Pfizer begins pediatric trial of COVID-19 antiviral
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Pfizer announced Wednesday that it has initiated a phase 2/3 study of its COVID-19 antiviral for pediatric patients.
Paxlovid, which contains tablets of the protease inhibitor nirmatrelvir and a low dose of ritonavir, is already available for patients aged 12 years or older under an emergency use authorization issued by the FDA in December.
The new pediatric trial is an open-label, multicenter, single-arm study that will enroll approximately 140 participants aged younger than 18 years.
Initial enrollment will include two cohorts of participants aged 6 to 17 years. The first will include children weighing at least 40 kg, who will receive 300 mg of nirmatrelvir and 100 mg of ritonavir orally twice daily for 5 days — the currently authorized dose for patients aged 12 years and older weighing at least 40 kg. A second cohort of children weighing between 20 kg and 40 kg will also receive the therapy orally twice daily for 5 days, but with a reduced dose of nirmatrelvir (150 mg).
Mikael Dolsten, MD, PhD, Pfizer’s chief scientific officer and president for worldwide research, development and medical, said the antiviral may fill a “significant unmet need” for outpatient treatments for children and adolescents with COVID-19.
“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,” Dolsten said in a press release.
“Paxlovid is already authorized 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,” he said. “We are proud to expand studies of our novel COVID-19 treatment to include pediatric participants to further evaluate the safety and efficacy of this treatment in this important population.”
A final analysis of data from the Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients (EPIC-HR) trial demonstrated that Paxlovid reduced COVID-19-related hospitalizations and deaths by almost 90% among adults. The new trial is called EPIC-PEDS.
“Data from the EPIC-PEDS study will provide further support for the dose recommendations in this population, as well as potentially expand the indication to younger age groups and lower weights,” Pfizer said.
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