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
NCT ID: NCT05261139
Last Updated: 2025-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
160 participants
INTERVENTIONAL
2022-03-07
2026-07-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir will be given by tablets or powder by mouth twice a day for 5 days (10 doses total).
Weight ≥40 kg
1. ≥12 to \<18 years
2. ≥6 to \<12 years
nirmatrelvir
PF-07321332
ritonavir
ritonavir
Cohort 2 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir will be given as powder by mouth twice a day for 5 days (10 doses total) Weight ≥20 to \<40 kg, ≥6 to \<18 years
nirmatrelvir
PF-07321332
ritonavir
ritonavir
Cohort 3 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir
≥2 to \<6 years
nirmatrelvir
PF-07321332
ritonavir
ritonavir
Cohort 4 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir
≥1 month (≥28 days) to \<2 years
nirmatrelvir
PF-07321332
ritonavir
ritonavir
Cohort 5 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir \<1 month (\<28 days) old
nirmatrelvir
PF-07321332
ritonavir
ritonavir
Interventions
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nirmatrelvir
PF-07321332
ritonavir
ritonavir
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
0 Years
17 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
University of New Mexico Hospital, COVID-19 Research Clinic
Albuquerque, New Mexico, United States
University of New Mexico Clinical and Translational Science Center
Albuquerque, New Mexico, United States
Suny University at Buffalo
Buffalo, New York, United States
Advanced Specialty Care
Commack, New York, United States
Stony Brook Medicine Clinical Research Center
East Setauket, New York, United States
Cohen Children's Medical Center
New Hyde Park, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Stony Brook University
Stony Brook, New York, United States
Upstate Health Care Center
Syracuse, New York, United States
Crouse Physicians Office Building
Syracuse, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Upstate Golisano Children's Hospital
Syracuse, New York, United States
Clinical and Translational Research Center
Chapel Hill, North Carolina, United States
investigational Drug Services Pharmacy, UNC Hospitals
Chapel Hill, North Carolina, United States
UNC Children's Hospital
Chapel Hill, North Carolina, United States
UNC Global Clinical Research North
Chapel Hill, North Carolina, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
UNC Children's Raleigh
Raleigh, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
UH Landerbrook Health Center
Mayfield Heights, Ohio, United States
UH Parma Medical Center
Parma, Ohio, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
The Miriam Hospital-Clinical Trials
Providence, Rhode Island, United States
Avera McKennan Hospital & University Health Center
Sioux Falls, South Dakota, United States
Avera Research Institute - Sioux Falls
Sioux Falls, South Dakota, United States
Texas Children's Hospital
Houston, Texas, United States
Biopharma Informatic, LLC
McAllen, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
University of Utah
Salt Lake City, Utah, United States
МHAT "Sveti Ivan Rilski" Gorna Oryahovitsa
Gorna Oryahovitsa, , Bulgaria
"Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -
Rousse, , Bulgaria
Medical Center-1-Sevlievo EOOD
Sevlievo, , Bulgaria
DCC "Alexandrovska"
Sofia, , Bulgaria
Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD
Vratsa, , Bulgaria
Tokyo Metropolitan Children's Medical Center
Fuchū, Tokyo, Japan
Osaka City General Hospital
Osaka, , Japan
Instituto Nacional de Pediatria
Mexico City, Mexico City, Mexico
Hospital Infantil de Mexico Federico Gomez
Mexico City, Mexico City, Mexico
JM Research SC
Cuernavaca, Morelos, Mexico
Fundación Santos y De la Garza Evia
Monterrey, Nuevo León, Mexico
Eukarya Pharmasite S.C.
Monterrey, Nuevo León, Mexico
Unidad de Atención Médica e Investigación en Salud
Mérida, Yucatán, Mexico
Kohler & Milstein Research S.A. De C.V.
Mérida, Yucatán, Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatán S.
Mérida, Yucatán, Mexico
Centenario Hospital Miguel Hidalgo
Aguascalientes, , Mexico
Arké SMO S.A de C.V
Veracruz, , Mexico
Sociedad de Metabolismo y Corazon S.C.
Veracruz, , Mexico
San Miguel Medical
Trujillo Alto, , Puerto Rico
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Botho Ke Bontle Health Services
Pretoria, Gauteng, South Africa
St. George's Hospital
London, England, United Kingdom
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2023-509773-23-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4671026
Identifier Type: -
Identifier Source: org_study_id
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