A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease

June 4, 2026 updated by: Pfizer

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED IBUZATRELVIR COMPARED WITH PLACEBO IN NON-HOSPITALIZED SYMPTOMATIC ADULT AND ADOLESCENT PARTICIPANTS WITH COVID-19 WHO ARE AT HIGH RISK OF PROGRESSING TO SEVERE ILLNESS

The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.

Study Overview

Status

Recruiting

Conditions

COVID-19 SARS-CoV-2 Infection

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2330

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Pfizer CT.gov Call Center
Phone Number: 1-800-718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

Argentina
- - Buenos Aires, Argentina, C1428BNF
    - Recruiting
    - Equipo Ciencia
- Buenos Aires
  - Ciudad de Buenos Aires, Buenos Aires, Argentina, 1180
    - Recruiting
    - Sanatorio Güemes
  - La Plata, Buenos Aires, Argentina, B1900XI
    - Not yet recruiting
    - Hospital Italiano de La Plata
  - La Plata, Buenos Aires, Argentina, B1900AVG
    - Not yet recruiting
    - Instituto Médico Platense (IMP)
  - Mar del Plata, Buenos Aires, Argentina, 7600
    - Recruiting
    - Centro de Investigaciones Médicas Mar del Plata
- Córdoba Province
  - Río Cuarto, Córdoba Province, Argentina, X5800
    - Recruiting
    - Instituto Medico Rio Cuarto
- Tucumán Province
  - San Miguel de Tucumán, Tucumán Province, Argentina, 4000
    - Recruiting
    - Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
Belgium
- - Erpent, Belgium, 5101
    - Recruiting
    - Pneumocare
- Limburg
  - Alken, Limburg, Belgium, 3570
    - Recruiting
    - ANIMA Research
Brazil
- - Rio de Janeiro, Brazil, 21040-360
    - Recruiting
    - Instituto Nacional de Infectologia Evandro Chagas
  - São Paulo, Brazil, 01246900
    - Recruiting
    - Instituto de Infectologia Emilio Ribas
- Estado de Bahia
  - Salvador, Estado de Bahia, Brazil, 40110-060
    - Recruiting
    - Hospital Universitario Professor Edgard Santos
- Minas Gerais
  - Belo Horizonte, Minas Gerais, Brazil, 30110-945
    - Recruiting
    - Infection Control
  - Belo Horizonte, Minas Gerais, Brazil, 30130-100
    - Recruiting
    - School of Medicine Federal University of Minas Gerais
- Paraná
  - Curitiba, Paraná, Brazil, 80810-050
    - Recruiting
    - Centro Médico São Francisco
  - Curitiba, Paraná, Brazil, 80.060-900
    - Recruiting
    - Complexo Hospital de Clínicas da Universidade Federal do Paraná
- Pernambuco
  - Recife, Pernambuco, Brazil, 52010-075
    - Active, not recruiting
    - Real Hospital Portugues
- Rio Grande do Norte
  - Natal, Rio Grande do Norte, Brazil, 59020-500
    - Recruiting
    - Instituto Atena de Pesquisa Clinica
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90610000
    - Recruiting
    - Hospital São Lucas da PUCRS
  - Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
    - Recruiting
    - Irmandade Da Santa Casa de Misericordia de Porto Alegre
  - Santa Maria, Rio Grande do Sul, Brazil, 97060-360
    - Recruiting
    - Centro de Pesquisa Clínica - CPC/UFSM
- São Paulo
  - Campinas, São Paulo, Brazil, 13060-803
    - Recruiting
    - Hospital e Maternidade Celso Pierro
  - Campinas, São Paulo, Brazil, 13092-133
    - Recruiting
    - i9 Pesquisas Clínicas - Loema Instituto de Pesquisa Clínica e Consultores SS Ltda
  - Jaú, São Paulo, Brazil, 17201130
    - Recruiting
    - CECIP - Centro de Estudos do Interior Paulista
  - Santo André, São Paulo, Brazil, 09060-870
    - Recruiting
    - Faculdade de Medicina do ABC
  - São Paulo, São Paulo, Brazil, 04121-000
    - Recruiting
    - Centro de Referência e Treinamento DST/AIDS
Bulgaria
- - Haskovo, Bulgaria, 6300
    - Recruiting
    - Medical Center Pulmo - 2018 EOOD
  - Pernik, Bulgaria, 2300
    - Recruiting
    - MHAT "Rahila Angelova" Pernik
  - Plovdiv, Bulgaria, 4000
    - Recruiting
    - Diagnostic Consultative Center "Sveti Georgi" Plovdiv
  - Plovdiv, Bulgaria, 4003
    - Recruiting
    - Medical Center Sveti Ivan Rilski Chudotvorets - 2010
  - Sofia, Bulgaria, 1510
    - Recruiting
    - Medical Center Hera EOOD
  - Sofia, Bulgaria, 1142
    - Recruiting
    - Ambulatory for Individual Primary Medical Care - Dr. Pavlina Petrova - Poli ET
  - Yambol, Bulgaria, 8600
    - Recruiting
    - Medical Center Diana Med 2001
- Gabrovo
  - Sevlievo, Gabrovo, Bulgaria, 5400
    - Recruiting
    - Diagnostic Consultative Center - 1 - Sevlievo EOOD
- Kyustendil
  - Dupnitsa, Kyustendil, Bulgaria, 2600
