Trials / Recruiting
RecruitingNCT05261139
EPIC-Peds: A Study to Learn About the Study Medicine Called PF-07321332 (Nirmatrelvir)/Ritonavir in Patients Under 18 Years of Age With COVID-19 That Are Not Hospitalized But Are at Risk for Severe Disease
A PHASE 2/3, INTERVENTIONAL SAFETY, PHARMACOKINETICS, AND EFFICACY, OPEN-LABEL, MULTI-CENTER, SINGLE-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332 (NIRMATRELVIR)/RITONAVIR IN NONHOSPITALIZED SYMPTOMATIC PEDIATRIC PARTICIPANTS WITH COVID-19 WHO ARE AT RISK OF PROGRESSION TO SEVERE DISEASE
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 0 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical trial is to learn about the safety, pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it), and efficacy (how well a study treatment works in the study) of the study medicine (called nirmatrelvir/ritonavir) for potential treatment of coronavirus disease 2019 (COVID-19). The study medicine will be given to patients under 18 years of age with COVID-19 that are not hospitalized but are at risk for severe disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | nirmatrelvir | PF-07321332 |
| DRUG | ritonavir | ritonavir |
Timeline
- Start date
- 2022-03-07
- Primary completion
- 2026-07-30
- Completion
- 2026-07-30
- First posted
- 2022-03-02
- Last updated
- 2025-07-17
Locations
73 sites across 7 countries: United States, Bulgaria, Japan, Mexico, Puerto Rico, South Africa, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05261139. Inclusion in this directory is not an endorsement.