EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19

• ClinicalTrials.gov Identifier: NCT04960202
• Recruitment Status: Completed
• First Posted: July 13, 2021
• Results First Posted: February 9, 2023
• Last Update Posted: February 9, 2023
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
COVID-19	Drug: PF-07321332; Drug: Ritonavir; Drug: Placebo	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2246 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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).
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2/3, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332/RITONAVIR COMPARED WITH PLACEBO IN NONHOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19 WHO ARE AT INCREASED RISK OF PROGRESSING TO SEVERE ILLNESS
• Actual Study Start Date: July 16, 2021
• Actual Primary Completion Date: December 9, 2021
• Actual Study Completion Date: April 25, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: PF-07321332/ritonavir; Orally administered PF-07321332+ritonavir	Drug: PF-07321332; PF-07321332 (tablet); Drug: Ritonavir; Ritonavir (capsule)
Placebo Comparator: Placebo; Orally administered placebo	Drug: Placebo; Placebo (tablet or capsule)

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population [ Time Frame: 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 Outcome Measures :

1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 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.
2. Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs) [ Time Frame: 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.
3. Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population [ Time Frame: 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.
4. Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population [ Time Frame: 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.
5. Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population [ Time Frame: 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.
6. Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- Modified Intent-to-Treat 2 (mITT2) Population [ Time Frame: 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.
7. Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT Population [ Time Frame: 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.
8. Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 Population [ Time Frame: 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.
9. Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 Population [ Time Frame: 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.
10. Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
    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.
11. Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
    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.
12. Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
    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.
13. Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
    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.
14. Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
    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.
15. Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
    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.
16. Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
    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.
17. Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
    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.
18. Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
    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.
19. Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT Population [ Time Frame: From Day 1 (baseline) 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 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).
20. Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT1 Population [ Time Frame: From Day 1 (baseline) 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 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).
21. Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT2 Population [ Time Frame: From Day 1 (baseline) 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 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).
22. Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT Population [ Time Frame: Day 1, 5 ]
    In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation >=95% were reported.
23. Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 Population [ Time Frame: Day 1, 5 ]
    In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation >=95% were reported.
24. Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 Population [ Time Frame: Day 1, 5 ]
    In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation >=95% were reported.
25. Percentage of Participants Who Died Through Week 24- mITT Population [ Time Frame: From Day 1 up to Week 24 ]
    In this outcome measure, percentage of participants with death due to any cause was presented.
26. Percentage of Participants Who Died Through Week 24- mITT1 Population [ Time Frame: From Day 1 up to Week 24 ]
    In this outcome measure, percentage of participants with death due to any cause was presented.
27. Percentage of Participants Who Died Through Week 24- mITT2 Population [ Time Frame: From Day 1 up to Week 24 ]
    In this outcome measure, percentage of participants with death due to any cause was presented.
28. Plasma Concentration Versus Time Summary of PF-07321332 [ Time Frame: 1 Hour post-dose on Day 1 and pre-dose on Day 5 ]
29. Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population [ Time Frame: Baseline, Day 3, 5, 10 and 14 ]
    The viral load was measured in nasal or nasopharyngeal samples using reverse transcription polymerase chain reaction (RT-PCR).
30. Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population [ Time Frame: Baseline, Day 3, 5, 10 and 14 ]
    The viral load was measured in nasal or nasopharyngeal samples using RT-PCR.
31. Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population [ Time Frame: Baseline, Day 3, 5, 10 and 14 ]
    The viral load was measured in nasal or nasopharyngeal samples using RT-PCR.
32. Number of COVID-19 Related Medical Visits- mITT Population [ Time Frame: From Day 1 up to Day 34 ]
    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.
33. Number of COVID-19 Related Medical Visits- mITT1 Population [ Time Frame: From Day 1 up to Day 34 ]
    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.
34. Number of COVID-19 Related Medical Visits- mITT2 Population [ Time Frame: From Day 1 up to Day 34 ]
    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.
35. Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population [ Time Frame: From Day 1 up to Day 34 ]
36. Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population [ Time Frame: From Day 1 up to Day 34 ]
37. Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population [ Time Frame: From Day 1 up to Day 34 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Confirmed SARS-CoV-2 infection within 5 days prior to randomization
• Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of randomization and at least 1 of the specified COVID-19 signs/symptoms present on the day of randomization
• Fertile participants must agree to use a highly effective method of contraception
• Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19

