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
3 other identifiers
interventional
2,954
17 countries
170
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 covid19
Started Sep 2021
170 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2021
CompletedStudy Start
First participant enrolled
September 9, 2021
CompletedFirst Posted
Study publicly available on registry
September 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2022
CompletedResults Posted
Study results publicly available
May 6, 2023
CompletedMay 6, 2023
April 1, 2023
7 months
September 1, 2021
April 11, 2023
April 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
From Day 1 to Day 14
Secondary Outcomes (15)
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation
From start of study intervention (Day 1) up to 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
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
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
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
From Day 1 to Day 14
- +10 more secondary outcomes
Study Arms (3)
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
PF-07321332/ritonavir (10-Day)
EXPERIMENTALParticipants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 10.
Placebo
PLACEBO COMPARATORParticipants will receive placebo every 12 hours from Day 1 through Day 10.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (170)
Cahaba Research Inc
Pelham, Alabama, 35124, United States
The Institute for Liver Health dba Arizona Clinical Trials
Tucson, Arizona, 85712, United States
Ascada Health PC
Fullerton, California, 92835, United States
Optimus Medical Group
San Francisco, California, 94102, United States
Synergy Healthcare
Bradenton, Florida, 34208, United States
MOORE Clinical Research, Inc.
Brandon, Florida, 33511, United States
TrueBlue Clinical Research
Brandon, Florida, 33511, United States
Herco Medical and Research Center Inc
Coral Gables, Florida, 33134, United States
Advance Clinical Research Group
Cutler Bay, Florida, 33157, United States
Beautiful Minds Clinical Research Center
Cutler Bay, Florida, 33157, United States
Qway Research
Hialeah, Florida, 33010, United States
Eastern Research Inc
Hialeah, Florida, 33013, United States
Inpatient Research Clinic
Hialeah, Florida, 33013, United States
Doral Medical Research,LLC
Hialeah, Florida, 33016, United States
Unlimited Medical Research Group, LLC
Hialeah Gardens, Florida, 33018, United States
ASCLEPES Research Centers
Lutz, Florida, 33549, United States
Angels Clinical Research Institute
Miami, Florida, 33122, United States
LCC Medical Research Institute, LLC
Miami, Florida, 33126, United States
Premium Medical Research Corp
Miami, Florida, 33126, United States
Global Health Clinical Trials Corp
Miami, Florida, 33135, United States
South Florida Research Center, Inc.
Miami, Florida, 33135, United States
University of Miami Health System
Miami, Florida, 33136, United States
I.V.A.M. Clinical & Investigational Center, LLC
Miami, Florida, 33144, United States
Medical Research of Westchester Inc
Miami, Florida, 33165, United States
C'A Research
Miami, Florida, 33174, United States
ProLive Medical Research, Corp.
Miami, Florida, 33175, United States
Entrust Clinical Research
Miami, Florida, 33176, United States
Reed Medical Research
Miami, Florida, 33176, United States
Kendall South Medical Center, Inc.
Miami, Florida, 33185, United States
Clinical Site Partners, Inc dba CSP Miami
Miami, Florida, 33186, United States
Coral Research Clinic Corp
Miami, Florida, 33186, United States
Pro-Care Research Center, Corp.
Miami Gardens, Florida, 33014, United States
Savin Medical Group, LLC
Miami Lakes, Florida, 33014, United States
Omega Research Orlando
Orlando, Florida, 32808, United States
NAPA Research LLC
Pompano Beach, Florida, 33064, United States
CDC Research Institute, LLC
Port Saint Lucie, Florida, 34952, United States
USPA Advance Concept Medical Research Group LLC
South Miami, Florida, 33143, United States
ASCLEPES Research Centers
Spring Hill, Florida, 34609, United States
GCP, Global Clinical Professionals
St. Petersburg, Florida, 33705, United States
Sunrise Research Institute
Sunrise, Florida, 33325, United States
Santos Research Center, CORP
Tampa, Florida, 33615, United States
Research by Design, LLC
Chicago, Illinois, 60643, United States
Accellacare
Ames, Iowa, 50010, United States
McFarland Clinic, PC
Ames, Iowa, 50010, United States
Southern Clinical Research Associates. LLC
Metairie, Louisiana, 70001, United States
Meridian Clinical Research, LLC
Grand Island, Nebraska, 68803, United States
Quality Clinical Research Inc
Omaha, Nebraska, 68112, United States
Quality Clinical Research
Omaha, Nebraska, 68114, United States
Walmart
Las Vegas, Nevada, 89108, United States
Excel Clinical research
Las Vegas, Nevada, 89109, United States
Walgreens
Las Vegas, Nevada, 89121, United States
NYC Health + Hospitals / Harlem
New York, New York, 10037, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
Innovo Research: Wilmington Health
Wilmington, North Carolina, 28401, United States
PharmaTex Research, LLC
Amarillo, Texas, 79109, United States
Conroe Willis Medical Research
Conroe, Texas, 77304, United States
South Texas Clinical Research
Corpus Christi, Texas, 78413, United States
SingnatureCare Emergency Center
Houston, Texas, 77008, United States
Trio Clinical Trials, LLC
Houston, Texas, 77008, United States
C & R Research Services USA
Houston, Texas, 77022, United States
SMS Clinical Research, LLC
Mesquite, Texas, 75149, United States
Epic Medical Research
Red Oak, Texas, 75154, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
Tranquility Research
Webster, Texas, 77598, United States
Instituto de Investigaciones Clinicas Zarate
Zárate, Buenos Aires, B2800DGH, Argentina
Instituto Médico de la Fundación Estudios Clínicos (Fundación Estudios Clínicos)
Rosario, Santa Fe Province, 2000, Argentina
Pesquisare Saude S/S Ltda
Santo André, São Paulo, 09080-110, Brazil
Conjunto Hospitalar do Mandaqui
São Paulo, 02401-400, Brazil
"Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo" Ltd
Haskovo, 6300, Bulgaria
MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD
Kozloduy, 3320, Bulgaria
Diagnostic-Consultative Center I Lom EOOD
Lom, 3600, Bulgaria
Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD
Lom, 3600, Bulgaria
Medical centre Leo Clinic EOOD
Lovech, 5500, Bulgaria
MHAT Heart and Brain EAD
Pleven, 5800, Bulgaria
DCC Sveti Georgi EOOD
Plovdiv, 4000, Bulgaria
MHAT "St. Panteleimon "- Plovdiv
Plovdiv, 4004, Bulgaria
UMHAT Medica Ruse OOD
Rousse, 7013, Bulgaria
Multiprofile Hospital for Active Treatment - Samokov EOOD
Samokov, 2000, Bulgaria
Multiprofile hospital for active treatment - Sliven to Military Medical Academy
Sliven, 8800, Bulgaria
Diagnostic-Consultative Center XXII- Sofia ЕООD
Sofia, 1113, Bulgaria
UMHATEM N. I. Pirogov EAD
Sofia, 1606, Bulgaria
Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD
Stara Zagora, 6000, Bulgaria
Medical center Leo Clinic EOOD
Varna, 9020, Bulgaria
MOBAL "D-r Stefan Cherkezov" AD
Veliko Tarnovo, 5002, Bulgaria
Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD
Vratsa, 3000, Bulgaria
Clinica de la Costa LTDA.
Barranquilla, Atlántico, 080020, Colombia
Caimed S.A.S.
Yopal, Casanare Department, 850001, Colombia
Cireem Sas
Bogota, Cundinamarca, 110221, Colombia
Doktor Brno s.r.o.
Brno, 602 00, Czechia
Zdraví-Fit, s.r.o.
Protivín, 398 11, Czechia
Nemocnice Slany
Slaný, 274 01, Czechia
Medifarma-98 Kft.
Nyíregyháza, 4400, Hungary
International University of Health and Welfare Narita Hospital
Narita, Chiba, 286-8520, Japan
Rakuwakai Otowa Hospital
Kyoto, Kyoto, 607-8062, Japan
Rinku General Medical Center
Izumisano, Osaka, 598-8577, Japan
Denenchofu Family Clinic
Ōta-ku, Tokyo, 145-0071, Japan
Sekino Hospital
Toshimaku, Tokyo, 171-0014, Japan
Hospital Miri
Miri, Sarawak, 98000, Malaysia
Clinical Research Institute Saltillo S.A. de C.V.
Saltillo, Coahuila, 25020, Mexico
InfectoLab Consultorios de Especialidad en Infectologia
Tijuana, Estado de Baja California, 22010, Mexico
Instituto Jalisciense de Metabolismo, S.C.
Guadalajara, Jalisco, 44670, Mexico
Christus- Latam Hub Center of Excellence and Innovation Center S.C.
Monterrey, Nuevo León, 64060, Mexico
Eukarya Pharmasite S.C.
Monterrey, Nuevo León, 64718, Mexico
EME RED Hospitalaria
Mérida, Yucatán, 97000, Mexico
Instituto de Investigaciones Clinicas para la Salud A.C.
Durango, 34000, Mexico
FAICIC Clinical Research
Veracruz, 91900, Mexico
Sociedad de Metabolismo y Corazon S.C.
