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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
NCT05261139 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG nirmatrelvir
- DRUG ritonavir
Study Locations (20)
California
- Children's Hospital Los Angeles — Los Angeles
- Kaiser Permanente — Los Angeles
- UCLA David Geffen School of Medicine — Los Angeles
- UCLA — Los Angeles
Georgia
- Children's Healthcare of Atlanta - Arthur M. Blank Hospital — Atlanta
- Rophe Adult and Pediatric Medicine/SKYCRNG — Union City
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
- University of Chicago Medical Center — Chicago
Massachusetts
- Boston Medical Center — Boston
- University of Massachusetts Chan Medical School — Worcester
Missouri
- St. Louis Children's Hospital — St Louis
- Washington University School of Medicine — St Louis
Arizona
- Phoenix Children's Hospital — Phoenix
District of Columbia
- Children's National Medical Center — Washington D.C.
Florida
- Life Spring Research Foundation — Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2022-03-07 |
| Est. Completion | 2026-07-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05261139
The ClinicalTrials.gov registry entry for NCT05261139 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 2 interventions — of which nirmatrelvir is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05261139 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Georgia, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05261139 about?
NCT05261139 is a clinical study titled "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". 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/ri...
What is the current status of trial NCT05261139?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2022-03-07. Estimated completion is 2026-07-30.
What conditions does trial NCT05261139 study?
This clinical trial studies the following conditions: COVID-19. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05261139?
The interventions under investigation include: nirmatrelvir (DRUG), ritonavir (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05261139?
This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05261139 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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