AzTrials
AzTrials

COVID-19 SARS-CoV-2 InfectionPhase 3NCT06679140

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

A Phase 3 study testing ibuzatrelvir in people with COVID-19 SARS-CoV-2 Infection, run by Pfizer at 256 sites in 19 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
COVID-19 SARS-CoV-2 Infection
What is being tested?
ibuzatrelvir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,330 participants
Where
256 sitesin 19 countries
Study dates
8 Dec 2024to 12 Feb 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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:
  • 12 to 49 years of age with at least two risk factors, where one must be moderate immunocompromise;
  • 50 to 64 years of age with at least two risk factors;
  • 65 to 74 years of age with at least one risk factor;
  • For participants 75 years of age or older, there are no requirements related to risk factors.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

256 sites in 19 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

256 sites in 19 countries

United States90 sites, 83 recruiting

  • National Institute of Clinical Research - Bakersfield

    Bakersfield, California, 93309

    Recruiting

  • St. Luke's Humphreys Diabetes Center

    Boise, Idaho, 83702

    Recruiting

  • St. Luke's Children's

    Boise, Idaho, 83712

    Recruiting

  • St. Luke's Elks Children's Pavilion

    Boise, Idaho, 83712

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Recruiting

  • Mercury Street Medical Group, PLLC

    Butte, Montana, 59701

    Recruiting

  • Medical University of South Carolina Ashley River Tower

    Charleston, South Carolina, 29401

    Not yet recruiting

  • Medical University of South Carolina - SCTR Research Nexus

    Charleston, South Carolina, 29425

    Not yet recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Not yet recruiting

  • WR-Clinsearch, LLC

    Chattanooga, Tennessee, 37421

    Recruiting

  • Innovative Research of West Florida

    Clearwater, Florida, 33756

    Recruiting

  • Alpine Research Organization

    Clinton, Utah, 84015

    Recruiting

  • Invictus Clinical Research Group

    Coconut Creek, Florida, 33073

    Recruiting

  • Centennial Medical Group

    Columbia, Maryland, 21045

    Recruiting

  • Remington-Davis, Inc

    Columbus, Ohio, 43215

    Recruiting

  • Zenos Clinical Research

    Dallas, Texas, 75230

    Recruiting

  • Southwest Family Medicine Associates

    Dallas, Texas, 75235

    Recruiting

  • Southwest Mind and Body Care

    Dallas, Texas, 75235

    Recruiting

  • Revival Research Institute, LLC

    Dearborn, Michigan, 48126

    Recruiting

  • The Hope Clinic of Emory University

    Decatur, Georgia, 30030

    Recruiting

  • Hillcrest Medical Research LLC

    DeLand, Florida, 32720

    Active, not recruiting

  • Hillcrest Medical Research

    DeLand, Florida, 32720

    Active, not recruiting

  • Universal Axon Clinical Research, LLC

    Doral, Florida, 33166

    Recruiting

  • Upstate Global Health Institute

    East Syracuse, New York, 13057

    Recruiting

  • Endeavor Health Evanston Hospital

    Evanston, Illinois, 60201

    Not yet recruiting

  • Javara - Privia Medical Group Georgia - Fayetteville

    Fayetteville, Georgia, 30214

    Recruiting

  • Herco Medical and Research Center Inc

    Flagami, Florida, 33126

    Recruiting

  • Proactive Clinical Research,LLC

    Fort Lauderdale, Florida, 33308

    Recruiting

  • C & R Research Services USA

    Fort Myers, Florida, 33919

    Recruiting

  • Velocity Clinical Research, Grand Island

    Grand Island, Nebraska, 68803

    Recruiting

  • Henry Ford St. John Hospital

    Grosse Pointe Woods, Michigan, 48236

    Recruiting

  • Qway Research LLC

    Hialeah, Florida, 33010

    Recruiting

  • Coastal Heritage Clinical Research

    Hinesville, Georgia, 31313

    Recruiting

  • Sunbright Health Medical Centers

    Homestead, Florida, 33032

    Recruiting

  • Memorial Hermann Hospital TMC

    Houston, Texas, 77030

    Recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Recruiting

  • UT Physicians

    Houston, Texas, 77030

    Recruiting

  • Next Level Urgent Care

    Houston, Texas, 77057

    Recruiting

  • Gulf Coast Clinical Research - Houston

    Houston, Texas, 77070

    Recruiting

  • Mercury Clinical Research - Santa Clara Family Clinic

    Houston, Texas, 77087

    Recruiting

  • The Crofoot Research Center

    Houston, Texas, 77098

    Recruiting

  • Velocity Clinical Research, Huntington Park

    Huntington Park, California, 90255

    Recruiting

  • University of Alabama at Birmingham, Huntsville Regional Medical Campus (HRMC)

    Huntsville, Alabama, 35801

    Recruiting

  • 310 Clinical Research

    Inglewood, California, 90301

    Recruiting

  • Epic Clinical Research

    Lewisville, Texas, 75057

    Recruiting

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72205

    Recruiting

  • Long Beach Research Institute

    Long Beach, California, 90805

    Recruiting

  • Long Beach Clinical Trials

    Long Beach, California, 90806

    Recruiting

  • Pacific Clinical Studies Inc.

    Los Alamitos, California, 90720

    Recruiting

  • Downtown L.A. Research Center, Inc.

    Los Angeles, California, 90017

    Recruiting

  • UL International Travel Clinic

    Louisville, Kentucky, 40202

    Recruiting

  • University of Louisville Hospital

    Louisville, Kentucky, 40202

    Recruiting

  • University of Louisville School of Medicine

    Louisville, Kentucky, 40202

    Recruiting

  • Infinite Clinical Research

    Miami, Florida, 33133

    Recruiting

  • Bio-Medical Research LLC

    Miami, Florida, 33144

    Recruiting

  • Kendall South Medical Center

    Miami, Florida, 33185

    Recruiting

  • Global Health Research Center, Inc.

    Miami Lakes, Florida, 33016

    Recruiting

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112

    Active, not recruiting

  • Koch Family Medicine

    Morton, Illinois, 61550

    Recruiting

  • Adult Medicine of Lake County, Inc.

    Mt. Dora, Florida, 32757

    Recruiting

  • Lucida Clinical Trials

    New Bedford, Massachusetts, 02740

    Recruiting

  • Las Vegas Clinical Trials

    North Las Vegas, Nevada, 89030

    Recruiting

  • Velocity Clinical Research, Omaha

    Omaha, Nebraska, 68134

    Recruiting

  • Clinica mi Salud by Focil Med

    Oxnard, California, 93030

    Recruiting

  • FOMAT Medical Research

    Oxnard, California, 93030

    Recruiting

  • Innovation Medical Research Center

    Palmetto Bay, Florida, 33157

    Recruiting

  • McGill Family Practice

    Papillion, Nebraska, 68046

    Recruiting

  • DBC Research USA

    Pembroke Pines, Florida, 33029

    Recruiting

  • Paradigm Clinical Research, LLC

    Redding, California, 96001

    Recruiting

  • Acclaim Clinical Research

    San Diego, California, 92120

    Active, not recruiting

  • Velocity Clinical Research, Savannah

    Savannah, Georgia, 31406

    Recruiting

  • Jadestone Clinical Research

    Silver Spring, Maryland, 20904

    Recruiting

  • Endeavor Health Clinical Trials Center

    Skokie, Illinois, 60077

    Not yet recruiting

  • Endeavor Health Immediate Care - Old Orchard

    Skokie, Illinois, 60077

    Not yet recruiting

  • Tweedy Medical Group - Charity Health

    South Gate, California, 90280

    Recruiting

  • GCP , Global Clinical Professionals

    St. Petersburg, Florida, 33714

    Recruiting

  • Javara - Privia Medical Group North Texas - Stephenville

    Stephenville, Texas, 76401

    Active, not recruiting

  • Velocity Clinical Research, Suffolk

    Suffolk, Virginia, 23435

    Recruiting

  • Javara - Privia Medical Group Gulf Coast - Sugarland

    Sugar Land, Texas, 77478

    Active, not recruiting

  • Upstate Connect Care

    Syracuse, New York, 13210

    Recruiting

  • Global Health Research Center - Tampa

    Tampa, Florida, 33615

    Recruiting

  • Prime Global Research

    The Bronx, New York, 10456

    Recruiting

  • Mercury Clinical Research - North Houston Internal Medicine & Pediatric Clinic

    Tomball, Texas, 77375

    Active, not recruiting

  • Breathe Clear Institute for Sinus and Allergy Relief

    Torrance, California, 90503

    Recruiting

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401

    Recruiting

  • Velocity Clinical Research, Waco

    Waco, Texas, 76710

    Recruiting

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

    Recruiting

  • Emerson Clinical Research Institute

    Washington D.C., District of Columbia, 20009

    Recruiting

  • Paradigm Clinical Research, LLC

    Wheat Ridge, Colorado, 80033

    Recruiting

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01655

    Recruiting

Other trials in United States

Brazil17 sites, 16 recruiting

  • Infection Control

    Belo Horizonte, Minas Gerais, 30110-945

    Recruiting

  • Centro Avançado de Tratamento Oncológico - CENANTRON

    Belo Horizonte, Minas Gerais, 30130-090

    Recruiting

  • School of Medicine Federal University of Minas Gerais

    Belo Horizonte, Minas Gerais, 30130-100

    Recruiting

  • Hospital e Maternidade Celso Pierro

    Campinas, São Paulo, 13060-803

    Recruiting

  • i9 Pesquisas Clínicas - Loema Instituto de Pesquisa Clínica e Consultores SS Ltda

    Campinas, São Paulo, 13092-133

    Recruiting

  • Complexo Hospital de Clínicas da Universidade Federal do Paraná

    Curitiba, Paraná, 80.060-900

    Recruiting

  • CECIP - Centro de Estudos do Interior Paulista

    Jaú, São Paulo, 17201130

    Recruiting

  • Instituto Atena de Pesquisa Clinica

    Natal, Rio Grande do Norte, 59020-500

    Recruiting

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90050-170

    Recruiting

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610000

    Recruiting

  • Real Hospital Portugues

    Recife, Pernambuco, 52010-075

    Terminated

  • Instituto Nacional de Infectologia Evandro Chagas

    Rio de Janeiro, 21040-360

    Recruiting

  • Hospital Universitario Professor Edgard Santos

    Salvador, Estado de Bahia, 40110-060

    Recruiting

  • Centro de Pesquisa Clínica - CPC/UFSM

    Santa Maria, Rio Grande do Sul, 97060-360

    Recruiting

  • Faculdade de Medicina do ABC

    Santo André, São Paulo, 09060-870

    Recruiting

  • Centro de Referência e Treinamento DST/AIDS

    São Paulo, São Paulo, 04121-000

    Recruiting

  • Instituto de Infectologia Emilio Ribas

    São Paulo, 01246900

    Recruiting

Other trials in Brazil

China17 sites, 17 recruiting

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

    Recruiting

  • Beijing Ditan Hospital Capital Medical

    Beijing, 100015

    Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

    Recruiting

  • The Third Hospital of Changsha

    Changsha, Hunan, 410015

    Recruiting

  • The People's Hospital of Chizhou

    Chizhou, Anhui, 247000

    Recruiting

  • ZhuJiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

    Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

    Recruiting

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan, 650032

    Recruiting

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330038

    Recruiting

  • The Second Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530007

    Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040

    Recruiting

  • Shanghai Children's Medical Center

    Shanghai, Shanghai Municipality, 200120

    Recruiting

  • Shanghai Minhang District Central Hospital

    Shanghai, Shanghai Municipality, 201199

    Recruiting

  • First Affiliated Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

    Recruiting

  • Tianjin First Central Hospital

    Tianjin, Tianjin Municipality, 300384

    Recruiting

  • Zhongshan Hospital Fudan University (Xiamen Branch)

