Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

A Phase 2/3 Single-Arm, Open-label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Obeldesivir in Pediatric Participants With COVID-19

This research study is testing a new medicine called Obeldesivir for children who have COVID-19. The main goals are to understand if the medicine is safe for children, how it acts in their bodies, and if it helps them feel better. Researchers will give some children a 175mg tablet and others a 350mg tablet. They will be watching closely for any side effects and checking if the medicine reduces the amount of virus in the body. The study also looks at how quickly children's symptoms improve and if they need oxygen or hospital care. It's a way to learn more about treating COVID-19 in young people.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Gilead Sciences Inc.

Enrolment target

Start

13 Dec 2023

COVID-19

What is this study about?

Imagine you or someone you know has COVID-19, and doctors are always looking for better ways to help people get well. This particular study is focused on children and teens who have COVID-19, and it's looking at a new medicine called Obeldesivir. The main idea is to see if this medicine is both safe for young people and effective at helping them recover from the virus.

The researchers are trying to find answers to a few important questions. Firstly, they want to understand how the medicine moves through a child's body – how it's absorbed, how much stays in the system, and how it eventually leaves. This helps them work out the best dose. Secondly, they're keeping a very close eye on any possible side effects, making sure the medicine is well-tolerated. Finally, they want to see if Obeldesivir actually makes a difference to how quickly children's COVID-19 symptoms improve, if it reduces the amount of virus in their body, and if it lowers the chance of needing extra medical support like oxygen or hospital care.

This kind of study, called a 'Phase 2/3 Integrated study', combines two important stages of testing a new medicine. Phase 2 usually focuses on safety and finding the right dose, while Phase 3 looks at how well the medicine works compared to other treatments or no treatment at all, and continues to monitor safety. By doing it together, researchers can get answers more quickly about whether Obeldesivir could be a helpful treatment option for children with COVID-19 in the future.

Key takeaways

New medicine (Obeldesivir) being tested for children with COVID-19.
Aims to check safety, how it works in the body, and if it helps recovery.
Involves taking tablets and regular check-ups for about 35 days.
Participants receive one of two doses (175mg or 350mg).
Looks for symptom improvement, reduced virus levels, and fewer hospitalisations.

Who may be eligible?

This study is open to both boys and girls of all ages who have been diagnosed with COVID-19. While the information provided doesn't list specific age limits, it suggests that children are the focus of this research.

To be considered for the study, you or your child would need to meet certain health criteria that the doctors involved in the study would explain. This often includes things like having a confirmed COVID-19 diagnosis and not having other serious health conditions that might interfere with the study medicine or results.

The study team will carefully review each potential participant to make sure the study is a safe and good fit for them. They will answer any questions you have about whether you or your child can take part.

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.

Do I have a confirmed diagnosis of COVID-19?
Am I a child or teenager?
Am I willing to take study medicine in tablet form?
Am I able to attend regular check-up appointments for approximately 35 days?

Answer every question to see your result.

What does participation involve?

If you or your child were to take part in this study, it would involve several steps. You would be given the study medicine, Obeldesivir, in tablet form, at either a 175mg or 350mg dose. You would likely have a number of visits to the clinic or hospital over a period of time, up to about 35 days.

During these visits, the study team would perform various assessments. This might include taking blood samples to check how the medicine is working in the body and to look for any changes in your health. They would also take samples from your nose to test for the COVID-19 virus. You would be asked regularly about your symptoms and how you are feeling, tracking how quickly symptoms improve. The team would also want to know if you're taking any other medicines and if you need any extra medical care like oxygen.

Some parts of the study might also involve giving feedback on how easy or pleasant the tablets are to take. The total duration of active participation and follow-up would be around 35 days from when you start taking the medicine.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You or your child might benefit from receiving a new medicine for COVID-19 that could help you recover faster or more completely, or reduce the need for hospital care. However, as this is a new medicine being tested, there's a chance it might not be effective for everyone, or it could cause side effects. Researchers will be carefully monitoring for any unwanted effects. It's very important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Poland
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Unverified
Spain
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Unverified
Italy
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Unverified
Hungary
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Unverified
Bulgaria

Common questions

What is Obeldesivir?

Obeldesivir is a new medicine being tested to see if it can help children and teens recover from COVID-19.

Will I or my child have to take a pill?

Yes, Obeldesivir is given as a tablet, and participants will receive one of two different strengths.

How long will the study last?

The main part of the study where you're closely monitored for symptoms and effects will last about 35 days.

What if I feel unwell during the study?

The study team will be checking on you regularly. You should always tell them immediately if you feel unwell or have any new symptoms.

Will I know if I'm getting the medicine or a dummy pill?

This study is 'single-arm' and 'open-label', which means everyone who enrolls will receive the Obeldesivir medicine, and both you and the doctors will know it.