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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT06679140•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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

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).
+5 more criteria

Locations (234)

Applied Research Center of Arkansas

Little Rock, Arkansas, United States

National Institute of Clinical Research - Bakersfield

Bakersfield, 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

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

Key Dates

Start Date

December 8, 2024

Primary Completion Date

October 3, 2027

Completion Date

March 2, 2028

Last Updated

March 11, 2026

Enrollment

2,330

ESTIMATED participants

Conditions

COVID-19 SARS-CoV-2 Infection

Interventions

ibuzatrelvir

DRUG

placebo

DRUG

Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com