๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-07-16

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)

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

๐ŸŸข Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Pfizer

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Phoenix Children's Hospital โ€” Phoenix, Arizona

Age range: 0 Years to 17 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (73 Sites)

Showing the first 25 of 73 sites.

  • Phoenix Children's Hospital โ€” Phoenix, Arizona
  • Children's Hospital Los Angeles โ€” Los Angeles, California
  • Kaiser Permanente โ€” Los Angeles, California
  • UCLA David Geffen School of Medicine โ€” Los Angeles, California
  • UCLA โ€” Los Angeles, California
  • Children's National Medical Center โ€” Washington D.C., District of Columbia
  • Life Spring Research Foundation โ€” Miami, Florida
  • Children's Healthcare of Atlanta - Arthur M. Blank Hospital โ€” Atlanta, Georgia
  • Rophe Adult and Pediatric Medicine/SKYCRNG โ€” Union City, Georgia
  • Ann & Robert H. Lurie Children's Hospital of Chicago โ€” Chicago, Illinois
  • University of Chicago Medical Center โ€” Chicago, Illinois
  • Louisiana State University Health Sciences Shreveport โ€” Shreveport, Louisiana
  • Johns Hopkins Hospital โ€” Baltimore, Maryland
  • Boston Medical Center โ€” Boston, Massachusetts
  • University of Massachusetts Chan Medical School โ€” Worcester, Massachusetts
  • Childrens Hospitals and Clinics of Minnesota โ€” Minneapolis, Minnesota
  • SKY Integrative Medical Center/SKYCRNG โ€” Ridgeland, Mississippi
  • St. Louis Children's Hospital โ€” St Louis, Missouri
  • Washington University School of Medicine โ€” St Louis, Missouri
  • Children's Hospital & Medical Center โ€” Omaha, Nebraska
  • University of New Mexico Hospital, COVID-19 Research Clinic โ€” Albuquerque, New Mexico
  • University of New Mexico Clinical and Translational Science Center โ€” Albuquerque, New Mexico
  • Suny University at Buffalo โ€” Buffalo, New York
  • Advanced Specialty Care โ€” Commack, New York
  • Stony Brook Medicine Clinical Research Center โ€” East Setauket, New York

๐Ÿ“ž Contact the Study Coordinator

Phone: (800) 718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All COVID-19 clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—