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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002895-38 | EudraCT Number | ||
| EPIC-HR | Other Identifier | Alias Study Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-07321332/ritonavir | Experimental | Orally administered PF-07321332+ritonavir |
|
| Placebo | Placebo Comparator | Orally administered placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07321332 | Drug | PF-07321332 (tablet) |
| |
| Ritonavir |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Research Inc | Pelham | Alabama | 35124 | United States | ||
| The Institute for Liver Health dba Arizona Clinical Trials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40809391 | Derived | Ansari W, Coetzer H, Gebo KA, Ren J, Scott A, Cappelleri JC, Cha-Silva AS, Leister-Tebbe H. Patient-Reported Outcomes of Nirmatrelvir Treatment for High-Risk, Nonhospitalized Adults With Symptomatic COVID-19. Open Forum Infect Dis. 2025 Aug 1;12(8):ofaf449. doi: 10.1093/ofid/ofaf449. eCollection 2025 Aug. | |
| 40592258 | Derived |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 20, 2021 | Nov 22, 2022 |
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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).
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| Drug |
Ritonavir (capsule) |
|
| Placebo | Drug | Placebo (tablet or capsule) |
|
| From start of study intervention (Day 1) up to end of safety follow-up (Day 34) |
| 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) |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Mesa |
| Arizona |
| 85210 |
| United States |
| The Institute for Liver Health dba Arizona Clinical Trials | Tucson | Arizona | 85712 | United States |
| Hope Clinical Research | Canoga Park | California | 91303 | United States |
| Ascada Research | Fullerton | California | 92835 | United States |
| Atella Clinical Research LLC. | La Palma | California | 90623 | United States |
| Ark Clinical Research | Long Beach | California | 90806 | United States |
| American Institute of Research | Los Angeles | California | 90017 | United States |
| South Bay Clinical Research Institute | Redondo Beach | California | 90277 | United States |
| Hope Clinical Research (COVID Satellite Site) | West Hills | California | 91304 | United States |
| Future Innovative Treatments, LLC | Colorado Springs | Colorado | 80907 | United States |
| Xera Med Research | Boca Raton | Florida | 33487 | United States |
| MOORE Clinical Research, Inc. | Brandon | Florida | 33511 | United States |
| Innovative Research of West Florida, Inc. | Clearwater | Florida | 33756 | United States |
| Herco Medical and Research Center Inc | Coral Gables | Florida | 33134 | United States |
| Advance Clinical Research Group | Cutler Bay | Florida | 33157 | United States |
| Beautiful Minds Clinical Research Center | Cutler Bay | Florida | 33157 | United States |
| Qway Research | Hialeah | Florida | 33010 | United States |
| Eastern Research Inc | Hialeah | Florida | 33013 | United States |
| Inpatient Research Clinic | Hialeah | Florida | 33013 | United States |
| Doral Medical Research LLC. | Hialeah | Florida | 33016 | United States |
| Doral Medical Research,LLC | Hialeah | Florida | 33016 | United States |
| Unlimited Medical Research Group, LLC | Hialeah Gardens | Florida | 33018 | United States |
| Advanced Pulmonary Research Institute | Loxahatchee Groves | Florida | 33470 | United States |
| Angels Clinical Research Institute | Miami | Florida | 33122 | United States |
| LCC Medical Research Institute, LLC | Miami | Florida | 33126 | United States |
| Premium Medical Research Corp | Miami | Florida | 33126 | United States |
| Global Health Clinical Trials Corp | Miami | Florida | 33135 | United States |
| South Florida Research Center, Inc. | Miami | Florida | 33135 | United States |
| Suncoast Research Group, LLC | Miami | Florida | 33135 | United States |
| I.V.A.M. Clinical & Investigational Center, LLC | Miami | Florida | 33144 | United States |
| C'A Research | Miami | Florida | 33174 | United States |
| ProLive Medical Research, Corp. | Miami | Florida | 33175 | United States |
| Entrust Clinical Research | Miami | Florida | 33176 | United States |
| Reed Medical Research | Miami | Florida | 33176 | United States |
| Kendall South Medical Center | Miami | Florida | 33185 | United States |
| Clinical Site Partners, Inc d/b/a CSP Miami | Miami | Florida | 33186 | United States |
| Coral Research Clinic Corp | Miami | Florida | 33186 | United States |
| Savin Medical Group, LLC | Miami Lakes | Florida | 33014 | United States |
| Omega Research Orlando, LLC | Orlando | Florida | 32808 | United States |
| NAPA Research LLC | Pompano Beach | Florida | 33064 | United States |
| CDC Research Institute | Port Saint Lucie | Florida | 34952 | United States |
| USPA Advance Concept Medical Research Group LLC | South Miami | Florida | 33143 | United States |
| GCP, Global Clinical Professionals | St. Petersburg | Florida | 33705 | United States |
| Sunrise Research Institute | Sunrise | Florida | 33325 | United States |
| Santos Research Center, CORP | Tampa | Florida | 33615 | United States |
| Clinical Site Partners, Inc. dba CSP Orlando | Winter Park | Florida | 32789 | United States |
| Research by Design, LLC | Chicago | Illinois | 60643 | United States |
| New Orleans Sinus Center (COVID-19 Testing) | Marrero | Louisiana | 70072 | United States |
| Tandem Clinical Research GI, LLC | Marrero | Louisiana | 70072 | United States |
| Mercury Street Medical Group, PLLC | Butte | Montana | 59701 | United States |
| Excel Clinical research | Las Vegas | Nevada | 89109 | United States |
| Meridian Clinical Research, LLC | Endwell | New York | 13760 | United States |
| Monroe Biomedical Research | Monroe | North Carolina | 28112 | United States |
| Accellacare | Wilmington | North Carolina | 28401 | United States |
| Premier Medical Group | Clarksville | Tennessee | 37040 | United States |
| PharmaTex Research, LLC | Amarillo | Texas | 79109 | United States |
| ARC Clinical Research at William Cannon | Austin | Texas | 78745 | United States |
| St Hope Foundation | Bellaire | Texas | 77401 | United States |
| Conroe Willis Medical Research | Conroe | Texas | 77304 | United States |
| South Texas Clinical Research | Corpus Christi | Texas | 78413 | United States |
| SignatureCare Emergency Center | Houston | Texas | 77008 | United States |
| Trio Clinical Trials, LLC | Houston | Texas | 77008 | United States |
| C & R Research Services USA | Houston | Texas | 77022 | United States |
| Next Level Urgent Care | Houston | Texas | 77057 | United States |
| SMS Clinical Research, LLC | Mesquite | Texas | 75149 | United States |
| SMS Clinical Research | Mesquite | Texas | 75149 | United States |
| LinQ Research, LLC | Pearland | Texas | 77584 | United States |
| Epic Medical Research | Red Oak | Texas | 75154 | United States |
| Sun Research Institute | San Antonio | Texas | 78215 | United States |
| BFHC Research | San Antonio | Texas | 78249 | United States |
| Tranquility Research | Webster | Texas | 77598 | United States |
| TPMG (Tidewater Physicians Multispecialty Group) Clinical Research | Newport News | Virginia | 23606 | United States |
| Instituto de Investigaciones Clinicas Zarate | Zárate | Buenos Aires | B2800DGH | Argentina |
| Hospital De Clínicas Presidente Dr.Nicolas Avellaneda | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Chronos Pesquisa Clinica | Brasília | Federal District | 72145-450 | Brazil |
| Hospital Agamenon Magalhaes | Recife | Pernambuco | 52051-380 | Brazil |
| CECIP JAÚ - Centro de Estudos Clínicos do Interior Paulista - LTDA | Jaú | São Paulo | 17201-130 | Brazil |
| Individual Practice for Primary Medical Care - IPPMC - Dr. P. Panayotov EOOD | Burgas | 8001 | Bulgaria |
| "Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo" Ltd | Haskovo | 6300 | Bulgaria |
| MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD | Kozloduy | 3320 | Bulgaria |
| Diagnostic-Consultative Center I Lom EOOD | Lom | 3600 | Bulgaria |
| Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD | Lom | 3600 | Bulgaria |
| Medical centre Leo Clinic EOOD | Lovech | 5500 | Bulgaria |
| MHAT Heart and Brain EAD | Pleven | 5800 | Bulgaria |
| DCC Sveti Georgi EOOD | Plovdiv | 4000 | Bulgaria |
| MHAT "St. Panteleimon "- Plovdiv | Plovdiv | 4004 | Bulgaria |
| Multiprofile Hospital for Active Treatment Sveti Ivan Rilski - Razgrad AD | Razgrad | 7200 | Bulgaria |
| "Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov - | Rousse | 7002 | Bulgaria |
| UMHAT Medica Ruse OOD | Rousse | 7013 | Bulgaria |
| Multiprofile Hospital for Active Treatment - Samokov EOOD | Samokov | 2000 | Bulgaria |
| Medical Center-1-Sevlievo EOOD | Sevlievo | 5400 | Bulgaria |
| Multiprofile Hospital For Active Treatment Shumen AD | Shumen | 9700 | Bulgaria |
| Multiprofile hospital for active treatment - Sliven to Military Medical Academy | Sliven | 8800 | Bulgaria |
| MHAT "Dr. Ivan Seliminski" AD, Sliven | Sliven | 8801 | Bulgaria |
| Diagnostic-Consultative Center XXII- Sofia ЕООD | Sofia | 1113 | Bulgaria |
| MHAT "St. Sofia" EOOD | Sofia | 1618 | Bulgaria |
| Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD | Stara Zagora | 6000 | Bulgaria |
| Multiprofile Hospital for Active Treatment Targovishte AD | Targovishte | 7700 | Bulgaria |
| Outpatient Clinic for Primary Outpatient Medical Care "Puls" - Dr. Mladen Buchvarov EOOD | Tsarevo | 8260 | Bulgaria |
| Medical center Leo Clinic EOOD | Varna | 9020 | Bulgaria |
| Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD | Vratsa | 3000 | Bulgaria |