Exclusion Criteria:

• History of or need for hospitalization for the medical treatment of COVID-19
• Prior to current disease episode, any confirmed SARS-CoV-2 infection
• Known medical history of active liver disease
• Receiving dialysis or have known moderate to severe renal impairment
• Known human immunodeficiency virus (HIV) infection with a viral load greater than 400 copies/mL or taking prohibited medications for HIV treatment
• Suspected or confirmed concurrent active systemic infection other than COVID-19
• History of hypersensitivity or other contraindication to any of the components of the study intervention
• Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance or are strong inducers of CYP3A4
• Has received or is expected to receive convalescent COVID-19 plasma
• Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day 34 visit
• Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 through the long-term follow-up visit
• Known prior participation in this trial or other trial involving PF-07321332
• Oxygen saturation of <92% on room air, or on their standard home oxygen supplementation for those who regularly receive chronic supplementary oxygen for an underlying lung condition
• Females who are pregnant or breastfeeding

Contacts and Locations

Locations

United States, Alabama

Cahaba Research Inc

Pelham, Alabama, United States, 35124

United States, Arizona

The Institute for Liver Health dba Arizona Clinical Trials

Mesa, Arizona, United States, 85210

The Institute for Liver Health dba Arizona Clinical Trials

Tucson, Arizona, United States, 85712

United States, California

Hope Clinical Research

Canoga Park, California, United States, 91303

Ascada Research

Fullerton, California, United States, 92835

Atella Clinical Research LLC.

La Palma, California, United States, 90623

Ark Clinical Research

Long Beach, California, United States, 90806

American Institute of Research

Los Angeles, California, United States, 90017

South Bay Clinical Research Institute

Redondo Beach, California, United States, 90277

Hope Clinical Research (COVID Satellite Site)

West Hills, California, United States, 91304

United States, Colorado

Future Innovative Treatments, LLC

Colorado Springs, Colorado, United States, 80907

United States, Florida

Xera Med Research

Boca Raton, Florida, United States, 33487

MOORE Clinical Research, Inc.

Brandon, Florida, United States, 33511

Innovative Research of West Florida, Inc.

Clearwater, Florida, United States, 33756

Herco Medical and Research Center Inc

Coral Gables, Florida, United States, 33134

Advance Clinical Research Group

Cutler Bay, Florida, United States, 33157

Beautiful Minds Clinical Research Center

Cutler Bay, Florida, United States, 33157

Unlimited Medical Research Group, LLC

Hialeah Gardens, Florida, United States, 33018

Qway Research

Hialeah, Florida, United States, 33010

Eastern Research Inc

Hialeah, Florida, United States, 33013

Inpatient Research Clinic

Hialeah, Florida, United States, 33013

Doral Medical Research LLC.

Hialeah, Florida, United States, 33016

Doral Medical Research,LLC

Hialeah, Florida, United States, 33016

Advanced Pulmonary Research Institute

Loxahatchee Groves, Florida, United States, 33470

Savin Medical Group, LLC

Miami Lakes, Florida, United States, 33014

Angels Clinical Research Institute

Miami, Florida, United States, 33122

LCC Medical Research Institute, LLC

Miami, Florida, United States, 33126

Premium Medical Research Corp

Miami, Florida, United States, 33126

Global Health Clinical Trials Corp

Miami, Florida, United States, 33135

South Florida Research Center, Inc.

Miami, Florida, United States, 33135

Suncoast Research Group, LLC

Miami, Florida, United States, 33135

I.V.A.M. Clinical & Investigational Center, LLC

Miami, Florida, United States, 33144

C'A Research

Miami, Florida, United States, 33174

ProLive Medical Research, Corp.

