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

Last updated: May 15, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

3

Condition

Covid-19

Treatment

placebo

ibuzatrelvir

Clinical Study ID

NCT06679140
C5091017
2024-517727-39-00
  • Ages > 12
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 12 to <18 years of age, weighing at least 40 kg, or ≥18 years of age of any weightat screening.

  2. Presence of risk factors for progression to severe COVID-19 at the time of screeningbased on age:

  3. 12 to 49 years of age with at least two risk factors, where one must bemoderate immunocompromise;

  4. 50 to 64 years of age with at least two risk factors;

  5. 65 to 74 years of age with at least one risk factor;

  6. For participants 75 years of age or older, there are no requirements related torisk factors. The list of risk factors includes: BMI ≥30 kg/m2; Current smoker; Chronic lung disease; Cardiovascular disease; Type 1or Type 2 diabetes mellitus; Mild to moderate renal impairment; Neurodevelopmentaldisorders; Sickle cell disease; Moderate immunosuppression.

  7. Confirmed SARS-CoV-2 infection as determined by RAT in nasal specimen collectedwithin 1 day prior to randomization. Initial onset of symptoms attributable toCOVID-19 within 5 days prior to randomization and at least 1 of the specifiedsymptoms attributable to COVID-19 present on the day of randomization. Randomizationmust occur no later than the 5th day, where the onset of symptoms is the first day.

  8. Participants must be unable or unwilling to take nirmatrelvir/ritonavir.

Exclusion

Exclusion Criteria:

  1. Current need or anticipated need for hospitalization within 24 hours, due to signsof severe COVID-19 illness (eg, SpO2 <94% on room air, respiratory rate >30breaths/minute, or lung infiltrates >50%) or due to other medical conditionsrequiring hospitalization in the opinion of the site investigator.

  2. Receiving dialysis or have known severe renal impairment [ie, eGFR <30 mL/min/1.73m2 for adults or CrCl <30 mL/min for adolescents] within 6 months of the screeningvisit, using the serum creatinine-based CKD-EPI formula or the Cockroft Gault,respectively.

  3. Active liver disease with AST or ALT >3 ULN, Total bilirubin ≥2 × ULN (for Gilbert'ssyndrome, direct bilirubin >ULN is exclusionary) within the past 3 months, or liverfunction impairment with Class C per Child Pugh classification.

  4. Suspected or confirmed concurrent active systemic infection other than COVID-19 thatmay interfere with the evaluation of response to the study intervention.

  5. Ongoing Long COVID or Post Acute Sequelae of COVID-19 diagnosis.

  6. Severely immunocompromised.

  7. Any comorbidity requiring hospitalization and/or surgery within 7 days prior tostudy entry, or that is considered life threatening within 30 days prior to studyentry, as determined by the investigator.

  8. Any medical or psychiatric condition including recent (within the past year) oractive suicidal ideation/behavior or laboratory abnormality that may increase therisk of study participation or, in the investigator's judgment, make the participantinappropriate for the study.

  9. Current use of any prohibited concomitant medication(s).

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

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

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

  13. Prior participation in this clinical trial or any other clinical trial ofibuzatrelvir.

  14. Investigator site staff directly involved in the conduct of the study and theirfamily members, site staff otherwise supervised by the investigator, and sponsor andsponsor delegate employees directly involved in the conduct of the study and theirfamily members.

Study Design

Total Participants: 2330
Treatment Group(s): 2
Primary Treatment: placebo
Phase: 3
Study Start date:
December 08, 2024
Estimated Completion Date:
May 06, 2027

Connect with a study center

  • Vancouver Infectious Diseases Centre

    Vancouver, British Columbia V6Z 2C7
    Canada

    Site Not Available

  • Clinical Research of Ontario

    Scarborough, Ontario M1S 4T7
    Canada

    Site Not Available

  • Diex Recherche Quebec

    Quebec, G1V 4T3
    Canada

    Site Not Available

  • Kamezawa Clinic

    Kasugai, Aichi 486-0817
    Japan

    Site Not Available

  • International University of Health and Welfare Narita Hospital

    Narita, Chiba 286-8520
    Japan

    Site Not Available

  • Tashiro Endocrinology Clinic

    Fukuoka-shi, Fukuoka 814-0153
    Japan

    Site Not Available

  • Medical Corporation Kouhoukai Takagi Hospital

    Okawa-shi, Fukuoka 831-0016
    Japan

    Site Not Available

  • Nishioka Hospital

    Sapporo, Hokkaido 062-0034
    Japan

    Site Not Available

  • Terada Clinic Respiratory Medicine & General Practice

    Himeji, Hyogo 670-0849
    Japan

    Site Not Available

  • Tsuchiura Beryl Clinic

    Tsuchiura, Ibaraki 300-0062
    Japan

    Site Not Available

  • National Hospital Organization Okinawa Hospital

    Ginowan, Okinawa 901-2214
    Japan

    Site Not Available

  • Fukuwa Clinic

    Chuo-ku, Tokyo 104-0031
    Japan

    Site Not Available

  • Musashino Emergency Hospital

    Kodaira-shi, Tokyo 187-0031
    Japan

    Site Not Available

  • Swing Nozaki Clinic

    Musashino-shi, Tokyo 180-0022
    Japan

    Site Not Available

  • Yoshijima Hospital

    Hiroshima, 730-0822
    Japan

    Site Not Available

  • Rakuwakai Otowa Hospital

    Kyoto, 607-8062
    Japan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

  • Applied Research Center of Arkansas

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • National Institute of Clinical Research - Bakersfield

    Bakersfield, California 93309
    United States

    Active - Recruiting

  • 310 Clinical Research

    Inglewood, California 90301
    United States

    Site Not Available

  • Long Beach Research Institute

    Long Beach, California 90805
    United States

    Active - Recruiting

  • Downtown L.A. Research Center, Inc.

