RECRUITING

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

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Conditions

COVID-19Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2)Pediatrics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-03-07
Study Completion:2026-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05261139

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Male and female, age 0 to \< 18 years, able to swallow for some participants
  2. * Confirmed SARS-CoV-2 infection within 72 hours prior to enrollment
  3. * 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
  4. * Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19
  1. * History of or need for hospitalization for the medical treatment of COVID-19
  2. * Total bilirubin \>=2X upper limit of normal (ULN) (except for Gilbert's syndrome)
  3. * Receiving dialysis or have known moderate to severe renal impairment
  4. * Suspected or confirmed concurrent active systemic infection other than COVID-19
  5. * History of hypersensitivity or other contraindication to any of the components of the study intervention
  6. * 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
  7. * Has received or is expected to receive antibody treatment, antiviral treatment or convalescent COVID-19 plasma
  8. * Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 through the study follow up
  9. * Females who are pregnant or breastfeeding

Contacts and Locations

Study Contact

Pfizer CT.gov Call Center
CONTACT
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

University of Alabama at Birmingham - School of Medicine
Birmingham, Alabama, 35233
United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016
United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
Kaiser Permanente
Los Angeles, California, 90027
United States
The Regents of the University of California - Los Angeles (UCLA Pediatrics)
Los Angeles, California, 90095-1752
United States
UCLA David Geffen School of Medicine
Los Angeles, California, 90095
United States
UCLA
Los Angeles, California, 90095
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
United States
Children's National Medical Center
Washington, District of Columbia, 20010
United States
Life Spring Research Foundation
Miami, Florida, 33130
United States
Clinical Site Partners, Inc.
Winter Park, Florida, 32789
United States
Children's Healthcare of Atlanta - Arthur M. Blank Hospital
Atlanta, Georgia, 30322
United States
Children's Healthcare of Atlanta - Egleston Hospital
Atlanta, Georgia, 30322
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
SKY Clinical Research Network Group-Blake
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
Norton Children´s Hospital
Louisville, Kentucky, 40202
United States
Novak Center for Children's Health
Louisville, Kentucky, 40202
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
Wayne Pediatrics
Detroit, Michigan, 48201
United States
Childrens Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
United States
SKY Clinical Research Network Group-Quinn
Ridgeland, Mississippi, 39157
United States
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, 39157
United States
St. Louis Children's Hospital
Saint Louis, Missouri, 63110
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Washington University
Saint Louis, Missouri, 63110
United States
Children's Hospital & Medical Center
Omaha, Nebraska, 68114
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Rutgers University
New Brunswick, New Jersey, 08901
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, 11794-8111
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
Duke Vaccine And Trials Unit
Durham, North Carolina, 27705
United States
Duke University - Main Hospital and Clinics
Durham, North Carolina, 27710
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
Oklahoma Childrens Hospital at OU Health
Oklahoma City, Oklahoma, 73104-4637
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104-5008
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
Coastal Pediatric Research
Summerville, South Carolina, 29486
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
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
United States
Le Bonheur Children's Hospital
Memphis, Tennessee, 38105
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
Childrens Hospital of The Kings Daughters
Norfolk, Virginia, 23507
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-07
Study Completion Date2026-07-30

Study Record Updates

Study Start Date2022-03-07
Study Completion Date2026-07-30

Terms related to this study

Keywords Provided by Researchers

  • Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2)
  • Pediatrics

Additional Relevant MeSH Terms

  • COVID-19