NCT06679140From ClinicalTrials.govRecruiting

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

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

COVID-19 SARS-CoV-2 Infection

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Pfizer
Enrolment target: 2,330
Started: 8 December 2024
Main results due: 1 October 2027
Study sites: 253
Registry updated: 25 September 2026

Can you take part?

Aged 12 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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.

What this study is about

In the sponsor’s own words, from the registry.

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 sites(253)

University of Alabama at Birmingham, Huntsville Regional Medical Campus (HRMC)
Huntsville, Alabama, United States
Not yet recruiting
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Recruiting
National Institute of Clinical Research - Bakersfield
Bakersfield, California, United States
Recruiting
Velocity Clinical Research, Huntington Park
Huntington Park, California, United States
Recruiting
310 Clinical Research
Inglewood, California, United States
Recruiting
Long Beach Research Institute
Long Beach, California, United States
Recruiting
Long Beach Clinical Trials
Long Beach, California, United States
Recruiting
Pacific Clinical Studies Inc.
Los Alamitos, California, United States
Recruiting
Downtown L.A. Research Center, Inc.
Los Angeles, California, United States
Recruiting
Clinica mi Salud by Focil Med
Oxnard, California, United States
Recruiting
FOMAT Medical Research
Oxnard, California, United States
Recruiting
Paradigm Clinical Research, LLC
Redding, California, United States
Recruiting
Acclaim Clinical Research
San Diego, California, United States
Active, not recruiting
Tweedy Medical Group - Charity Health
South Gate, California, United States
Recruiting
Breathe Clear Institute for Sinus and Allergy Relief
Torrance, California, United States
Recruiting
Paradigm Clinical Research, LLC
Wheat Ridge, Colorado, United States
Recruiting
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Recruiting
Emerson Clinical Research Institute
Washington D.C., District of Columbia, United States
Recruiting
Innovative Research of West Florida
Clearwater, Florida, United States
Recruiting
Invictus Clinical Research Group
Coconut Creek, Florida, United States
Recruiting
Hillcrest Medical Research LLC
DeLand, Florida, United States
Recruiting
Hillcrest Medical Research
DeLand, Florida, United States
Recruiting
Universal Axon Clinical Research, LLC
Doral, Florida, United States
Recruiting
Herco Medical and Research Center Inc
Flagami, Florida, United States
Recruiting
Proactive Clinical Research,LLC
Fort Lauderdale, Florida, United States
Recruiting
C & R Research Services USA
Fort Myers, Florida, United States
Recruiting
Qway Research LLC
Hialeah, Florida, United States
Recruiting
Sunbright Health Medical Centers
Homestead, Florida, United States
Recruiting
Infinite Clinical Research
Miami, Florida, United States
Recruiting
Bio-Medical Research LLC
Miami, Florida, United States
Recruiting
Kendall South Medical Center
Miami, Florida, United States
Recruiting
Global Health Research Center, Inc.
Miami Lakes, Florida, United States
Recruiting
Adult Medicine of Lake County, Inc.
Mt. Dora, Florida, United States
Recruiting
Innovation Medical Research Center
Palmetto Bay, Florida, United States
Recruiting
DBC Research USA
Pembroke Pines, Florida, United States
Recruiting
GCP , Global Clinical Professionals
St. Petersburg, Florida, United States
Recruiting
Global Health Research Center - Tampa
Tampa, Florida, United States
Recruiting
The Hope Clinic of Emory University
Decatur, Georgia, United States
Recruiting
Javara - Privia Medical Group Georgia - Fayetteville
Fayetteville, Georgia, United States
Recruiting
Coastal Heritage Clinical Research
Hinesville, Georgia, United States
Recruiting
Velocity Clinical Research, Savannah
Savannah, Georgia, United States
Recruiting
St. Luke's Humphreys Diabetes Center
Boise, Idaho, United States
Recruiting
St. Luke's Children's
Boise, Idaho, United States
Recruiting
St. Luke's Elks Children's Pavilion
Boise, Idaho, United States
Recruiting
Koch Family Medicine
Morton, Illinois, United States
Recruiting
UL International Travel Clinic
Louisville, Kentucky, United States
Recruiting
University of Louisville Hospital
Louisville, Kentucky, United States
Recruiting
University of Louisville School of Medicine
Louisville, Kentucky, United States
Recruiting
Centennial Medical Group
Columbia, Maryland, United States
Recruiting
Jadestone Clinical Research
Silver Spring, Maryland, United States
Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, United States
Recruiting
Lucida Clinical Trials
New Bedford, Massachusetts, United States
Recruiting
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
Recruiting
Revival Research Institute, LLC
Dearborn, Michigan, United States
Recruiting
Henry Ford St. John Hospital
Grosse Pointe Woods, Michigan, United States
Recruiting
Mercury Street Medical Group, PLLC
Butte, Montana, United States
Recruiting
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, United States
Recruiting
Velocity Clinical Research, Omaha
Omaha, Nebraska, United States
Recruiting
McGill Family Practice
Papillion, Nebraska, United States
Recruiting
Las Vegas Clinical Trials
North Las Vegas, Nevada, United States
Recruiting

Showing 60 of 253 sites — filter to narrow it down. 239 of the 253 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06679140. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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