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 - 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) and/or absolute neutrophil count < 1000/mm3 - 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 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 3
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir will be given as tablets by mouth twice a day for 5 days (10 doses total). Weight ≥40 kg ≥12 to <18 years ≥6 to <12 years
  • Drug: nirmatrelvir
    PF-07321332
  • Drug: ritonavir
    ritonavir
Experimental
Cohort 2 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir will be given as tablets by mouth twice a day for 5 days (10 doses total) Weight ≥20 to <40 kg, ≥6 to <18 years
  • Drug: nirmatrelvir
    PF-07321332
  • Drug: ritonavir
    ritonavir
Experimental
Cohort 3 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir ≥2 to <6 years
  • Drug: nirmatrelvir
    PF-07321332
  • Drug: ritonavir
    ritonavir
Experimental
Cohort 4 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir ≥1 month to <2 years
  • Drug: nirmatrelvir
    PF-07321332
  • Drug: ritonavir
    ritonavir
Experimental
Cohort 5 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir <1 month old
  • Drug: nirmatrelvir
    PF-07321332
  • Drug: ritonavir
    ritonavir

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com