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AzTrials

COVID-19Phase 2/3NCT05047601

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 study testing PF-07321332 and Ritonavir in people with COVID-19, run by Pfizer at 170 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
PF-07321332 and Ritonavir
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,954 participants
Where
170 sitesin 17 countries
Study dates
9 Sep 2021to 12 Apr 2022
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

170 sites in 17 countries.

170 sites in 17 countries

United States64 sites

  • PharmaTex Research, LLC

    Amarillo, Texas, 79109

  • Accellacare

    Ames, Iowa, 50010

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Synergy Healthcare

    Bradenton, Florida, 34208

  • MOORE Clinical Research, Inc.

    Brandon, Florida, 33511

  • TrueBlue Clinical Research

    Brandon, Florida, 33511

  • Research by Design, LLC

    Chicago, Illinois, 60643

  • Conroe Willis Medical Research

    Conroe, Texas, 77304

  • Herco Medical and Research Center Inc

    Coral Gables, Florida, 33134

  • South Texas Clinical Research

    Corpus Christi, Texas, 78413

  • Advance Clinical Research Group

    Cutler Bay, Florida, 33157

  • Beautiful Minds Clinical Research Center

    Cutler Bay, Florida, 33157

  • Ascada Health PC

    Fullerton, California, 92835

  • Meridian Clinical Research, LLC

    Grand Island, Nebraska, 68803

  • Qway Research

    Hialeah, Florida, 33010

  • Eastern Research Inc

    Hialeah, Florida, 33013

  • Inpatient Research Clinic

    Hialeah, Florida, 33013

  • Doral Medical Research,LLC

    Hialeah, Florida, 33016

  • Unlimited Medical Research Group, LLC

    Hialeah Gardens, Florida, 33018

  • SingnatureCare Emergency Center

    Houston, Texas, 77008

  • Trio Clinical Trials, LLC

    Houston, Texas, 77008

  • C & R Research Services USA

    Houston, Texas, 77022

  • Walmart

    Las Vegas, Nevada, 89108

  • Excel Clinical research

    Las Vegas, Nevada, 89109

  • Walgreens

    Las Vegas, Nevada, 89121

  • ASCLEPES Research Centers

    Lutz, Florida, 33549

  • SMS Clinical Research, LLC

    Mesquite, Texas, 75149

  • Southern Clinical Research Associates. LLC

    Metairie, Louisiana, 70001

  • Angels Clinical Research Institute

    Miami, Florida, 33122

  • LCC Medical Research Institute, LLC

    Miami, Florida, 33126

  • Premium Medical Research Corp

    Miami, Florida, 33126

  • Global Health Clinical Trials Corp

    Miami, Florida, 33135

  • South Florida Research Center, Inc.

    Miami, Florida, 33135

  • University of Miami Health System

    Miami, Florida, 33136

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

    Miami, Florida, 33144

  • Medical Research of Westchester Inc

    Miami, Florida, 33165

  • C'A Research

    Miami, Florida, 33174

  • ProLive Medical Research, Corp.

    Miami, Florida, 33175

  • Entrust Clinical Research

    Miami, Florida, 33176

  • Reed Medical Research

    Miami, Florida, 33176

  • Kendall South Medical Center, Inc.

    Miami, Florida, 33185

  • Clinical Site Partners, Inc dba CSP Miami

    Miami, Florida, 33186

  • Coral Research Clinic Corp

    Miami, Florida, 33186

  • Pro-Care Research Center, Corp.

