Pfizer has announced that it has started a phase 2/3 study – EPIC-PEDS (Evaluation of Protease Inhibition for COVID-19 in Paediatric Patients – to assess the safety and effectiveness of its treatment Paxlovid (nirmatrelvir tablets and ritonavir tablets).
Paxlovid is an oral treatment and the trial will involve non-hospitalised, symptomatic, paediatric patients with a confirmed diagnosis of COVID-19 who are at risk of progression to severe disease.
The phase 2/3 trial is an open-label, multi-centre, single-part study in approximately 140 paediatric patients under 18 years of age. Two groups make up the initial enrolment – group 1 involves patients aged six to 17 weighing at least 40kg, while group 2 involves patients aged six to 17 weighing more than 20kg and less than 40kg.
The first group will receive Paxlovid orally twice daily for five days – nirmatrelvir/ritonavir 300mg/100mg – totalling ten doses. While those enrolled in the second group will receive the treatment – nirmatrelvir/ritonavir 150mg/100mg – orally twice daily for five days with ten doses in total.
The company is also working to develop an age-appropriate formulation for three additionally planned groups of patients aged younger than six years old. Pfizer plans to develop the trial to include these younger age groups as the data from groups 1 and 2 and the new formulation become available.
An independent Data Monitoring Committee (DMC) will be implemented to review the safety data of patients in each group.
“Since the beginning of the pandemic, more than 11 million children under the age of 18 in the United States alone have tested positive for COVID-19, representing nearly 18% of reported cases and leading to more than 100,000 hospital admissions. There is a significant unmet need for outpatient treatments that can be taken by children and adolescents to help prevent progression to severe illness, including hospitalisation or death,” said Mikael Dolsten, chief scientific officer and president, Worldwide Research, Development and Medical, Pfizer.
“PAXLOVID is already authorised or approved in many countries around the world, with more than 1.5 million treatment courses delivered thus far and 30 million expected by July to help combat this devastating disease.”
Paxlovid’s safety and effectiveness profile has not yet been directly established in paediatric patients. Despite other Paxlovid clinical trials not including patients under the age of 18, the US Food and Drug Administration (FDA) authorised the treatment for emergency use in paediatric patients aged 12 years and older, weighing at least 40kg.
Data produced by the EPIC-PEDS trial could reinforce support for the dose recommendations in this age group. Additionally, it has the potential to expand the indication to younger age groups and lower body weights.