    - Recruiting
    - Medical Centre "Asklepiy"
- Lovech
  - Troyan Municipality, Lovech, Bulgaria, 5600
    - Recruiting
    - SHATPD Troyan
- Montana
  - Lom, Montana, Bulgaria, 3600
    - Recruiting
    - Diagnostic Consultative Center - 1 Lom EOOD
- Sofia
  - Samokov, Sofia, Bulgaria, 2000
    - Recruiting
    - MHAT Samokov
- Sofia (stolitsa)
  - Sofia, Sofia (stolitsa), Bulgaria, 1606
    - Recruiting
    - Military Medical Academy
Canada
- - Québec, Canada, G1V 4T3
    - Recruiting
    - Diex Recherche Quebec
- British Columbia
  - Vancouver, British Columbia, Canada, V6Z 2E9
    - Recruiting
    - Vancouver Infectious Diseases Centre
- Ontario
  - Scarborough Village, Ontario, Canada, M1S 4T7
    - Recruiting
    - Clinical Research of Ontario
  - Winchester, Ontario, Canada, K0C 2K0
    - Recruiting
    - Winchester District Memorial Hospital
  - Winchester, Ontario, Canada, K0C 2K0
    - Recruiting
    - Community Care Building
  - Winchester, Ontario, Canada, K0C 2K0
    - Recruiting
    - Dundas Manor Nursing Home
China
- - Beijing, China, 100015
    - Recruiting
    - Beijing Ditan Hospital Capital Medical
- Anhui
  - Chizhou, Anhui, China, 247000
    - Recruiting
    - The People's Hospital of Chizhou
- Beijing Municipality
  - Beijing, Beijing Municipality, China, 100044
    - Recruiting
    - Peking University People's Hospital
- Fujian
  - Xiamen, Fujian, China, 361004
    - Recruiting
    - Zhongshan Hospital Xiamen University
  - Xiamen, Fujian, China, 361004
    - Recruiting
    - Zhongshan Hospital Fudan University (Xiamen Branch)
- Guangdong
  - Guangzhou, Guangdong, China, 510280
    - Recruiting
    - ZhuJiang Hospital of Southern Medical University
- Guangxi
  - Nanning, Guangxi, China, 530007
    - Recruiting
    - The Second Affiliated Hospital of Guangxi Medical University
- Hunan
  - Changsha, Hunan, China, 410015
    - Recruiting
    - The Third Hospital of Changsha
- Jiangxi
  - Nanchang, Jiangxi, China, 330038
    - Recruiting
    - Jiangxi Provincial People's Hospital
- Jilin
  - Changchun, Jilin, China, 130021
    - Recruiting
    - The First Hospital of Jilin University
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, China, 200040
    - Recruiting
    - Huashan Hospital, Fudan University
  - Shanghai, Shanghai Municipality, China, 201199
    - Not yet recruiting
    - Shanghai Minhang District Central Hospital
  - Shanghai, Shanghai Municipality, China, 200120
    - Recruiting
    - Shanghai Children's Medical Center
- Shanxi
  - Taiyuan, Shanxi, China, 030001
    - Recruiting
    - First Affiliated Hospital of Shanxi Medical University
- Tianjin Municipality
  - Tianjin, Tianjin Municipality, China, 300384
    - Recruiting
    - Tianjin First Central Hospital
- Yunnan
  - Kunming, Yunnan, China, 650032
    - Not yet recruiting
    - The First People's Hospital of Yunnan Province
- Zhejiang
  - Hangzhou, Zhejiang, China, 310016
    - Recruiting
    - Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Czechia
- - Olomouc, Czechia, 779 00
    - Recruiting
    - ORL MUDr Pavel Navratil
- Brno-město
  - Brno, Brno-město, Czechia, 602 00
    - Recruiting
    - Doktor Brno
- Praha 1
  - Prague, Praha 1, Czechia, 110 00
    - Recruiting
    - Lékařský dům v Mezibranské
- South Bohemian Region
  - Protivín, South Bohemian Region, Czechia, 398 11
    - Recruiting
    - Zdravi-fit
  - České Budějovice, South Bohemian Region, Czechia, 370 01
    - Recruiting
    - Ordinace Hradebni s.r.o.
Denmark
- - Gistrup, Denmark, 9260
    - Recruiting
    - Aalborg Universitetshospital, Syd
- Capital Region
  - Copenhagen, Capital Region, Denmark, 2100
    - Recruiting
    - Rigshospitalet
  - Hilleroed, Capital Region, Denmark, 3400
    - Recruiting
    - Nordsjællands Hospital - Hillerød
- Central Jutland
  - Herning, Central Jutland, Denmark, 7400
    - Recruiting
    - Regionshospitalet Gødstrup
- Region Sjælland
  - Roskilde, Region Sjælland, Denmark, 4000
    - Recruiting
    - Roskilde Sygehus
Finland
- North Ostrobothnia
  - Oulu, North Ostrobothnia, Finland, 90220
    - Recruiting
    - FVR, Oulun rokotetutkimusklinikka
- Pirkanmaa
  - Tampere, Pirkanmaa, Finland, 33100
    - Recruiting
    - FVR, Tampereen rokotetutkimusklinikka
- Uusimaa
  - Helsinki, Uusimaa, Finland, 00100
    - Recruiting
    - FVR, Etelä-Helsingin rokotetutkimusklinikka
  - Helsinki, Uusimaa, Finland, 00290
    - Recruiting
    - MeVac - Meilahti Vaccine Research Center
