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

Recruiting now · Phase 3

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT05261139

Run by

Pfizer

People needed

160

Starts

2022-03-07

Expected to finish

2026-07-30

Last updated by the study team

2025-07-17

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female, age 0 to < 18 years, able to swallow for some participants
• Confirmed SARS-CoV-2 infection within 72 hours prior to enrollment
• Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of enrollment and at least 1 of the specified COVID-19 signs/symptoms present at enrollment
• Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19

You may not qualify if…

• History of or need for hospitalization for the medical treatment of COVID-19
• Total bilirubin >=2X upper limit of normal (ULN) (except for Gilbert's syndrome)
• Receiving dialysis or have known moderate to severe renal impairment
• Suspected or confirmed concurrent active systemic infection other than COVID-19
• History of hypersensitivity or other contraindication to any of the components of the study intervention
• Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance or strong inducers of cytochrome P450 (CYP)3A4
• Has received or is expected to receive antibody treatment, antiviral treatment or convalescent COVID-19 plasma
• Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 through the study follow up
• Females who are pregnant or breastfeeding

Where it is running

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

Full record on ClinicalTrials.gov

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