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Nirmatrelvir/Ritonavir for COVID-19 in Children
Study Summary
This trial is testing a new drug to see if it is safe and effective in treating kids with COVID-19 who are not hospitalized.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2012 Phase 4 trial • 68 Patients • NCT00757783Trial Design
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Who is running the clinical trial?
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- You are able to swallow.You have received or are going to receive specific treatments for COVID-19.You have a serious infection other than COVID-19.You are currently on dialysis or have serious problems with your kidneys.You have tested positive for COVID-19 within the last 3 days before joining the study.Your total bilirubin level is more than twice the normal limit, unless you have Gilbert's syndrome.You are currently taking or expected to take medications that interact with CYP3A4, a protein in the body that breaks down certain medications.You have been hospitalized for COVID-19 treatment or currently need hospitalization for COVID-19.You started showing signs of COVID-19 within 5 days before joining the study, and you still have at least one of the specific COVID-19 signs.You have a medical condition that makes you more likely to get very sick from COVID-19.
- Group 1: Cohort 2 nirmatrelvir/ritonavir
- Group 2: Cohort 5 nirmatrelvir/ritonavir
- Group 3: Cohort 3 nirmatrelvir/ritonavir
- Group 4: Cohort 4 nirmatrelvir/ritonavir
- Group 5: Cohort 1 nirmatrelvir/ritonavir
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many medical centers are coordinating this research project?
"At the moment, there are 70 medical centres running this clinical trial. If you are interested in participating, know that some of the locations include Houston, Minneapolis and Parma. Additionally, selecting the site nearest to your home can help reduce travel-related burdens."
Who does this clinical trial hope to include in its sample size for research?
"Eligible participants for this coronavirus trial must be infected with SARS-CoV-2 and between the ages of 0 to 17. This research is looking to have around 140 patients enrolled."
Does the age restriction for this clinical trial end at 70 years old?
"The target patient demographic for this clinical trial are those that have not yet reached their 18th birthday."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Coastal Pediatric Research: < 48 hours
Average response time
- < 2 Days
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