RecruitingPHASE3INTERVENTIONAL

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

This research study, called EPIC-Peds, is investigating a medicine called nirmatrelvir/ritonavir. It's for children and young people under 18 years old who have COVID-19. The study is focusing on those who are not in hospital but have other health conditions that might make them more likely to become very poorly from COVID-19. We want to understand how safe this medicine is for them, how their bodies handle it, and how well it works to treat COVID-19. This information will help us learn if this medicine could be a useful treatment option for younger people at risk.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Pfizer

Enrolment target

160

Start

07 Mar 2022

Estimated completion

30 Jul 2026

COVID-19

What is this study about?

This study, known as EPIC-Peds, is looking into a new medicine called nirmatrelvir/ritonavir. It's designed for children and young people under the age of 18 who have COVID-19. We're specifically interested in those who are not sick enough to be in hospital, but who have other health conditions or factors that mean they could become seriously ill from COVID-19.

The main goals of this study are to understand three key things about the medicine. Firstly, its safety – how well young people tolerate it and if there are any side effects. Secondly, how the body processes the medicine; this helps us understand how much to give and how often. And thirdly, its effectiveness – simply put, how well it works to treat COVID-19 symptoms and prevent severe illness in this age group.

The information gathered from this study will be really important. It will help doctors and researchers decide if nirmatrelvir/ritonavir could be a helpful treatment option for children and young people who get COVID-19 and are at a higher risk of complications. This kind of research is vital for finding effective ways to protect vulnerable members of our community.

Key takeaways

The study is for children and young people under 18 with COVID-19.
It focuses on those not in hospital but at higher risk of serious illness.
The medicine being tested is nirmatrelvir/ritonavir.
The study aims to check the medicine's safety, how the body handles it, and how well it works.
Taking part involves taking the medicine and attending health checks.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, participants need to be between 0 and 17 years old. They must have a confirmed COVID-19 infection that was diagnosed within the last three days, and their COVID-19 symptoms must have started within the last five days and still be present.

Crucially, participants must *not* be in hospital for COVID-19, but they do need to have at least one health condition or characteristic that puts them at increased risk of becoming seriously unwell from COVID-19. For example, this could include certain long-term health conditions.

There are also some reasons why someone might not be able to join. For instance, if they have ever needed hospital treatment for COVID-19, have severe kidney problems, or have certain other active infections. People who are pregnant or breastfeeding, or who are already taking part in another study with a new medicine, would also not be able to participate. It's important to discuss any existing health conditions and all medications with the study team to see if this study is right for you or your child.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you/is your child aged between 0 and 17 years?
Do you/does your child have a confirmed COVID-19 infection diagnosed in the last 3 days?
Did COVID-19 symptoms start within the last 5 days and are they still present?
Are you/is your child NOT currently in hospital for COVID-19?
Do you/does your child have a health condition that puts them at higher risk of severe COVID-19?
Are you/is your child NOT pregnant or breastfeeding (for females)?

Answer every question to see your result.

What does participation involve?

If you or your child decide to take part in this study, you will be given the study medicine, nirmatrelvir/ritonavir. This medicine will be taken as directed by the study team. Over the course of the study, there will be a series of visits to the clinic or study site. These visits will involve health checks, answering questions about symptoms, and likely providing blood samples. These assessments help the study team monitor safety, see how the medicine is working, and understand how the body uses it. There will also be follow-up calls or visits after the main treatment period to ensure continued well-being. The exact number of visits and the total length of time you'll be involved will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical study can offer potential benefits, such as contributing to new medical knowledge that could help others in the future, and receiving close medical attention during the study. However, there are also potential risks, including side effects from the study medicine, or mild discomfort from procedures like blood tests. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (73)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Phoenix Children's Hospital
Verified postcode
Phoenix, United States· Active not recruiting
Children's Hospital Los Angeles
Verified postcode
Los Angeles, United States· Active not recruiting
Kaiser Permanente
Verified postcode
Los Angeles, United States· Active not recruiting
UCLA David Geffen School of Medicine
Verified postcode
Los Angeles, United States· Not yet recruiting
UCLA
Verified postcode
Los Angeles, United States· Not yet recruiting
Children's National Medical Center
Verified postcode
Washington D.C., United States· Active not recruiting
Life Spring Research Foundation
Verified postcode
Miami, United States· Recruiting
Children's Healthcare of Atlanta - Arthur M. Blank Hospital
Verified postcode
Atlanta, United States· Recruiting
Rophe Adult and Pediatric Medicine/SKYCRNG
Verified postcode
Union City, United States· Terminated
Ann & Robert H. Lurie Children's Hospital of Chicago
Verified postcode
Chicago, United States· Active not recruiting
University of Chicago Medical Center
Verified postcode
Chicago, United States· Recruiting
Louisiana State University Health Sciences Shreveport
Verified postcode
Shreveport, United States· Recruiting

Common questions

What is nirmatrelvir/ritonavir?

It's a medicine being tested to see if it can help treat COVID-19, especially in people who are at higher risk of becoming very ill.

Who is this study for?

It's for children and young people under 18 who have COVID-19, are not in hospital, but have health conditions that put them at higher risk of getting very sick.

What does 'at risk for severe disease' mean?

It means having certain health conditions or characteristics that make someone more likely to develop serious COVID-19 symptoms or complications.

What will I or my child have to do if we join?

You'll take the study medicine and attend planned visits for health checks, symptom monitoring, and possibly blood tests.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any point, and your decision will not affect your medical care.

How to find out more

Pfizer CT.gov Call Center

clinicaltrials.gov_inquiries@pfizer.com 1-800-718-1021 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.