Not currently recruiting at University of California Health

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 study on COVID-19

Eligibility: for people ages 0-17 (full criteria)
Location: at UCLA
Dates: study started March 2022
completion around July 2026
Principal Investigator: by Jaime G. Deville, MD (ucla)

Jaime G. Deville

Description

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.

Official Title

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

Keywords

COVID-19, Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2), Pediatrics, Ritonavir, Nirmatrelvir

Eligibility

You can join if…

Open to people ages 0-17

Male and female, age 0 to < 18 years, able to swallow for some participants
Confirmed SARS-CoV-2 infection within 72 hours 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

You CAN'T join if...

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)
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, antiviral 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

Locations

UCLA David Geffen School of Medicine not yet accepting patients
Los Angeles California 90095 United States
UCLA not yet accepting patients
Los Angeles California 90095 United States
Children's Hospital Los Angeles in progress, not accepting new patients
Los Angeles California 90027 United States
Kaiser Permanente in progress, not accepting new patients
Los Angeles California 90027 United States
Consano Clinical Research, LLC accepting new patients
Shavano Park Texas 78231 United States
Life Spring Research Foundation accepting new patients
Miami Florida 33130 United States

Lead Scientist at University of California Health

Jaime G. Deville, MD (ucla)
HS Clinical Professor, Pediatrics, Medicine. Authored (or co-authored) 57 research publications

Details

Status: accepting new patients at some sites,
but this study is not currently recruiting here
Start Date: March 2022
Completion Date: July 2026 (estimated)
Sponsor: Pfizer
ID: NCT05261139
Phase: Phase 3 COVID-19 Research Study
Study Type: Interventional
Participants: Expecting 160 study participants
Last Updated: April 30, 2025