 1= mild for 1 to 2 times, 2= moderate for 3 to 4 times, and 3= severe for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline).
Time frame: From Day 1 (baseline) to Day 28
Population: mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \<=3 days of COVID-19 onset. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT Population | 507 Participants |
| Placebo | Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT Population | 483 Participants |
Comparison: Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).p-value: 0.529395% CI: [0.836, 1.416]Regression, Logistic
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. Serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical events. AEs included both SAEs and all non-SAEs. An AE was considered as TEAE if the event started on or after start date of study intervention.
Time frame: From start of study intervention (Day 1) up to end of safety follow-up (Day 34)
Population: Safety analysis set (SAS) included all participants who received at least one dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 228 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 256 Participants |
Secondary
Percentage of Participants Who Died Through Week 24- mITT1 Population
In this outcome measure, percentage of participants with death due to any cause was presented.
Time frame: From Day 1 up to Week 24
Population: mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Percentage of Participants Who Died Through Week 24- mITT1 Population | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Died Through Week 24- mITT1 Population | 1.5 Percentage of participants |
Secondary
Percentage of Participants Who Died Through Week 24- mITT2 Population
In this outcome measure, percentage of participants with death due to any cause was presented.
Time frame: From Day 1 up to Week 24
Population: mITT2 population included all participants who were randomized and took at least one dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Percentage of Participants Who Died Through Week 24- mITT2 Population | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Died Through Week 24- mITT2 Population | 1.4 Percentage of participants |
Secondary
Percentage of Participants Who Died Through Week 24- mITT Population
In this outcome measure, percentage of participants with death due to any cause was presented.
Time frame: From Day 1 up to Week 24
Population: mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \<=3 days of COVID-19 onset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Percentage of Participants Who Died Through Week 24- mITT Population | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Died Through Week 24- mITT Population | 1.7 Percentage of participants |
Secondary
Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 Population
In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation \>=95% were reported.
Time frame: Day 1, 5
Population: mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here, Number Analyzed signifies participants evaluable for each specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 Population | Day 1 | 93.347 Percentage of participants |
| PF-07321332 300 mg + Ritonavir 100 mg | Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 Population | Day 5 | 91.577 Percentage of participants |
| Placebo | Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 Population | Day 1 | 92.214 Percentage of participants |
| Placebo | Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 Population | Day 5 | 87.610 Percentage of participants |
p-value: 0.28195% CI: [10.097, 43.156]Breslow-Day test
95% CI: [6.823, 22.725]Breslow Day test
Secondary
Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 Population
In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation \>=95% were reported.
Time frame: Day 1, 5
Population: mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here, Number Analyzed signifies participants evaluable for each specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 Population | Day 1 | 93.353 Percentage of participants |
| PF-07321332 300 mg + Ritonavir 100 mg | Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 Population | Day 5 | 91.538 Percentage of participants |
| Placebo | Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 Population | Day 1 | 91.738 Percentage of participants |
| Placebo | Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 Population | Day 5 | 87.681 Percentage of participants |
p-value: 0.222695% CI: [10.412, 42.837]Breslow-Day test
p-value: 0.234295% CI: [6.808, 21.28]Breslow-Day test
Secondary
Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT Population
In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation \>=95% were reported.
Time frame: Day 1, 5
Population: mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \<=3 days of COVID-19 onset. Here, Number Analyzed signifies participants evaluable for each specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT Population | Day 1 | 93.443 Percentage of participants |
| PF-07321332 300 mg + Ritonavir 100 mg | Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT Population | Day 5 | 92.823 Percentage of participants |
| Placebo | Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT Population | Day 1 | 91.963 Percentage of participants |
| Placebo | Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT Population | Day 5 | 89.076 Percentage of participants |
p-value: 0.199795% CI: [7.788, 48.328]Breslow-Day test
95% CI: [4.159, 19.253]Breslow-Day test
Secondary
Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population
Percentage of participants with COVID-19 related hospitalization or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier method.
Time frame: From Day 1 to Day 28
Population: mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population | 0.933 Percentage of participants |
| Placebo | Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population | 6.571 Percentage of participants |
Comparison: The difference of the percentage in the 2 treatment groups and its 95% confidence interval, and p-value based on Normal approximation of the data are presented.p-value: <0.000195% CI: [-7.308, -3.967]Normal approximation
Secondary
Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 Population
Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported.
