AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 3Ages 0 Years - 17 YearsAllPfizer
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
๐Ÿ’Š

What it tests

  • nirmatrelvir
  • ritonavir
๐Ÿ“

Where

73 sites
Phoenix Children's Hospital
Phoenix, United States
Children's Hospital Los Angeles
Los Angeles, United States
Kaiser Permanente
Los Angeles, United States
UCLA David Geffen School of Medicine
Los Angeles, United States
UCLA
Los Angeles, United States
Children's National Medical Center
Washington D.C., United States
Life Spring Research Foundation
Miami, United States
Children's Healthcare of Atlanta - Arthur M. Blank Hospital
Atlanta, United States

โ€ฆand 65 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy