Study of Oral NirmatrelvirRitonavir to Treat COVID-19 in Children Under 18 at Risk for Severe Illness

What this Trial Is About

Researchers are evaluating the safety, how the body processes, and how well the study medicine nirmatrelvirritonavir works for treating COVID-19 in children under 18 years old who are not hospitalized but at risk of severe illness. This trial is a Phase 3, open-label study focusing on nonhospitalized pediatric patients with COVID-19 to better understand the effects of this oral medication. The study medicine is given by mouth as tablets or powder twice daily for 5 days, totaling 10 doses. Different dosing forms and amounts are used depending on the participants age and weight, ranging from under 1 month old up to 18 years. Participants are assigned to one of several groups based on these factors to receive the medicine accordingly. During the study, participants will have blood samples taken to measure drug levels at specific times, and researchers will monitor for any side effects or changes in vital signs up to 34 days after starting treatment. They will also measure viral load through nasal swabs at several points over 28 days and assess hospitalizations or deaths related to COVID-19. Participants feedback on the medicines taste and acceptability will be collected during treatment.

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