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

Pfizer

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: COVID-19

Treatments: Drug: nirmatrelvir; Drug: ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT05261139

C4671026

2023-509773-23-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

160 participants in 5 patient groups

Cohort 1 nirmatrelvir/ritonavir

Experimental group

Description:

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

Treatment:

Drug: ritonavir

Drug: nirmatrelvir

Cohort 2 nirmatrelvir/ritonavir

Experimental group

Description:

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

Treatment:

Drug: ritonavir

Drug: nirmatrelvir

Cohort 3 nirmatrelvir/ritonavir

Experimental group

Description:

nirmatrelvir/ritonavir ≥2 to \<6 years

Treatment:

Drug: ritonavir

Drug: nirmatrelvir

Cohort 4 nirmatrelvir/ritonavir

Experimental group

Description:

nirmatrelvir/ritonavir ≥1 month (≥28 days) to \<2 years

Treatment:

Drug: ritonavir

Drug: nirmatrelvir

Cohort 5 nirmatrelvir/ritonavir

Experimental group

Description:

nirmatrelvir/ritonavir \<1 month (\<28 days) old

Treatment:

Drug: ritonavir

Drug: nirmatrelvir