A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection

A PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF 2 REGIMENS OF ORALLY ADMINISTERED PF 07321332/RITONAVIR IN PREVENTING SYMPTOMATIC SARS-COV-2 INFECTION IN ADULT HOUSEHOLD CONTACTS OF AN INDIVIDUAL WITH SYMPTOMATIC COVID-19

The purpose of this clinical trial is to learn whether the study medicine prevent symptoms of COVID-19 in adults who have been exposed to household member(s) with a confirmed symptomatic COVID-19 infection.

All participants in the study will receive treatment for COVID-19 as needed, based on their regular doctor's recommendation. Two-thirds of participants will also receive two study medicines (PF-07321332 and ritonavir) by mouth twice a day for either five or ten days. We will compare the experiences of people receiving the study medicines to those of the people who do not. This will help us determine if the study medicines are safe and effective

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Ritonavir; Drug: PF-07321332; Drug: Placebo for PF-07321332; Drug: Placebo for Ritonavir

• Study Type: Interventional
• Enrollment (Actual): 2954
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Zarate, Buenos Aires, Argentina, B2800DGH
      • Instituto de Investigaciones Clinicas Zarate
  • Santa FE
    • Rosario, Santa FE, Argentina, 2000
      • Instituto Médico de la Fundación Estudios Clínicos (Fundación Estudios Clínicos)
• Brazil
  • São Paulo, Brazil, 02401-400
    • Conjunto Hospitalar do Mandaqui
  • SP
    • Santo André, SP, Brazil, 09080-110
      • Pesquisare Saude S/S LTDA
• Bulgaria
  • Haskovo, Bulgaria, 6300
    • "Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo" Ltd
  • Kozloduy, Bulgaria, 3320
    • MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD
  • Lom, Bulgaria, 3600
    • Diagnostic-Consultative Center I Lom EOOD
  • Lom, Bulgaria, 3600
    • Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD
  • Lovech, Bulgaria, 5500
    • Medical Centre Leo Clinic EOOD
  • Pleven, Bulgaria, 5800
    • MHAT Heart and Brain EAD
  • Plovdiv, Bulgaria, 4000
    • DCC Sveti Georgi EOOD
  • Plovdiv, Bulgaria, 4004
    • MHAT "St. Panteleimon "- Plovdiv
  • Ruse, Bulgaria, 7013
    • UMHAT Medica Ruse OOD
  • Samokov, Bulgaria, 2000
    • Multiprofile Hospital for Active Treatment - Samokov EOOD
  • Sliven, Bulgaria, 8800
    • Multiprofile hospital for active treatment - Sliven to Military Medical Academy
  • Sofia, Bulgaria, 1606
    • UMHATEM N. I. Pirogov EAD
  • Sofia, Bulgaria, 1113
    • Diagnostic-Consultative Center XXII- Sofia ЕООD
  • Stara Zagora, Bulgaria, 6000
    • Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD
  • Varna, Bulgaria, 9020
    • Medical Center Leo Clinic EOOD
  • Veliko Tarnovo, Bulgaria, 5002
    • MOBAL "D-r Stefan Cherkezov" AD
  • Vratsa, Bulgaria, 3000
    • Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD
• Colombia
  • Atlantico
    • Barranquilla, Atlantico, Colombia, 080020
      • Clínica de la Costa Ltda.
  • Casanare
    • Yopal, Casanare, Colombia, 850001
      • Caimed S.A.S.
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 110221
      • Cireem Sas
• Czechia
  • Brno, Czechia, 602 00
    • Doktor Brno s.r.o.
  • Protivín, Czechia, 398 11
    • Zdravi-fit, s.r.o.
  • Slany, Czechia, 274 01
    • Nemocnice Slany
• Hungary
  • Nyiregyhaza, Hungary, 4400
    • Medifarma-98 Kft.
