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
| NCT ID | NCT05261139 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Pfizer |
| Condition | COVID-19 |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2022-03-07 |
| Primary Completion | 2026-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 160 participants in total. It began in 2022-03-07 with a primary completion date of 2026-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT05261139 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 17 Years, studying COVID-19. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05261139 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 160 participants.
Is NCT05261139 currently recruiting?
Yes, NCT05261139 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT05261139 trial being conducted?
This trial is being conducted at Phoenix, United States, Los Angeles, United States, Los Angeles, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT05261139 clinical trial?
NCT05261139 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 160 participants.
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