RecruitingCOVID-19 SARS-CoV-2 Infection

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

Eligible age

12+ yrs

Accepts

All genders

Locations

24 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

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.

Sponsor: Pfizer

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.