    Xiamen, Fujian, 361004

    Recruiting

  • Zhongshan Hospital Xiamen University

    Xiamen, Fujian, 361004

    Recruiting

Other trials in China

Japan16 sites, 16 recruiting

  • Fukuwa Clinic

    Chuo-ku, Tokyo, 104-0031

    Recruiting

  • Shonan Fujisawa Tokushukai Hospital

    Fujisawa, Kanagawa, 251-0041

    Recruiting

  • Tashiro Endocrinology Clinic

    Fukuoka, Fukuoka, 814-0153

    Recruiting

  • National Hospital Organization Okinawa Hospital

    Ginowan, Okinawa, 901-2214

    Recruiting

  • Terada Clinic Respiratory Medicine & General Practice

    Himeji, Hyōgo, 670-0849

    Recruiting

  • Yoshijima Hospital

    Hiroshima, 730-0822

    Recruiting

  • Shonan Kamakura General Hospital

    Kamakura, Kanagawa, 247-8533

    Recruiting

  • Kamezawa Clinic

    Kasugai, Aichi-ken, 486-0817

    Recruiting

  • Musashino Emergency Hospital

    Kodaira-shi, Tokyo, 187-0031

    Recruiting

  • Koga General Hospital

    Koga-shi, Ibaraki, 306-0041

    Recruiting

  • Rakuwakai Otowa Hospital

    Kyoto, Kyoto, 607-8062

    Recruiting

  • Swing Nozaki Clinic

    Musashino-shi, Tokyo, 180-0022

    Recruiting

  • International University of Health and Welfare Narita Hospital

    Narita, Chiba, 286-8520

    Recruiting

  • Medical Corporation Kouhoukai Takagi Hospital

    Okawa-shi, Fukuoka, 831-0016

    Recruiting

  • Nishioka Hospital

    Sapporo, Hokkaido, 062-0034

    Recruiting

  • Tsuchiura Beryl Clinic

    Tsuchiura, Ibaraki, 300-0062

    Recruiting

Other trials in Japan

Bulgaria13 sites, 13 recruiting

  • Medical Centre "Asklepiy"