| Fundacion Cardiomet Cequin | Armenia | Quindío Department | 630004 | Colombia |
| Zdraví-Fit, s.r.o. | Protivín | 398 11 | Czechia |
| Nemocnice Slany | Slaný | 274 01 | Czechia |
| Trial Pharma Kft. | Békéscsaba | 5600 | Hungary |
| Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika | Debrecen | 4031 | Hungary |
| Agria-Study Kft. | Eger | 3300 | Hungary |
| Trial Pharma Kft. | Gyula | 5700 | Hungary |
| Medifarma-98 Kft. | Nyíregyháza | 4400 | Hungary |
| AIIMS Raipur | Raipur | Chhattisgarh | 492099 | India |
| Jupiter Hospital | Vadodara | Gujarat | 390012 | India |
| BGS Global Institute of Medical Sciences and Hospital | Bangalore | Karnataka | 560060 | India |
| Lisie Hospital | Kochi | Kerala | 682018 | India |
| Jehangir Clinical Development Centre Pvt. Ltd | Pune | Maharashtra | 411001 | India |
| Lifepoint Research LLP | Pune | Maharashtra | 411057 | India |
| Jawahar Lal Nehru Medical College | Ajmer | Rajasthan | 305001 | India |
| Apex Hospitals Pvt Ltd | Jaipur | Rajasthan | 302017 | India |
| Maharaja Agrasen Superspeciality Hospital | Jaipur | Rajasthan | 302039 | India |
| Nil Ratan Sircar Medical College and Hospital | Kolkata | West Bengal | 700014 | India |
| Aakash Healthcare Private Limited | New Delhi | 110075 | India |
| Sardar Patel Medical College | Pavan PURI Bikaner, Rajasthan | 334003 | India |
| International University of Health and Welfare Narita Hospital | Narita | Chiba | 286-8520 | Japan |
| National Hokkaido Medical Center | Sapporo | Hokkaido | 063-0005 | Japan |
| Rinku General Medical Center | Izumisano | Osaka | 598-8577 | Japan |
| Tokyo Medical University Hachioji Medical Center | Hachiōji | Tokyo | 1930998 | Japan |
| National Center for Global Health and Medicine | Shinjuku | Tokyo | 162-8655 | Japan |
| Hospital Umum Sarawak | Kuching | Sarawak | 93586 | Malaysia |
| Hospital Miri | Miri | Sarawak | 98000 | Malaysia |
| Clinical Research Institute Saltillo S.A. de C.V. | Saltillo | Coahuila | 25020 | Mexico |
| Asociacion Mexicana para la Investigacion Clinica A.C. (AMIC) | Pachuca | Hidalgo | 42070 | Mexico |
| Instituto Jalisciense de Metabolismo, S.C. | Guadalajara | Jalisco | 44670 | Mexico |
| JM Research SC | Cuernavaca | Morelos | 62290 | Mexico |
| Christus - Latam Hub Center of Excellence and Innovation Center S.C. | Monterrey | Nuevo León | 64060 | Mexico |
| Eukarya Pharmasite S.C. | Monterrey | Nuevo León | 64718 | Mexico |
| Oaxaca Site Management Organization | Oaxaca City | Oaxaca | 68000 | Mexico |
| InfectoLab Consultorios de Especialidad en Infectologia | Baja California | Tijuana | 22010 | Mexico |
| EME RED Hospitalaria | Mérida | Yucatán | 97000 | Mexico |
| Kohler & Milstein Research S.A. de C.V. | Mérida | Yucatán | 97070 | Mexico |
| Centro de Investigacion Clinica Del Pacifico SA de CV | Acapulco | Mexico |
| Hospital Cardiologica Aguascalientes | Aguascalientes | CP 201230 | Mexico |
| Instituto de Investigaciones Clínicas para la Salud | Durango | 34000 | Mexico |
| FAICIC S. de R.L. de C.V. | Veracruz | 91900 | Mexico |
| Sociedad de Metabolismo y Corazon S.C. | Veracruz | 91900 | Mexico |
| Arké SMO S.A de C.V | Veracruz | 91910 | Mexico |
| KLIMED Marek Klimkiewicz | Bialystok | 15-704 | Poland |
| Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska | Wroclaw | 51-162 | Poland |
| Clinical Research Management Group Inc | Ponce | 00780 | Puerto Rico |
| Advance Medical Research Center | San Juan | 00926 | Puerto Rico |
| LLC Trekhgorka Medicine | Odintsovo | Moscow Oblast | 143005 | Russia |
| Barnaul City Hospital Number 5 | Barnaul | 656045 | Russia |
| KDC "Evromedservis", OJSC | Moscow | 115419 | Russia |
| Smolensk State Medical University | Smolensk | 214019 | Russia |
| MERC Welkom | Welkom | Free State | 9460 | South Africa |
| East Rand Research Centre T/A Worthwhile Clinical Trials | Benoni | Gauteng | 1500 | South Africa |
| Botho Ke Bontle Health Services | Pretoria | Gauteng | 0122 | South Africa |
| Synapta Clinical Research Center | Durban | KwaZulu-Natal | 4001 | South Africa |
| Limpopo Clinical Research Initiative | Thabazimbi | Limpopo | 0380 | South Africa |
| MERC Middelburg | Middelburg | Mpumalanga | 1055 | South Africa |
| Kyungpook National University Chilgok Hospital | Daegu | 41404 | South Korea |
| Incheon Medical Center | Incheon | 22532 | South Korea |
| Chonnam National University Bitgoeul Hospital | Nam-gu | 61748 | South Korea |
| SMG-SNU Boramae Medical Center | Seoul | 07061 | South Korea |
| Eba Centelles | Centelles | Barcelona [barcelona] | 08540 | Spain |
| Complexo Hospitalario Universitario da Coruna | A Coruña | 15006 | Spain |
| Bangkok Centre Hotel | Bang Rak | Bangkok | 10500 | Thailand |
| Chula Field Hospital, Chulalongkorn University Sport center (Chantanayingyong Gymnasium) | Pathum Wan District, | Bangkok | 10330 | Thailand |
