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
- Registration Number
- NCT05261139
- Lead Sponsor
- Pfizer
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
Not provided
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 1 nirmatrelvir/ritonavir 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 Cohort 3 nirmatrelvir/ritonavir ritonavir nirmatrelvir/ritonavir ≥2 to \<6 years Cohort 1 nirmatrelvir/ritonavir nirmatrelvir 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 Cohort 5 nirmatrelvir/ritonavir ritonavir nirmatrelvir/ritonavir \<1 month (\<28 days) old Cohort 2 nirmatrelvir/ritonavir nirmatrelvir 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 Cohort 2 nirmatrelvir/ritonavir 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 Cohort 3 nirmatrelvir/ritonavir nirmatrelvir nirmatrelvir/ritonavir ≥2 to \<6 years Cohort 4 nirmatrelvir/ritonavir nirmatrelvir nirmatrelvir/ritonavir ≥1 month (≥28 days) to \<2 years Cohort 4 nirmatrelvir/ritonavir ritonavir nirmatrelvir/ritonavir ≥1 month (≥28 days) to \<2 years Cohort 5 nirmatrelvir/ritonavir nirmatrelvir nirmatrelvir/ritonavir \<1 month (\<28 days) old
- Primary Outcome Measures
Name Time Method Number of participants with change from Baseline in Vital Signs From Baseline up through Day 34 Incidence of Serious Adverse Events (SAEs) leading to discontinuations. From Baseline up through Day 34 Incidence of Adverse Events (AEs) leading to discontinuations. From Baseline up through Day 34 Cohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, and 2 hours post dose Cohort 1-2: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, and 2 hours post dose Incidence of Treatment Emergent Adverse Events (TEAEs) leading to discontinuations. From Baseline up through Day 34
- Secondary Outcome Measures
Name Time Method Viral load assessment titers measured via reverse transcription polymerase chain reaction (RT-PCR) in nasopharyngeal or nasal swabs over time Baseline, Day 5, 6, 10, 14 and 28 Proportion of participants with COVID-19 related hospitalization or death from any cause From Baseline through Day 28 Patient assessment on acceptability and palatability of nirmatrelvir/ritonavir (film-coated tablets and oral powder) At baseline only for tablets and after each dose for powder formulation Frequency of responses to visual questionnaire on taste.
Trial Locations
- Locations (73)
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Kaiser Permanente
🇺🇸Los Angeles, California, United States
UCLA David Geffen School of Medicine
🇺🇸Los Angeles, California, United States
UCLA
🇺🇸Los Angeles, California, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Life Spring Research Foundation
🇺🇸Miami, Florida, United States
Children's Healthcare of Atlanta - Arthur M. Blank Hospital
🇺🇸Atlanta, Georgia, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
🇺🇸Union City, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Scroll for more (63 remaining)Phoenix Children's Hospital🇺🇸Phoenix, Arizona, United States