Time frame: From Day 1 to Day 28
Population: mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 Population | 19.691 Percentage of participants |
| Placebo | Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 Population | 21.298 Percentage of participants |
Comparison: Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).p-value: 0.576295% CI: [0.74, 1.182]Regression, Logistic
Secondary
Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 Population
Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported.
Time frame: From Day 1 to Day 28
Population: mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 Population | 20.660 Percentage of participants |
| Placebo | Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 Population | 21.810 Percentage of participants |
Comparison: Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No),baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).p-value: 0.780795% CI: [0.773, 1.213]Regression, Logistic
Secondary
Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT Population
Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported.
Time frame: From Day 1 to Day 28
Population: mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \<=3 days of COVID-19 onset. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT Population | 18.168 Percentage of participants |
| Placebo | Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT Population | 20.775 Percentage of participants |
Comparison: Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).p-value: 0.347395% CI: [0.652, 1.162]Regression, Logistic
Secondary
Plasma Concentration Versus Time Summary of PF-07321332
Time frame: 1 Hour post-dose on Day 1 and pre-dose on Day 5
Population: SAS population included all participants who were randomized and took at least one dose of study intervention. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. Here Number Analyzed signifies participants evaluable for the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Plasma Concentration Versus Time Summary of PF-07321332 | Day 1 (1 Hour post dose) | 2201 Nanograms per milliliter | Standard Deviation 2130.7 |
| PF-07321332 300 mg + Ritonavir 100 mg | Plasma Concentration Versus Time Summary of PF-07321332 | Day 5 (Pre-dose) | 3087 Nanograms per milliliter | Standard Deviation 2884.3 |
Secondary
Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population
Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time frame: From Day 1 (baseline) to Day 28
Population: mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population | 13.00 Days |
| Placebo | Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population | 15.00 Days |
Comparison: Analysis of treatment effect on time to sustained alleviation is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.p-value: <0.000195% CI: [1.134, 1.412]Cox Proportional Hazard Model
Secondary
Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population
Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time frame: From Day 1 (baseline) to Day 28
Population: mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \<=3 days of COVID-19 onset. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population | 12.00 Days |
| Placebo | Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population | 15.00 Days |
Comparison: Analysis of treatment effect on time to sustained alleviation is based on Cox proportional hazard (PH) model with treatment and geographic region effects as independent variables, and baseline SARS-CoV-2 serology status and baseline viral load (\<4 logarithm to base 10 \[log10\] copies/milliliter \[mL\], \>=4 log10 copies/mL) as covariates.p-value: 0.000395% CI: [1.136, 1.476]Cox Proportional Hazard Model
Secondary
Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- Modified Intent-to-Treat 2 (mITT2) Population
Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time frame: From Day 1 (baseline) to Day 28
Population: mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- Modified Intent-to-Treat 2 (mITT2) Population | 13.00 Days |
| Placebo | Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- Modified Intent-to-Treat 2 (mITT2) Population | 16.00 Days |
Comparison: Analysis of treatment effect on time to sustained alleviation is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.p-value: <0.000195% CI: [1.131, 1.4]Cox Proportional Hazard Model
Secondary
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population
Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time frame: From Day 1 (baseline) to Day 28
Population: mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. Here, Number Analyzed signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Cough | 9.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Headache | 5.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Chills or shivering | 3.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Nausea | 5.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Diarrhea | 5.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Stuffy or runny nose | 6.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Shortness of breath or difficulty breathing | 6.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Sore throat | 5.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Feeling hot or feverish | 3.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Vomit | 3.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Muscle or body aches | 6.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Vomit | 3.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Muscle or body aches | 7.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Shortness of breath or difficulty breathing | 8.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Chills or shivering | 5.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Cough | 10.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Diarrhea | 4.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Feeling hot or feverish | 5.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Headache | 7.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Nausea | 6.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Stuffy or runny nose | 7.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Sore throat | 6.000 Days |
Secondary
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population
Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time frame: From Day 1 (baseline) to Day 28
Population: mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. Here, Number Analyzed signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Shortness of breath or difficulty breathing | 6.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Headache | 5.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Muscle or body aches | 6.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Nausea | 5.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Diarrhea | 5.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Stuffy or runny nose | 6.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Chills or shivering | 3.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Sore throat | 5.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Feeling hot or feverish | 3.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Vomit | 3.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Cough | 9.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Vomit | 3.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Muscle or body aches | 8.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Shortness of breath or difficulty breathing | 9.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Chills or shivering | 5.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Cough | 10.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Diarrhea | 4.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Feeling hot or feverish | 5.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Headache | 7.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Nausea | 6.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Stuffy or runny nose | 7.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Sore throat | 6.000 Days |
Secondary
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population
Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time frame: From Day 1 (baseline) to Day 28