    Dupnitsa, Kyustendil, 2600

    Recruiting

  • Medical Center Pulmo - 2018 EOOD

    Haskovo, 6300

    Recruiting

  • Diagnostic Consultative Center - 1 Lom EOOD

    Lom, Montana, 3600

    Recruiting

  • MHAT "Rahila Angelova" Pernik

    Pernik, 2300

    Recruiting

  • Diagnostic Consultative Center "Sveti Georgi" Plovdiv

    Plovdiv, 4000

    Recruiting

  • Medical Center Sveti Ivan Rilski Chudotvorets - 2010

    Plovdiv, 4003

    Recruiting

  • MHAT Samokov

    Samokov, Sofia, 2000

    Recruiting

  • Diagnostic Consultative Center - 1 - Sevlievo EOOD

    Sevlievo, Gabrovo, 5400

    Recruiting

  • Military Medical Academy

    Sofia, Sofia (stolitsa), 1606

    Recruiting

  • Ambulatory for Individual Primary Medical Care - Dr. Pavlina Petrova - Poli ET

    Sofia, 1142

    Recruiting

  • Medical Center Hera EOOD

    Sofia, 1510

    Recruiting

  • SHATPD Troyan

    Troyan Municipality, Lovech, 5600

    Recruiting

  • Medical Center Diana Med 2001

    Yambol, 8600

    Recruiting

Other trials in Bulgaria

South Korea13 sites, 13 recruiting

  • Korea University Ansan Hospital

    Ansan-si, Kyǒnggi-do, 15355

    Recruiting

  • Keimyung University Dongsan Hospital

    Daegu, Taegu-kwangyǒkshi, 42601

    Recruiting

  • Incheon Medical Center

    Donggu, Incheon-gwangyeoksi [incheon], 22532

    Recruiting

  • Chung-Ang University Hospital

    Dongjak-gu, Seoul-teukbyeolsi [seoul], 06973

    Recruiting

  • Gangnam Severance Hospital, Yonsei University Health System

    Gangnam-gu, Seoul-teukbyeolsi [seoul], 06273

    Recruiting

  • Chonnam National University Hospital

    Gwangju, Kwangju-kwangyǒkshi, 61469

    Recruiting

  • Gachon University Gil Medical Center

    Namdong-gu, Incheon-gwangyeoksi [incheon], 21565

    Recruiting

  • Korea University Anam Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 02841

    Recruiting

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 03312

    Recruiting

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 07441

    Recruiting

  • Korea University Guro Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 08308

    Recruiting

  • Ajou University Hospital

    Suwon, Kyǒnggi-do, 16499

    Recruiting

  • Wonju Severance Christian Hospital

    Wŏnju, Kang-won-do, 26426

    Recruiting

Other trials in South Korea

Germany12 sites, 11 recruiting

  • Universitätsklinikum Augsburg

    Augsburg, 86156

    Recruiting

  • Novopraxis Berlin GbR

    Berlin, 10117

    Recruiting

  • zibp Zentrum für lnfektiologie Berlin Prenzlauer Berg GmbH

    Berlin, 10439

    Recruiting

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353

    Recruiting

  • Praxis am Ebertplatz

    Cologne, North Rhine-Westphalia, 50668

    Recruiting

  • IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardio

    Frankfurt am Main, Hesse, 60596

    Recruiting

  • Universitätsklinik Freiburg

    Freiburg im Breisgau, 79106

    Recruiting

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

    Recruiting

  • LMU Klinikum München

    Munich, Bavaria, 80336

    Recruiting

  • Praxisgemeinschaft Heimeranplatz

    Munich, Bavaria, 80339

    Active, not recruiting

  • Studien Rahman & Detho

    Obertshausen, Hesse, 63179

    Recruiting

  • University of Rostock

    Rostock, 18057

    Recruiting

Other trials in Germany

Spain10 sites, 10 recruiting

  • CHUAC-Complejo Hospitalario Universitario A Coruña

    A Coruña, A Coruña [LA Coruña], 15006

    Recruiting

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010

    Recruiting

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona [barcelona], 08916

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [barcelona], 08035

    Recruiting

  • Hospital Vithas Xanit Internacional

    Benalmádena, Andalusia, 29631

    Recruiting

  • Hospital Universitario Reina Sofia

    Córdoba, Andalusia, 14004

    Recruiting

  • Hospital Universitario La Paz

    Madrid, Madrid, Comunidad de, 28046

    Recruiting

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

    Recruiting

  • Hospital Universitario Virgen de Valme

    Seville, 41014

    Recruiting

  • CHUVI- Hospital Alvaro Cunqueiro

    Vigo, Pontevedra [pontevedra], 36312

    Recruiting

Other trials in Spain

Slovakia9 sites, 9 recruiting

  • AMB4YOU s.r.o.

    Hlohovec, Trnava Region, 920 01

    Recruiting

  • Artromac n.o.

    Košice, Košice Region, 040 11

    Recruiting

  • IRS - Medicinska cinnost s.r.o., Vseobecna ambulancia pre dospelych

    Kosice-Juh, Košice Region, 040 01

    Recruiting

  • ML MED, s.r.o., Vseobecna ambulancia pre dospelych

    Moldava nad Bodvou, Košice Region, 045 01

    Recruiting

  • SALUBER SK s.r.o., Vseobecna ambulancia pre dospelych

    Nové Mesto nad Váhom, Trenčín Region, 915 01

    Recruiting

  • PULMO, s.r.o., Pneumologicko-ftizeologicka ambulancia

    Prešov, Presov, 080 01

    Recruiting

  • MUDr. Viliam Cibik, PhD., s.r.o.

