Status:
RECRUITING
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
Lead Sponsor:
Pfizer
Conditions:
COVID-19
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE3
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 ef...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
March 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT05261139
Start Date
March 7 2022
End Date
July 30 2026
Last Update
July 17 2025
Active Locations (73)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
3
Kaiser Permanente
Los Angeles, California, United States, 90027
4
UCLA David Geffen School of Medicine
Los Angeles, California, United States, 90095