    Miami Gardens, Florida, 33014

  • Savin Medical Group, LLC

    Miami Lakes, Florida, 33014

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112

  • NYC Health + Hospitals / Harlem

    New York, New York, 10037

  • Quality Clinical Research Inc

    Omaha, Nebraska, 68112

  • Quality Clinical Research

    Omaha, Nebraska, 68114

  • Omega Research Orlando

    Orlando, Florida, 32808

  • Cahaba Research Inc

    Pelham, Alabama, 35124

  • NAPA Research LLC

    Pompano Beach, Florida, 33064

  • CDC Research Institute, LLC

    Port Saint Lucie, Florida, 34952

  • Epic Medical Research

    Red Oak, Texas, 75154

  • Sun Research Institute

    San Antonio, Texas, 78215

  • Optimus Medical Group

    San Francisco, California, 94102

  • USPA Advance Concept Medical Research Group LLC

    South Miami, Florida, 33143

  • ASCLEPES Research Centers

    Spring Hill, Florida, 34609

  • GCP, Global Clinical Professionals

    St. Petersburg, Florida, 33705

  • Sunrise Research Institute

    Sunrise, Florida, 33325

  • Santos Research Center, CORP

    Tampa, Florida, 33615

  • The Institute for Liver Health dba Arizona Clinical Trials

    Tucson, Arizona, 85712

  • Tranquility Research

    Webster, Texas, 77598

  • Innovo Research: Wilmington Health

    Wilmington, North Carolina, 28401

Other trials in United States

South Africa18 sites

  • Worthwhile Clinical Trials

    Benoni, Gauteng, 1500

  • Madibeng Centre for Research

    Brits, North West, 0250

  • Synapta Clinical Research Center

    Durban, KwaZulu-Natal, 4001

  • Dr PJ Sebastian Clinical Research Centre

    Durban, KwaZulu-Natal, 4092

  • LCS Clinical Research

    Johannesburg, Gauteng, 1868

  • Peermed CTC (Pty) Ltd T/A MERC Kempton

    Kempton Park, Gauteng, 1619

  • Ahmed Al-Kadi Private Hospital

    Mayville, Durban, KwaZulu-Natal, 4091

  • MERC Middelburg

    Middelburg, Mpumalanga, 1055

  • Global Clinical Trials

    Pretoria, Gauteng, 0001

  • Botho Ke Bontle Health Services

    Pretoria, Gauteng, 0122

  • About Allergy (PTY) Ltd

    Pretoria, Gauteng, 0181

  • Into Research

    Pretoria, Gauteng, 0181

  • Clinical Trial Systems (Pty) Ltd

    Pretoria, Gauteng, 0186

  • Sandton Medical Clinic

    Sandton, Gauteng, 2196

  • Limpopo Clinical Research Initiative

    Thabazimbi, Limpopo, 0380

  • NHC Thohoyandou CRS

    Thohoyandou, Limpopo, 0950

  • FCRN Clinical Trial Centre

    Vereeniging, 1935

  • MERC Welkom

    Welkom, Free State, 9460

Other trials in South Africa

Bulgaria17 sites

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

    Haskovo, 6300

  • MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD

    Kozloduy, 3320

  • Diagnostic-Consultative Center I Lom EOOD

    Lom, 3600

  • Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD

    Lom, 3600

  • Medical centre Leo Clinic EOOD

    Lovech, 5500

  • MHAT Heart and Brain EAD

    Pleven, 5800

  • DCC Sveti Georgi EOOD

    Plovdiv, 4000

  • MHAT "St. Panteleimon "- Plovdiv

    Plovdiv, 4004

  • UMHAT Medica Ruse OOD

    Rousse, 7013

  • Multiprofile Hospital for Active Treatment - Samokov EOOD

    Samokov, 2000

  • Multiprofile hospital for active treatment - Sliven to Military Medical Academy

    Sliven, 8800

  • Diagnostic-Consultative Center XXII- Sofia ЕООD

    Sofia, 1113

  • UMHATEM N. I. Pirogov EAD

    Sofia, 1606

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

    Stara Zagora, 6000

  • Medical center Leo Clinic EOOD

    Varna, 9020

  • MOBAL "D-r Stefan Cherkezov" AD

    Veliko Tarnovo, 5002

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

    Vratsa, 3000

Other trials in Bulgaria

Russia16 sites

  • Barnaul City Hospital Number 5

    Barnaul, 656045

  • Kirovsk Interdistrict Hospital

    Kirovsk, Leningradskaya Oblast', 187342

  • Korolev Medicine

    Korolyov, 141070

  • KDC "Evromedservis", OJSC

    Moscow, 115419

  • LLC Trekhgorka Medicine

    Odintsovo, Moscow Oblast, 143005

  • Clinica UZI 4D

    Pyatigorsk, Stavropol Kray, 357502

  • City Polyclinic #44

    Saint Petersburg, 192071

  • City Polyclinic No. 109

    Saint Petersburg, 192298

  • LLC Strategic Medical Systems

    Saint Petersburg, 194291

  • City Out-patient clinic #112

    Saint Petersburg, 195427

  • "Research Center Eco-safety" LLC

    Saint Petersburg, 196143

  • LLC Kurator

    Saint Petersburg, 196240

  • Saint-Petersburg State Budgetary Healthcare Institution "City Pokrovskaya hospital"