Miami, Florida, United States, 33175

Entrust Clinical Research

Miami, Florida, United States, 33176

Reed Medical Research

Miami, Florida, United States, 33176

Kendall South Medical Center

Miami, Florida, United States, 33185

Clinical Site Partners, Inc d/b/a CSP Miami

Miami, Florida, United States, 33186

Coral Research Clinic Corp

Miami, Florida, United States, 33186

Omega Research Orlando, LLC

Orlando, Florida, United States, 32808

NAPA Research LLC

Pompano Beach, Florida, United States, 33064

CDC Research Institute

Port Saint Lucie, Florida, United States, 34952

GCP, Global Clinical Professionals

Saint Petersburg, Florida, United States, 33705

USPA Advance Concept Medical Research Group LLC

South Miami, Florida, United States, 33143

Sunrise Research Institute

Sunrise, Florida, United States, 33325

Santos Research Center, CORP

Tampa, Florida, United States, 33615

Clinical Site Partners, Inc. dba CSP Orlando

Winter Park, Florida, United States, 32789

United States, Illinois

Research by Design, LLC

Chicago, Illinois, United States, 60643

United States, Louisiana

New Orleans Sinus Center (COVID-19 Testing)

Marrero, Louisiana, United States, 70072

Tandem Clinical Research GI, LLC

Marrero, Louisiana, United States, 70072

United States, Montana

Mercury Street Medical Group, PLLC

Butte, Montana, United States, 59701

United States, Nevada

Excel Clinical Research

Las Vegas, Nevada, United States, 89109

United States, New York

Meridian Clinical Research, LLC

Endwell, New York, United States, 13760

United States, North Carolina

Monroe Biomedical Research

Monroe, North Carolina, United States, 28112

Accellacare

Wilmington, North Carolina, United States, 28401

United States, Tennessee

Premier Medical Group

Clarksville, Tennessee, United States, 37040

United States, Texas

PharmaTex Research, LLC

Amarillo, Texas, United States, 79109

ARC Clinical Research at William Cannon

Austin, Texas, United States, 78745

St Hope Foundation

Bellaire, Texas, United States, 77401

Conroe Willis Medical Research

Conroe, Texas, United States, 77304

South Texas Clinical Research

Corpus Christi, Texas, United States, 78413

SignatureCare Emergency Center

Houston, Texas, United States, 77008

Trio Clinical Trials, LLC

Houston, Texas, United States, 77008

C & R Research Services USA

Houston, Texas, United States, 77022

Next Level Urgent Care

Houston, Texas, United States, 77057

SMS Clinical Research, LLC

Mesquite, Texas, United States, 75149

SMS Clinical Research

Mesquite, Texas, United States, 75149

LinQ Research, LLC

Pearland, Texas, United States, 77584

Epic Medical Research

Red Oak, Texas, United States, 75154

Sun Research Institute

San Antonio, Texas, United States, 78215

BFHC Research

San Antonio, Texas, United States, 78249

Tranquility Research