Germany
- - Berlin, Germany, 13353
    - Recruiting
    - Charité - Universitätsmedizin Berlin
  - Berlin, Germany, 10117
    - Recruiting
    - Novopraxis Berlin GbR
  - Berlin, Germany, 10439
    - Recruiting
    - zibp Zentrum für lnfektiologie Berlin Prenzlauer Berg GmbH
  - Freiburg im Breisgau, Germany, 79106
    - Recruiting
    - Universitätsklinik Freiburg
  - Rostock, Germany, 18057
    - Recruiting
    - University of Rostock
- Bavaria
  - Munich, Bavaria, Germany, 80339
    - Recruiting
    - Praxisgemeinschaft Heimeranplatz
  - Munich, Bavaria, Germany, 80336
    - Recruiting
    - LMU Klinikum München
- Hesse
  - Frankfurt am Main, Hesse, Germany, 60596
    - Recruiting
    - IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardio
  - Obertshausen, Hesse, Germany, 63179
    - Recruiting
    - Studien Rahman & Detho
- North Rhine-Westphalia
  - Cologne, North Rhine-Westphalia, Germany, 50668
    - Recruiting
    - Praxis am Ebertplatz
Japan
- - Hiroshima, Japan, 730-0822
    - Recruiting
    - Yoshijima Hospital
- Aichi-ken
  - Kasugai, Aichi-ken, Japan, 486-0817
    - Recruiting
    - Kamezawa Clinic
- Chiba
  - Narita, Chiba, Japan, 286-8520
    - Recruiting
    - International University of Health and Welfare Narita Hospital
- Fukuoka
  - Fukuoka, Fukuoka, Japan, 814-0153
    - Recruiting
    - Tashiro Endocrinology Clinic
  - Okawa-shi, Fukuoka, Japan, 831-0016
    - Recruiting
    - Medical Corporation Kouhoukai Takagi Hospital
- Hokkaido
  - Sapporo, Hokkaido, Japan, 062-0034
    - Recruiting
    - Nishioka Hospital
- Hyōgo
  - Himeji, Hyōgo, Japan, 670-0849
    - Recruiting
    - Terada Clinic Respiratory Medicine & General Practice
- Ibaraki
  - Koga-shi, Ibaraki, Japan, 306-0041
    - Recruiting
    - Koga General Hospital
  - Tsuchiura, Ibaraki, Japan, 300-0062
    - Recruiting
    - Tsuchiura Beryl Clinic
- Kanagawa
  - Fujisawa, Kanagawa, Japan, 251-0041
    - Recruiting
    - Shonan Fujisawa Tokushukai Hospital
  - Kamakura, Kanagawa, Japan, 247-8533
    - Recruiting
    - Shonan Kamakura General Hospital
- Kyoto
  - Kyoto, Kyoto, Japan, 607-8062
    - Recruiting
    - Rakuwakai Otowa Hospital
- Okinawa
  - Ginowan, Okinawa, Japan, 901-2214
    - Recruiting
    - National Hospital Organization Okinawa Hospital
- Tokyo
  - Chuo-ku, Tokyo, Japan, 104-0031
    - Recruiting
    - Fukuwa Clinic
  - Kodaira-shi, Tokyo, Japan, 187-0031
    - Recruiting
    - Musashino Emergency Hospital
  - Musashino-shi, Tokyo, Japan, 180-0022
    - Recruiting
    - Swing Nozaki Clinic
Mexico
- - Mexico City, Mexico, 14080
    - Not yet recruiting
    - Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  - Veracruz, Mexico, 91900
    - Not yet recruiting
    - Arké SMO S.A de C.V
- Hidalgo
  - Pachuca, Hidalgo, Mexico, 42070
    - Not yet recruiting
    - Asociación Mexicana para la Investigación Clínica A.C.
- Morelos
  - Cuernavaca, Morelos, Mexico, 62290
    - Not yet recruiting
    - JM Research SC
Slovakia
- Košice Region
  - Kosice-Juh, Košice Region, Slovakia, 040 01
    - Recruiting
    - IRS - Medicinska cinnost s.r.o., Vseobecna ambulancia pre dospelych
  - Košice, Košice Region, Slovakia, 040 11
    - Recruiting
    - Artromac n.o.
  - Moldava nad Bodvou, Košice Region, Slovakia, 045 01
    - Recruiting
    - ML MED, s.r.o., Vseobecna ambulancia pre dospelych
  - Spišská Nová Ves, Košice Region, Slovakia, 052 01
    - Recruiting
    - Plucna ambulancia Hrebenar, s.r.o., Pneumologicko-ftizeologicka ambulancia
- Presov
  - Prešov, Presov, Slovakia, 080 01
    - Recruiting
    - PULMO, s.r.o., Pneumologicko-ftizeologicka ambulancia
- Trenčín Region
  - Nové Mesto nad Váhom, Trenčín Region, Slovakia, 915 01
    - Recruiting
    - SALUBER SK s.r.o., Vseobecna ambulancia pre dospelych
  - Pruské, Trenčín Region, Slovakia, 018 52
    - Recruiting
    - MUDr. Viliam Cibik, PhD., s.r.o.
- Trnava Region
  - Hlohovec, Trnava Region, Slovakia, 920 01
    - Recruiting
    - AMB4YOU s.r.o.
  - Trnava, Trnava Region, Slovakia, 917 01
    - Recruiting
    - VL.AK s.r.o. Vseobecna ambulancia pre dospelych
South Africa
- Gauteng
  - Johannesburg, Gauteng, South Africa, 2113
    - Recruiting
    - Newtown Clinical Research
  - Pretoria, Gauteng, South Africa, 0157
    - Recruiting
    - Global Clinical Trials
  - Pretoria West, Gauteng, South Africa, 0183
    - Recruiting
    - Jongaie Research
  - Sandton, Gauteng, South Africa, 2196
    - Recruiting
    - Sandton Medical Research Centre