• Japan
  • Chiba
    • Narita, Chiba, Japan, 286-8520
      • International University of Health and Welfare Narita Hospital
  • Kyoto
    • Kyoto-shi, Kyoto, Japan, 607-8062
      • Rakuwakai Otowa Hospital
  • Osaka
    • Izumisano, Osaka, Japan, 598-8577
      • Rinku General Medical Center
  • Tokyo
    • Ota, Tokyo, Japan, 145-0071
      • Denenchofu Family Clinic
    • Toshimaku, Tokyo, Japan, 171-0014
      • Sekino Hospital
• Malaysia
  • Sarawak
    • Miri, Sarawak, Malaysia, 98000
      • Hospital Miri
• Mexico
  • Durango, Mexico, 34000
    • Instituto de Investigaciones Clinicas para la Salud A.C.
  • Veracruz, Mexico, 91900
    • FAICIC Clínical Research
  • Veracruz, Mexico, 91900
    • Sociedad de Metabolismo y Corazón S.C.
  • BAJA California
    • Tijuana, BAJA California, Mexico, 22010
      • InfectoLab Consultorios de Especialidad en Infectologia
  • Coahuila
    • Saltillo, Coahuila, Mexico, 25020
      • Clinical Research Institute Saltillo S.A. de C.V.
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44670
      • Instituto Jalisciense de Metabolismo, S.C.
  • Nuevo LEON
    • Monterrey, Nuevo LEON, Mexico, 64718
      • Eukarya PharmaSite S.C.
  • Nuevo LEÓN
    • Monterrey, Nuevo LEÓN, Mexico, 64060
      • Christus- Latam Hub Center of Excellence and Innovation Center S.C.
  • Yucatán
    • Mérida, Yucatán, Mexico, 97000
      • EME RED Hospitalaria
• Poland
  • Wroclaw, Poland, 51-162
    • Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska
• Russian Federation
  • Barnaul, Russian Federation, 656045
    • Barnaul City Hospital Number 5
  • Korolev, Russian Federation, 141070
    • Korolev Medicine
  • Moscow, Russian Federation, 115419
    • KDC "Evromedservis", OJSC
  • Saint Petersburg, Russian Federation, 192071
    • City Polyclinic #44
  • Saint Petersburg, Russian Federation, 194291
    • LLC Strategic Medical Systems
  • Saint-Petersburg, Russian Federation, 192298
    • City Polyclinic No. 109
  • Saint-Petersburg, Russian Federation, 195427
    • City Out-patient clinic #112
  • Saint-Petersburg, Russian Federation, 196143
    • "Research Center Eco-safety" LLC
  • Saint-Petersburg, Russian Federation, 196240
    • LLC Kurator
  • Saint-Petersburg, Russian Federation, 199106
    • Saint-Petersburg State Budgetary Healthcare Institution "City Pokrovskaya hospital"
  • Saint-Petersburg, Russian Federation, 199406
    • City Out-patient clinic #4
  • Smolensk, Russian Federation, 214019
    • Smolensk State Medical University
  • Yekaterinburg, Russian Federation, 620109
    • LLC Family clinic
  • Leningrad Region
    • Kirovsk, Leningrad Region, Russian Federation, 187342
      • Kirovsk Interdistrict Hospital
  • Moscow Region
    • Odintsovo, Moscow Region, Russian Federation, 143005
      • LLC Trekhgorka Medicine
  • Stavropol Region
    • Pyatigorsk, Stavropol Region, Russian Federation, 357502
      • Clinica UZI 4D
• South Africa
  • Vereeniging, South Africa, 1935
    • FCRN Clinical Trial Centre
  • FREE State
    • Welkom, FREE State, South Africa, 9460
      • MERC Welkom
  • Gauteng
    • Benoni, Gauteng, South Africa, 1500
      • Worthwhile Clinical Trials
    • Johannesburg, Gauteng, South Africa, 1868
      • LCS Clinical Research
    • Kempton Park, Gauteng, South Africa, 1619
      • Peermed CTC (Pty) Ltd T/A MERC Kempton
    • Pretoria, Gauteng, South Africa, 0186
      • Clinical Trial Systems (Pty) Ltd
    • Pretoria, Gauteng, South Africa, 0181
      • Into Research
    • Pretoria, Gauteng, South Africa, 0122
      • Botho Ke Bontle Health Services
    • Pretoria, Gauteng, South Africa, 0001
      • Global Clinical Trials
    • Pretoria, Gauteng, South Africa, 0181
      • About Allergy (PTY) Ltd
    • Sandton, Gauteng, South Africa, 2196
      • Sandton Medical Clinic
  • Kwa-zulu Natal
    • Durban, Kwa-zulu Natal, South Africa, 4092
      • Dr PJ Sebastian Clinical Research Centre
  • Kwazulu Natal
    • Durban, Kwazulu Natal, South Africa, 4001
      • Synapta Clinical Research Center
  • Kwazulu-natal
    • Mayville, Durban, Kwazulu-natal, South Africa, 4091
      • Ahmed Al-Kadi Private Hospital
  • Limpopo
    • Thabazimbi, Limpopo, South Africa, 0380
      • Limpopo Clinical Research Initiative
    • Thohoyandou, Limpopo, South Africa, 0950
      • NHC Thohoyandou CRS
  • Mpumalanga
    • Middelburg, Mpumalanga, South Africa, 1055
      • MERC Middelburg
  • North WEST
    • Brits, North WEST, South Africa, 0250
      • Madibeng Centre for Research
• Spain
  • A Coruña, Spain, 15006
    • Complexo Hospitalario Universitario da Coruna
• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital
  • Bangkok, Thailand, 10400
    • Faculty of Tropical Medicine, Mahidol University
  • Bangkok, Thailand, 10400
    • Tropical Medicine Hospital
  • Bangkok
    • Pathumwan, Bangkok, Thailand, 10330
      • The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),
  • Khon Kaen
    • Muang, Khon Kaen, Thailand, 40002
      • Faculty of Medicine - Khon Kaen University
• Turkey
  • Ankara, Turkey, 06230
    • Ankara University Medical Faculty, Ibni-Sina Hospital
  • Fatih / Istanbul, Turkey, 34093
    • Istanbul University Istanbul Medical Faculty
  • Gaziantep, Turkey, 27310
    • Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi
  • Istanbul, Turkey, 34303
    • Acibadem University Atakent Hospital
  • Izmir, Turkey, 35110
    • Izmir Suat Seren Chest Disease and Surgery Training and Research Hospital
  • Mersin, Turkey, 33110
    • Mersin University Medical Faculty
  • Trabzon, Turkey, 61080
    • Karadeniz Teknik Universitesi Farabi Hastanesi
• Ukraine
  • Chernivtsi, Ukraine, 58001
    • Regional Communal Nonprofit Institution "Chernivtsi Regional Clinical Hospital"
  • Chernivtsi, Ukraine, 58002
    • Communal non-commercial Enterprise "City Central Clinical Hospital" of Chernivtsi City Council
  • Dnipro, Ukraine, 49069
    • Communal non-profit enterprise "City Clinical Hospital #16" of Dnipro City Council
  • Ivano-Frankivsk, Ukraine, 76018
    • Municipal Non-profit Enterprise "Ivano-Frankivsk Regional Phthisiopulmonology Center of
  • Ivano-Frankivsk, Ukraine, 76018
    • Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council"
  • Kharkiv, Ukraine, 61096
    • Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases
  • Kharkiv, Ukraine, 61002
    • Municipal Nonprofit Enterprise "City Student Hospital" of Kharkiv City Council
  • Kharkiv, Ukraine, 61124
    • Municipal Nonprofit Enterprise "City Clinic Hospital # 13" of Kharkiv City Council
  • Kyiv, Ukraine, 04050
    • Polyclinic of Center for Medical Services and Rehabilitation of State Joint-Stock Holding Company
  • Lviv, Ukraine, 79011
    • Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4"
  • Lviv, Ukraine, 79005
    • Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4"
  • Lviv, Ukraine, 79008
    • Municipal NonProfit Enterprise of the Lviv Regional Council Lviv Regional Information and Analytical
  • Poltava, Ukraine, 36011
    • Municipal Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional
  • Tarasove Village, Ukraine, 45625
    • Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council
  • Zhytomyr, Ukraine, 10002
    • Communal Enterprise "Hospital #1" of Zhytomyr City Council
• United States
  • Alabama
    • Pelham, Alabama, United States, 35124
      • Cahaba Research Inc
  • Arizona
    • Tucson, Arizona, United States, 85712
      • The Institute for Liver Health dba Arizona Clinical Trials
  • California
    • Fullerton, California, United States, 92835
      • Ascada Health PC
    • San Francisco, California, United States, 94102
      • Optimus Medical Group
  • Florida
    • Bradenton, Florida, United States, 34208
      • Synergy Healthcare
    • Brandon, Florida, United States, 33511
      • MOORE Clinical Research, Inc.