Webster, Texas, United States, 77598

United States, Virginia

TPMG (Tidewater Physicians Multispecialty Group) Clinical Research

Newport News, Virginia, United States, 23606

Argentina

Instituto de Investigaciones Clinicas Zarate

Zarate, Buenos Aires, Argentina, B2800DGH

Hospital De Clínicas Presidente Dr.Nicolas Avellaneda

San Miguel de Tucuman, Tucuman, Argentina, 4000

Brazil

Chronos Pesquisa Clinica

Brasilia, Distrito Federal, Brazil, 72145-450

Hospital Agamenon Magalhaes

Recife, Pernambuco, Brazil, 52051-380

CECIP JAÚ - Centro de Estudos Clínicos do Interior Paulista - LTDA

Jau, SAO Paulo, Brazil, 17201-130

Bulgaria

Individual Practice for Primary Medical Care - IPPMC - Dr. P. Panayotov EOOD

Burgas, Bulgaria, 8001

"Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo" Ltd

Haskovo, Bulgaria, 6300

MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD

Kozloduy, Bulgaria, 3320

Diagnostic-Consultative Center I Lom EOOD

Lom, Bulgaria, 3600

Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD

Lom, Bulgaria, 3600

Medical centre Leo Clinic EOOD

Lovech, Bulgaria, 5500

MHAT Heart and Brain EAD

Pleven, Bulgaria, 5800

DCC Sveti Georgi EOOD

Plovdiv, Bulgaria, 4000

MHAT "St. Panteleimon "- Plovdiv

Plovdiv, Bulgaria, 4004

Multiprofile Hospital for Active Treatment Sveti Ivan Rilski - Razgrad AD

Razgrad, Bulgaria, 7200

"Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -

Ruse, Bulgaria, 7002

UMHAT Medica Ruse OOD

Ruse, Bulgaria, 7013

Multiprofile Hospital for Active Treatment - Samokov EOOD

Samokov, Bulgaria, 2000

Medical Center-1-Sevlievo EOOD

Sevlievo, Bulgaria, 5400

Multiprofile Hospital For Active Treatment Shumen AD

Shumen, Bulgaria, 9700

Multiprofile hospital for active treatment - Sliven to Military Medical Academy

Sliven, Bulgaria, 8800

MHAT "Dr. Ivan Seliminski" AD, Sliven

Sliven, Bulgaria, 8801

Diagnostic-Consultative Center XXII- Sofia ЕООD

Sofia, Bulgaria, 1113

MHAT "St. Sofia" EOOD

Sofia, Bulgaria, 1618

Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD

Stara Zagora, Bulgaria, 6000

Multiprofile Hospital for Active Treatment Targovishte AD

Targovishte, Bulgaria, 7700

Outpatient Clinic for Primary Outpatient Medical Care "Puls" - Dr. Mladen Buchvarov EOOD

Tsarevo, Bulgaria, 8260

Medical center Leo Clinic EOOD

Varna, Bulgaria, 9020

Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD

Vratsa, Bulgaria, 3000

Colombia

Fundacion Cardiomet Cequin

Armenia, Quindio, Colombia, 630004

Czechia

Zdraví-Fit, s.r.o.

Protivín, Czechia, 398 11

Nemocnice Slany

Slany, Czechia, 274 01

Hungary

Trial Pharma Kft.

Bekescsaba, Hungary, 5600

Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika

Debrecen, Hungary, 4031

Agria-Study Kft.

Eger, Hungary, 3300

Trial Pharma Kft.

Gyula, Hungary, 5700

Medifarma-98 Kft.

