C4671026-A PHASE 2/3, INTERVENTIONAL SAFETY, PHARMACOKINETICS, AND EFFICACY, OPEN-LABEL, MULTI-CENTER, SINGLE-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332 (NIRMATRELVIR)/RITONAVIR IN NONHOSPITALIZED SYMPTOMATIC PEDIATRIC PARTICIPANTS WITH COVID-19 WHO ARE AT RISK OF PROGRESSION TO SEVERE DISEASE
This clinical trial is testing a combination of two antiviral medicines, nirmatrelvir and ritonavir, in children and young people who have COVID-19. These medicines are already used in adults to help stop the virus from multiplying. The study focuses on children who have symptoms but are not in hospital, and who have a higher chance of becoming very unwell because of other health conditions. Researchers want to check how the body breaks down the medicine, what the best dose is, and whether it causes any side effects. Doctors will also see if the treatment lowers the amount of virus in the body and prevents hospital visits. They will test both regular tablets and an oral powder to see how easy it is for children to take.
At a glance
What is this study about?
When people catch COVID-19, most have mild illness and recover at home. However, some children and young people have underlying health conditions that put them at higher risk of becoming seriously ill. While treatments exist for adults, doctors need clear evidence to know the safest and most effective ways to treat younger patients.
This study is testing an oral antiviral medicine made of two drugs: nirmatrelvir and ritonavir (commonly known together as Paxlovid). Nirmatrelvir works by stopping the COVID-19 virus from copying itself inside the body, while ritonavir helps keep the medicine at the right level in the blood for longer.
Researchers want to see how the medicine moves through a child's body, what side effects might happen, and how well it helps clear the virus. They are also testing different forms of the medicine, such as swallowable tablets and a powder that can be mixed into liquid, to make sure it is easy and pleasant for children of different ages to take.
Key takeaways
- Tests an antiviral treatment for children with COVID-19 who are at risk of severe illness.
- Aims to check the safety, correct dose, and effectiveness of the medicine in younger people.
- Available as tablets or an oral powder to make taking it easier for children.
- Involves home treatment with clinic visits, blood tests, and swabs over about 28 days.
- Participation is entirely voluntary and you can withdraw at any time.
Who may be eligible?
This trial is designed for children and young people who currently have COVID-19 symptoms and have tested positive for the virus, but are well enough to be treated at home rather than in hospital.
To be considered, participants usually need to have certain health factors or pre-existing conditions that put them at a higher risk of getting severe COVID-19. Both boys and girls can take part.
Children who are already admitted to hospital for severe illness, or who take certain medicines that cannot be mixed safely with the trial drug, may not be able to join. The study doctor will check each child's full medical history to make sure taking part is safe for them.
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.
- My child currently has symptoms of COVID-19.
- My child has a confirmed positive test for COVID-19.
- My child is not currently hospitalised for their illness.
- My child has an underlying condition that puts them at higher risk from COVID-19.
- We are able to attend clinic visits and complete follow-up checks over about four weeks.
What does participation involve?
If your child joins the trial, they will take the study medicine by mouth for a set number of days. Depending on their age and what they can manage, they will receive either tablets or an oral powder mixed into a drink. You will be asked to report how easy it was for your child to take the medicine and what they thought of the taste.
Taking part involves regular check-ups with the study team over about four weeks (28 days). During these visits, doctors will check vital signs such as temperature, heart rate, and blood pressure. They will also take gentle nose or throat swabs to measure virus levels, and small blood samples to see how much medicine is in the blood.
Most care happens while your child rests at home, but you will need to attend clinic appointments or speak with the study team regularly so they can monitor your child's recovery and watch for any side effects.
Potential risks and benefits
Locations (2)
- —UnverifiedBulgaria
- —UnverifiedHungary
Common questions
What is the medicine being tested?
It is a combination of two antiviral drugs, nirmatrelvir and ritonavir, which work together to stop the COVID-19 virus from multiplying in the body.
Does my child have to stay in hospital?
No. This study is for children who are well enough to recover at home, though you will need to attend study visits for health checks.
What if my child cannot swallow pills?
The study includes an oral powder form that can be mixed into liquid, designed specifically for children who struggle to swallow tablets.
Will we have to pay for anything?
No, all trial medicines, tests, and study-related care are provided free of charge, and travel costs to visits are often reimbursed.
Can we change our minds after starting?
Yes. You can leave the study at any point without giving a reason, and your child's routine healthcare will not be affected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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