| Thai Red Cross Emerging Infectious Diseases (EDI) Clinic | Pathumwan, | Bangkok | 10330 | Thailand |
| The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), | Pathumwan | Bangkok | 10330 | Thailand |
| Faculty of Medicine - Khon Kaen University | Muang | Changwat Khon Kaen | 40002 | Thailand |
| Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, | Hat Yai | Changwat Songkhla | 90110 | Thailand |
| Ankara University Medical Faculty, Ibni-Sina Hospital | Ankara | 06230 | Turkey (Türkiye) |
| Hacettepe University Medical Faculty Hospital | Ankara | 06230 | Turkey (Türkiye) |
| Akdeniz Universitesi Hastanesi | Antalya | 07059 | Turkey (Türkiye) |
| Istanbul Medipol University Clinical Research Ethics Committee | Beykoz / Istanbul | 34810 | Turkey (Türkiye) |
| Gaziantep University Medical Faculty | Gaziantep | 27300 | Turkey (Türkiye) |
| Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi | Istanbul | 34020 | Turkey (Türkiye) |
| Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty | Istanbul | 34098 | Turkey (Türkiye) |
| Acibadem Saglik Hizmetleri ve Tic.A.S, Acibadem Atakent Hastanesi | Istanbul | 34303 | Turkey (Türkiye) |
| Istanbul Universitesi Klinik Arastirmalar Mukemmeliyet Uygulama ve Arastirma Merkezi | Istanbul | 34452 | Turkey (Türkiye) |
| Basaksehir Cam ve Sakura Sehir Hastanesi | Istanbul | 34480 | Turkey (Türkiye) |
| Kocaeli University Medical Faculty | Kocaeli | 41380 | Turkey (Türkiye) |
| Sbü Dr. Suat Seren Göğüs Hastaliklari Ve Cerrahisi Eğitim Ve Araştirma Hastanesi | Konak/Izmir | 35170 | Turkey (Türkiye) |
| Mersin University Health Research and Application Hospital | Mersin | 33110 | Turkey (Türkiye) |
| Sakarya University Training and Research Hospital | Sakarya | 54100 | Turkey (Türkiye) |
| Karadeniz Teknik Universitesi Farabi Hastanesi | Trabzon | 61080 | Turkey (Türkiye) |
| Communal non-profit enterprise "City Clinical Hospital #16" of Dnipro City Council | Dnipro | 49069 | Ukraine |
| Municipal Nonprofit Enterprise "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital of | Ivano-Frankivsk | 76007 | Ukraine |
| Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council" | Ivano-Frankivsk | 76018 | Ukraine |
| Municipal Nonprofit Enterprise "City Student Hospital" of Kharkiv City Council | Kharkiv | 61002 | Ukraine |
| Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases | Kharkiv | 61096 | Ukraine |
| "Municipal Non-Profit Enterprise "Alexander Clinical Hospital of Kyiv" of the Kyiv City Council | Kyiv | 01601 | Ukraine |
| Municipal non-commercial enterprise "Kyiv City Clinical Hospital #1" Of Executive Body Of the Kyiv | Kyiv | 02091 | Ukraine |
| Kyiv Railway Clinical Hospital No.2 of Branch "Health Center of the Public Joint Stock Company | Kyiv | 03049 | Ukraine |
| Polyclinic of Center for Medical Services and Rehabilitation of State Joint-Stock Holding Company | Kyiv | 04050 | Ukraine |
| Municipal NonProfit Enterprise of the Lviv Regional Council Lviv Regional Information and Analitical | Lviv | 79008 | Ukraine |
| Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4" | Lviv | 79011 | Ukraine |
| Municipal Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional | Poltava | 36011 | Ukraine |
| Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council | Tarasove Village | 45625 | Ukraine |
| Municipal Non-commercial Enterprise "Vinnytsia City Clinical Hospital №1" | Vinnytsia | 21029 | Ukraine |
| Communal Enterprise "Hospital #1" of Zhytomyr City Council | Zhytomyr | 10002 | Ukraine |
| Baniecki ML, Guan S, Rai DK, Yang Q, Lee JT, Hao L, Weinstein E, Hyde C, Cardin RD, Soares H, Hammond J. Integrated virologic analysis of resistance to nirmatrelvir/ritonavir in individuals across four phase 2/3 clinical studies for the treatment of COVID-19. EBioMedicine. 2025 Aug;118:105819. doi: 10.1016/j.ebiom.2025.105819. Epub 2025 Jun 30. |
| 39523543 | Derived | Hammond J, Leister-Tebbe H, Gardner A, Abreu P, Bao W, Wisemandle W, Ansari W, Harrington MA, Simon-Campos A, Chew KW, Pypstra R, Rusnak JM. Alleviation of COVID-19 Symptoms and Reduction in Healthcare Utilization Among High-risk Patients Treated With Nirmatrelvir/Ritonavir (NMV/R): A Phase 3 Randomized Trial. Clin Infect Dis. 2025 Feb 24;80(2):323-330. doi: 10.1093/cid/ciae551. |
| 35172054 | Derived | Hammond J, Leister-Tebbe H, Gardner A, Abreu P, Bao W, Wisemandle W, Baniecki M, Hendrick VM, Damle B, Simon-Campos A, Pypstra R, Rusnak JM; EPIC-HR Investigators. Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19. N Engl J Med. 2022 Apr 14;386(15):1397-1408. doi: 10.1056/NEJMoa2118542. Epub 2022 Feb 16. |
| FG001 |
| 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis set included all participants randomly assigned to study intervention, whether or not administered the study intervention.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 to Day 28 |