- KwaZulu-Natal
  - Durban, KwaZulu-Natal, South Africa, 4001
    - Recruiting
    - Synapta Clinical Research Centre
  - Silverglen Durban, KwaZulu-Natal, South Africa, 4092
    - Recruiting
    - Private Practice - Dr. Peter Sebastian
- Western Cape
  - Cape Town, Western Cape, South Africa, 7530
    - Recruiting
    - Tread Research
  - Cape Town, Western Cape, South Africa, 7570
    - Not yet recruiting
    - Langeberg Clinical Trials
  - Paarl, Western Cape, South Africa, 7646
    - Recruiting
    - Paarl Research Centre
South Korea
- Incheon-gwangyeoksi [incheon]
  - Donggu, Incheon-gwangyeoksi [incheon], South Korea, 22532
    - Recruiting
    - Incheon Medical Center
  - Namdong-gu, Incheon-gwangyeoksi [incheon], South Korea, 21565
    - Recruiting
    - Gachon University Gil Medical Center
- Kang-won-do
  - Wŏnju, Kang-won-do, South Korea, 26426
    - Recruiting
    - WonJu Severance Christian Hospital
- Kwangju-kwangyǒkshi
  - Gwangju, Kwangju-kwangyǒkshi, South Korea, 61469
    - Recruiting
    - Chonnam National University Hospital
- Kyǒnggi-do
  - Ansan-si, Kyǒnggi-do, South Korea, 15355
    - Recruiting
    - Korea University Ansan Hospital
  - Suwon, Kyǒnggi-do, South Korea, 16499
    - Recruiting
    - Ajou University Hospital
- Seoul-teukbyeolsi [seoul]
  - Dongjak-gu, Seoul-teukbyeolsi [seoul], South Korea, 06973
    - Recruiting
    - Chung-Ang University Hospital
  - Gangnam-gu, Seoul-teukbyeolsi [seoul], South Korea, 06273
    - Recruiting
    - Gangnam Severance Hospital, Yonsei University Health System
  - Seoul, Seoul-teukbyeolsi [seoul], South Korea, 02841
    - Recruiting
    - Korea University Anam Hospital
  - Seoul, Seoul-teukbyeolsi [seoul], South Korea, 08308
    - Recruiting
    - Korea University Guro Hospital
  - Seoul, Seoul-teukbyeolsi [seoul], South Korea, 07441
    - Recruiting
    - Hallym University Kangnam Sacred Heart Hospital
  - Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03312
    - Recruiting
    - The Catholic University of Korea, Eunpyeong St. Mary's Hospital
- Taegu-kwangyǒkshi
  - Daegu, Taegu-kwangyǒkshi, South Korea, 42601
    - Recruiting
    - Keimyung University Dongsan Hospital
Spain
- - Alicante, Spain, 03010
    - Recruiting
    - Hospital General Universitario Dr. Balmis
  - Madrid, Spain, 28031
    - Recruiting
    - Hospital Universitario Infanta Leonor
  - Seville, Spain, 41014
    - Recruiting
    - Hospital Universitario Virgen de Valme
- A Coruña [LA Coruña]
  - A Coruña, A Coruña [LA Coruña], Spain, 15006
    - Not yet recruiting
    - CHUAC-Complejo Hospitalario Universitario A Coruña
- Andalusia
  - Benalmádena, Andalusia, Spain, 29631
    - Recruiting
    - Hospital Vithas Xanit Internacional
  - Córdoba, Andalusia, Spain, 14004
    - Not yet recruiting
    - Hospital Universitario Reina Sofia
- Barcelona [barcelona]
  - Badalona, Barcelona [barcelona], Spain, 08916
    - Recruiting
    - Hospital Germans Trias i Pujol
  - Barcelona, Barcelona [barcelona], Spain, 08035
    - Recruiting
    - Hospital Universitari Vall d'Hebron
- Madrid, Comunidad de
  - Madrid, Madrid, Comunidad de, Spain, 28046
    - Recruiting
    - Hospital Universitario La Paz
- Pontevedra [pontevedra]
  - Vigo, Pontevedra [pontevedra], Spain, 36312
    - Recruiting
    - CHUVI- Hospital Alvaro Cunqueiro
Taiwan
- - Taichung, Taiwan, 407
    - Recruiting
    - Taichung Veterans General Hospital
  - Taipei, Taiwan, 114
    - Recruiting
    - Tri-Service General Hospital
  - Taipei, Taiwan, 11217
    - Recruiting
    - Taipei Veterans General Hospital
  - Taoyuan, Taiwan, 333
    - Recruiting
    - Chang Gung Medical Foundation-Linkou Branch
- NEW Taipei
  - New Taipei City, NEW Taipei, Taiwan, 220
    - Recruiting
    - Far Eastern Memorial Hospital
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06800
    - Recruiting
    - Ankara Bilkent Sehir Hastanesi
  - Ankara, Turkey (Türkiye), 06230
    - Recruiting
    - Hacettepe Universite Hastaneleri
  - Ankara, Turkey (Türkiye), 06230
    - Recruiting
    - Ankara University Ibni Sina Hospital
  - Gaziantep, Turkey (Türkiye), 27310
    - Recruiting
    - Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
  - Kocaeli, Turkey (Türkiye), 41380
    - Recruiting
    - Kocaeli Üniversitesi
  - Sakarya, Turkey (Türkiye), 54100
    - Recruiting
    - Sakarya Training and Research Hospital
  - Trabzon, Turkey (Türkiye), 61080
    - Recruiting
    - Karadeniz Technical University
- İ̇stanbul
