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NCT05261139PHASE3Recruiting

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

Pfizer

Start Date

3/7/2022

Completion Date

7/30/2026

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 Criteria

Age Range: No minimum to 17 years

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

Interventions

DRUG

nirmatrelvir

DRUG

ritonavir

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

COVID-19

Locations

Phoenix Children's Hospital

Phoenix, Arizona 85016

United States

Children's Hospital Los Angeles

Los Angeles, California 90027

United States

Kaiser Permanente

Los Angeles, California 90027

United States

UCLA David Geffen School of Medicine

Los Angeles, California 90095

United States

UCLA

Los Angeles, California 90095

United States

Children's National Medical Center

Washington D.C., District of Columbia 20010

United States

Life Spring Research Foundation

Miami, Florida 33130

United States

Children's Healthcare of Atlanta - Arthur M. Blank Hospital

Atlanta, Georgia 30329

United States

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia 30291

United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois 60611

United States

University of Chicago Medical Center

Chicago, Illinois 60637

United States

Louisiana State University Health Sciences Shreveport

Shreveport, Louisiana 71101

United States

Johns Hopkins Hospital

Baltimore, Maryland 21287

United States

Boston Medical Center

Boston, Massachusetts 02118

United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts 01655

United States

Childrens Hospitals and Clinics of Minnesota

Minneapolis, Minnesota 55404

United States

SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi 39157

United States

St. Louis Children's Hospital

St Louis, Missouri 63110

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Children's Hospital & Medical Center

Omaha, Nebraska 68114

United States

University of New Mexico Hospital, COVID-19 Research Clinic

Albuquerque, New Mexico 87102

United States

University of New Mexico Clinical and Translational Science Center

Albuquerque, New Mexico 87106

United States

Suny University at Buffalo

Buffalo, New York 14203

United States

Advanced Specialty Care

Commack, New York 11725

United States

Stony Brook Medicine Clinical Research Center

East Setauket, New York 11733

United States

Cohen Children's Medical Center

New Hyde Park, New York 11040

United States

Columbia University Irving Medical Center

New York, New York 10032

United States

Stony Brook University

Stony Brook, New York 11794

United States

Upstate Health Care Center

Syracuse, New York 13202

United States

Crouse Physicians Office Building

Syracuse, New York 13210

United States

SUNY Upstate Medical University

Syracuse, New York 13210

United States

Upstate Golisano Children's Hospital

Syracuse, New York 13210

United States

Clinical and Translational Research Center

Chapel Hill, North Carolina 27514

United States

investigational Drug Services Pharmacy, UNC Hospitals

Chapel Hill, North Carolina 27514

United States

UNC Children's Hospital

Chapel Hill, North Carolina 27514

United States

UNC Global Clinical Research North

Chapel Hill, North Carolina 27514

United States

University of North Carolina Medical Center

Chapel Hill, North Carolina 27599

United States

UNC Children's Raleigh

Raleigh, North Carolina 27607

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

UH Landerbrook Health Center

Mayfield Heights, Ohio 44124

United States

UH Parma Medical Center

Parma, Ohio 44129

United States

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania 15213

United States

Rhode Island Hospital

Providence, Rhode Island 02903

United States

The Miriam Hospital-Clinical Trials

Providence, Rhode Island 02904

United States

Avera McKennan Hospital & University Health Center

Sioux Falls, South Dakota 57105

United States

Avera Research Institute - Sioux Falls

Sioux Falls, South Dakota 57108

United States

Texas Children's Hospital

Houston, Texas 77030

United States

Biopharma Informatic, LLC

McAllen, Texas 78503

United States

Consano Clinical Research, LLC

Shavano Park, Texas 78231

United States

University of Utah

Salt Lake City, Utah 84108

United States

МHAT "Sveti Ivan Rilski" Gorna Oryahovitsa

Gorna Oryahovitsa, 5100

Bulgaria

"Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -

Rousse, 7002

Bulgaria

Medical Center-1-Sevlievo EOOD

Sevlievo, 5400

Bulgaria

DCC "Alexandrovska"

Sofia, 1431

Bulgaria

Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD

Vratsa, 3000

Bulgaria

Tokyo Metropolitan Children's Medical Center

Fuchū, Tokyo 183-8561

Japan

Osaka City General Hospital

Osaka, 534-0021

Japan

Instituto Nacional de Pediatria

Mexico City, Mexico City 04530

Mexico

Hospital Infantil de Mexico Federico Gomez

Mexico City, Mexico City 06720

Mexico

JM Research SC

Cuernavaca, Morelos 62290

Mexico

Fundación Santos y De la Garza Evia

Monterrey, Nuevo León 64710

Mexico

Eukarya Pharmasite S.C.

Monterrey, Nuevo León 64718

Mexico

Unidad de Atención Médica e Investigación en Salud

Mérida, Yucatán 97000

Mexico

Kohler & Milstein Research S.A. De C.V.

Mérida, Yucatán 97070

Mexico

Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatán S.

Mérida, Yucatán 97130

Mexico

Centenario Hospital Miguel Hidalgo

Aguascalientes, 20259

Mexico

Arké SMO S.A de C.V

Veracruz, 91900

Mexico

Sociedad de Metabolismo y Corazon S.C.

Veracruz, C.P. 91900

Mexico

San Miguel Medical

Trujillo Alto, 00976

Puerto Rico

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