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NCT05261139 · ClinicalTrials.gov registry record · Phase 3

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 3 study of COVID-19, sponsored by Pfizer.

Recruiting
Registry status
Phase 3
Development phase
160
Enrollment target
20
Study locations

NCT05261139 is a Phase 3 study of COVID-19 that is actively recruiting participants, run by Pfizer. The registered enrollment target is 160 participants, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT05261139, a Phase 3 study of COVID-19, is actively recruiting participants, sponsored by Pfizer.

RECRUITING
Registry status
Phase 3
Development phase
160 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Interventions

  • DRUG nirmatrelvir
  • DRUG ritonavir

Study Locations (20)

California

  • Children's Hospital Los Angeles - Los Angeles
  • Kaiser Permanente - Los Angeles
  • UCLA David Geffen School of Medicine - Los Angeles
  • UCLA - Los Angeles

Georgia

  • Children's Healthcare of Atlanta - Arthur M. Blank Hospital - Atlanta
  • Rophe Adult and Pediatric Medicine/SKYCRNG - Union City

Illinois

  • Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
  • University of Chicago Medical Center - Chicago

Massachusetts

  • Boston Medical Center - Boston
  • University of Massachusetts Chan Medical School - Worcester

Missouri

  • St. Louis Children's Hospital - St Louis
  • Washington University School of Medicine - St Louis

Arizona

  • Phoenix Children's Hospital - Phoenix

District of Columbia

  • Children's National Medical Center - Washington D.C.

Florida

  • Life Spring Research Foundation - Miami

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2022-03-07
Est. Completion 2026-07-30
Phase Phase 3

Sponsor

Pfizer

1,845 total trials

What the Registry Record Tells You About NCT05261139

The ClinicalTrials.gov registry entry for NCT05261139 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which nirmatrelvir is the first listed.

NCT05261139 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Georgia, Illinois.

Frequently Asked Questions

What is clinical trial NCT05261139 about?

NCT05261139 is a clinical study titled "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". 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/ri...

What is the current status of trial NCT05261139?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2022-03-07. Estimated completion is 2026-07-30.

What conditions does trial NCT05261139 study?

This clinical trial studies the following conditions: COVID-19.

What interventions are being tested in trial NCT05261139?

The interventions under investigation include: nirmatrelvir (DRUG), ritonavir (DRUG).

Who is sponsoring clinical trial NCT05261139?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05261139 being conducted?

This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.