Trials / Recruiting
RecruitingNCT06679140
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,330 (estimated)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ibuzatrelvir | ibuzatrelvir tablets |
| DRUG | placebo | placebo tablets |
Timeline
- Start date
- 2024-12-08
- Primary completion
- 2027-10-03
- Completion
- 2028-03-02
- First posted
- 2024-11-07
- Last updated
- 2026-04-16
Locations
237 sites across 19 countries: United States, Argentina, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, Finland, Germany, Japan, Mexico, Slovakia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06679140. Inclusion in this directory is not an endorsement.