    • Brandon, Florida, United States, 33511
      • TrueBlue Clinical Research
    • Coral Gables, Florida, United States, 33134
      • Herco Medical and Research Center Inc
    • Cutler Bay, Florida, United States, 33157
      • Advance Clinical Research Group
    • Cutler Bay, Florida, United States, 33157
      • Beautiful Minds Clinical Research Center
    • Hialeah, Florida, United States, 33010
      • Qway Research
    • Hialeah, Florida, United States, 33013
      • Eastern Research Inc
    • Hialeah, Florida, United States, 33013
      • Inpatient Research Clinic
    • Hialeah, Florida, United States, 33016
      • Doral Medical Research,LLC
    • Hialeah Gardens, Florida, United States, 33018
      • Unlimited Medical Research Group, LLC
    • Lutz, Florida, United States, 33549
      • ASCLEPES Research Centers
    • Miami, Florida, United States, 33136
      • University of Miami Health System
    • Miami, Florida, United States, 33126
      • LCC Medical Research Institute, LLC
    • Miami, Florida, United States, 33122
      • Angels Clinical Research Institute
    • Miami, Florida, United States, 33126
      • Premium Medical Research Corp
    • Miami, Florida, United States, 33135
      • Global Health Clinical Trials Corp
    • Miami, Florida, United States, 33135
      • South Florida Research Center, Inc.
    • Miami, Florida, United States, 33144
      • I.V.A.M. Clinical & Investigational Center, LLC
    • Miami, Florida, United States, 33174
      • C'A Research
    • Miami, Florida, United States, 33175
      • ProLive Medical Research, Corp.
    • Miami, Florida, United States, 33176
      • Entrust Clinical Research
    • Miami, Florida, United States, 33176
      • Reed Medical Research
    • Miami, Florida, United States, 33185
      • Kendall South Medical Center, Inc.
    • Miami, Florida, United States, 33186
      • Coral Research Clinic Corp
    • Miami, Florida, United States, 33186
      • Clinical Site Partners, Inc dba CSP Miami
    • Miami, Florida, United States, 33165
      • Medical Research of Westchester Inc
    • Miami Gardens, Florida, United States, 33014
      • Pro-Care Research Center, Corp.