  - Istanbul, İ̇stanbul, Turkey (Türkiye), 34303
    - Recruiting
    - Acibadem Universitesi Atakent Hastanesi
United States
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Recruiting
    - Applied Research Center of Arkansas
- California
  - Bakersfield, California, United States, 93309
    - Recruiting
    - National Institute of Clinical Research - Bakersfield
  - Huntington Park, California, United States, 90255
    - Recruiting
    - Velocity Clinical Research, Huntington Park
  - Inglewood, California, United States, 90301
    - Recruiting
    - 310 Clinical Research
  - Long Beach, California, United States, 90806
    - Recruiting
    - Long Beach Clinical Trials
  - Long Beach, California, United States, 90805
    - Recruiting
    - Long Beach Research Institute
  - Los Alamitos, California, United States, 90720
    - Recruiting
    - Pacific Clinical Studies Inc.
  - Los Angeles, California, United States, 90017
    - Recruiting
    - Downtown L.A. Research Center, Inc.
  - Oxnard, California, United States, 93030
    - Recruiting
    - FOMAT Medical Research
  - Oxnard, California, United States, 93030
    - Recruiting
    - Clinica mi Salud by Focil Med
  - Redding, California, United States, 96001
    - Recruiting
    - Paradigm Clinical Research, LLC
  - San Diego, California, United States, 92120
    - Recruiting
    - Acclaim Clinical Research
  - South Gate, California, United States, 90280
    - Recruiting
    - Tweedy Medical Group - Charity Health
  - Torrance, California, United States, 90503
    - Recruiting
    - Breathe Clear Institute for Sinus and Allergy Relief
- Colorado
  - Wheat Ridge, Colorado, United States, 80033
    - Recruiting
    - Paradigm Clinical Research, LLC
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20009
    - Recruiting
    - Emerson Clinical Research Institute
  - Washington D.C., District of Columbia, United States, 20007
    - Recruiting
    - Georgetown University Medical Center
- Florida
  - Clearwater, Florida, United States, 33756
    - Recruiting
    - Innovative Research of West Florida
  - Coconut Creek, Florida, United States, 33073
    - Recruiting
    - Invictus Clinical Research Group
  - DeLand, Florida, United States, 32720
    - Recruiting
    - Hillcrest Medical Research
  - DeLand, Florida, United States, 32720
    - Recruiting
    - Hillcrest Medical Research LLC
  - Doral, Florida, United States, 33166
    - Recruiting
    - Universal Axon Clinical Research, LLC
  - Flagami, Florida, United States, 33126
    - Recruiting
    - Herco Medical and Research Center Inc
  - Fort Lauderdale, Florida, United States, 33308
    - Recruiting
    - Proactive Clinical Research,LLC
  - Fort Myers, Florida, United States, 33919
    - Recruiting
    - C & R Research Services USA
  - Hialeah, Florida, United States, 33010
    - Recruiting
    - Qway Research LLC
  - Homestead, Florida, United States, 33032
    - Recruiting
    - Sunbright Health Medical Centers
  - Miami, Florida, United States, 33133
    - Recruiting
    - Infinite Clinical Research
  - Miami, Florida, United States, 33144
    - Recruiting
    - Bio-Medical Research LLC
  - Miami, Florida, United States, 33186
    - Recruiting
    - Nuovida Research Center
  - Miami, Florida, United States, 33185
    - Recruiting
    - Kendall South Medical Center
  - Miami Lakes, Florida, United States, 33016
    - Recruiting
    - Global Health Research Center, Inc.
  - Mt. Dora, Florida, United States, 32757
    - Recruiting
    - Adult Medicine of Lake County, Inc.
  - Palmetto Bay, Florida, United States, 33157
    - Recruiting
    - Innovation Medical Research Center
  - Pembroke Pines, Florida, United States, 33029
    - Recruiting
    - DBC Research USA
  - St. Petersburg, Florida, United States, 33705
    - Recruiting
    - GCP , Global Clinical Professionals
  - Tampa, Florida, United States, 33615
    - Recruiting
    - Global Health Research Center - Tampa
- Georgia
  - Decatur, Georgia, United States, 30030
    - Recruiting
    - The Hope Clinic of Emory University
  - Fayetteville, Georgia, United States, 30214
    - Recruiting
    - Javara - Privia Medical Group Georgia - Fayetteville
  - Hinesville, Georgia, United States, 31313
    - Recruiting
    - Coastal Heritage Clinical Research
  - Savannah, Georgia, United States, 31406
    - Recruiting
    - Velocity Clinical Research, Savannah
- Idaho
  - Boise, Idaho, United States, 83702
    - Recruiting