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| 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. | Safety analysis set (SAS) included all participants who received at least one dose of study intervention. | Posted | Count of Participants | Participants | From start of study intervention (Day 1) up to end of safety follow-up (Day 34) |
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| 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. | SAS population included all participants who were randomized and took at least one dose of investigational product. | Posted | Count of Participants | Participants | From start of study intervention (Day 1) up to end of safety follow-up (Day 34) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 to Day 28 |
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| 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. | 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. | Posted | Median | 95% Confidence Interval | Days | From Day 1 (baseline) to Day 28 |
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| 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. | 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. | Posted | Median | 95% Confidence Interval | Days | From Day 1 (baseline) to Day 28 |
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| 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. | 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. | Posted | Median | 95% Confidence Interval | Days | From Day 1 (baseline) to Day 28 |
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| 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. | 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. | Posted | Number | Percentage of participants | From Day 1 to Day 28 |
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| 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. | 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. | Posted | Number | Percentage of participants | From Day 1 to Day 28 |
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| 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. | 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. | Posted | Number | Percentage of participants | From Day 1 to Day 28 |
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| 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. | 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. | Posted | Median | 95% Confidence Interval | Days | From Day 1 (baseline) to Day 28 |
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| 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. | 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. | Posted | Median | 95% Confidence Interval | Days | From Day 1 (baseline) to Day 28 |
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| 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. | 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. | Posted | Median | 95% Confidence Interval | Days | From Day 1 (baseline) to Day 28 |
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| 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. | 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. | Posted | Median | 95% Confidence Interval | Days | From Day 1 (baseline) to Day 28 |
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| 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. | 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. | Posted | Median | 95% Confidence Interval | Days | From Day 1 (baseline) to Day 28 |
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| 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. | 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. | Posted | Median | 95% Confidence Interval | Days | From Day 1 (baseline) to Day 28 |
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| 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. | 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. | Posted | Median | 95% Confidence Interval | Days | From Day 1 (baseline) to Day 28 |
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| 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. | 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. | Posted | Median | 95% Confidence Interval | Days | From Day 1 (baseline) to Day 28 |
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| 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. | 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. | Posted | Median | 95% Confidence Interval | Days | From Day 1 (baseline) to Day 28 |
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| 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). | 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. | Posted | Count of Participants | Participants | From Day 1 (baseline) to Day 28 |
