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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

RecruitingPhase 3

Sponsor: Pfizer

Conditions: COVID-19

Interventions: nirmatrelvir, ritonavir

Countries: United States, Bulgaria, Japan, Mexico, Puerto Rico, South Africa, United Kingdom

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 overview

Sex: ALL

Age: 0 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (73)

Phoenix, Arizona, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Washington D.C., District of Columbia, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Union City, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Minneapolis, Minnesota, United States
Ridgeland, Mississippi, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Albuquerque, New Mexico, United States
Albuquerque, New Mexico, United States
Buffalo, New York, United States
Commack, New York, United States
East Setauket, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
Stony Brook, New York, United States
Syracuse, New York, United States
Syracuse, New York, United States
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