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RECRUITING

NCT06679140

PHASE3

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2330

Start Date

2024-12-08

Completion Date

2028-02-12

Last Updated

2026-10-15

Healthy Volunteers

Conditions

COVID-19 SARS-CoV-2 Infection

Interventions

DRUG

ibuzatrelvir

ibuzatrelvir tablets

DRUG

placebo

placebo tablets

Inclusion Criteria: 1. 12 to \<18 years of age, weighing at least 40 kg, or ≥18 years of age of any weight at screening. 2. 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. 3. 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. 4. Participants must be unable or unwilling to take nirmatrelvir/ritonavir. Exclusion Criteria: 1. 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. 2. 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. 3. 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. 4. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may 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 to study entry, or that is considered life threatening within 30 days prior to study entry, as determined by the investigator. 8. History of hypersensitivity or other contraindication to any of the components of the study interventions. 9. 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. 10. 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.

Locations (256)

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

Huntsville, Alabama, United States

Applied Research Center of Arkansas

Little Rock, Arkansas, United States

National Institute of Clinical Research - Bakersfield

Bakersfield, California, United States

Velocity Clinical Research, Huntington Park

Huntington Park, California, United States

310 Clinical Research

Inglewood, California, United States

Long Beach Research Institute

Long Beach, California, United States

Long Beach Clinical Trials

Long Beach, California, United States

Pacific Clinical Studies Inc.

Los Alamitos, California, United States

Downtown L.A. Research Center, Inc.

Los Angeles, California, United States

Clinica mi Salud by Focil Med

Oxnard, California, United States

FOMAT Medical Research

Oxnard, California, United States

Paradigm Clinical Research, LLC

Redding, California, United States

Acclaim Clinical Research

San Diego, California, United States

Tweedy Medical Group - Charity Health

South Gate, California, United States

Breathe Clear Institute for Sinus and Allergy Relief

Torrance, California, United States

Paradigm Clinical Research, LLC

Wheat Ridge, Colorado, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Emerson Clinical Research Institute

Washington D.C., District of Columbia, United States

Innovative Research of West Florida

Clearwater, Florida, United States

Invictus Clinical Research Group

Coconut Creek, Florida, United States

Hillcrest Medical Research LLC

DeLand, Florida, United States

Hillcrest Medical Research

DeLand, Florida, United States

Universal Axon Clinical Research, LLC

Doral, Florida, United States

Herco Medical and Research Center Inc

Flagami, Florida, United States

Proactive Clinical Research,LLC

Fort Lauderdale, Florida, United States

C & R Research Services USA

Fort Myers, Florida, United States

Qway Research LLC

Hialeah, Florida, United States

Sunbright Health Medical Centers

Homestead, Florida, United States

Infinite Clinical Research

Miami, Florida, United States

Bio-Medical Research LLC

Miami, Florida, United States

Kendall South Medical Center

Miami, Florida, United States

Global Health Research Center, Inc.

Miami Lakes, Florida, United States

Adult Medicine of Lake County, Inc.

Mt. Dora, Florida, United States

Innovation Medical Research Center

Palmetto Bay, Florida, United States

DBC Research USA

Pembroke Pines, Florida, United States

GCP , Global Clinical Professionals

St. Petersburg, Florida, United States

Global Health Research Center - Tampa

Tampa, Florida, United States

The Hope Clinic of Emory University

Decatur, Georgia, United States

Javara - Privia Medical Group Georgia - Fayetteville

Fayetteville, Georgia, United States

Coastal Heritage Clinical Research

Hinesville, Georgia, United States

Velocity Clinical Research, Savannah

Savannah, Georgia, United States

St. Luke's Humphreys Diabetes Center

Boise, Idaho, United States

St. Luke's Children's

Boise, Idaho, United States

St. Luke's Elks Children's Pavilion

Boise, Idaho, United States

Endeavor Health Evanston Hospital

Evanston, Illinois, United States

Koch Family Medicine

Morton, Illinois, United States

Endeavor Health Clinical Trials Center

Skokie, Illinois, United States

Endeavor Health Immediate Care - Old Orchard

Skokie, Illinois, United States

UL International Travel Clinic

Louisville, Kentucky, United States

University of Louisville Hospital

Louisville, Kentucky, United States

University of Louisville School of Medicine

Louisville, Kentucky, United States

Centennial Medical Group

Columbia, Maryland, United States

Jadestone Clinical Research

Silver Spring, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Lucida Clinical Trials

New Bedford, Massachusetts, United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Revival Research Institute, LLC

Dearborn, Michigan, United States

Henry Ford St. John Hospital

Grosse Pointe Woods, Michigan, United States

Mercury Street Medical Group, PLLC

Butte, Montana, United States

Velocity Clinical Research, Grand Island

Grand Island, Nebraska, United States

Velocity Clinical Research, Omaha

Omaha, Nebraska, United States

McGill Family Practice

Papillion, Nebraska, United States

Las Vegas Clinical Trials

North Las Vegas, Nevada, United States

Upstate Global Health Institute

East Syracuse, New York, United States

Upstate Connect Care

Syracuse, New York, United States

Prime Global Research

The Bronx, New York, United States

Monroe Biomedical Research

Monroe, North Carolina, United States

Remington-Davis, Inc

Columbus, Ohio, United States

Preferred Primary Care Physicians

Uniontown, Pennsylvania, United States

Medical University of South Carolina Ashley River Tower

Charleston, South Carolina, United States

Medical University of South Carolina - SCTR Research Nexus

Charleston, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

WR-Clinsearch, LLC

Chattanooga, Tennessee, United States

Zenos Clinical Research

Dallas, Texas, United States

Southwest Family Medicine Associates

Dallas, Texas, United States

Southwest Mind and Body Care

Dallas, Texas, United States

Memorial Hermann Hospital TMC

Houston, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

UT Physicians

Houston, Texas, United States

Next Level Urgent Care

Houston, Texas, United States

Gulf Coast Clinical Research - Houston

Houston, Texas, United States

Mercury Clinical Research - Santa Clara Family Clinic

Houston, Texas, United States

The Crofoot Research Center

Houston, Texas, United States

Epic Clinical Research

Lewisville, Texas, United States

Javara - Privia Medical Group North Texas - Stephenville

Stephenville, Texas, United States

Javara - Privia Medical Group Gulf Coast - Sugarland

Sugar Land, Texas, United States

Mercury Clinical Research - North Houston Internal Medicine & Pediatric Clinic

Tomball, Texas, United States

Velocity Clinical Research, Waco

Waco, Texas, United States

Alpine Research Organization

Clinton, Utah, United States

Velocity Clinical Research, Suffolk

Suffolk, Virginia, United States

Sanatorio Guemes

Ciudad de Buenos Aires, Buenos Aires, Argentina

Instituto Médico Platense (IMP)

La Plata, Buenos Aires, Argentina

Hospital Italiano de La Plata

La Plata, Buenos Aires, Argentina

Centro de Investigaciones Médicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, Argentina

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

San Miguel de Tucumán, Tucumán Province, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Equipo Ciencia

Buenos Aires, Argentina

ANIMA Research

Alken, Limburg, Belgium

Pneumocare

Erpent, Belgium

And 156 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (256)