    - St. Luke's Humphreys Diabetes Center
  - Boise, Idaho, United States, 83712
    - Recruiting
    - St. Luke's Children's
  - Boise, Idaho, United States, 83712
    - Recruiting
    - St. Luke's Elks Children's Pavilion
- Illinois
  - Morton, Illinois, United States, 61550
    - Recruiting
    - Koch Family Medicine
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Recruiting
    - University of Louisville Hospital
  - Louisville, Kentucky, United States, 40202
    - Recruiting
    - University of Louisville School of Medicine
  - Louisville, Kentucky, United States, 40202
    - Recruiting
    - UL International Travel Clinic
- Maryland
  - Columbia, Maryland, United States, 21045
    - Recruiting
    - Centennial Medical Group
  - Silver Spring, Maryland, United States, 20904
    - Recruiting
    - Jadestone Clinical Research
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Recruiting
    - Brigham and Women's Hospital
  - Worcester, Massachusetts, United States, 01655
    - Recruiting
    - University of Massachusetts Chan Medical School
- Michigan
  - Dearborn, Michigan, United States, 48126
    - Recruiting
    - Revival Research Institute, LLC
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Recruiting
    - Henry Ford St. John Hospital
- Montana
  - Butte, Montana, United States, 59701
    - Recruiting
    - Mercury Street Medical Group, PLLC
- Nebraska
  - Grand Island, Nebraska, United States, 68803
    - Recruiting
    - Velocity Clinical Research, Grand Island
  - Omaha, Nebraska, United States, 68134
    - Not yet recruiting
    - Velocity Clinical Research, Omaha
  - Papillion, Nebraska, United States, 68046
    - Recruiting
    - McGill Family Practice
- Nevada
  - North Las Vegas, Nevada, United States, 89030
    - Recruiting
    - Las Vegas Clinical Trials
- New York
  - East Syracuse, New York, United States, 13057
    - Recruiting
    - Upstate Global Health Institute
  - Syracuse, New York, United States, 13210
    - Recruiting
    - Upstate Connect Care
  - The Bronx, New York, United States, 10467
    - Recruiting
    - Montefiore Medical Center
  - The Bronx, New York, United States, 10456
    - Recruiting
    - Prime Global Research
- North Carolina
  - Monroe, North Carolina, United States, 28112
    - Recruiting
    - Monroe Biomedical Research
- Ohio
  - Columbus, Ohio, United States, 43215
    - Recruiting
    - Remington-Davis, Inc
- Pennsylvania
  - Uniontown, Pennsylvania, United States, 15401
    - Recruiting
    - Preferred Primary Care Physicians
- Tennessee
  - Chattanooga, Tennessee, United States, 37421
    - Recruiting
    - WR-Clinsearch, LLC
- Texas
  - Dallas, Texas, United States, 75235
    - Recruiting
    - Southwest Family Medicine Associates
  - Dallas, Texas, United States, 75230
    - Recruiting
    - Zenos Clinical Research
  - Dallas, Texas, United States, 75235
    - Recruiting
    - Southwest Mind and Body Care
  - Houston, Texas, United States, 77030
    - Recruiting
    - The University of Texas Health Science Center at Houston
  - Houston, Texas, United States, 77057
    - Recruiting
    - Next Level Urgent Care
  - Houston, Texas, United States, 77098
    - Recruiting
    - The Crofoot Research Center
  - Houston, Texas, United States, 77070
    - Recruiting
    - Gulf Coast Clinical Research - Houston
  - Houston, Texas, United States, 77087
    - Recruiting
    - Mercury Clinical Research - Santa Clara Family Clinic
  - Houston, Texas, United States, 77030
    - Recruiting
    - UT Physicians
  - Houston, Texas, United States, 77030
    - Recruiting
    - Memorial Hermann Hospital TMC
  - Lewisville, Texas, United States, 75057
    - Recruiting
    - EPIC Clinical Research
  - Stephenville, Texas, United States, 76401
    - Recruiting
    - Javara - Privia Medical Group North Texas - Stephenville
  - Sugar Land, Texas, United States, 77478
    - Recruiting
    - Javara - Privia Medical Group Gulf Coast - Sugarland
  - Tomball, Texas, United States, 77375
    - Terminated
    - Mercury Clinical Research - North Houston Internal Medicine & Pediatric Clinic
- Utah
  - Clinton, Utah, United States, 84015
    - Recruiting
    - Alpine Research Organization
- Virginia
  - Suffolk, Virginia, United States, 23435
    - Recruiting
    - Velocity Clinical Research, Suffolk
- Washington
  - Redmond, Washington, United States, 98052
    - Recruiting
    - Eastside Research Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

