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 · tracked via the Priya Life Science UK tracker

Sponsor

Pfizer

Phase

Phase 3

Started

2022-03-07

Last updated

2025-07-17

Condition(s) studied

COVID-19

Investigational drug(s) / intervention(s)

nirmatrelvirritonavir

nirmatrelvir: PF-07321332

ritonavir: ritonavir

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.

Eligibility

Sex

ALL

Min age

0 Years

Max age

17 Years

Healthy volunteers

Inclusion criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Cohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir — Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, and 2 hours post dose
Cohort 1-2: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir — Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, and 2 hours post dose
Incidence of Treatment Emergent Adverse Events (TEAEs) leading to discontinuations. — From Baseline up through Day 34
Incidence of Serious Adverse Events (SAEs) leading to discontinuations. — From Baseline up through Day 34
Incidence of Adverse Events (AEs) leading to discontinuations. — From Baseline up through Day 34
Number of participants with change from Baseline in Vital Signs — From Baseline up through Day 34

Trial sites (73)

Facility	City	Region	Status
Phoenix Children's Hospital	Phoenix	Arizona	Active Not Recruiting
Children's Hospital Los Angeles	Los Angeles	California	Active Not Recruiting
Kaiser Permanente	Los Angeles	California	Active Not Recruiting
UCLA David Geffen School of Medicine	Los Angeles	California	Not Yet Recruiting
UCLA	Los Angeles	California	Not Yet Recruiting
Children's National Medical Center	Washington D.C.	District of Columbia	Active Not Recruiting
Life Spring Research Foundation	Miami	Florida	Recruiting
Children's Healthcare of Atlanta - Arthur M. Blank Hospital	Atlanta	Georgia	Recruiting
Rophe Adult and Pediatric Medicine/SKYCRNG	Union City	Georgia	Terminated
Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois	Active Not Recruiting
University of Chicago Medical Center	Chicago	Illinois	Recruiting
Louisiana State University Health Sciences Shreveport	Shreveport	Louisiana	Recruiting
Johns Hopkins Hospital	Baltimore	Maryland	Not Yet Recruiting
Boston Medical Center	Boston	Massachusetts	Active Not Recruiting
University of Massachusetts Chan Medical School	Worcester	Massachusetts	Terminated
Childrens Hospitals and Clinics of Minnesota	Minneapolis	Minnesota	Not Yet Recruiting
SKY Integrative Medical Center/SKYCRNG	Ridgeland	Mississippi	Active Not Recruiting
St. Louis Children's Hospital	St Louis	Missouri	Not Yet Recruiting
Washington University School of Medicine	St Louis	Missouri	Not Yet Recruiting
Children's Hospital & Medical Center	Omaha	Nebraska	Terminated
University of New Mexico Hospital, COVID-19 Research Clinic	Albuquerque	New Mexico	Terminated
University of New Mexico Clinical and Translational Science Center	Albuquerque	New Mexico	Terminated
Suny University at Buffalo	Buffalo	New York	Not Yet Recruiting
Advanced Specialty Care	Commack	New York	Not Yet Recruiting
Stony Brook Medicine Clinical Research Center	East Setauket	New York	Not Yet Recruiting
Cohen Children's Medical Center	New Hyde Park	New York	Not Yet Recruiting
Columbia University Irving Medical Center	New York	New York	Not Yet Recruiting
Stony Brook University	Stony Brook	New York	Not Yet Recruiting
Upstate Health Care Center	Syracuse	New York	Not Yet Recruiting
Crouse Physicians Office Building	Syracuse	New York	Not Yet Recruiting
SUNY Upstate Medical University	Syracuse	New York	Not Yet Recruiting
Upstate Golisano Children's Hospital	Syracuse	New York	Not Yet Recruiting
Clinical and Translational Research Center	Chapel Hill	North Carolina	Terminated
investigational Drug Services Pharmacy, UNC Hospitals	Chapel Hill	North Carolina	Terminated
UNC Children's Hospital	Chapel Hill	North Carolina	Terminated
UNC Global Clinical Research North	Chapel Hill	North Carolina	Terminated
University of North Carolina Medical Center	Chapel Hill	North Carolina	Terminated
UNC Children's Raleigh	Raleigh	North Carolina	Terminated
University Hospitals Cleveland Medical Center	Cleveland	Ohio	Active Not Recruiting
UH Landerbrook Health Center	Mayfield Heights	Ohio	Active Not Recruiting

+ 33 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05261139 on ClinicalTrials.gov ↗ ← All trials in the UK