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

Overview

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.

Interventions

• Drug nirmatrelvir
  PF-07321332
• Drug ritonavir
  ritonavir

Primary outcome measures

• Cohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir [Time frame: 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 [Time frame: 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. [Time frame: From Baseline up through Day 34]
• Incidence of Serious Adverse Events (SAEs) leading to discontinuations. [Time frame: From Baseline up through Day 34]
• Incidence of Adverse Events (AEs) leading to discontinuations. [Time frame: From Baseline up through Day 34]
• Number of participants with change from Baseline in Vital Signs [Time frame: From Baseline up through Day 34]

Secondary outcome measures (3)

• Viral load assessment titers measured via reverse transcription polymerase chain reaction (RT-PCR) in nasopharyngeal or nasal swabs over time [Time frame: Baseline, Day 5, 6, 10, 14 and 28]
• Proportion of participants with COVID-19 related hospitalization or death from any cause [Time frame: From Baseline through Day 28]
• Patient assessment on acceptability and palatability of nirmatrelvir/ritonavir (film-coated tablets and oral powder) [Time frame: At baseline only for tablets and after each dose for powder formulation]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 50 centers

• Phoenix Children's Hospital — Phoenix
• Children's Hospital Los Angeles — Los Angeles
• Kaiser Permanente — Los Angeles
• UCLA David Geffen School of Medicine — Los Angeles
• UCLA — Los Angeles
• Children's National Medical Center — Washington D.C.
• Life Spring Research Foundation — Miami
• Children's Healthcare of Atlanta - Arthur M. Blank Hospital — Atlanta
• … and 42 more centers

Mexico · 11 centers

• Instituto Nacional de Pediatria — Mexico City
• Hospital Infantil de Mexico Federico Gomez — Mexico City
• JM Research SC — Cuernavaca
• Fundación Santos y De la Garza Evia — Monterrey
• Eukarya Pharmasite S.C. — Monterrey
• Unidad de Atención Médica e Investigación en Salud — Mérida
• Kohler & Milstein Research S.A. De C.V. — Mérida
• Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en — Mérida
• … and 3 more centers

Bulgaria · 5 centers

• МHAT "Sveti Ivan Rilski" Gorna Oryahovitsa — Gorna Oryahovitsa
• "Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Grama — Rousse
• Medical Center-1-Sevlievo EOOD — Sevlievo
• DCC "Alexandrovska" — Sofia
• Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD — Vratsa

South Africa · 3 centers

• Worthwhile Clinical Trials — Benoni
• CRISMO Research Centre — Germiston
• Botho Ke Bontle Health Services — Pretoria

Japan · 2 centers

• Tokyo Metropolitan Children's Medical Center — Fuchū
• Osaka City General Hospital — Osaka

Puerto Rico · 1 center

• San Miguel Medical — Trujillo Alto

United Kingdom · 1 center

• St. George's Hospital — London

Identifiers

NCT: NCT05261139 · C4671026 · 2023-509773-23-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