12 to <18 years of age, weighing at least 40 kg, or ≥18 years of age of any weight at screening.
Presence of risk factors for progression to severe COVID-19 at the time of screening based on age:
1. 12 to 49 years of age with at least two risk factors, where one must be moderate immunocompromise;
2. 50 to 64 years of age with at least two risk factors;
3. 65 to 74 years of age with at least one risk factor;
4. For participants 75 years of age or older, there are no requirements related to risk factors.
The list of risk factors includes:
BMI ≥35 kg/m2; Current smoker; Chronic lung disease; Cardiovascular disease; Type 1 or Type 2 diabetes mellitus; Mild to moderate renal impairment; Neurodevelopmental disorders; Sickle cell disease; Moderate immunosuppression.
Confirmed SARS-CoV-2 infection as determined by RAT in nasal or NP specimen collected within 1 day prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization. Randomization must occur no later than the 5th day, where the onset of symptoms is the first day.
Participants must be unable or unwilling to take nirmatrelvir/ritonavir.

Exclusion Criteria:

Current need or anticipated need for hospitalization within 24 hours, due to signs of severe COVID-19 illness (eg, SpO2 <94% on room air, respiratory rate >30 breaths/minute, or lung infiltrates >50%) or due to other medical conditions requiring hospitalization in the opinion of the site investigator.
Receiving dialysis or have known severe renal impairment [ie, eGFR consistently <30 mL/min/1.73 m2 for adults or CrCl <30 mL/min for adolescents], using the serum creatinine-based CKD-EPI formula or the Cockroft Gault, respectively.
Active liver disease with AST or ALT >3 ULN, Total bilirubin ≥2 × ULN (for Gilbert's syndrome, direct bilirubin >ULN is exclusionary) within the past 3 months, or liver function impairment with Class C per Child Pugh classification.
Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
Ongoing Long COVID or Post Acute Sequelae of COVID-19 diagnosis.
Severely immunocompromised.
Any comorbidity requiring hospitalization and/or surgery within 7 days prior to study entry, or that is considered life threatening within 30 days prior to study entry, as determined by the investigator.
History of hypersensitivity or other contraindication to any of the components of the study interventions.
Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Current use of any prohibited concomitant medication(s).