    Pruské, Trenčín Region, 018 52

    Recruiting

  • Plucna ambulancia Hrebenar, s.r.o., Pneumologicko-ftizeologicka ambulancia

    Spišská Nová Ves, Košice Region, 052 01

    Recruiting

  • VL.AK s.r.o. Vseobecna ambulancia pre dospelych

    Trnava, Trnava Region, 917 01

    Recruiting

Other trials in Slovakia

South Africa9 sites, 9 recruiting

  • Langeberg Clinical Trials

    Cape Town, Western Cape, 7570

    Not yet recruiting

  • Synapta Clinical Research Centre

    Durban, KwaZulu-Natal, 4001

    Recruiting

  • Newtown Clinical Research

    Johannesburg, Gauteng, 2113

    Recruiting

  • Paarl Research Centre

    Paarl, Western Cape, 7646

    Recruiting

  • TREAD Research

    Parow, Western Cape, 7500

    Recruiting

  • Global Clinical Trials

    Pretoria, Gauteng, 0157

    Recruiting

  • Jongaie Research

    Pretoria West, Gauteng, 0183

    Recruiting

  • Sandton Medical Research Centre

    Sandton, Gauteng, 2196

    Recruiting

  • Private Practice - Dr. Peter Sebastian

    Silverglen Durban, KwaZulu-Natal, 4092

    Recruiting

Other trials in South Africa

Argentina8 sites, 8 recruiting

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABB

    Recruiting

  • Equipo Ciencia

    Buenos Aires, C1428BNF

    Recruiting

  • Sanatorio Guemes

    Ciudad de Buenos Aires, Buenos Aires, 1180

    Recruiting

  • Instituto Médico Platense (IMP)

    La Plata, Buenos Aires, B1900AVG

    Recruiting

  • Hospital Italiano de La Plata

    La Plata, Buenos Aires, B1900XI

    Recruiting

  • Centro de Investigaciones Médicas Mar del Plata

    Mar del Plata, Buenos Aires, 7600

    Recruiting

  • Instituto Médico Río Cuarto

    Río Cuarto, Córdoba Province, X5800

    Recruiting

  • Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L

    San Miguel de Tucumán, Tucumán Province, 4000

    Recruiting

Other trials in Argentina

Mexico8 sites, 8 recruiting

  • JM Research SC

    Cuernavaca, Morelos, 62290

    Recruiting

  • CIMOVA (Consultorio Anexo)

    León, Guanajuato, 37000

    Recruiting

  • Clinstile, S.A. de C.V.

    Mexico City, 06700

    Not yet recruiting

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, 14080

    Recruiting

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 64460

    Recruiting

  • Eukarya Pharmasite S.C.

    Monterrey, Nuevo León, 64718

    Recruiting

  • Asociación Mexicana para la Investigación Clínica A.C.

    Pachuca, Hidalgo, 42082

    Recruiting

  • Arké SMO S.A de C.V

    Veracruz, 91900

    Recruiting

Other trials in Mexico

Turkey (Türkiye)8 sites, 8 recruiting

  • Ankara University Ibni Sina Hospital

    Ankara, 06230

    Recruiting

  • Hacettepe Universite Hastaneleri

    Ankara, 06230

    Recruiting

  • Ankara Bilkent Şehir Hastanesi

    Ankara, 06800

    Recruiting

  • Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

    Gaziantep, 27310

    Recruiting

  • Acibadem Universitesi Atakent Hastanesi

    Istanbul, İ̇stanbul, 34303

    Recruiting

  • Kocaeli Üniversitesi

    Kocaeli, 41380

    Recruiting

  • Sakarya Training and Research Hospital

    Sakarya, 54100

    Recruiting

  • Karadeniz Technical University

    Trabzon, 61080

    Recruiting

Other trials in Turkey (Türkiye)

