臨床研究等提出・公開システム

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 (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 (EPIC-Peds)

Kawai Norisuke

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

clinical-trials@pfizer.com

Clinical Trials Information Desk

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

+81-3-5309-7000

clinical-trials@pfizer.com

Recruiting

April. 25, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

*Male and female, age 0 to < 18 years, able to swallow tablets of investigational drug 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

*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

Both

COVID-19

nirmatrelvir and ritonavir

*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 1and 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 1and 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]

*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]

+81-3-5494-7297

Jan. 17, 2024

Yes

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Bulgaria/Mexico/Puerto Rico/South Africa/United Kingdom/United States