Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| 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. |
From Day 1 to Day 28 |
|
| 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. |
From start of study intervention (Day 1) up to end of safety follow-up (Day 34) |
|
| 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. |
From start of study intervention (Day 1) up to end of safety follow-up (Day 34) |
|
| 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. |
From Day 1 to Day 28 |
|
| 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. |
From Day 1 (baseline) to Day 28 |
|
| 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. |
From Day 1 (baseline) to Day 28 |
|
| 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. |
From Day 1 (baseline) to Day 28 |
|
| 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. |
From Day 1 to Day 28 |
|
| 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. |
From Day 1 to Day 28 |
|
| 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. |
From Day 1 to Day 28 |
|
| 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. |
From Day 1 (baseline) to Day 28 |
|
| 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. |
From Day 1 (baseline) to Day 28 |
|
| 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. |
From Day 1 (baseline) to Day 28 |
|
| 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. |
From Day 1 (baseline) to Day 28 |
|
| 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. |
From Day 1 (baseline) to Day 28 |
|
| 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. |
From Day 1 (baseline) to Day 28 |
|
| 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. |
From Day 1 (baseline) to Day 28 |
|
| 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. |
From Day 1 (baseline) to Day 28 |
|
| 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. |
From Day 1 (baseline) to Day 28 |
|
| 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). |
From Day 1 (baseline) to Day 28 |
|
| 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). |
From Day 1 (baseline) to Day 28 |
|
| 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). |
From Day 1 (baseline) to Day 28 |
|
| 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. |
Day 1, 5 |
|
| 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. |
Day 1, 5 |
|
| 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. |
Day 1, 5 |
|
| 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. |
From Day 1 up to Week 24 |
|
| 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. |
From Day 1 up to Week 24 |
|
| 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. |
From Day 1 up to Week 24 |
|
| Secondary |
Plasma Concentration Versus Time Summary of PF-07321332 |
|
1 Hour post-dose on Day 1 and pre-dose on Day 5 |
|
| 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). |
Baseline, Day 3, 5, 10 and 14 |
|
| 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. |
Baseline, Day 3, 5, 10 and 14 |
|
| 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. |
Baseline, Day 3, 5, 10 and 14 |
|
| 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. |
From Day 1 up to Day 34 |
|
| 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. |
From Day 1 up to Day 34 |
|
| 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. |
From Day 1 up to Day 34 |
|
| Secondary |
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population |
|
From Day 1 up to Day 34 |
|
| Secondary |
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population |
|
From Day 1 up to Day 34 |
|
| Secondary |
Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population |
|
From Day 1 up to Day 34 |
|