Nyiregyhaza, Hungary, 4400

India

AIIMS Raipur

Raipur, Chhattisgarh, India, 492099

Jupiter Hospital

Vadodara, Gujarat, India, 390012

BGS Global Institute of Medical Sciences and Hospital

Bangalore, Karnataka, India, 560060

Lisie Hospital

Kochi, Kerala, India, 682018

Jehangir Clinical Development Centre Pvt. Ltd

Pune, Maharashtra, India, 411001

Lifepoint Research LLP

Pune, Maharashtra, India, 411057

Jawahar Lal Nehru Medical College

Ajmer, Rajasthan, India, 305001

Apex Hospitals Pvt Ltd

Jaipur, Rajasthan, India, 302017

Maharaja Agrasen Superspeciality Hospital

Jaipur, Rajasthan, India, 302039

Nil Ratan Sircar Medical College and Hospital

Kolkata, WEST Bengal, India, 700014

Aakash Healthcare Private Limited

New Delhi, India, 110075

Sardar Patel Medical College

Pavan PURI Bikaner, Rajasthan, India, 334003

Japan

International University of Health and Welfare Narita Hospital

Narita, Chiba, Japan, 286-8520

National Hokkaido Medical Center

Sapporo, Hokkaido, Japan, 063-0005

Rinku General Medical Center

Izumisano, Osaka, Japan, 598-8577

Tokyo Medical University Hachioji Medical Center

Hachioji, Tokyo, Japan, 1930998

National Center for Global Health and Medicine

Shinjuku City, Tokyo, Japan, 162-8655

Korea, Republic of

Kyungpook National University Chilgok Hospital

Daegu, Korea, Republic of, 41404

Incheon Medical Center

Incheon, Korea, Republic of, 22532

Chonnam National University Bitgoeul Hospital

Nam-gu, Korea, Republic of, 61748

SMG-SNU Boramae Medical Center

Seoul, Korea, Republic of, 07061

Malaysia

Hospital Umum Sarawak

Kuching, Sarawak, Malaysia, 93586

Hospital Miri

Miri, Sarawak, Malaysia, 98000

Mexico

Clinical Research Institute Saltillo S.A. de C.V.

Saltillo, Coahuila, Mexico, 25020

Asociacion Mexicana para la Investigacion Clinica A.C. (AMIC)

Pachuca de Soto, Hidalgo, Mexico, 42070

Instituto Jalisciense de Metabolismo, S.C.

Guadalajara, Jalisco, Mexico, 44670

JM Research SC

Cuernavaca, Morelos, Mexico, 62290

Christus - Latam Hub Center of Excellence and Innovation Center S.C.

Monterrey, Nuevo LEON, Mexico, 64060

Eukarya Pharmasite S.C.

Monterrey, Nuevo LEON, Mexico, 64718

Oaxaca Site Management Organization

Oaxaca de Juarez, Oaxaca, Mexico, 68000

InfectoLab Consultorios de Especialidad en Infectologia

Baja California, Tijuana, Mexico, 22010

Kohler & Milstein Research S.A. de C.V.

Merida, Yucatan, Mexico, 97070

EME RED Hospitalaria

Mérida, Yucatán, Mexico, 97000

Centro de Investigacion Clinica Del Pacifico SA de CV

Acapulco, Mexico

Hospital Cardiologica Aguascalientes

Aguascalientes, Mexico, CP 201230

Instituto de Investigaciones Clínicas para la Salud

Durango, Mexico, 34000

FAICIC S. de R.L. de C.V.

Veracruz, Mexico, 91900

Sociedad de Metabolismo y Corazon S.C.

Veracruz, Mexico, 91900

Arké SMO S.A de C.V

Veracruz, Mexico, 91910

Poland

KLIMED Marek Klimkiewicz

Bialystok, Poland, 15-704

Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska

Wroclaw, Poland, 51-162

Puerto Rico

Clinical Research Management Group Inc

Ponce, Puerto Rico, 00780

Advance Medical Research Center

San Juan, Puerto Rico, 00926

Russian Federation

LLC Trekhgorka Medicine

Odintsovo, Moscow Region, Russian Federation, 143005

Barnaul City Hospital Number 5

Barnaul, Russian Federation, 656045

KDC "Evromedservis", OJSC

Moscow, Russian Federation, 115419

Smolensk State Medical University

Smolensk, Russian Federation, 214019

South Africa

MERC Welkom

Welkom, FREE State, South Africa, 9460

East Rand Research Centre T/A Worthwhile Clinical Trials

Benoni, Gauteng, South Africa, 1500

Botho Ke Bontle Health Services

Pretoria, Gauteng, South Africa, 0122

Synapta Clinical Research Center

Durban, Kwazulu Natal, South Africa, 4001

Limpopo Clinical Research Initiative

Thabazimbi, Limpopo, South Africa, 0380

MERC Middelburg

Middelburg, Mpumalanga, South Africa, 1055

Spain

Eba Centelles

Centelles, Barcelona [barcelona], Spain, 08540

Complexo Hospitalario Universitario da Coruna

A Coruña, Spain, 15006

Thailand

Bangkok Centre Hotel

Bangrak, Bangkok, Thailand, 10500

Chula Field Hospital, Chulalongkorn University Sport center (Chantanayingyong Gymnasium)

