Clinical trial NCT05261139: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: COVID-19
Keywords: Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2)
Pediatrics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-03-02
Enrollment: 160
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir
timeFrame: Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, and 2 hours post dose
measure: Cohort 1-2: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir
timeFrame: Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, and 2 hours post dose
measure: Incidence of Treatment Emergent Adverse Events (TEAEs) leading to discontinuations.
timeFrame: From Baseline up through Day 34
measure: Incidence of Serious Adverse Events (SAEs) leading to discontinuations.
timeFrame: From Baseline up through Day 34
measure: Incidence of Adverse Events (AEs) leading to discontinuations.
timeFrame: From Baseline up through Day 34
measure: Number of participants with change from Baseline in Vital Signs
timeFrame: From Baseline up through Day 34
Secondary outcomes:
measure: Viral load assessment titers measured via reverse transcription polymerase chain reaction (RT-PCR) in nasopharyngeal or nasal swabs over time
timeFrame: Baseline, Day 5, 6, 10, 14 and 28
measure: Proportion of participants with COVID-19 related hospitalization or death from any cause
timeFrame: From Baseline through Day 28
measure: Patient assessment on acceptability and palatability of nirmatrelvir/ritonavir (film-coated tablets and oral powder)
timeFrame: At baseline only for tablets and after each dose for powder formulation
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
city: Los Angeles
country: United States
facility: UCLA David Geffen School of Medicine
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Miami
country: United States
facility: Life Spring Research Foundation
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta - Arthur M. Blank Hospital
state: Georgia
city: Union City
country: United States
facility: Rophe Adult and Pediatric Medicine/SKYCRNG
state: Georgia
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Louisville
country: United States
facility: Norton Children´s Hospital
state: Kentucky
city: Louisville
country: United States
facility: Novak Center for Children's Health
state: Kentucky
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Shreveport
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School
state: Massachusetts
city: Minneapolis
country: United States
facility: Childrens Hospitals and Clinics of Minnesota
state: Minnesota
city: Ridgeland
country: United States
facility: SKY Integrative Medical Center/SKYCRNG
state: Mississippi
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: Children's Hospital & Medical Center
state: Nebraska
city: Albuquerque
country: United States
facility: University of New Mexico Hospital, COVID-19 Research Clinic
state: New Mexico
city: Albuquerque
country: United States
facility: University of New Mexico Clinical and Translational Science Center
state: New Mexico
city: Buffalo
country: United States
facility: Suny University at Buffalo
state: New York
city: Commack
country: United States
facility: Advanced Specialty Care
state: New York
city: East Setauket
country: United States
facility: Stony Brook Medicine Clinical Research Center
state: New York
city: New Hyde Park
country: United States
facility: Cohen Children's Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Syracuse
country: United States
facility: Upstate Health Care Center
state: New York
city: Syracuse
country: United States
facility: Crouse Physicians Office Building
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Syracuse
country: United States
facility: Upstate Golisano Children's Hospital
state: New York
city: Chapel Hill
country: United States
facility: Clinical and Translational Research Center
state: North Carolina
city: Chapel Hill
country: United States
facility: investigational Drug Services Pharmacy, UNC Hospitals
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Children's Hospital
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Global Clinical Research North
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: UNC Children's Raleigh
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Mayfield Heights
country: United States
facility: UH Landerbrook Health Center
state: Ohio
city: Parma
country: United States
facility: UH Parma Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital-Clinical Trials
state: Rhode Island
city: Sioux Falls
country: United States
facility: Avera McKennan Hospital & University Health Center
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera Research Institute - Sioux Falls
state: South Dakota
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: McAllen
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Gorna Oryahovitsa
country: Bulgaria
facility: МHAT "Sveti Ivan Rilski" Gorna Oryahovitsa
city: Ruse
country: Bulgaria
facility: "Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -
city: Sevlievo
country: Bulgaria
facility: Medical Center-1-Sevlievo EOOD
city: Sofia
country: Bulgaria
facility: DCC "Alexandrovska"
city: Vratsa
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD
city: Fuchu
country: Japan
facility: Tokyo Metropolitan Children's Medical Center
state: Tokyo
city: Osaka
country: Japan
facility: Osaka City General Hospital
city: Mexico City
country: Mexico
facility: Instituto Nacional de Pediatria
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Hospital Infantil de Mexico Federico Gomez
state: Distrito Federal
city: Cuernavaca
country: Mexico
facility: JM Research SC
state: Morelos
city: Monterrey
country: Mexico
facility: Eukarya Pharmasite S.C.
state: Nuevo LEON
city: Monterrey
country: Mexico
facility: Fundación Santos y De la Garza Evia
state: Nuevo LEÓN
city: Merida
country: Mexico
facility: Kohler & Milstein Research S.A. De C.V.
state: Yucatan
city: Merida
country: Mexico
facility: Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatán S.
state: Yucatán
city: Mérida
country: Mexico
facility: Unidad de Atención Médica e Investigación en Salud
state: Yucatán
city: Aguascalientes
country: Mexico
facility: Centenario Hospital Miguel Hidalgo
city: Veracruz
country: Mexico
facility: Arké SMO S.A de C.V
city: Veracruz
country: Mexico
facility: Sociedad de Metabolismo y Corazon S.C.
city: Trujillo Alto
country: Puerto Rico
facility: San Miguel Medical
city: Benoni
country: South Africa
facility: Worthwhile Clinical Trials
state: Gauteng
city: Germiston
country: South Africa
facility: CRISMO Research Centre
state: Gauteng
city: Pretoria
country: South Africa
facility: Botho Ke Bontle Health Services
state: Gauteng
city: London
country: United Kingdom
facility: St. George's Hospital
state: England
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: