drugset / 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

NCT05261139

Phase 3 Recruiting 160 enrolled Pfizer
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-03-07
Primary completion
2026-07-30
Completion
2026-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Nirmatrelvir Small molecule Oral
Subject Ritonavir Other / unclassified Oral

Indications