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
Purpose
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.
Condition
- COVID-19
Eligibility
- Eligible Ages
- Between 0 Years and 17 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Cohort 1 nirmatrelvir/ritonavir |
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 |
|
Experimental Cohort 2 nirmatrelvir/ritonavir |
nirmatrelvir/ritonavir will be given as powder by mouth twice a day for 5 days (10 doses total) Weight ≥20 to <40 kg, ≥6 to <18 years |
|
Experimental Cohort 3 nirmatrelvir/ritonavir |
nirmatrelvir/ritonavir ≥2 to <6 years |
|
Experimental Cohort 4 nirmatrelvir/ritonavir |
nirmatrelvir/ritonavir ≥1 month (≥28 days) to <2 years |
|
Experimental Cohort 5 nirmatrelvir/ritonavir |
nirmatrelvir/ritonavir <1 month (<28 days) old |
|
Recruiting Locations
Arkansas Children's Hospital
Little Rock, Arkansas 72202
Little Rock, Arkansas 72202
Children's Hospital of Orange County
Orange, California 92868
Orange, California 92868
Clinical Site Partners, Inc.
Winter Park, Florida 32789
Winter Park, Florida 32789
Wayne Pediatrics
Detroit, Michigan 48201
Detroit, Michigan 48201
Hackensack University Medical Center
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
Duke Vaccine And Trials Unit
Durham, North Carolina 27705
Durham, North Carolina 27705
Duke University - Main Hospital and Clinics
Durham, North Carolina 27710
Durham, North Carolina 27710
Coastal Pediatric Research
Summerville, South Carolina 29486
Summerville, South Carolina 29486
Childrens Hospital of The Kings Daughters
Norfolk, Virginia 23507
Norfolk, Virginia 23507
More Details
- NCT ID
- NCT05261139
- Status
- Recruiting
- Sponsor
- Pfizer