Trial · NCT05011513
Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR).
NCT05011513, Phase 2, Phase 3, Terminated, Pfizer; results first posted 2023-08-14
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR). Trials, record NCT05011513. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05011513
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR).
- NCT number
- NCT05011513
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 1,440 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- COVID-19
- Interventions
- PF-07321332, Ritonavir, Placebo, Placebo
- First posted
- 2021-08-18
- Last updated
- 2023-08-14
- Other registries' IDs
- eudract:2021-002857-28
- Results first posted
- 2023-08-14
- Limitations and caveats
In participant flow, there was discontinuations due to AE, which was captured under Death as reason for discontinuation. Adverse event was COVID-19 pneumonia and the participant died due to that event and discontinued study.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Sustained Alleviation of Overall COVID-19 Signs and Symptoms Through Day 28 | From Day 1 to Day 28 | Sustained alleviation of 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. Missing severity at baseline was considered as mild. Time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28, was calculated as time (days) from start of study intervention or placebo (Day 1) until sustained alleviation of all targeted COVID-19 associated signs and symptoms. In this outcome measure time to sustained alleviation is reported consolidated for overall COVID-19 signs and symptoms. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | From start of study intervention (Day 1) up to Day 34 | An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening ; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity ; congenital anomaly/birth defect; or that was considered as an important medical event. TEAEs were defined as events that started on or after the study medication start date and time. AEs included both serious and all non-serious adverse events. AEs that led to study discontinuation and AEs that led to discontinuation of study intervention and then continued study were also reported in this outcome measure. |
| Secondary | Percentage of Participants With COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 | 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. |
| Secondary | Percentage of Participants With Death Through Week 24 | From Day 1 to Week 24 | Percentage of participants with death (all-cause) event were reported in this outcome measure. |
| Secondary | Number of COVID-19 Related Medical Visits Per Day Through Day 28 | From Day 1 to Day 28 | Number of COVID-19 related medical visits per day were reported in this outcome measure. |
| Secondary | Duration of Hospitalization and Intensive Care Unit (ICU) Stay Through Day 28 | From Day 1 to Day 28 | |
| Secondary | Percentage of Participants With Severe Signs and Symptoms of COVID-19 Through Day 28 | From Day 1 to Day 28 | Participants recorded a daily severity rating of their symptom severity over the past 24 hours based on a 4-point scale in which 0 was reported if no symptoms were present; 1 if mild; 2 if moderate; and 3 if severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Vomiting and diarrhea each was rated on a 4-point frequency scale where 0 was reported for no occurrence, 1 for 1 to 2 times, 2 for 3 to 4 times, and 3 for 5 or greater. Sense of smell and sense of taste each be rated on a 3-point Likert scale where 0 was reported if the sense of smell/taste was the same as usual, 1 if the sense of smell/taste was less than usual, and 2 for no sense of smell/taste. |
| Secondary | Time to Sustained Resolution of Overall COVID-19 Signs and Symptoms Through Day 28 | From Day 1 to Day 28 | Sustained resolution was defined as when targeted symptoms are scored as absent for 4 consecutive days. The first day of the 4 consecutive-day period was considered the first event date. |
| Secondary | Time to Sustained Alleviation of Each COVID-19 Signs and Symptoms Through Day 28 | From Day 1 to Day 28 | Sustained alleviation of 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. Missing severity at baseline was treated as mild. Time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28, was calculated as time (days) from start of study intervention or placebo (Day 1) until sustained alleviation of all targeted COVID-19 associated signs and symptoms. In this outcome measure time to sustained alleviation is reported for each COVID-19 signs and symptoms. |
| Secondary | Time to Sustained Resolution of Each COVID-19 Signs and Symptoms Through Day 28 | From Day 1 to Day 28 | Sustained resolution was defined as when targeted symptoms are scored as absent for 4 consecutive days. The first day of the 4 consecutive-day period was considered the first event date. In this outcome measure time to sustained resolution is reported consolidated for each COVID-19 signs and symptoms. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Sustained Alleviation of Overall COVID-19 Signs and Symptoms Through Day 28 | From Day 1 to Day 28 | Modified intent-to-treat (mITT1) population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. | Days | MEDIAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | From start of study intervention (Day 1) up to Day 34 | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received. A randomized but not treated participant was excluded from the safety analyses. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 | From Day 1 to Day 28 | Modified Intent-To-Treat (mITT1) population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Death Through Week 24 | From Day 1 to Week 24 | Modified Intent-To-Treat (mITT1) population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. | Percentage of participants | NUMBER |
