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
- Registration Number
- NCT05261139
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 1 nirmatrelvir/ritonavir 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 Cohort 3 nirmatrelvir/ritonavir ritonavir nirmatrelvir/ritonavir ≥2 to \<6 years Cohort 1 nirmatrelvir/ritonavir nirmatrelvir 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 Cohort 5 nirmatrelvir/ritonavir ritonavir nirmatrelvir/ritonavir \<1 month (\<28 days) old Cohort 2 nirmatrelvir/ritonavir nirmatrelvir 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 Cohort 2 nirmatrelvir/ritonavir 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 Cohort 3 nirmatrelvir/ritonavir nirmatrelvir nirmatrelvir/ritonavir ≥2 to \<6 years Cohort 4 nirmatrelvir/ritonavir nirmatrelvir nirmatrelvir/ritonavir ≥1 month (≥28 days) to \<2 years Cohort 4 nirmatrelvir/ritonavir ritonavir nirmatrelvir/ritonavir ≥1 month (≥28 days) to \<2 years Cohort 5 nirmatrelvir/ritonavir nirmatrelvir nirmatrelvir/ritonavir \<1 month (\<28 days) old
- Primary Outcome Measures
Name Time Method Incidence of Serious Adverse Events (SAEs) leading to discontinuations. From Baseline up through Day 34 Incidence of Adverse Events (AEs) leading to discontinuations. From Baseline up through Day 34 Number of participants with change from Baseline in Vital Signs From Baseline up through Day 34 Cohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, and 2 hours post dose Cohort 1-2: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, and 2 hours post dose Incidence of Treatment Emergent Adverse Events (TEAEs) leading to discontinuations. From Baseline up through Day 34
- Secondary Outcome Measures
Name Time Method Viral load assessment titers measured via reverse transcription polymerase chain reaction (RT-PCR) in nasopharyngeal or nasal swabs over time Baseline, Day 5, 6, 10, 14 and 28 Proportion of participants with COVID-19 related hospitalization or death from any cause From Baseline through Day 28 Patient assessment on acceptability and palatability of nirmatrelvir/ritonavir (film-coated tablets and oral powder) At baseline only for tablets and after each dose for powder formulation Frequency of responses to visual questionnaire on taste.
Trial Locations
- Locations (75)
DCC "Alexandrovska"
🇧🇬Sofia, Bulgaria
Medical Center-1-Sevlievo EOOD
🇧🇬Sevlievo, Bulgaria
Fundación Santos y De la Garza Evia
🇲🇽Monterrey, Nuevo LEÓN, Mexico
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Kaiser Permanente
🇺🇸Los Angeles, California, United States
UCLA David Geffen School of Medicine
🇺🇸Los Angeles, California, United States
UCLA
🇺🇸Los Angeles, California, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Life Spring Research Foundation
🇺🇸Miami, Florida, 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
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
Childrens Hospitals and Clinics of Minnesota
🇺🇸Minneapolis, Minnesota, 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
Children's Hospital & Medical Center
🇺🇸Omaha, Nebraska, 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
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
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
Avera McKennan Hospital & University Health Center
🇺🇸Sioux Falls, South Dakota, United States
Avera Research Institute - Sioux Falls
🇺🇸Sioux Falls, South Dakota, 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
МHAT "Sveti Ivan Rilski" Gorna Oryahovitsa
🇧🇬Gorna Oryahovitsa, Bulgaria
"Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -
🇧🇬Ruse, Bulgaria
Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD
🇧🇬Vratsa, Bulgaria
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
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
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
St. George's Hospital
🇬🇧London, England, United Kingdom