Recruiting PHASE3 INTERVENTIONAL 5-arm 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

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

Sponsor: Pfizer

Conditions COVID-19

Interventions nirmatrelvir ritonavir

Updated 28 times since 2022 Last updated: Jul 16, 2025 Started: Mar 7, 2022 Primary completion: Jul 30, 2026 Completion: Jul 30, 2026

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates COVID-19 and is currently actively recruiting participants. Pfizer leads this study, which shows 28 recorded versions since 2022 — indicating substantial longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

Change History

28 versions recorded

Sep 2025 — Present [monthly]

Recruiting PHASE3
Aug 2025 — Sep 2025 [monthly]

Recruiting PHASE3
Jun 2025 — Aug 2025 [monthly]

Recruiting PHASE3

Phase: PHASE2/PHASE3 → PHASE3
Dec 2024 — Jun 2025 [monthly]

Recruiting PHASE2/PHASE3

Status: Suspended → Recruiting
Nov 2024 — Dec 2024 [monthly]

Suspended PHASE2/PHASE3

▶ Show 23 earlier versions

Oct 2024 — Nov 2024 [monthly]

Suspended PHASE2/PHASE3
Sep 2024 — Oct 2024 [monthly]

Suspended PHASE2/PHASE3

Status: Recruiting → Suspended · Phase: PHASE3 → PHASE2/PHASE3
Aug 2024 — Sep 2024 [monthly]

Recruiting PHASE3

Phase: PHASE2/PHASE3 → PHASE3
Jul 2024 — Aug 2024 [monthly]

Recruiting PHASE2/PHASE3

Status: Suspended → Recruiting · Phase: PHASE2_PHASE3 → PHASE2/PHASE3
Jun 2024 — Jul 2024 [monthly]

Suspended PHASE2_PHASE3
May 2024 — Jun 2024 [monthly]

Suspended PHASE2_PHASE3
Feb 2024 — May 2024 [monthly]

Suspended PHASE2_PHASE3

Status: Recruiting → Suspended
Jan 2024 — Feb 2024 [monthly]

Recruiting PHASE2_PHASE3
Dec 2023 — Jan 2024 [monthly]

Recruiting PHASE2_PHASE3
Nov 2023 — Dec 2023 [monthly]

Recruiting PHASE2_PHASE3
Oct 2023 — Nov 2023 [monthly]

Recruiting PHASE2_PHASE3
Sep 2023 — Oct 2023 [monthly]

Recruiting PHASE2_PHASE3

Phase: PHASE3 → PHASE2_PHASE3
Jul 2023 — Sep 2023 [monthly]

Recruiting PHASE3

Status: Suspended → Recruiting · Phase: PHASE2_PHASE3 → PHASE3
Jun 2023 — Jul 2023 [monthly]

Suspended PHASE2_PHASE3
May 2023 — Jun 2023 [monthly]

Suspended PHASE2_PHASE3

Phase: PHASE3 → PHASE2_PHASE3
Apr 2023 — May 2023 [monthly]

Suspended PHASE3

Status: Recruiting → Suspended · Phase: PHASE2_PHASE3 → PHASE3
Feb 2023 — Apr 2023 [monthly]

Recruiting PHASE2_PHASE3
Jan 2023 — Feb 2023 [monthly]

Recruiting PHASE2_PHASE3

Phase: PHASE3 → PHASE2_PHASE3
Nov 2022 — Jan 2023 [monthly]

Recruiting PHASE3

Phase: PHASE2_PHASE3 → PHASE3
Sep 2022 — Nov 2022 [monthly]

Recruiting PHASE2_PHASE3
Jun 2022 — Sep 2022 [monthly]

Recruiting PHASE2_PHASE3
May 2022 — Jun 2022 [monthly]

Recruiting PHASE2_PHASE3
Apr 2022 — May 2022 [monthly]

Recruiting PHASE2_PHASE3

First recorded

Mar 2022

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Pfizer

Data source: Pfizer

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aguascalientes, Mexico , Albuquerque, United States , Atlanta, United States , Baltimore, United States , Benoni, South Africa , Boston, United States , Buffalo, United States , Chapel Hill, United States , Chicago, United States , Cleveland, United States and 43 more locations