Learning about a COVID-19 treatment for children at risk of severe disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of the medication nirmatrelvir/ritonavir in treating COVID-19 in pediatric patients under 18 years of age who are not hospitalized but are at risk for severe disease. Participants will receive the study medication within 72 hours of confirmed SARS-CoV-2 infection and must exhibit COVID-19 symptoms. The study will assess how the drug is processed in the body and its efficacy in alleviating symptoms and preventing severe illness.

Why it matters

Who can join: the full rules

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

Where it's running

• Life Spring Research Foundation
  Miami, Florida, United States Recruiting
• Children's Healthcare of Atlanta - Arthur M. Blank Hospital
  Atlanta, Georgia, United States Recruiting
• University of Chicago Medical Center
  Chicago, Illinois, United States Recruiting
• Louisiana State University Health Sciences Shreveport
  Shreveport, Louisiana, United States Recruiting
• Consano Clinical Research, LLC
  Shavano Park, Texas, United States Recruiting
• Phoenix Children's Hospital
  Phoenix, Arizona, United States Active not recruiting

+23 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• MDX2301 in healthy adults and adults at higher risk for severe COVID-19

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.