10.Has received any other antiviral for the treatment of COVID-19, including remdesivir, nirmatrelvir/ritonavir, molnupiravir, or COVID-19 mAbs within 30 days or 5 half-lives [whichever is longer] prior to screening, or received convalescent COVID-19 plasma within 12 months.

12.Received any dose of a COVID-19 vaccine within 4 months of randomization or expected to receive one through Day 34.

13.Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).

14.Prior participation in this clinical trial or any other clinical trial of ibuzatrelvir.

15.Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ibuzatrelvir Ibuzatrelvir administered orally every 12 hours (twice daily) for a total of 5 days.	Drug: ibuzatrelvir ibuzatrelvir tablets Other Names: PF-07817883
Placebo Comparator: placebo placebo administered orally every 12 hours (twice daily) for 5 days.	Drug: placebo placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with COVID-19 related emergency department visits, all cause hospitalization and all cause mortality Time Frame: Day 1 through Day 28	The difference in proportions of patients requiring COVID 19 related emergency department visits with administration of supplemental oxygen, COVID-19 antiviral or IV treatment (eg hydration, antibiotics, or corticosteroids), all-cause hospitalization, or all-cause death through Day 28 between ibuzatrelvir and placebo, among patients who were treated ≤5 days after COVID-19 symptom onset and who were not receiving background SoC treatment for their COVID-19 infection at baseline.	Day 1 through Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with post acute COVID-19 medical events Time Frame: Day 29 to Week 24	Medical events include cardiovascular events, pulmonary events, acute kidney disease and thromboembolic events.	Day 29 to Week 24
Proportion of participants with cardiovascular, renal and pulmonary events Time Frame: Day 1 to Week 24	Medical events include cardiovascular events, pulmonary events, acute kidney disease and thromboembolic events.	Day 1 to Week 24
Proportion of participants with Long COVID symptoms Time Frame: Day 29 to Week 24	The difference in proportions of patients with Long COVID symptoms at Week 24. Symptoms will be assessed through a weekly electronic diary.	Day 29 to Week 24
Time to SARS-CoV-2 RNA <LLOQ Time Frame: Day 1 through Day 34	Time needed to achieve a viral load below the lower limit of quantification of the essay used to measure it.	Day 1 through Day 34
Proportion of participants with SARS-CoV-2 RNA <LLOQ at each visit Time Frame: Day 1 through Day 34	Proportion of participants with a SARS-CoV-2 viral load below the lower limit of quantification of the essay used to measure it.	Day 1 through Day 34
Proportion of participants with rebound in SARS-CoV-2 RNA levels in nasopharyngeal swab Time Frame: Day 10 and Day 14	Virologic rebound is defined as: at any follow up visit, a viral RNA level increase from End of Treatment (Day 5) of ≥ 1.0 log10 copies/mL resulting in a viral RNA level ≥3.0 log10 copies/mL.	Day 10 and Day 14
Proportion of participants with virologic and symptomatic rebound through Day 28 Time Frame: Day 10 to Day 34	symptoms rebound is defined as: after achieving short symptom recovery (the first day of at least two consecutive diary entries where all targeted symptoms are absent), symptom rebound is the first day of at least two consecutive diary entries after Day 5 where there is any targeted symptom (regardless of severity), or when a participant is hospitalized after symptom recovery.	Day 10 to Day 34
Proportion of participants with COVID-19-related hospitalization or all cause death through Day 28. Time Frame: Day 1 to Day 28		Day 1 to Day 28
Number of days in hospital and ICU stay in participants with hospitalization (all-cause). Time Frame: Day 1 to Week 24		Day 1 to Week 24
Number of medical visits through Week 24. Time Frame: Day 1 to Week 24	medical visits include emergency department visits, hospitalizations, visits to the general practitioner and specialist.	Day 1 to Week 24
Proportion of participants with hospitalization (all-cause) or death (all-cause) through Week 24. Time Frame: Day 1 to Week 24		Day 1 to Week 24
Proportion of participants with severe symptoms attributed to COVID-19 through Day 28. Time Frame: Day 1 to Day 28	Participants are 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 is counted as severe. Percentage of participants with severe Covid-19 signs and symptoms is reported.	Day 1 to Day 28
Proportion of participants with symptomatic rebound through Day 28. Time Frame: Day 1 to Day 28	Definition of symptomatic rebound: After achieving short symptom recovery (the first day of at least two consecutive diary entries where all targeted symptoms are absent), symptom rebound is the first day of at least two consecutive diary entries after Day 5 where there is any targeted symptom (regardless of severity), or when a participant is hospitalized after symptom recovery	Day 1 to Day 28
Incidence of treatment emergent adverse events Time Frame: Day 1 to Day 34	An adverse event (AE) is 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) is 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 is considered as TEAE if the event started on or after start date of study intervention.	Day 1 to Day 34
Incidence of SAEs and AEs leading to discontinuations. Time Frame: Day 1 to Day 34		Day 1 to Day 34
Time to sustained resolution of all COVID-19 targeted symptoms Time Frame: Day 1 to Day 28	The difference in median time to sustained resolution of all targeted symptoms. Symptoms will be assessed through a daily electronic diary and include sore throat, cough, fever and diarrhea, among others.	Day 1 to Day 28
Changes from baseline in SARS-CoV-2 RNA levels in nasopharyngeal/nasal swabs Time Frame: Day 1 through Day 34	The viral load is measured in nasal or nasopharyngeal samples using reverse transcription polymerase chain reaction (RT-PCR)	Day 1 through Day 34
Time (days) to sustained alleviation of all targeted symptoms through Day 28. Time Frame: Day 1 to Day 28	The difference in median time to sustained alleviation of all targeted symptoms. Symptoms will be assessed through a daily electronic diary and include sore throat, cough, fever and diarrhea, among others.	Day 1 to Day 28
Duration of each targeted COVID-19 symptom. Time Frame: Day 1 to Day 28	Duration of each targeted COVID-19 symptom is defined as (First Date when the symptom achieved sustained alleviation/resolved)-(First Dose Date) + I for each participant with baseline severity of mild, moderate, or severe.	Day 1 to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2024

Primary Completion (Estimated)

October 3, 2027

Study Completion (Estimated)

March 2, 2028

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 7, 2024

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

C5091017
2024-517727-39-00 (Registry Identifier: CTIS (EU))

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on COVID-19 SARS-CoV-2 Infection

Clinical Trials on ibuzatrelvir

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations