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 yourbody after you take it), and efficacy (how well a study treatment works in the study) ofthe study medicine (called nirmatrelvir/ritonavir) for potential treatment of coronavirusdisease 2019 (COVID-19).The study medicine will be given to patients under 18 years of age with COVID-19 that arenot hospitalized but are at risk for severe disease.
Not Provided
Drug: nirmatrelvir
PF-07321332
Drug: ritonavir
ritonavir
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
University of Alabama at Birmingham - School of Medicine
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Kaiser Permanente
Los Angeles, California, United States
The Regents of the University of California - Los Angeles (UCLA Pediatrics)
Los Angeles, California, United States
UCLA David Geffen School of Medicine
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Children's National Medical Center
Washington, District of Columbia, United States
Life Spring Research Foundation
Miami, Florida, United States
Clinical Site Partners, Inc.
Winter Park, Florida, United States
Children's Healthcare of Atlanta - Arthur M. Blank Hospital
Atlanta, Georgia, United States
Children's Healthcare of Atlanta - Egleston Hospital
Atlanta, Georgia, 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
SKY Clinical Research Network Group-Blake
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
Norton Children´s Hospital
Louisville, Kentucky, United States
Novak Center for Children's Health
Louisville, Kentucky, 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
Wayne Pediatrics
Detroit, Michigan, United States
Childrens Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
SKY Clinical Research Network Group-Quinn
Ridgeland, Mississippi, United States
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, United States
St. Louis Children's Hospital
Saint Louis, Missouri, United States
Washington University School of Medicine
Saint Louis, Missouri, United States
Washington University
Saint Louis, Missouri, United States
Children's Hospital & Medical Center
Omaha, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Rutgers University
New Brunswick, New Jersey, 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
Duke Vaccine And Trials Unit
Durham, North Carolina, United States
Duke University - Main Hospital and Clinics
Durham, 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
Oklahoma Childrens Hospital at OU Health
Oklahoma City, Oklahoma, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 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
Coastal Pediatric Research
Summerville, South Carolina, 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
Le Bonheur Children's Hospital
Memphis, Tennessee, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, 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
Childrens Hospital of The Kings Daughters
Norfolk, Virginia, United States
МHAT "Sveti Ivan Rilski" Gorna Oryahovitsa
Gorna Oryahovitsa, Bulgaria
Diagnostic-Consultative Center I Lom EOOD
Lom, Bulgaria
DCC Sveti Georgi EOOD
Plovdiv, Bulgaria
"Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -
Ruse, 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
Markhot Ferenc Oktatokorhaz es Rendelointezet
Eger, Heves, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, Hungary
Tokyo Metropolitan Children's Medical Center
Fuchu, Tokyo, Japan
Osaka City General Hospital
Osaka, Japan
Instituto Nacional de Pediatria
Mexico City, Distrito Federal, Mexico
Hospital Infantil de Mexico Federico Gomez
Mexico City, Distrito Federal, Mexico
JM Research SC
Cuernavaca, Morelos, Mexico
Eukarya PharmaSite S.C.
Monterrey, Nuevo LEON, Mexico
Eukarya Pharmasite S.C.
Monterrey, Nuevo LEON, Mexico
Tecnologico de Monterrey
Monterrey, Nuevo LEÓN, Mexico
Kohler & Milstein Research S.A. De C.V.
Merida, Yucatan, Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatán S.
Merida, Yucatán, Mexico
Unidad de Atención Médica e Investigación en Salud
Mérida, Yucatán, Mexico
Centenario Hospital Miguel Hidalgo
Aguascalientes, Mexico
Sociedad de Metabolismo y Corazon
Veracruz, 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
Worthwhile Clinical Trials
Benoni, Gauteng, South Africa
CRISMO Research Centre
Germiston, Gauteng, South Africa
Botho Ke Bontle Health Services
Pretoria, Gauteng, South Africa
Ndlovu Research Centre
Dennilton, Limpopo, South Africa
Limpopo Clinical Research Initiative
Thabazimbi, Limpopo, South Africa
St. George's Hospital
London, England, United Kingdom
University College London Hospital
London, London, CITY OF, United Kingdom
King's College Hospital
London, London, CITY OF, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Royal Manchester Children's Hospital
Manchester, United Kingdom
Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
Pfizer CT.gov Call Center, Study Director
Pfizer