Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR).
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05011513 |
Recruitment Status :
Terminated
(Enrollment ceased due to a very low rate of hospitalization or death observed in the standard-risk patient population)
First Posted : August 18, 2021
Results First Posted : August 14, 2023
Last Update Posted : August 14, 2023
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
COVID-19 |
Interventions |
Drug: PF-07321332 Drug: Ritonavir Drug: Placebo |
Enrollment | 1440 |
Participant Flow
Recruitment Details | Participants who had confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined by reverse transcription polymerase chain reaction (RT-PCR) within 5 days prior to randomization were included in the study. |
Pre-assignment Details | A total of 1440 participants signed informed consent form. Out of which, 1296 subjects were randomized and assigned to study drug. 1288 participants were treated and remaining 8 participants were not treated. |
Arm/Group Title | Nirmatrelvir 300 Milligram (mg) + Ritonavir 100 mg | Placebo |
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Arm/Group Description | Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5 | Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 doses from Day 1 through Day 5. |
Period Title: Overall Study | ||
Started | 658 | 638 |
Treated | 654 | 634 |
Completed | 632 | 618 |
Not Completed | 26 | 20 |
Reason Not Completed | ||
Death | 0 | 1 |
Lost to Follow-up | 4 | 0 |
Withdrawal by Subject | 18 | 17 |
Other | 4 | 2 |
Baseline Characteristics
Arm/Group Title | Nirmatrelvir 300 mg + Ritonavir 100 mg | Placebo | Total | |
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Arm/Group Description | Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5. | Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 doses from Day 1 through Day 5. | Total of all reporting groups | |
Overall Number of Baseline Participants | 654 | 634 | 1288 | |
Baseline Analysis Population Description |
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.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 654 participants | 634 participants | 1288 participants | |
41.76 (13.47) | 42.63 (13.13) | 42.18 (13.31) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 654 participants | 634 participants | 1288 participants | |
Female |
344 52.6%
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352 55.5%
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696 54.0%
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Male |
310 47.4%
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282 44.5%
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592 46.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 654 participants | 634 participants | 1288 participants | |
Hispanic or Latino |
272 41.6%
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261 41.2%
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533 41.4%
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Not Hispanic or Latino |
378 57.8%
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367 57.9%
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745 57.8%
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Unknown or Not Reported |
4 0.6%
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6 0.9%
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10 0.8%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 654 participants | 634 participants | 1288 participants | |
American Indian or Alaska Native |
39 6.0%
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32 5.0%
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71 5.5%
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Asian |
69 10.6%
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72 11.4%
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141 10.9%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
28 4.3%
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23 3.6%
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51 4.0%
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White |
512 78.3%
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498 78.5%
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1010 78.4%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
6 0.9%
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9 1.4%
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15 1.2%
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Outcome Measures
Adverse Events
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.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
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 study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: | Pfizer ClinicalTrials.gov Call Center |
Organization: | Pfizer Inc. |
Phone: | 1-800-718-1021 |
EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT05011513 |
Other Study ID Numbers: |
C4671002 2021-002857-28 ( EudraCT Number ) EPIC-SR ( Other Identifier: Alias Study Number ) |
First Submitted: | July 30, 2021 |
First Posted: | August 18, 2021 |
Results First Submitted: | July 20, 2023 |
Results First Posted: | August 14, 2023 |
Last Update Posted: | August 14, 2023 |