Trial · NCT04960202
EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19
NCT04960202, Phase 2, Phase 3, Completed, Pfizer; results first posted 2023-02-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19. Trials, record NCT04960202. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04960202
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19
- NCT number
- NCT04960202
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 2,091 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- COVID-19
- Interventions
- PF-07321332, Ritonavir, Placebo
- First posted
- 2021-07-13
- Last updated
- 2025-07-10
- Other registries' IDs
- eudract:2021-002895-38
- Results first posted
- 2023-02-09
Source ClinicalTrials.gov
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population | From Day 1 to Day 28 | Percentage of participants with COVID-19 related hospitalization or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier (KM) method. Using KM method, survival probability for each time interval was calculated as the number of participants surviving divided by the number of participants at risk. Participants who had the event, dropped out, or moved out were not counted as "at risk" i.e., participants who were lost were considered "censored" and were not counted in the denominator. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From start of study intervention (Day 1) up to end of safety follow-up (Day 34) | An adverse event (AE) was any untoward medical occurrence in a participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. Serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical events. AEs included both SAEs and all non-SAEs. An AE was considered as TEAE if the event started on or after start date of study intervention. |
| Secondary | Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs) | From start of study intervention (Day 1) up to end of safety follow-up (Day 34) | An AE was any untoward medical occurrence in a participant, temporarily associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical events. |
| Secondary | Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population | From Day 1 to Day 28 | Percentage of participants with COVID-19 related hospitalization or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier method. |
| Secondary | Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population | From Day 1 (baseline) to Day 28 | Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. |
| Secondary | Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population | From Day 1 (baseline) to Day 28 | Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. |
| Secondary | Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- Modified Intent-to-Treat 2 (mITT2) Population | From Day 1 (baseline) to Day 28 | Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. |
| Secondary | Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT Population | From Day 1 to Day 28 | Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported. |
| Secondary | Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 Population | From Day 1 to Day 28 | Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported. |
| Secondary | Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 Population | From Day 1 to Day 28 | Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported. |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 registered outcomesOutcomes38
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population | From Day 1 to Day 28 | 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. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From start of study intervention (Day 1) up to end of safety follow-up (Day 34) | Safety analysis set (SAS) included all participants who received at least one dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs) | From start of study intervention (Day 1) up to end of safety follow-up (Day 34) | SAS population included all participants who were randomized and took at least one dose of investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population | From Day 1 to Day 28 | 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. | Percentage of participants | NUMBER |
| SECONDARY | Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population | From Day 1 (baseline) to Day 28 | 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. | Days | MEDIAN |
| SECONDARY | Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population | From Day 1 (baseline) to Day 28 | 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. | Days | MEDIAN |
| SECONDARY | Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- Modified Intent-to-Treat 2 (mITT2) Population | From Day 1 (baseline) to Day 28 | 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. | Days | MEDIAN |
| SECONDARY | Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT Population | From Day 1 to Day 28 | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 Population | From Day 1 to Day 28 | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 Population | From Day 1 to Day 28 | 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. | Percentage of participants | NUMBER |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 outcomesResults by group234
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population | PF-07321332 300 mg + Ritonavir 100 mg | 0.752 | 95% Confidence Interval 0.313 to 1.796 | Percentage of participants | |
| Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population | Placebo | 6.888 | 95% Confidence Interval 5.172 to 9.146 | Percentage of participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | PF-07321332 300 mg + Ritonavir 100 mg | 228 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Placebo | 256 | Participants | ||
| Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs) | PF-07321332 300 mg + Ritonavir 100 mg | AEs leading to study discontinuation | 0 | Participants | |
| Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs) | Placebo | AEs leading to study discontinuation | 13 | Participants | |
| Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs) | PF-07321332 300 mg + Ritonavir 100 mg | SAEs | 18 | Participants | |
| Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs) | Placebo | SAEs | 71 | Participants | |
| Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population | PF-07321332 300 mg + Ritonavir 100 mg | 0.933 | 95% Confidence Interval 0.487 to 1.786 | Percentage of participants | |
| Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population | Placebo | 6.571 | 95% Confidence Interval 5.180 to 8.318 | Percentage of participants |
1 to 10 of 234Source ClinicalTrials.gov
See all 234 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PF-07321332 300 mg + Ritonavir 100 mg | 1,038 | |
| Overall Study | STARTED | Placebo | 1,053 | |
| Overall Study | COMPLETED | PF-07321332 300 mg + Ritonavir 100 mg | 976 | |
| Overall Study | COMPLETED | Placebo | 979 | |
| Overall Study | NOT COMPLETED | PF-07321332 300 mg + Ritonavir 100 mg | 62 | |
| Overall Study | NOT COMPLETED | Placebo | 74 |
Source ClinicalTrials.gov
Adverse events524
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | PF-07321332 300 mg + Ritonavir 100 mg | 1 | 1,038 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 2 | 1,053 | |
| other | Leukocytosis | Blood and lymphatic system disorders | PF-07321332 300 mg + Ritonavir 100 mg | 2 | 1,038 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo | 0 | 1,053 | |
| other | Leukopenia | Blood and lymphatic system disorders | PF-07321332 300 mg + Ritonavir 100 mg | 2 | 1,038 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo | 2 | 1,053 | |
| other | Lymphadenopathy mediastinal | Blood and lymphatic system disorders | PF-07321332 300 mg + Ritonavir 100 mg | 0 | 1,038 | |
| other | Lymphadenopathy mediastinal | Blood and lymphatic system disorders | Placebo | 1 | 1,053 | |
| other | Microcytic anaemia | Blood and lymphatic system disorders | PF-07321332 300 mg + Ritonavir 100 mg | 0 | 1,038 | |
| other | Microcytic anaemia | Blood and lymphatic system disorders | Placebo | 1 | 1,053 |
1 to 10 of 524Source ClinicalTrials.gov
See all 524 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-07321332 300 mg + Ritonavir 100 mg | 0 | 1,038 |
| Total, all-cause mortality | Placebo | 15 | 1,053 |
| Total, other adverse events | PF-07321332 300 mg + Ritonavir 100 mg | 234 | 1,038 |
| Total, other adverse events | Placebo | 228 | 1,053 |
| Total, serious adverse events | PF-07321332 300 mg + Ritonavir 100 mg | 19 | 1,038 |
| Total, serious adverse events | Placebo | 72 | 1,053 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PF-07321332 300 mg + Ritonavir 100 mg vs Placebo: Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT Population | Trial comparisons |
| PF-07321332 300 mg + Ritonavir 100 mg vs Placebo: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Trial comparisons |
| PF-07321332 300 mg + Ritonavir 100 mg vs Placebo: Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT2 Population | Trial comparisons |
| PF-07321332 300 mg + Ritonavir 100 mg vs Placebo: Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT1 Population | Trial comparisons |
| PF-07321332 300 mg + Ritonavir 100 mg vs Placebo: deaths from any cause | Trial comparisons |
| PF-07321332 300 mg + Ritonavir 100 mg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04960202
GET https://conductscience.org/api/trials/v1/NCT04960202/registered?page=2