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New treatment option for COVID-19
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?
nirmatrelvir is an investigational medicine, being studied as a potential treatment for covid-19.
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 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.
- 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's taking place
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Union City, Georgia, United States
- Chicago, Illinois, United States
- Shreveport, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Worcester, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Ridgeland, Mississippi, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Albuquerque, New Mexico, United States
- Buffalo, New York, United States
- Commack, New York, United States
- East Setauket, New York, United States
- New Hyde Park, New York, United States
+ 33 more site(s).
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 - 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?
Study sites include Phoenix, Arizona, United States; Los Angeles, California, United States; Washington D.C., District of Columbia, United States; Miami, Florida, United States; Atlanta, Georgia, United States; Union City, Georgia, United States and 47 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.