    • Miami Lakes, Florida, United States, 33014
      • Savin Medical Group, LLC
    • Orlando, Florida, United States, 32808
      • Omega Research Orlando
    • Pompano Beach, Florida, United States, 33064
      • NAPA Research LLC
    • Port Saint Lucie, Florida, United States, 34952
      • CDC Research Institute, LLC
    • Saint Petersburg, Florida, United States, 33705
      • GCP, Global Clinical Professionals
    • South Miami, Florida, United States, 33143
      • USPA Advance Concept Medical Research Group LLC
    • Spring Hill, Florida, United States, 34609
      • ASCLEPES Research Centers
    • Sunrise, Florida, United States, 33325
      • Sunrise Research Institute
    • Tampa, Florida, United States, 33615
      • Santos Research Center, CORP
  • Illinois
    • Chicago, Illinois, United States, 60643
      • Research by Design, LLC
  • Iowa
    • Ames, Iowa, United States, 50010
      • McFarland Clinic, PC
    • Ames, Iowa, United States, 50010
      • Accellacare
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • Southern Clinical Research Associates. LLC
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Meridian Clinical Research, LLC
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research
    • Omaha, Nebraska, United States, 68112
      • Quality Clinical Research Inc
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Excel Clinical Research
    • Las Vegas, Nevada, United States, 89108
      • Walmart
    • Las Vegas, Nevada, United States, 89121
      • Walgreens
  • New York
    • New York, New York, United States, 10037
      • NYC Health + Hospitals / Harlem
  • North Carolina
    • Monroe, North Carolina, United States, 28112
      • Monroe Biomedical Research
    • Wilmington, North Carolina, United States, 28401
      • Innovo Research: Wilmington Health
  • Texas
    • Amarillo, Texas, United States, 79109
      • PharmaTex Research, LLC
    • Conroe, Texas, United States, 77304
      • Conroe Willis Medical Research
    • Corpus Christi, Texas, United States, 78413
      • South Texas Clinical Research
    • Houston, Texas, United States, 77008
      • Trio Clinical Trials, LLC
    • Houston, Texas, United States, 77022
      • C & R Research Services USA
    • Houston, Texas, United States, 77008
      • SingnatureCare Emergency Center
    • Mesquite, Texas, United States, 75149
      • SMS Clinical Research, LLC
    • Red Oak, Texas, United States, 75154
      • Epic Medical Research
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute
    • Webster, Texas, United States, 77598
      • Tranquility Research

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Participants who have a negative screening SARS-CoV-2 rapid antigen test result and who are asymptomatic household contacts with exposure within 96 hours to an individual who is symptomatic and recently tested positive for SARS CoV-2.
• Fertile participants must agree to use a highly effective method of contraception

Exclusion Criteria:

• History of SARS-CoV-2 infection in the past 6 months
• Experiencing measured fever (documented temperature >38˚C or 100.4˚F) or other signs or symptoms consistent with COVID-19
• Known medical history of active liver disease
• Chronic Kidney Disease or have known moderate to severe renal impairment.
• Known Human Immunodeficiency Virus (HIV) infection with viral load > 400 copies/ml within the last 6 months or taking prohibited medications for HIV treatment
• Suspected or confirmed concurrent active systemic infection
• Active cancer requiring treatment with prohibited medication.
• Current or expected use of any medications or substances that are highly dependent on Cytochrome P450 3A4 (CYP3A4) for clearance or are strong inducers of CYP3A4
• Has received approved, authorized, or investigational anti-SARS-CoV-2 mAb, convalescent plasma, other drugs for treatment of COVID-19, or other anti-SARS-CoV-2 biologic products within 6 months of screening
• Has received any SARS-CoV-2 vaccine within 6 months prior to screening or is expected to receive a SARS-CoV-2 vaccine or other approved, authorized, or investigational postexposure prophylaxis treatments through Day 38.
• Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19
• Known or prior participation in this trial or another trial involving PF-07321332.
