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
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Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
160estimated
Sites
73
Countries
Bulgaria, Japan, Mexico +4
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-03-07 | actual | When the study began enrolling |
| Primary completion | 2026-07-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-07-30 | estimated | The whole study's end, after follow-up |
| First posted | 2022-03-02 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-07-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- COVID-19
Interventions
- Drug: nirmatrelvir
- Drug: ritonavir
Primary outcomes
what the primary-completion date above is the date OFCohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir
measured 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
measured 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.
measured From Baseline up through Day 34
Incidence of Serious Adverse Events (SAEs) leading to discontinuations.
measured From Baseline up through Day 34
Incidence of Adverse Events (AEs) leading to discontinuations.
measured From Baseline up through Day 34
Number of participants with change from Baseline in Vital Signs
measured From Baseline up through Day 34
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