Canada5 sites, 5 recruiting

  • Clinical Research of Ontario

    Scarborough Village, Ontario, M1S 4T7

    Recruiting

  • Vancouver Infectious Diseases Centre

    Vancouver, British Columbia, V6Z 2E9

    Recruiting

  • Community Care Building

    Winchester, Ontario, K0C 2K0

    Recruiting

  • Dundas Manor Nursing Home

    Winchester, Ontario, K0C 2K0

    Recruiting

  • Winchester District Memorial Hospital

    Winchester, Ontario, K0C 2K0

    Recruiting

Other trials in Canada

Czechia5 sites, 3 recruiting

  • Doktor Brno

    Brno, Brno-město, 602 00

    Active, not recruiting

  • Ordinace Hradebni s.r.o.

    České Budějovice, South Bohemian Region, 370 01

    Recruiting

  • ORL MUDr Pavel Navratil

    Olomouc, 779 00

    Recruiting

  • Lékařský dům v Mezibranské

    Prague, Praha 1, 110 00

    Active, not recruiting

  • Zdravi-fit

    Protivín, South Bohemian Region, 398 11

    Recruiting

Other trials in Czechia

Denmark5 sites, 5 recruiting

  • Rigshospitalet

    Copenhagen, Capital Region, 2100

    Recruiting

  • Aalborg Universitetshospital, Syd

    Gistrup, 9260

    Not yet recruiting

  • Regionshospitalet Gødstrup

    Herning, Central Jutland, 7400

    Recruiting

  • Nordsjællands Hospital - Hillerød

    Hilleroed, Capital Region, 3400

    Recruiting

  • Roskilde Sygehus

    Roskilde, Region Sjælland, 4000

    Recruiting

Other trials in Denmark

Taiwan5 sites, 5 recruiting

  • Far Eastern Memorial Hospital

    New Taipei City, NEW Taipei, 220

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 407

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Recruiting

  • Tri-Service General Hospital

    Taipei, 114

    Recruiting

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

    Recruiting

Other trials in Taiwan

Finland4 sites, 4 recruiting

  • FVR, Etelä-Helsingin rokotetutkimusklinikka

    Helsinki, Uusimaa, 00100

    Recruiting

  • MeVac - Meilahti Vaccine Research Center

    Helsinki, Uusimaa, 00290

    Recruiting

  • FVR, Oulun rokotetutkimusklinikka

    Oulu, North Ostrobothnia, 90220

    Recruiting

  • FVR, Tampereen rokotetutkimusklinikka

    Tampere, Pirkanmaa, 33100

    Recruiting

Other trials in Finland

Belgium2 sites, 2 recruiting

  • ANIMA Research

    Alken, Limburg, 3570

    Recruiting

  • Pneumocare

    Erpent, 5101

    Recruiting

Other trials in Belgium

About this study

Official title: 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.

Being tested
ibuzatrelvir, placebo
Keywords
Pneumonia, Viral, Pneumonia, Respiratory Tract Infections, Infections, Virus Diseases, Coronavirus Infections, Coronaviridae Infections, Nidovirales Infections, RNA Virus Infections, Lung Diseases, Respiratory Tract Diseases, COVID-19, Viral Protease Inhibitors, Protease Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action, Antiviral Agents, Anti-Infective Agents, ibuzatrelvir
Medical subject headings
Pneumonia, Viral, Pneumonia, Respiratory Tract Infections, Infections, Virus Diseases, Coronavirus Infections, Coronaviridae Infections, Nidovirales Infections

What participants receive

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

  • ibuzatrelvirDrug

    Also called PF-07817883

    ibuzatrelvir tablets

  • placeboDrug

    placebo tablets

Study groups in NCT06679140
Study groupRoleWhat they receive
ibuzatrelvirExperimentalIbuzatrelvir administered orally every 12 hours (twice daily) for a total of 5 days.
Receives: Drug: ibuzatrelvir
placeboPlacebo comparatorplacebo administered orally every 12 hours (twice daily) for 5 days.
Receives: Drug: placebo

What is being measured

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

  1. Proportion of participants with COVID-19 related emergency department visits, all cause hospitalization and all cause mortality

    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.

    Measured: Day 1 through Day 28

Secondary outcomes (19)

  1. Time to sustained resolution of all COVID-19 targeted symptoms

    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.

    Measured: Day 1 to Day 28

  2. Proportion of participants with post acute COVID-19 medical events

    Medical events include cardiovascular events, pulmonary events, acute kidney disease and thromboembolic events.

    Measured: Day 29 to Week 24

  3. Proportion of participants with cardiovascular, renal and pulmonary events

    Medical events include cardiovascular events, pulmonary events, acute kidney disease and thromboembolic events.

    Measured: Day 1 to Week 24

  4. Proportion of participants with Long COVID symptoms

    The difference in proportions of patients with Long COVID symptoms at Week 24. Symptoms will be assessed through a weekly electronic diary.

    Measured: Day 29 to Week 24

  5. Changes from baseline in SARS-CoV-2 RNA levels in nasopharyngeal/nasal swabs

    The viral load is measured in nasal or nasopharyngeal samples using reverse transcription polymerase chain reaction (RT-PCR)

    Measured: Day 1 through Day 34

  6. Time to SARS-CoV-2 RNA <LLOQ

    Time needed to achieve a viral load below the lower limit of quantification of the essay used to measure it.

    Measured: Day 1 through Day 34

  7. Proportion of participants with SARS-CoV-2 RNA <LLOQ at each visit

    Proportion of participants with a SARS-CoV-2 viral load below the lower limit of quantification of the essay used to measure it.

    Measured: Day 1 through Day 34

  8. Proportion of participants with rebound in SARS-CoV-2 RNA levels in nasopharyngeal swab

    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.

    Measured: Day 10 and Day 14

  9. Proportion of participants with virologic and symptomatic rebound through Day 28

    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.

    Measured: Day 10 to Day 34

  10. Proportion of participants with COVID-19-related hospitalization or all cause death through Day 28.

    Measured: Day 1 to Day 28

  11. Number of days in hospital and ICU stay in participants with hospitalization (all-cause).

    Measured: Day 1 to Week 24

  12. Number of medical visits through Week 24.

    medical visits include emergency department visits, hospitalizations, visits to the general practitioner and specialist.

    Measured: Day 1 to Week 24

  13. Proportion of participants with hospitalization (all-cause) or death (all-cause) through Week 24.

    Measured: Day 1 to Week 24

  14. Time (days) to sustained alleviation of all targeted symptoms through 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.

    Measured: Day 1 to Day 28

  15. Proportion of participants with severe symptoms attributed to COVID-19 through 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.

    Measured: Day 1 to Day 28

  16. Duration of each targeted COVID-19 symptom.

    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.

    Measured: Day 1 to Day 28

  17. Proportion of participants with symptomatic rebound through 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

    Measured: Day 1 to Day 28

  18. Incidence of treatment emergent adverse events

    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.

    Measured: Day 1 to Day 34

  19. Incidence of SAEs and AEs leading to discontinuations.

    Measured: Day 1 to Day 34

Timeline

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

  1. First posted7 Nov 2024
  2. Study start8 Dec 2024
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion12 Feb 2028 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06679140
Sponsor's protocol ID
C5091017
Other IDs
2024-517727-39-00
Status last verified
Oct 2026
First submitted
5 Nov 2024
Last updated
15 Oct 2026
Results posted
No
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ibuzatrelvir in people with COVID-19 SARS-CoV-2 Infection, run by Pfizer at 256 sites in 19 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 10 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 256 sites in United States, Brazil, China, Japan, Bulgaria and 14 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 phase mean?

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with COVID-19 related emergency department visits, all cause hospitalization and all cause mortality (time frame: Day 1 through Day 28). 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 NCT06679140.

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 15 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in