• Females who are pregnant or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-07321332/ritonavir (5 days); Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 5 followed by Placebo every 12 hours from Day 6 through Day 10	Drug: Ritonavir; Ritonavir; Drug: PF-07321332; PF-07321332; Drug: Placebo for PF-07321332; Placebo; Drug: Placebo for Ritonavir; Placebo
Experimental: PF-07321332/ritonavir (10-Day); Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 10.	Drug: Ritonavir; Ritonavir; Drug: PF-07321332; PF-07321332
Placebo Comparator: Placebo; Participants will receive placebo every 12 hours from Day 1 through Day 10.	Drug: Placebo for PF-07321332; Placebo; Drug: Placebo for Ritonavir; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline	Percentage of participants who developed symptomatic Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) or Rapid Antigen Test (RAT) confirmed SARS-Cov-2 infection were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.	From Day 1 to Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation	An AE was defined as any untoward medical occurrence in a 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.	From start of study intervention (Day 1) up to end of safety follow-up (Day 38)
Percentage of Participants Who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline With Increased Risk of Severe COVID-19 Illness	Percentage of participants who had a symptomatic RT-PCR or RAT confirmed SARS-Cov-2 infection were reported in this outcome measure. The risk factors associated with severe covid-19 illness included age greater than or equal to 60 years, body mass index greater than 25, social history of smoking and presence of comorbidities. Index case was defined as participants with symptomatic COVID-19.	From Day 1 to Day 14
Percentage of Participants With COVID-19 Related Hospitalization or Death From Any Cause Through Day 28: Among Participants With Negative RT-PCR at Baseline With Increased Risk of Severe COVID-19 Illness	The risk factors associated with severe covid-19 illness included age greater than or equal to 60 years, body mass index greater than 25, social history of smoking and presence of comorbidities.	From Day 1 to Day 28
Percentage of Participants With Asymptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline	Percentage of participants who had asymptomatic RT-PCR or RAT confirmed SARS-CoV-2 infection through day 14 among participants with negative RT-PCR at baseline were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.	From Day 1 to Day 14
Time to RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline	Number of days between first dose and confirmation of the SARS-CoV-2 infection by RT-PCR or RAT was reported in this outcome measure.	From Day 1 to Day 14
Percentage of Participants With Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Positive RT-PCR at Baseline	Percentage of participants with a positive RT-PCR result at baseline who had a symptomatic SARS-CoV-2 infection confirmed by RAT or RT-PCR through Day 14 were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.	From Day 1 to Day 14
Percentage of Participants With Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative, Positive or Missing RT-PCR at Baseline	Percentage of participants with a negative, positive, or missing RT-PCR result at baseline, who had a symptomatic SARS-CoV-2 infection confirmed by RAT or RT-PCR through Day 14 were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.	From Day 1 to Day 14
Percentage of Participants With no, Mild, Moderate, or Severe Signs and Symptoms Attributed to COVID-19 Through Day 28: Among Participants With Negative RT-PCR at Baseline	Participants were categorized according to severity of signs and symptoms as no, mild, moderate, severe in this outcome measure. The 12 signs and symptoms included stuffy or runny nose, sore throat, shortness of breath or difficulty breathing, cough, low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea. Participants recorded their daily severity rating of their symptoms 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.	From Day 1 to Day 28
Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline	This outcome measure has been reported in terms of number of participants according to days of symptomatic SARS-CoV-2 infection through Day 28.	From Day 1 to Day 28
Plasma Concentration Versus Time Summary of Nirmatrelvir (PF-07321332)		Day 1: 1 hour post dose; Day 5: 2 hours pre-dose
Percentage of Participants With Death Event Through Day 38: Among Participants With Negative RT-PCR at Baseline	Percentage of participants with death (all-cause) event were reported in this outcome measure.	From Day 1 to Day 38
Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline	Nasal samples were collected to estimate the viral load in terms of logarithm to base 10 (log10) copies per milliliter in participants with negative RT-PCR at baseline and were reported in this outcome measure.	From Day 1 to Day 14
Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline	Nasal samples were collected to estimate the viral load in terms of logarithm to base 10 (log10) copies per milliliter in participants with positive RT-PCR at baseline and were reported in this outcome measure.	From Day 1 to Day 14
Number of Days of Hospitalization and Intensive Care Unit (ICU) Stay: Among Participants With Negative RT-PCR at Baseline	This outcome measure has been presented in terms of participants according to number of days of hospitalization and in ICU as 0 days and more than or equal to 1 day.	From Day 1 to Day 28
Number of COVID-19 Related Medical Visits Through Day 28: Among Participants With Negative RT-PCR at Baseline	In this outcome measure number of COVID-19 related medical visits per day were reported. Number of medical visits per day = number of medical visits/number of days follow up through day 28 visit or the last collection date on or before day 28, if day 28 visit was missing.	From Day 1 to Day 28

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2021
• Primary Completion (Actual): April 12, 2022
• Study Completion (Actual): April 12, 2022

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: September 15, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2)
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir
• Other Study ID Numbers: C4671006; 2021-002894-24 (EudraCT Number); EPIC-PEP (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No