    Los Angeles, California 90017
    United States

    Active - Recruiting

  • Clinica mi Salud by Focil Med

    Oxnard, California 93030
    United States

    Site Not Available

  • FOMAT Medical Research

    Oxnard, California 93030
    United States

    Site Not Available

  • Tweedy Medical Group - Charity Health

    S. Gate, California 90280
    United States

    Site Not Available

  • Acclaim Clinical Research

    San Diego, California 92120
    United States

    Active - Recruiting

  • Breathe Clear Institute for Sinus and Allergy Relief

    Torrance, California 90503
    United States

    Site Not Available

  • Clinical Research of California

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Clinical Research of California

    West Hills, California 91307
    United States

    Active - Recruiting

  • Paradigm Clinical Research, LLC

    Wheat Ridge, Colorado 80033
    United States

    Site Not Available

  • Emerson Clinical Research Institute

    Washington, District of Columbia 20009
    United States

    Site Not Available

  • Innovative Research of West Florida

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Invictus Clinical Research Group

    Coconut Creek, Florida 33073
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research, LLC

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Herco Medical and Research Center Inc

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • Hillcrest Medical Research

    DeLand, Florida 32720
    United States

    Active - Recruiting

  • Hillcrest Medical Research LLC

    DeLand, Florida 32720
    United States

    Active - Recruiting

  • Universal Axon Clinical Research, LLC

    Doral, Florida 33166
    United States

    Site Not Available

  • Proactive Clinical Research,LLC

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Qway Research LLC

    Hialeah, Florida 33010
    United States

    Site Not Available

  • Sunbright Health Medical Centers

    Homestead, Florida 33032
    United States

    Active - Recruiting

  • Bio-Medical Research LLC

    Miami, Florida 33144
    United States

    Active - Recruiting

  • Kendall South Medical Center

    Miami, Florida 33185
    United States

    Active - Recruiting

  • Global Health Research Center, Inc.

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • Adult Medicine of Lake County, Inc.

    Mount Dora, Florida 32757
    United States

    Site Not Available

  • Innovation Medical Research Center

    Palmetto Bay, Florida 33157
    United States

    Active - Recruiting

  • DBC Research USA

    Pembroke Pines, Florida 33029
    United States

    Site Not Available

  • GCP Research, Global Clinical professionals

    Saint Petersburg, Florida 33705
    United States

    Active - Recruiting

  • Global Health Research Center - Tampa

    Tampa, Florida 33615
    United States

    Site Not Available

  • Javara - Privia Medical Group Georgia - Fayetteville

    Fayetteville, Georgia 30214
    United States

    Site Not Available

  • Coastal Heritage Clinical Research

    Hinesville, Georgia 31313
    United States

    Active - Recruiting

  • Koch Family Medicine

    Morton, Illinois 61550
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Oak Brook, Illinois 60523
    United States

    Active - Recruiting

  • Centennial Medical Group

    Columbia, Maryland 21045
    United States

    Site Not Available

  • Jadestone Clinical Research

    Silver Spring, Maryland 20904
    United States

    Site Not Available

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Revival Research Institute, LLC

    Dearborn, Michigan 48126
    United States

    Active - Recruiting

  • Henry Ford St. John Hospital

    Grosse Pointe Woods, Michigan 48236
    United States

    Active - Recruiting

  • Mercury Street Medical Group, PLLC

    Butte, Montana 59701
    United States

    Active - Recruiting

  • Velocity Clinical Research, Grand Island

    Grand Island, Nebraska 68803
    United States

    Active - Recruiting

  • McGill Family Practice

    Papillion, Nebraska 68046
    United States

    Site Not Available

  • Las Vegas Clinical Trials

    North Las Vegas, Nevada 89030
    United States

    Active - Recruiting

  • Prime Global Research

    Bronx, New York 10456
    United States

    Site Not Available

  • Monroe Biomedical Research

    Monroe, North Carolina 28112
    United States

    Active - Recruiting

  • Remington-Davis, Inc

    Columbus, Ohio 43215
    United States

    Active - Recruiting

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania 15401
    United States

    Active - Recruiting

  • WR-Clinsearch, LLC

    Chattanooga, Tennessee 37421
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research, LLC

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Southwest Family Medicine Associates

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • Southwest Mind and Body Care

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • Gulf Coast Clinical Research - Houston

    Houston, Texas 77070
    United States

    Active - Recruiting

  • Mercury Clinical Research - Santa Clara Family Clinic

    Houston, Texas 77087
    United States

    Active - Recruiting

  • Next Level Urgent Care

    Houston, Texas 77057
    United States

    Active - Recruiting

  • Santa Clara Family Clinic

    Houston, Texas 77087
    United States

    Active - Recruiting

  • The Crofoot Research Center

    Houston, Texas 77098
    United States

    Active - Recruiting

  • Epic Clinical Research

    Lewisville, Texas 75057
    United States

    Site Not Available

  • Javara - Privia Medical Group North Texas - Stephenville

    Stephenville, Texas 76401
    United States

    Active - Recruiting

  • Javara - Privia Medical Group Gulf Coast - Sugarland

    Sugar Land, Texas 77478
    United States

    Active - Recruiting

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

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • North Houston Internal Medicine & Pediatric Clinic

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • Alpine Research Organization

    Clinton, Utah 84015
    United States

    Active - Recruiting

  • Eastside Research Associates

    Redmond, Washington 98052
    United States

    Site Not Available

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