| SECONDARY | Number of COVID-19 Related Medical Visits Per Day Through Day 28 | From Day 1 to Day 28 | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. | Medical visits per day | LEAST_SQUARES_MEAN |
| SECONDARY | Duration of Hospitalization and Intensive Care Unit (ICU) Stay Through Day 28 | From Day 1 to Day 28 | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. | Days | MEAN |
| SECONDARY | Percentage of Participants With Severe Signs and Symptoms of COVID-19 Through Day 28 | From Day 1 to Day 28 | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Time to Sustained Resolution of Overall COVID-19 Signs and Symptoms Through Day 28 | From Day 1 to Day 28 | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. In this outcome measure time to sustained resolution is reported consolidated for overall COVID-19 signs and symptoms. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Days | MEDIAN |
| SECONDARY | Time to Sustained Alleviation of Each COVID-19 Signs and Symptoms Through Day 28 | From Day 1 to Day 28 | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. Here, ''Number Analyzed'' signifies participants evaluable at specific rows. | Days | MEDIAN |
| SECONDARY | Time to Sustained Resolution of Each COVID-19 Signs and Symptoms Through Day 28 | From Day 1 to Day 28 | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. Here ''Overall Number of Participants Analyzed''=participants evaluable for this outcome measure and ''number analyzed''= participants evaluable at specified time points. | Days | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group86
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Sustained Alleviation of Overall COVID-19 Signs and Symptoms Through Day 28 | Nirmatrelvir 300 mg + Ritonavir 100 mg | 12.000 | 95% Confidence Interval 11.000 to 13.000 | Days | |
| Time to Sustained Alleviation of Overall COVID-19 Signs and Symptoms Through Day 28 | Placebo | 13.000 | 95% Confidence Interval 12.000 to 14.000 | Days | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | Nirmatrelvir 300 mg + Ritonavir 100 mg | TEAEs | 169 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | Placebo | TEAEs | 153 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | Nirmatrelvir 300 mg + Ritonavir 100 mg | SAEs | 8 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | Placebo | SAEs | 13 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | Nirmatrelvir 300 mg + Ritonavir 100 mg | AEs led to discontinuation of study | 0 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | Placebo | AEs led to discontinuation of study | 1 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | Nirmatrelvir 300 mg + Ritonavir 100 mg | AEs led to discontinue study intervention and continued study | 16 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | Placebo | AEs led to discontinue study intervention and continued study | 5 | Participants |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nirmatrelvir 300 Milligram (mg) + Ritonavir 100 mg | 658 | |
| Overall Study | STARTED | Placebo | 638 | |
| Overall Study | Treated | Nirmatrelvir 300 Milligram (mg) + Ritonavir 100 mg | 654 | |
| Overall Study | Treated | Placebo | 634 | |
| Overall Study | COMPLETED | Nirmatrelvir 300 Milligram (mg) + Ritonavir 100 mg | 632 | |
| Overall Study | COMPLETED | Placebo | 618 | |
| Overall Study | NOT COMPLETED | Nirmatrelvir 300 Milligram (mg) + Ritonavir 100 mg | 26 | |
| Overall Study | NOT COMPLETED | Placebo | 20 |
Source ClinicalTrials.gov
Adverse events46
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 | Diarrhoea | Gastrointestinal disorders | Nirmatrelvir 300 mg + Ritonavir 100 mg | 26 | 654 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 19 | 634 | |
| other | Dyspepsia | Gastrointestinal disorders | Nirmatrelvir 300 mg + Ritonavir 100 mg | 8 | 654 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 2 | 634 | |
| other | Nausea | Gastrointestinal disorders | Nirmatrelvir 300 mg + Ritonavir 100 mg | 21 | 654 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 17 | 634 | |
| other | Vomiting | Gastrointestinal disorders | Nirmatrelvir 300 mg + Ritonavir 100 mg | 11 | 654 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 11 | 634 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Nirmatrelvir 300 mg + Ritonavir 100 mg | 7 | 654 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Placebo | 12 | 634 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nirmatrelvir 300 mg + Ritonavir 100 mg | 0 | 654 |
| Total, all-cause mortality | Placebo | 1 | 634 |
| Total, other adverse events | Nirmatrelvir 300 mg + Ritonavir 100 mg | 120 | 654 |
| Total, other adverse events | Placebo | 71 | 634 |
| Total, serious adverse events | Nirmatrelvir 300 mg + Ritonavir 100 mg | 8 | 654 |
| Total, serious adverse events | Placebo | 13 | 634 |
Source ClinicalTrials.gov
Papers3
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nirmatrelvir 300 mg + Ritonavir 100 mg vs Placebo: deaths from any cause | Trial comparisons |
| Nirmatrelvir 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/NCT05011513
GET https://conductscience.org/api/trials/v1/NCT05011513/results?page=2