The COVID-19 Paediatric Oral Treatment Study 

Status: Open to Recruitment

Population: Paediatric 

Disease group: COVID-19

Funder: Pfizer INC

Sponsor: Pfizer INC

Principal Investigator: Dr Simon Drysdale

Study Aims 

The purpose of the study is to find out of the study drug PF-07321332 (nirmatrelvir) given with ritonavir, which is the study drug, helps treat non-hospitalised symptomatic children with COVID-19 who are at risk of their COVID-19 infection getting worse.  

If your child is eligible to participate in this study, your child will be enrolled to receive Paxlovid (the study drug, nirmatrelvir and ritonavir)).  

The UK Medicines and Healthcare products Regulatory Agency (MHRA) granted Paxlovid a conditional marketing authorisation for use after it was found to be safe and effective at reducing the risk of hospitalisation in people with mild to moderate COVID-19 infection who are at an increased risk of developing severe disease. Ritonavir is approved for other uses, but not for COVID-19 and is a medication given with nirmatrelvir to increase the levels of nirmatrelvir in the blood so that it may be more effective. Ritonavir is not expected to have any effect on SARS-Cov-2 virus.  

What does participating in the study involve? 

Your child’s participation in the study is completely voluntary (your and their choice (where age is appropriate). You also can choose to allow your child to take part in the study now, and then change your mind later at any time. Please keep in mind even if you child participates, it may turn out that they do not meet the study’s entry requirements.  

If you and your child agree to participate in the study and after you sign the consent and assent documents, your child’s participation in the study will start with a screening visit to learn about their medical history and to check if they meet the study requirements.  

If your child is eligible to participate in the study, your child will start taking Paxlovid either 5 days from the onset of symptoms, or 72 hours from a positive test.  

Participants will be in this study for about 5 weeks. If your child is enrolled into the study, they will need to visit the study site (an in-clinic visit) once or twice at the start and then 7 more visits (if your child is 2 to 5 years, they will have an additional 2 visits) which can be done at the study site or remotely.