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
Who is this study for? Patients with COVID19
What treatments are being studied? Nirmatrelvir+Ritonavir
Status: Recruiting
Location: See all (73) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Maximum Age: 17
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Phoenix Children's Hospital
ACTIVE_NOT_RECRUITING
Phoenix
California
Children's Hospital Los Angeles
ACTIVE_NOT_RECRUITING
Los Angeles
Kaiser Permanente
ACTIVE_NOT_RECRUITING
Los Angeles
UCLA
NOT_YET_RECRUITING
Los Angeles
UCLA David Geffen School of Medicine
NOT_YET_RECRUITING
Los Angeles
Washington, D.c.
Children's National Medical Center
ACTIVE_NOT_RECRUITING
Washington D.c.
Florida
Life Spring Research Foundation
RECRUITING
Miami
Georgia
Children's Healthcare of Atlanta - Arthur M. Blank Hospital
RECRUITING
Atlanta
Rophe Adult and Pediatric Medicine/SKYCRNG
TERMINATED
Union City
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
ACTIVE_NOT_RECRUITING
Chicago
University of Chicago Medical Center
RECRUITING
Chicago
Louisiana
Louisiana State University Health Sciences Shreveport
RECRUITING
Shreveport
Massachusetts
Boston Medical Center
ACTIVE_NOT_RECRUITING
Boston
University of Massachusetts Chan Medical School
TERMINATED
Worcester
Maryland
Johns Hopkins Hospital
NOT_YET_RECRUITING
Baltimore
Minnesota
Childrens Hospitals and Clinics of Minnesota
NOT_YET_RECRUITING
Minneapolis
Missouri
St. Louis Children's Hospital
NOT_YET_RECRUITING
St Louis
Washington University School of Medicine
NOT_YET_RECRUITING
St Louis
Mississippi
SKY Integrative Medical Center/SKYCRNG
ACTIVE_NOT_RECRUITING
Ridgeland
North Carolina
Clinical and Translational Research Center
TERMINATED
Chapel Hill
investigational Drug Services Pharmacy, UNC Hospitals
TERMINATED
Chapel Hill
UNC Children's Hospital
TERMINATED
Chapel Hill
UNC Global Clinical Research North
TERMINATED
Chapel Hill
University of North Carolina Medical Center
TERMINATED
Chapel Hill
UNC Children's Raleigh
TERMINATED
Raleigh
Nebraska
Children's Hospital & Medical Center
TERMINATED
Omaha
New Mexico
University of New Mexico Clinical and Translational Science Center
TERMINATED
Albuquerque
University of New Mexico Hospital, COVID-19 Research Clinic
TERMINATED
Albuquerque
New York
Suny University at Buffalo
NOT_YET_RECRUITING
Buffalo
Advanced Specialty Care
NOT_YET_RECRUITING
Commack
Stony Brook Medicine Clinical Research Center
NOT_YET_RECRUITING
East Setauket
Cohen Children's Medical Center
NOT_YET_RECRUITING
New Hyde Park
Columbia University Irving Medical Center
NOT_YET_RECRUITING
New York
Stony Brook University
NOT_YET_RECRUITING
Stony Brook
Crouse Physicians Office Building
NOT_YET_RECRUITING
Syracuse
SUNY Upstate Medical University
NOT_YET_RECRUITING
Syracuse
Upstate Golisano Children's Hospital
NOT_YET_RECRUITING
Syracuse
Upstate Health Care Center
NOT_YET_RECRUITING
Syracuse
Ohio
University Hospitals Cleveland Medical Center
ACTIVE_NOT_RECRUITING
Cleveland
UH Landerbrook Health Center
ACTIVE_NOT_RECRUITING
Mayfield Heights
UH Parma Medical Center
ACTIVE_NOT_RECRUITING
Parma
Pennsylvania
Children's Hospital of Pittsburgh
NOT_YET_RECRUITING
Pittsburgh
Rhode Island
Rhode Island Hospital
ACTIVE_NOT_RECRUITING
Providence
The Miriam Hospital-Clinical Trials
ACTIVE_NOT_RECRUITING
Providence
South Dakota
Avera McKennan Hospital & University Health Center
TERMINATED
Sioux Falls
Avera Research Institute - Sioux Falls
TERMINATED
Sioux Falls
Texas
Texas Children's Hospital
NOT_YET_RECRUITING
Houston
Biopharma Informatic, LLC
TERMINATED
Mcallen
Consano Clinical Research, LLC
RECRUITING
Shavano Park
Utah
University of Utah
NOT_YET_RECRUITING
Salt Lake City
Other Locations
Bulgaria
МHAT Sveti Ivan Rilski Gorna Oryahovitsa
NOT_YET_RECRUITING
Gorna Oryahovitsa
Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -
NOT_YET_RECRUITING
Rousse
Medical Center-1-Sevlievo EOOD
NOT_YET_RECRUITING
Sevlievo
DCC Alexandrovska
TERMINATED
Sofia
Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD
NOT_YET_RECRUITING
Vratsa
Japan
Tokyo Metropolitan Children's Medical Center
NOT_YET_RECRUITING
Fuchū
Osaka City General Hospital
NOT_YET_RECRUITING
Osaka
Mexico
Centenario Hospital Miguel Hidalgo
NOT_YET_RECRUITING
Aguascalientes
JM Research SC
ACTIVE_NOT_RECRUITING
Cuernavaca
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatán S.
ACTIVE_NOT_RECRUITING
Mérida
Kohler & Milstein Research S.A. De C.V.
ACTIVE_NOT_RECRUITING
Mérida
Unidad de Atención Médica e Investigación en Salud
ACTIVE_NOT_RECRUITING
Mérida
Hospital Infantil de Mexico Federico Gomez
ACTIVE_NOT_RECRUITING
Mexico City
Instituto Nacional de Pediatria
NOT_YET_RECRUITING
Mexico City
Eukarya Pharmasite S.C.
TERMINATED
Monterrey
Fundación Santos y De la Garza Evia
ACTIVE_NOT_RECRUITING
Monterrey
Arké SMO S.A de C.V
ACTIVE_NOT_RECRUITING
Veracruz
Sociedad de Metabolismo y Corazon S.C.
ACTIVE_NOT_RECRUITING
Veracruz
Puerto Rico
San Miguel Medical
NOT_YET_RECRUITING
Trujillo Alto
South Africa
Worthwhile Clinical Trials
ACTIVE_NOT_RECRUITING
Benoni
CRISMO Research Centre
ACTIVE_NOT_RECRUITING
Germiston
Botho Ke Bontle Health Services
NOT_YET_RECRUITING
Pretoria
United Kingdom
St. George's Hospital
ACTIVE_NOT_RECRUITING
London
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2022-03-07
Estimated Completion Date: 2026-07-30
Participants
Target number of participants: 160
Treatments
Experimental: 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
Experimental: 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
Experimental: Cohort 3 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir~≥2 to \<6 years
Experimental: Cohort 4 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir~≥1 month (≥28 days) to \<2 years
Experimental: Cohort 5 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir \<1 month (\<28 days) old
Related Therapeutic Areas
Sponsors
Leads: Pfizer