Population: mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \<=3 days of COVID-19 onset. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. Here, Number Analyzed signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Cough | 8.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Headache | 5.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Chills or shivering | 3.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Nausea | 4.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Diarrhea | 4.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Stuffy or runny nose | 6.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Shortness of breath or difficulty breathing | 6.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Sore throat | 5.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Feeling hot or feverish | 3.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Vomit | 3.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Muscle or body aches | 6.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Vomit | 3.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Muscle or body aches | 7.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Shortness of breath or difficulty breathing | 8.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Chills or shivering | 5.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Cough | 10.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Diarrhea | 4.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Feeling hot or feverish | 5.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Headache | 7.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Nausea | 5.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Stuffy or runny nose | 7.000 Days |
| Placebo | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Sore throat | 6.000 Days |
Secondary
Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population
Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time frame: From Day 1 (baseline) to Day 28
Population: mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population | 16.00 Days |
| Placebo | Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population | 19.00 Days |
Comparison: Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.p-value: 0.002295% CI: [1.068, 1.348]Cox Proportional Hazard Model
Secondary
Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population
Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time frame: From Day 1 (baseline) to Day 28
Population: mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population | 17.00 Days |
| Placebo | Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population | 19.00 Days |
Comparison: Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.p-value: 0.002195% CI: [1.066, 1.337]Cox Proportional Hazard Model
Secondary
Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population
Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time frame: From Day 1 (baseline) to Day 28
Population: mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \<=3 days of COVID-19 onset. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population | 16.00 Days |
| Placebo | Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population | 18.00 Days |
Comparison: Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.p-value: 0.005395% CI: [1.061, 1.401]Cox Proportional Hazard Model
Secondary
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population
Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time frame: From Day 1 (baseline) to Day 28
Population: mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. Here, Number Analyzed signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Diarrhea | 6.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Feeling hot or feverish | 5.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Nausea | 7.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Headache | 9.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Chills or shivering | 5.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Vomit | 3.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Stuffy or runny nose | 9.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Cough | 13.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Sore throat | 7.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Muscle or body aches | 9.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Shortness of breath or difficulty breathing | 9.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Vomit | 3.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Muscle or body aches | 12.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Shortness of breath or difficulty breathing | 12.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Chills or shivering | 7.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Cough | 15.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Diarrhea | 6.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Feeling hot or feverish | 7.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Headache | 11.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Nausea | 7.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Stuffy or runny nose | 10.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | Sore throat | 9.000 Days |
Secondary
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population
Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time frame: From Day 1 (baseline) to Day 28
Population: mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. Here, Number Analyzed signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Diarrhea | 6.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Stuffy or runny nose | 9.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Feeling hot or feverish | 5.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Shortness of breath or difficulty breathing | 9.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Headache | 9.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Sore throat | 7.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Nausea | 7.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Chills or shivering | 5.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Muscle or body aches | 9.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Vomit | 3.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Cough | 13.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Vomit | 4.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Stuffy or runny nose | 11.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Muscle or body aches | 12.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Shortness of breath or difficulty breathing | 13.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Chills or shivering | 7.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Diarrhea | 6.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Feeling hot or feverish | 7.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Headache | 11.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Nausea | 7.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Sore throat | 9.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | Cough | 15.000 Days |
Secondary
Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population
Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
Time frame: From Day 1 (baseline) to Day 28
Population: mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \<=3 days of COVID-19 onset. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. Here, Number Analyzed signifies participants evaluable for each specified category.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Shortness of breath or difficulty breathing | 8.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Headache | 8.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Cough | 13.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Nausea | 5.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Diarrhea | 6.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Stuffy or runny nose | 9.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Chills or shivering | 5.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Sore throat | 7.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Feeling hot or feverish | 5.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Vomit | 3.000 Days |
| PF-07321332 300 mg + Ritonavir 100 mg | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Muscle or body aches | 9.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Vomit | 3.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Cough | 15.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Muscle or body aches | 12.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Shortness of breath or difficulty breathing | 11.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Chills or shivering | 7.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Diarrhea | 6.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Feeling hot or feverish | 7.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Headache | 11.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Nausea | 7.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Stuffy or runny nose | 10.000 Days |
| Placebo | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | Sore throat | 9.000 Days |