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| 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). | 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. | Posted | Count of Participants | Participants | From Day 1 (baseline) to Day 28 |
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| 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). | 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. | Posted | Count of Participants | Participants | From Day 1 (baseline) to Day 28 |
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| 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. | 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. | Posted | Number | Percentage of participants | Day 1, 5 |
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| 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. | 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. | Posted | Number | Percentage of participants | Day 1, 5 |
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| 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. | 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. | Posted | Number | Percentage of participants | Day 1, 5 |
|
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| 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. | 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. | Posted | Number | Percentage of participants | From Day 1 up to Week 24 |
|
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| 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. | 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. | Posted | Number | Percentage of participants | From Day 1 up to Week 24 |
|
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| 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. | mITT2 population included all participants who were randomized and took at least one dose of study intervention. | Posted | Number | Percentage of participants | From Day 1 up to Week 24 |
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| Secondary | Plasma Concentration Versus Time Summary of PF-07321332 | 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. | Posted | Mean | Standard Deviation | Nanograms per milliliter | 1 Hour post-dose on Day 1 and pre-dose on Day 5 |
|
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| 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). | 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. | Posted | Mean | Standard Deviation | Log10 copies per milliliter | Baseline, Day 3, 5, 10 and 14 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Log10 copies per milliliter | Baseline, Day 3, 5, 10 and 14 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Log10 copies per milliliter | Baseline, Day 3, 5, 10 and 14 |
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| 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. | 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. | Posted | Number | Visits | From Day 1 up to Day 34 |
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| 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. | 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. | Posted | Number | Visits | From Day 1 up to Day 34 |
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| 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. | mITT2 population included all participants who were randomized and took at least one dose of study intervention. | Posted | Number | Visits | From Day 1 up to Day 34 |
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| Secondary | Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT 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). | Posted | Mean | Standard Deviation | Days | From Day 1 up to Day 34 |
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| Secondary | Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 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). | Posted | Mean | Standard Deviation | Days | From Day 1 up to Day 34 |
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| Secondary | Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 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). | Posted | Mean | Standard Deviation | Days | From Day 1 up to Day 34 |
|
|
From start of study intervention at Day 1 up to end of long-term safety follow-up (Week 24)
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both serious and non-serious event during the study. SAS population included all participants who were randomized and took at least one dose of investigational product.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 1,038 | 19 | 1,038 | 234 | 1,038 |
| EG001 | 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. | 15 | 1,053 | 72 | 1,053 | 228 | 1,053 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Brain stem stroke | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Abortion threatened | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | Non-systematic Assessment |