    Saint Petersburg, 199106

  • City Out-patient clinic #4

    Saint Petersburg, 199406

  • Smolensk State Medical University

    Smolensk, 214019

  • LLC Family clinic

    Yekaterinburg, 620109

Other trials in Russia

Ukraine15 sites

  • Regional Communal Nonprofit Institution "Chernivtsi Regional Clinical Hospital"

    Chernivtsi, 58001

  • Communal non-commercial Enterprise "City Central Clinical Hospital" of Chernivtsi City Council

    Chernivtsi, 58002

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

    Dnipro, 49069

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

    Ivano-Frankivsk, 76018

  • Municipal Non-profit Enterprise "Ivano-Frankivsk Regional Phthisiopulmonology Center of

    Ivano-Frankivsk, 76018

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

    Kharkiv, 61002

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

    Kharkiv, 61096

  • Municipal Nonprofit Enterprise "City Clinic Hospital # 13" of Kharkiv City Council

    Kharkiv, 61124

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

    Kyiv, 04050

  • Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4"

    Lviv, 79005

  • Municipal NonProfit Enterprise of the Lviv Regional Council Lviv Regional Information and Analytical

    Lviv, 79008

  • Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4"

    Lviv, 79011

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

    Poltava, 36011

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

    Tarasove Village, 45625

  • Communal Enterprise "Hospital #1" of Zhytomyr City Council

    Zhytomyr, 10002

Other trials in Ukraine

Mexico9 sites

  • Instituto de Investigaciones Clinicas para la Salud A.C.

    Durango, 34000

  • Instituto Jalisciense de Metabolismo, S.C.

    Guadalajara, Jalisco, 44670

  • EME RED Hospitalaria

    Mérida, Yucatán, 97000

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

    Monterrey, Nuevo León, 64060

  • Eukarya Pharmasite S.C.

    Monterrey, Nuevo León, 64718

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

    Saltillo, Coahuila, 25020

  • InfectoLab Consultorios de Especialidad en Infectologia

    Tijuana, Estado de Baja California, 22010

  • FAICIC Clinical Research

    Veracruz, 91900

  • Sociedad de Metabolismo y Corazon S.C.

    Veracruz, 91900

Other trials in Mexico

Turkey (Türkiye)7 sites

  • Ankara University Medical Faculty, Ibni-Sina Hospital

    Ankara, 06230

  • Istanbul University Istanbul Medical Faculty

    Fatih / Istanbul, 34093

  • Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi

    Gaziantep, 27310

  • Acibadem University Atakent Hospital

    Istanbul, 34303

  • Izmir Suat Seren Chest Disease and Surgery Training and Research Hospital

    Izmir, 35110

  • Mersin University Medical Faculty

    Mersin, 33110

  • Karadeniz Teknik Universitesi Farabi Hastanesi

    Trabzon, 61080

Other trials in Turkey (Türkiye)

Japan5 sites

  • Rinku General Medical Center

    Izumisano, Osaka, 598-8577

  • Rakuwakai Otowa Hospital

    Kyoto, Kyoto, 607-8062

  • International University of Health and Welfare Narita Hospital

    Narita, Chiba, 286-8520

  • Denenchofu Family Clinic

    Ōta-ku, Tokyo, 145-0071

  • Sekino Hospital

    Toshimaku, Tokyo, 171-0014

Other trials in Japan

Thailand5 sites

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330

  • Faculty of Tropical Medicine, Mahidol University

    Bangkok, 10400

  • Tropical Medicine Hospital

    Bangkok, 10400

  • Faculty of Medicine - Khon Kaen University

    Muang, Changwat Khon Kaen, 40002

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

    Pathumwan, Bangkok, 10330

Other trials in Thailand

Colombia3 sites

  • Clinica de la Costa LTDA.

    Barranquilla, Atlántico, 080020

  • Cireem Sas

    Bogota, Cundinamarca, 110221

  • Caimed S.A.S.

    Yopal, Casanare Department, 850001

Other trials in Colombia

Czechia3 sites

  • Doktor Brno s.r.o.

    Brno, 602 00

  • Zdraví-Fit, s.r.o.

    Protivín, 398 11

  • Nemocnice Slany

    Slaný, 274 01

Other trials in Czechia

Argentina2 sites

  • Instituto Médico de la Fundación Estudios Clínicos (Fundación Estudios Clínicos)

    Rosario, Santa Fe Province, 2000

  • Instituto de Investigaciones Clinicas Zarate

    Zárate, Buenos Aires, B2800DGH

Other trials in Argentina

Brazil2 sites

  • Pesquisare Saude S/S Ltda

    Santo André, São Paulo, 09080-110

  • Conjunto Hospitalar do Mandaqui

    São Paulo, 02401-400

Other trials in Brazil

Hungary1 site

  • Medifarma-98 Kft.

    Nyíregyháza, 4400

Other trials in Hungary

Malaysia1 site

  • Hospital Miri

    Miri, Sarawak, 98000

Other trials in Malaysia

Poland1 site

  • Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska

    Wroclaw, 51-162

Other trials in Poland

Spain1 site

  • Complexo Hospitalario Universitario da Coruna

    A Coruña, 15006

Other trials in Spain

About this study

Official title: 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

Conditions
COVID-19
Being tested
PF-07321332, Placebo for PF-07321332, Placebo for Ritonavir, Ritonavir
Keywords
Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2)
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-07321332Drug

    PF-07321332

  • Placebo for PF-07321332Drug

    Placebo

  • Placebo for RitonavirDrug

    Placebo

  • RitonavirDrug

    Ritonavir

Study groups in NCT05047601
Study groupRoleWhat they receive
PF-07321332/ritonavir (5 days)ExperimentalParticipants 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
Receives: Drug: PF-07321332; Drug: Placebo for PF-07321332; Drug: Placebo for Ritonavir; Drug: Ritonavir
PF-07321332/ritonavir (10-Day)ExperimentalParticipants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 10.
Receives: Drug: PF-07321332; Drug: Ritonavir
PlaceboPlacebo comparatorParticipants will receive placebo every 12 hours from Day 1 through Day 10.
Receives: Drug: Placebo for PF-07321332; Drug: Placebo for Ritonavir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From Day 1 to Day 14

Secondary outcomes (15)

  1. 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.

    Measured: From start of study intervention (Day 1) up to end of safety follow-up (Day 38)

  2. 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.

    Measured: From Day 1 to Day 14

  3. 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.

    Measured: From Day 1 to Day 28

  4. 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.

    Measured: From Day 1 to Day 14

  5. 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.

    Measured: From Day 1 to Day 14

  6. 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.

    Measured: From Day 1 to Day 14

  7. 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.

    Measured: From Day 1 to Day 14

  8. 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.

    Measured: From Day 1 to Day 28

  9. 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.

    Measured: From Day 1 to Day 28

  10. Plasma Concentration Versus Time Summary of Nirmatrelvir (PF-07321332)

    Measured: Day 1: 1 hour post dose; Day 5: 2 hours pre-dose

  11. 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.

    Measured: From Day 1 to Day 38

  12. 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.

    Measured: From Day 1 to Day 14

  13. 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.

    Measured: From Day 1 to Day 14

  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.

    Measured: From Day 1 to Day 28

  15. 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.

    Measured: From Day 1 to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2021
  2. Study start9 Sep 2021
  3. Primary completion12 Apr 2022
  4. Study completion12 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible participants who are asymptomatic household contacts of an individual with symptomatic COVID-19 will be randomized (1:1:1) to receive orally every 12 hours: PF-07321332/ritonavir for 5 days followed by placebo for 5 days or PF-07321332/ritonavir for 10 days or Placebo for 10 days
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,954 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05047601
Sponsor's protocol ID
C4671006
Other IDs
2021-002894-24, EPIC-PEP
Status last verified
Apr 2023
First submitted
1 Sep 2021
Last updated
6 May 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Hammond J, Yunis C, Fountaine RJ, Luscan G, Burr AM, Zhang W, Wisemandle W, Soares H, Baniecki ML, Hendrick VM, Kalfov V, Pypstra R, Rusnak JM. Oral Nirmatrelvir-Ritonavir as Postexposure Prophylaxis for Covid-19. N Engl J Med. 2024 Jul 18;391(3):224-234. doi: 10.1056/NEJMoa2309002.

    PubMed 39018532

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing PF-07321332 and Ritonavir in people with COVID-19, run by Pfizer at 170 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 170 sites in United States, South Africa, Bulgaria, Russia, Ukraine and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: From Day 1 to Day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05047601, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.

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