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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05261139

Public ClinicalTrials.gov record NCT05261139. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 12:31 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05261139
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Pfizer
Industry
Enrollment
160 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
0 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 6, 2022
Primary completion
Jul 29, 2026
Completion
Jul 29, 2026
Last update posted
Jul 16, 2025

2022 – 2026

United States locations

U.S. sites
50
U.S. states
22
U.S. cities
35
Facility City State ZIP Site status
Phoenix Children's Hospital Phoenix Arizona 85016 Active, not recruiting
Children's Hospital Los Angeles Los Angeles California 90027 Active, not recruiting
Kaiser Permanente Los Angeles California 90027 Active, not recruiting
UCLA David Geffen School of Medicine Los Angeles California 90095 Not yet recruiting
UCLA Los Angeles California 90095 Not yet recruiting
Children's National Medical Center Washington D.C. District of Columbia 20010 Active, not recruiting
Life Spring Research Foundation Miami Florida 33130 Recruiting
Children's Healthcare of Atlanta - Arthur M. Blank Hospital Atlanta Georgia 30329 Recruiting
Rophe Adult and Pediatric Medicine/SKYCRNG Union City Georgia 30291 Terminated
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois 60611 Active, not recruiting
University of Chicago Medical Center Chicago Illinois 60637 Recruiting
Louisiana State University Health Sciences Shreveport Shreveport Louisiana 71101 Recruiting
Johns Hopkins Hospital Baltimore Maryland 21287 Not yet recruiting
Boston Medical Center Boston Massachusetts 02118 Active, not recruiting
University of Massachusetts Chan Medical School Worcester Massachusetts 01655 Terminated
Childrens Hospitals and Clinics of Minnesota Minneapolis Minnesota 55404 Not yet recruiting
SKY Integrative Medical Center/SKYCRNG Ridgeland Mississippi 39157 Active, not recruiting
St. Louis Children's Hospital St Louis Missouri 63110 Not yet recruiting
Washington University School of Medicine St Louis Missouri 63110 Not yet recruiting
Children's Hospital & Medical Center Omaha Nebraska 68114 Terminated
University of New Mexico Hospital, COVID-19 Research Clinic Albuquerque New Mexico 87102 Terminated
University of New Mexico Clinical and Translational Science Center Albuquerque New Mexico 87106 Terminated
Suny University at Buffalo Buffalo New York 14203 Not yet recruiting
Advanced Specialty Care Commack New York 11725 Not yet recruiting
Stony Brook Medicine Clinical Research Center East Setauket New York 11733 Not yet recruiting
Cohen Children's Medical Center New Hyde Park New York 11040 Not yet recruiting
Columbia University Irving Medical Center New York New York 10032 Not yet recruiting
Stony Brook University Stony Brook New York 11794 Not yet recruiting
Upstate Health Care Center Syracuse New York 13202 Not yet recruiting
Crouse Physicians Office Building Syracuse New York 13210 Not yet recruiting
SUNY Upstate Medical University Syracuse New York 13210 Not yet recruiting
Upstate Golisano Children's Hospital Syracuse New York 13210 Not yet recruiting
Clinical and Translational Research Center Chapel Hill North Carolina 27514 Terminated
investigational Drug Services Pharmacy, UNC Hospitals Chapel Hill North Carolina 27514 Terminated
UNC Children's Hospital Chapel Hill North Carolina 27514 Terminated
UNC Global Clinical Research North Chapel Hill North Carolina 27514 Terminated
University of North Carolina Medical Center Chapel Hill North Carolina 27599 Terminated
UNC Children's Raleigh Raleigh North Carolina 27607 Terminated
University Hospitals Cleveland Medical Center Cleveland Ohio 44106 Active, not recruiting
UH Landerbrook Health Center Mayfield Heights Ohio 44124 Active, not recruiting
UH Parma Medical Center Parma Ohio 44129 Active, not recruiting
Children's Hospital of Pittsburgh Pittsburgh Pennsylvania 15213 Not yet recruiting
Rhode Island Hospital Providence Rhode Island 02903 Active, not recruiting
The Miriam Hospital-Clinical Trials Providence Rhode Island 02904 Active, not recruiting
Avera McKennan Hospital & University Health Center Sioux Falls South Dakota 57105 Terminated
Avera Research Institute - Sioux Falls Sioux Falls South Dakota 57108 Terminated
Texas Children's Hospital Houston Texas 77030 Not yet recruiting
Biopharma Informatic, LLC McAllen Texas 78503 Terminated
Consano Clinical Research, LLC Shavano Park Texas 78231 Recruiting
University of Utah Salt Lake City Utah 84108 Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05261139, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 16, 2025 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05261139 live on ClinicalTrials.gov.

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