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

Description

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.

Conditions

COVID-19

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
COVID-19
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham - School of Medicine, Birmingham, Alabama, United States, 35233

Phoenix

Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016

Little Rock

Arkansas Children's Hospital, Little Rock, Arkansas, United States, 72202

Los Angeles

Children's Hospital Los Angeles, Los Angeles, California, United States, 90027

Los Angeles

Kaiser Permanente, Los Angeles, California, United States, 90027

Los Angeles

The Regents of the University of California - Los Angeles (UCLA Pediatrics), Los Angeles, California, United States, 90095-1752

Los Angeles

UCLA David Geffen School of Medicine, Los Angeles, California, United States, 90095

Los Angeles

UCLA, Los Angeles, California, United States, 90095

Orange

Children's Hospital of Orange County, Orange, California, United States, 92868

Hartford

Connecticut Children's Medical Center, Hartford, Connecticut, United States, 06106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

0 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pfizer,

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

2026-07-30