Pathum Wan District,, Bangkok, Thailand, 10330

Thai Red Cross Emerging Infectious Diseases (EDI) Clinic

Pathumwan,, Bangkok, Thailand, 10330

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),

Pathumwan, Bangkok, Thailand, 10330

Faculty of Medicine - Khon Kaen University

Muang, Khon Kaen, Thailand, 40002

Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University,

Hat Yai, Songkhla, Thailand, 90110

Turkey

Ankara University Medical Faculty, Ibni-Sina Hospital

Ankara, Turkey, 06230

Hacettepe University Medical Faculty Hospital

Ankara, Turkey, 06230

Akdeniz Universitesi Hastanesi

Antalya, Turkey, 07059

Istanbul Medipol University Clinical Research Ethics Committee

Beykoz / Istanbul, Turkey, 34810

Gaziantep University Medical Faculty

Gaziantep, Turkey, 27300

Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi

Istanbul, Turkey, 34020

Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty

Istanbul, Turkey, 34098

Acibadem Saglik Hizmetleri ve Tic.A.S, Acibadem Atakent Hastanesi

Istanbul, Turkey, 34303

Istanbul Universitesi Klinik Arastirmalar Mukemmeliyet Uygulama ve Arastirma Merkezi

Istanbul, Turkey, 34452

Basaksehir Cam ve Sakura Sehir Hastanesi

Istanbul, Turkey, 34480

Kocaeli University Medical Faculty

Kocaeli, Turkey, 41380

Sbü Dr. Suat Seren Göğüs Hastaliklari Ve Cerrahisi Eğitim Ve Araştirma Hastanesi

Konak/Izmir, Turkey, 35170

Mersin University Health Research and Application Hospital

Mersin, Turkey, 33110

Sakarya University Training and Research Hospital

Sakarya, Turkey, 54100

Karadeniz Teknik Universitesi Farabi Hastanesi

Trabzon, Turkey, 61080

Ukraine

Communal non-profit enterprise "City Clinical Hospital #16" of Dnipro City Council

Dnipro, Ukraine, 49069

Municipal Nonprofit Enterprise "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital of

Ivano-Frankivsk, Ukraine, 76007

Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council"

Ivano-Frankivsk, Ukraine, 76018

Municipal Nonprofit Enterprise "City Student Hospital" of Kharkiv City Council

Kharkiv, Ukraine, 61002

Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases

Kharkiv, Ukraine, 61096

"Municipal Non-Profit Enterprise "Alexander Clinical Hospital of Kyiv" of the Kyiv City Council

Kyiv, Ukraine, 01601

Municipal non-commercial enterprise "Kyiv City Clinical Hospital #1" Of Executive Body Of the Kyiv

Kyiv, Ukraine, 02091

Kyiv Railway Clinical Hospital No.2 of Branch "Health Center of the Public Joint Stock Company

Kyiv, Ukraine, 03049

Polyclinic of Center for Medical Services and Rehabilitation of State Joint-Stock Holding Company

Kyiv, Ukraine, 04050

Municipal NonProfit Enterprise of the Lviv Regional Council Lviv Regional Information and Analitical

Lviv, Ukraine, 79008

Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4"

Lviv, Ukraine, 79011

Municipal Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional

Poltava, Ukraine, 36011

Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council

Tarasove Village, Ukraine, 45625

Municipal Non-commercial Enterprise "Vinnytsia City Clinical Hospital №1"

Vinnytsia, Ukraine, 21029

Communal Enterprise "Hospital #1" of Zhytomyr City Council

Zhytomyr, Ukraine, 10002

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

  Study Documents (Full-Text)

Documents provided by Pfizer:

Study Protocol  [PDF] November 20, 2021

Statistical Analysis Plan  [PDF] April 28, 2022

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04960202
• Other Study ID Numbers: C4671005; 2021-002895-38 ( EudraCT Number ); EPIC-HR ( Other Identifier: Alias Study Number )
• First Posted: July 13, 2021
• Results First Posted: February 9, 2023
• Last Update Posted: February 9, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:

severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

Additional relevant MeSH terms:

Ritonavir; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Nirmatrelvir; HIV Protease Inhibitors; Viral Protease Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors