I4V-MC-KHAB: A Multicenter, Open-Label, Pharmacokinetic and Safety Study of Baricitinib in Pediatric Patients From 1 Year to Less Than 18 Years Old Hospitalized With COVID-19
This study, called I4V-MC-KHAB, is testing a medicine called Baricitinib in children and teenagers (from 1 to under 18 years old) who are in hospital because of COVID-19. It’s an 'open-label' study, meaning everyone involved knows what medicine is being given. The main goal is to understand how the body uses and gets rid of Baricitinib, and to make sure it's safe for children. This is a 'Phase III' study, which means it’s a later stage of research designed to confirm if the treatment works and is safe after earlier studies showed promise. We want to measure the amount of the drug in the blood over time and its highest level to see how well it's absorbed and processed.
At a glance
What is this study about?
This research study is looking into a medication called Baricitinib for children and young people who have needed hospital care because of COVID-19. The study is called I4V-MC-KHAB. We are testing patients aged from 1 year old up to, but not including, 18 years old. The main purpose is to understand how Baricitinib behaves in a child's body – how much of it reaches the bloodstream, how long it stays there, and how the body breaks it down and gets rid of it. This information is very important because children's bodies often handle medicines differently than adults'.
This is a 'Phase III' study. Think of medicine development like stages of a race. Phase I and II studies check for basic safety and if the drug shows any promise. Phase III is a larger stage where we aim to confirm if the treatment is effective and safe for a wider group of people compared to other options.
Ultimately, by learning more about Baricitinib in children with COVID-19, particularly how their bodies process it and if it's safe, doctors hope to gain better ways to treat young patients. This helps ensure that if the drug is proven beneficial, it can be used safely and effectively in the future for this age group.
Key takeaways
- This study investigates Baricitinib for hospitalised children (1-17 years old) with COVID-19.
- The main goals are to understand how the medicine works in children's bodies and check its safety.
- This is a Phase III study, a later stage of research to confirm effectiveness.
- Participation involves receiving the medicine, blood tests, and close health monitoring.
- You can withdraw from the study at any time without affecting medical care.
Who may be eligible?
This study is looking for children and young people who are currently in hospital because they have COVID-19. The study includes patients of all genders.
To be considered, participants must be at least 1 year old but not yet 18 years old (e.g., up to 17 years and 364 days old). This ensures the study focuses on a specific age range where finding effective treatments is very important.
More specific details about a participant's health history or other medications they might be taking would be discussed by the study team to make sure it's safe and appropriate for them to take part.
- Is my child currently in hospital with COVID-19?
- Is my child between 1 and under 18 years old?
- Has my child's doctor confirmed they meet other specific health requirements for the study?
- Am I, as a parent or guardian, comfortable with my child receiving an investigational medicine?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you or your child decides to take part in this study, they would receive the study medicine, Baricitinib. The study team would need to take regular blood samples to measure how much of the medicine is in the body and how it changes over time. They would also carefully check your child's health and any side effects during their hospital stay.
There might be additional visits or follow-ups after leaving the hospital, which would be explained in detail. All assessments, including blood tests and health checks, are part of understanding the medicine's safety and how it works. The total duration of participation, including hospital stay and follow-up, would be clearly explained by the study team.
Potential risks and benefits
Locations (2)
- —Belgium
- —Spain
Common questions
What is Baricitinib?
Baricitinib is a medicine being studied to see how it affects people with COVID-19. It helps calm down the body’s overactive immune response.
Why are you focusing on children?
Children's bodies handle medicines differently than adults. This study aims to find the safest and most effective way to use Baricitinib for young people with COVID-19.
Is this medicine approved for COVID-19 in children already?
No, it's not. This is a research study (Phase III), which means we are still gathering important information to see if it should be approved and used.
Will my child definitely get the study medicine?
Yes, in this open-label study, all participants will receive the study medicine, Baricitinib.
What does 'pharmacokinetic' mean in simple terms?
It means we are studying how the body handles the medicine – how it's absorbed, distributed, broken down, and leaves the body.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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