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RECRUITING

NCT05261139

PHASE3

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

0 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2022-03-07

Completion Date

2026-07-30

Last Updated

2025-07-17

Healthy Volunteers

Conditions

COVID-19

Interventions

DRUG

nirmatrelvir

PF-07321332

DRUG

ritonavir

Locations (73)

Phoenix Children's Hospital

Phoenix, Arizona, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Kaiser Permanente

Los Angeles, California, United States

UCLA David Geffen School of Medicine

Los Angeles, California, United States

UCLA

Los Angeles, California, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Life Spring Research Foundation

Miami, Florida, United States

Children's Healthcare of Atlanta - Arthur M. Blank Hospital

Atlanta, Georgia, United States

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Louisiana State University Health Sciences Shreveport

Shreveport, Louisiana, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Childrens Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, United States

SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi, United States

St. Louis Children's Hospital

St Louis, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Children's Hospital & Medical Center

Omaha, Nebraska, United States

University of New Mexico Hospital, COVID-19 Research Clinic

Albuquerque, New Mexico, United States

University of New Mexico Clinical and Translational Science Center

Albuquerque, New Mexico, United States

Suny University at Buffalo

Buffalo, New York, United States

Advanced Specialty Care

Commack, New York, United States

Stony Brook Medicine Clinical Research Center

East Setauket, New York, United States

Cohen Children's Medical Center

New Hyde Park, New York, United States

Columbia University Irving Medical Center

New York, New York, United States

Stony Brook University

Stony Brook, New York, United States

Upstate Health Care Center

Syracuse, New York, United States

Crouse Physicians Office Building

Syracuse, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Upstate Golisano Children's Hospital

Syracuse, New York, United States

Clinical and Translational Research Center