NCT05261139|RecruitingPhase 3DMCFDA Drug

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

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

Pfizer ClinicalTrials.gov

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2 other identifiers

C46710262023-509773-23-00

Study Type

interventional

Target

160

Locations

7 countries

Sites

Timeline

RegisteredMar 2022

StartedMar 2022

CompletionJul 2026

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

160

participants targeted

Target at P25-P50 for phase_3 covid19

Timeline

3mo left

Started Mar 2022

Longer than P75 for phase_3 covid19

Geographic Reach

7 countries

73 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.4 years study duration

Study Progress95%

Mar 2022Jul 2026

First Submitted

Initial submission to the registry

February 25, 2022

Completed

5 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed

5 days until next milestone

Study Start

First participant enrolled

March 7, 2022

Completed

4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

4.4 years

First QC Date

February 25, 2022

Last Update Submit

July 16, 2025

Conditions

COVID-19

Keywords

Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2)Pediatrics

Outcome Measures

Primary Outcomes (6)

Cohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir
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
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.
From Baseline up through Day 34
Incidence of Serious Adverse Events (SAEs) leading to discontinuations.
From Baseline up through Day 34
Incidence of Adverse Events (AEs) leading to discontinuations.
From Baseline up through Day 34
Number of participants with change from Baseline in Vital Signs
From Baseline up through Day 34

Secondary Outcomes (3)

Viral load assessment titers measured via reverse transcription polymerase chain reaction (RT-PCR) in nasopharyngeal or nasal swabs over time
Baseline, Day 5, 6, 10, 14 and 28
Proportion of participants with COVID-19 related hospitalization or death from any cause
From Baseline through Day 28
Patient assessment on acceptability and palatability of nirmatrelvir/ritonavir (film-coated tablets and oral powder)
At baseline only for tablets and after each dose for powder formulation

Study Arms (5)

Cohort 1 nirmatrelvir/ritonavir

EXPERIMENTAL

nirmatrelvir/ritonavir will be given by tablets or powder by mouth twice a day for 5 days (10 doses total). Weight ≥40 kg 1. ≥12 to \<18 years 2. ≥6 to \<12 years