Veracruz, 91900, Mexico
Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska
Wroclaw, 51-162, Poland
Kirovsk Interdistrict Hospital
Kirovsk, Leningradskaya Oblast', 187342, Russia
LLC Trekhgorka Medicine
Odintsovo, Moscow Oblast, 143005, Russia
Clinica UZI 4D
Pyatigorsk, Stavropol Kray, 357502, Russia
Barnaul City Hospital Number 5
Barnaul, 656045, Russia
Korolev Medicine
Korolyov, 141070, Russia
KDC "Evromedservis", OJSC
Moscow, 115419, Russia
City Polyclinic #44
Saint Petersburg, 192071, Russia
City Polyclinic No. 109
Saint Petersburg, 192298, Russia
LLC Strategic Medical Systems
Saint Petersburg, 194291, Russia
City Out-patient clinic #112
Saint Petersburg, 195427, Russia
"Research Center Eco-safety" LLC
Saint Petersburg, 196143, Russia
LLC Kurator
Saint Petersburg, 196240, Russia
Saint-Petersburg State Budgetary Healthcare Institution "City Pokrovskaya hospital"
Saint Petersburg, 199106, Russia
City Out-patient clinic #4
Saint Petersburg, 199406, Russia
Smolensk State Medical University
Smolensk, 214019, Russia
LLC Family clinic
Yekaterinburg, 620109, Russia
MERC Welkom
Welkom, Free State, 9460, South Africa
Worthwhile Clinical Trials
Benoni, Gauteng, 1500, South Africa
LCS Clinical Research
Johannesburg, Gauteng, 1868, South Africa
Peermed CTC (Pty) Ltd T/A MERC Kempton
Kempton Park, Gauteng, 1619, South Africa
Global Clinical Trials
Pretoria, Gauteng, 0001, South Africa
Botho Ke Bontle Health Services
Pretoria, Gauteng, 0122, South Africa
About Allergy (PTY) Ltd
Pretoria, Gauteng, 0181, South Africa
Into Research
Pretoria, Gauteng, 0181, South Africa
Clinical Trial Systems (Pty) Ltd
Pretoria, Gauteng, 0186, South Africa
Sandton Medical Clinic
Sandton, Gauteng, 2196, South Africa
Synapta Clinical Research Center
Durban, KwaZulu-Natal, 4001, South Africa
Dr PJ Sebastian Clinical Research Centre
Durban, KwaZulu-Natal, 4092, South Africa
Ahmed Al-Kadi Private Hospital
Mayville, Durban, KwaZulu-Natal, 4091, South Africa
Limpopo Clinical Research Initiative
Thabazimbi, Limpopo, 0380, South Africa
NHC Thohoyandou CRS
Thohoyandou, Limpopo, 0950, South Africa
MERC Middelburg
Middelburg, Mpumalanga, 1055, South Africa
Madibeng Centre for Research
Brits, North West, 0250, South Africa
FCRN Clinical Trial Centre
Vereeniging, 1935, South Africa
Complexo Hospitalario Universitario da Coruna
A Coruña, 15006, Spain
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),
Pathumwan, Bangkok, 10330, Thailand
Faculty of Medicine - Khon Kaen University
Muang, Changwat Khon Kaen, 40002, Thailand
King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
Faculty of Tropical Medicine, Mahidol University
Bangkok, 10400, Thailand
Tropical Medicine Hospital
Bangkok, 10400, Thailand
Ankara University Medical Faculty, Ibni-Sina Hospital
Ankara, 06230, Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty
Fatih / Istanbul, 34093, Turkey (Türkiye)
Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi
Gaziantep, 27310, Turkey (Türkiye)
Acibadem University Atakent Hospital
Istanbul, 34303, Turkey (Türkiye)
Izmir Suat Seren Chest Disease and Surgery Training and Research Hospital
Izmir, 35110, Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, 33110, Turkey (Türkiye)
Karadeniz Teknik Universitesi Farabi Hastanesi
Trabzon, 61080, Turkey (Türkiye)
Regional Communal Nonprofit Institution "Chernivtsi Regional Clinical Hospital"
Chernivtsi, 58001, Ukraine
Communal non-commercial Enterprise "City Central Clinical Hospital" of Chernivtsi City Council
Chernivtsi, 58002, Ukraine
Communal non-profit enterprise "City Clinical Hospital #16" of Dnipro City Council
Dnipro, 49069, Ukraine
Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council"
Ivano-Frankivsk, 76018, Ukraine
Municipal Non-profit Enterprise "Ivano-Frankivsk Regional Phthisiopulmonology Center of
Ivano-Frankivsk, 76018, Ukraine
Municipal Nonprofit Enterprise "City Student Hospital" of Kharkiv City Council
Kharkiv, 61002, Ukraine
Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases
Kharkiv, 61096, Ukraine
Municipal Nonprofit Enterprise "City Clinic Hospital # 13" of Kharkiv City Council
Kharkiv, 61124, Ukraine
Polyclinic of Center for Medical Services and Rehabilitation of State Joint-Stock Holding Company
Kyiv, 04050, Ukraine
Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4"
Lviv, 79005, Ukraine
Municipal NonProfit Enterprise of the Lviv Regional Council Lviv Regional Information and Analytical
Lviv, 79008, Ukraine
Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4"
Lviv, 79011, Ukraine
Municipal Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional
Poltava, 36011, Ukraine
Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council
Tarasove Village, 45625, Ukraine
Communal Enterprise "Hospital #1" of Zhytomyr City Council
Zhytomyr, 10002, Ukraine
Related Publications (1)
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.
PMID: 39018532DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double Blind Double Dummy
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2021
First Posted
September 17, 2021
Study Start
September 9, 2021
Primary Completion
April 12, 2022
Study Completion
April 12, 2022
Last Updated
May 6, 2023
Results First Posted
May 6, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
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.