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Recruiting

NCT Number: NCT05261139

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

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.

Recruiting

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

МHAT "Sveti Ivan Rilski" Gorna Oryahovitsa, Gorna Oryahovitsa, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nirmatrelvir

Drug

PF-07321332

Ritonavir

Drug

ritonavir

Primary outcomes

  1. 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

  2. Cohort 1-2: Area Under the Curve to the End of the Dosing Period (AUC0-tau) 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

  3. Incidence of Treatment Emergent Adverse Events (TEAEs) leading to discontinuations.

    Time frame: From Baseline up through Day 34

  4. Incidence of Serious Adverse Events (SAEs) leading to discontinuations.

    Time frame: From Baseline up through Day 34

  5. Incidence of Adverse Events (AEs) leading to discontinuations.

    Time frame: From Baseline up through Day 34

  6. Number of participants with change from Baseline in Vital Signs

    Time frame: From Baseline up through Day 34

Secondary outcomes

  1. Viral load assessment titers measured via reverse transcription polymerase chain reaction (RT-PCR) in nasopharyngeal or nasal swabs over time

    Time frame: Baseline, Day 5, 6, 10, 14 and 28

  2. Proportion of participants with COVID-19 related hospitalization or death from any cause

    Time frame: From Baseline through Day 28

  3. Patient assessment on acceptability and palatability of nirmatrelvir/ritonavir (film-coated tablets and oral powder)

    Time frame: At baseline only for tablets and after each dose for powder formulation

    Frequency of responses to visual questionnaire on taste.

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 2/3, INTERVENTIONAL SAFETY, PHARMACOKINETICS, AND EFFICACY, OPEN-LABEL, MULTI-CENTER, SINGLE-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332 (NIRMATRELVIR)/RITONAVIR IN NONHOSPITALIZED SYMPTOMATIC PEDIATRIC PARTICIPANTS WITH COVID-19 WHO ARE AT RISK OF PROGRESSION TO SEVERE DISEASE

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2022
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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