EPIC-Peds: Study of Oral PF-07321332 (Nirmatrelvir)/Ritonavir in Nonhospitalized COVID-19 Pediatric Patients at Risk for Severe Disease

• Status: Not yet recruiting
• Trial end date: 2023-03-04
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the safety, pharmacokinetics, and efficacy of nirmatrelvir/ritonavir for the treatment of nonhospitalized, symptomatic pediatric participants with coronavirus disease 2019 (COVID-19) who are at risk of progression to severe disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Ritonavir

Criteria

Inclusion criteria:

Male and female, age 0 to < 18 years, able to swallow Confirmed SARS-CoV-2 infection within 5 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) and/or absolute neutrophil count < 1000/mm3 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 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