Pfizer Begins Phase 2/3 Pediatric Paxlovid Study
Pfizer has launched a phase 2/3 trial evaluating its COVID-19 antiviral Paxlovid (nirmatrelvir/ritonavir) in pediatric patients with symptomatic COVID-19 who haven’t been hospitalized.
The study has already enrolled about 140 patients under age 18, who have been split into two dosing cohorts based on weight. Patients who weigh at least 88 pounds will receive Paxlovid twice daily for five days, while those weighing less than 88 pounds but more than 44 pounds, will receive a lower dose of nirmatrelvir.
Plans are underway to include children under six years old in the trial, the company said.
Paxlovid has not yet received full approval from the FDA but has been granted Emergency Use Authorization for patients with mild-to-moderate COVID-19 who are 12 years or older at high risk of developing severe disease.