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

Conditions

• COVID-19

Eligibility Criteria

Sex

ALL

Age

0 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• nirmatrelvir — DRUG
  PF-07321332
• ritonavir — DRUG
  ritonavir

Study Details

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.

Key Dates

Start date

Mar 7, 2022

Status verified

Jul 2025

Primary completion

Jul 30, 2026

Completion

Jul 30, 2026

Study Design

Enrollment

160 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

Cohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir [ Time Frame: Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, and 2 hours post dose ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (50)

Find similar trials in Phoenix, AZ

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