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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

nirmatrelvir

PF-07321332

DRUG

ritonavir

ritonavir

Locations (20)

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