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

Last updated: November 14, 2024
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

2/3

Condition

Covid-19

Treatment

ritonavir

nirmatrelvir

Clinical Study ID

NCT05261139
C4671026
2023-509773-23-00
  • Ages < 17
  • All Genders

Study 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

Inclusion

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 ofenrollment and at least 1 of the specified COVID-19 signs/symptoms present atenrollment

  • Has at least 1 characteristic or underlying medical condition associated with anincreased risk of developing severe illness from COVID-19

Exclusion

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 ofthe study intervention

  • Current or expected use of any medications or substances that are highly dependenton CYP3A4 for clearance or strong inducers of cytochrome P450 (CYP)3A4

  • Has received or is expected to receive antibody treatment, antiviral treatment orconvalescent COVID-19 plasma

  • Participating in another interventional clinical study with an investigationalcompound or device, including those for COVID-19 through the study follow up

  • Females who are pregnant or breastfeeding

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: ritonavir
Phase: 2/3
Study Start date:
March 07, 2022
Estimated Completion Date:
July 30, 2026

Connect with a study center

  • МHAT "Sveti Ivan Rilski" Gorna Oryahovitsa

    Gorna Oryahovitsa, 5100
    Bulgaria

    Site Not Available

  • Diagnostic-Consultative Center I Lom EOOD

    Lom, 3600
    Bulgaria

    Site Not Available

  • DCC Sveti Georgi EOOD

    Plovdiv, 4000
    Bulgaria

    Site Not Available

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

    Ruse, 7002
    Bulgaria

    Site Not Available

  • Medical Center-1-Sevlievo EOOD

    Sevlievo, 5400
    Bulgaria

    Site Not Available

  • DCC "Alexandrovska"

    Sofia, 1431
    Bulgaria

    Terminated

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

    Vratsa, 3000
    Bulgaria

    Site Not Available

  • Markhot Ferenc Oktatokorhaz es Rendelointezet

    Eger, Heves 3300
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 04032
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Központ

    Debrecen, 4031
    Hungary

    Site Not Available

  • Tokyo Metropolitan Children's Medical Center

    Fuchu, Tokyo 183-8561
    Japan

    Site Not Available

  • Osaka City General Hospital

    Osaka, 534-0021
    Japan

    Site Not Available

  • Hospital Infantil de Mexico Federico Gomez

    Mexico City, Distrito Federal 06720
    Mexico

    Site Not Available

  • Instituto Nacional de Pediatria

    Mexico City, Distrito Federal 04530
    Mexico

    Site Not Available

  • JM Research SC

    Cuernavaca, Morelos 62290
    Mexico

    Site Not Available

  • Eukarya PharmaSite S.C.

    Monterrey, Nuevo LEON 64718
    Mexico

    Site Not Available

  • Eukarya Pharmasite S.C.

    Monterrey, Nuevo LEON 64718
    Mexico

    Terminated

  • Tecnologico de Monterrey

    Monterrey, Nuevo LEÓN 64710
    Mexico

    Site Not Available

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

    Merida, Yucatan 97070
    Mexico

    Site Not Available

  • Kohler and Milstein Research S.A. de C.V.

    Merida, Yucatan 97070
    Mexico

    Site Not Available

  • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan

    Merida, Yucatán 97130
    Mexico

    Site Not Available

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

    Merida, Yucatán 97130
    Mexico

    Site Not Available

  • Unidad de Atención Médica e Investigación en Salud

    Mérida, Yucatán 97000
    Mexico

    Site Not Available

  • Centenario Hospital Miguel Hidalgo

    Aguascalientes, 20259
    Mexico

    Site Not Available

  • Arké SMO S.A de C.V

    Veracruz, 91910
    Mexico

    Site Not Available

  • Sociedad de Metabolismo y Corazon

    Veracruz, 91900
    Mexico

    Site Not Available

  • Sociedad de Metabolismo y Corazon S.C.

    Veracruz, C.P. 91900
    Mexico

    Site Not Available

  • San Miguel Medical

    Trujillo Alto, 00976
    Puerto Rico

    Site Not Available

  • Worthwhile Clinical Trials

    Benoni, Gauteng 1500
    South Africa

    Site Not Available

  • CRISMO Research Centre

    Germiston, Gauteng 1401
    South Africa

    Site Not Available

  • Botho Ke Bontle Health Services

    Pretoria, Gauteng 0184
    South Africa

    Site Not Available

  • Ndlovu Research Centre

    Dennilton, Limpopo 0470
    South Africa

    Site Not Available

  • Limpopo Clinical Research Initiative

    Thabazimbi, Limpopo 0380
    South Africa

    Site Not Available

  • St. George's Hospital

    London, England SW17 0QT
    United Kingdom

    Site Not Available

  • King's College Hospital

    London, London, CITY OF SE5 9RL
    United Kingdom

    Site Not Available

  • University College London Hospital

    London, London, CITY OF NW1 2PG
    United Kingdom

    Site Not Available

  • Imperial College Healthcare NHS Trust

    London, W2 1NY
    United Kingdom

    Site Not Available

  • Royal Manchester Children's Hospital

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • University of Alabama at Birmingham - School of Medicine

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Phoenix Children's Hospital

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Active - Recruiting

  • Children's Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Site Not Available

  • Kaiser Permanente

    Los Angeles, California 90027
    United States

    Site Not Available

  • The Regents of the University of California - Los Angeles (UCLA Pediatrics)

    Los Angeles, California 90095-1752
    United States

    Site Not Available

  • UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

  • UCLA David Geffen School of Medicine

    Los Angeles, California 90095
    United States

    Site Not Available

  • Children's Hospital of Orange County

    Orange, California 92868
    United States

    Active - Recruiting

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Children's National Medical Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Life Spring Research Foundation

    Miami, Florida 33130
    United States

    Site Not Available

  • Clinical Site Partners, Inc.

    Winter Park, Florida 32789
    United States

    Active - Recruiting

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

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Children's Healthcare of Atlanta - Egleston Hospital

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia 30291
    United States

    Terminated

  • SKY Clinical Research Network Group-Blake

    Union City, Georgia 30291
    United States

    Site Not Available

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

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Norton Children´s Hospital

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Novak Center for Children's Health

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Louisiana State University Health Sciences Shreveport

    Shreveport, Louisiana 71101
    United States

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts 01655
    United States

    Terminated

  • Wayne Pediatrics

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Childrens Hospitals and Clinics of Minnesota

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • SKY Clinical Research Network Group-Quinn

    Ridgeland, Mississippi 39157
    United States

    Site Not Available

  • SKY Integrative Medical Center/SKYCRNG

    Ridgeland, Mississippi 39157
    United States

    Site Not Available

  • St. Louis Children's Hospital

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Children's Hospital & Medical Center

    Omaha, Nebraska 68114
    United States

    Terminated

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Rutgers University

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • University of New Mexico Clinical and Translational Science Center

    Albuquerque, New Mexico 87106
    United States

    Terminated

  • University of New Mexico Hospital, COVID-19 Research Clinic

    Albuquerque, New Mexico 87102
    United States

    Terminated

  • Suny University at Buffalo

    Buffalo, New York 14203
    United States

    Site Not Available

  • Advanced Specialty Care

    Commack, New York 11725
    United States

    Site Not Available

  • Stony Brook Medicine Clinical Research Center

    East Setauket, New York 11733
    United States

    Site Not Available

  • Cohen Children's Medical Center

    New Hyde Park, New York 11040
    United States

    Site Not Available

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Stony Brook University

    Stony Brook, New York 11794-8111
    United States

    Site Not Available

  • Crouse Physicians Office Building

    Syracuse, New York 13210
    United States

    Site Not Available

  • SUNY Upstate Medical University

    Syracuse, New York 13210
    United States

    Site Not Available

  • Upstate Golisano Children's Hospital

    Syracuse, New York 13210
    United States

    Site Not Available

  • Upstate Health Care Center

    Syracuse, New York 13202
    United States

    Site Not Available

  • Clinical and Translational Research Center

    Chapel Hill, North Carolina 27514
    United States

    Terminated

  • UNC Children's Hospital

    Chapel Hill, North Carolina 27514
    United States

    Terminated

  • UNC Global Clinical Research North

    Chapel Hill, North Carolina 27514
    United States

    Terminated

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina 27599
    United States

    Terminated

  • investigational Drug Services Pharmacy, UNC Hospitals

    Chapel Hill, North Carolina 27514
    United States

    Terminated

  • Duke Research at Pickett Road

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Duke University - Main Hospital and Clinics

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Duke Vaccine And Trials Unit

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • UNC Children's Raleigh

    Raleigh, North Carolina 27607
    United States

    Terminated

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • UH Landerbrook Health Center

    Mayfield Heights, Ohio 44124
    United States

    Site Not Available

  • UH Parma Medical Center

    Parma, Ohio 44129
    United States

    Site Not Available

  • Oklahoma Childrens Hospital at OU Health

    Oklahoma City, Oklahoma 73104-4637
    United States

    Site Not Available

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104-5008
    United States

    Site Not Available

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • The Miriam Hospital-Clinical Trials

    Providence, Rhode Island 02904
    United States

    Site Not Available

  • Coastal Pediatric Research

    Summerville, South Carolina 29486
    United States

    Active - Recruiting

  • Avera McKennan Hospital & University Health Center

    Sioux Falls, South Dakota 57105
    United States

    Terminated

  • Avera Research Institute - Sioux Falls

    Sioux Falls, South Dakota 57108
    United States

    Terminated

  • Le Bonheur Children's Hospital

    Memphis, Tennessee 38105
    United States

    Site Not Available

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Zion Urgent Care Clinic

    Katy, Texas 77494
    United States

    Site Not Available

  • Biopharma Informatic, LLC

    McAllen, Texas 78503
    United States

    Terminated

  • Consano Clinical Research, LLC

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84108
    United States

    Site Not Available

  • Childrens Hospital of The Kings Daughters

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.