| |
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Lymphadenopathy mediastinal | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hyperacusis | Ear and labyrinth disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Thyroiditis chronic | Endocrine disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Faeces soft | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Oedema due to cardiac disease | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hepatitis toxic | Hepatobiliary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Steatohepatitis | Hepatobiliary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Mycotic allergy | Immune system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hepatitis viral | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Mumps | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Oropharyngeal candidiasis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pyelonephritis chronic | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Respiratory tract infection bacterial | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Viral rhinitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Viral sepsis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Blood creatinine decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| C-reactive protein | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Coagulation time prolonged | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Creatinine renal clearance increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Differential white blood cell count abnormal | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Fibrin D dimer | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Glomerular filtration rate abnormal | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Haematocrit increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Haemoglobin increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Haptoglobin increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hepatic enzyme abnormal | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hepatitis C virus test positive | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| International normalised ratio abnormal | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Procalcitonin increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Red blood cell count increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Serum ferritin decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Serum ferritin increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Thyroxine free increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Thyroxine increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Impaired fasting glucose | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Lack of satiety | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Anosmia | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Parosmia | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vascular dementia | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Product after taste | Product Issues | MedDRA v24.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Stress | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Nephrosclerosis | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Intermenstrual bleeding | Reproductive system and breast disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Allergic cough | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Skin oedema | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Disease risk factor | Social circumstances | MedDRA v24.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hyperaemia | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vein collapse | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from the study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 28, 2022 | Nov 22, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718217 | nirmatrelvir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
| OG001 | 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. |
|
|
|
| OG001 | 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. |
|
|
|
| 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. |
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
| OG001 | 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. |
|
|
| OG001 | 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. |
|
|
| OG001 |
| 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. |
|
|
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.
|
|
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.
|
|
|
|
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. |
|
|
|
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.
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|