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
Pfizer
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 range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Drugibuzatrelvir
ibuzatrelvir tablets
- Drugplacebo
placebo tablets
Locations (103)
- National Institute of Clinical Research - BakersfieldBakersfield, California
- Velocity Clinical Research, Huntington ParkHuntington Park, California
- 310 Clinical ResearchInglewood, California
- Long Beach Clinical TrialsLong Beach, California
- Pacific Clinical Studies Inc.Los Alamitos, California
- FOMAT Medical ResearchOxnard, California