COVID-19 study: Nirmatrelvir vs Ritonavir
Official title 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
ClinicalTrials.gov ID: NCT05261139
What this study is testing
What is nirmatrelvir?
an investigational oral medicine being studied as a potential treatment for COVID-19 in patients under 18 who are not hospitalized but at risk for severe disease is designed to block the SARS‑CoV‑2 main protease, preventing the virus from replicating, while ritonavir is used to increase its level in the body
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out how safe the medicine is, how the body processes it, and how well it works against COVID-19 in this age group.
- Who it's for
- Children and teens under 18 who have COVID-19, are not hospitalized, and are at risk for severe illness.
- What's involved
- Participants will take the study medicine and undergo scheduled visits and tests to monitor safety and how the drug works.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 17
You may be able to join if
- 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...
- Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19
You likely can't join if
- 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...
See the full eligibility 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
- 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 treatment clinical study with an investigational compound or device, including those for COVID-19 through the study follow up
- Females who are pregnant or breastfeeding
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Shreveport, Louisiana, United States
- Shavano Park, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Miami, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Shreveport, Louisiana, United States; Shavano Park, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.