WEDNESDAY, March 9, 2022 (HealthDay News) -- Pfizer Inc. announced Tuesday that it has launched a phase 2/3 clinical trial of its COVID-19 antiviral pill known as Paxlovid in children ages 6 to 17 years.
A news release from the company said the trial will assess the safety and efficacy of the drug in children with COVID-19 symptoms and a confirmed infection who are not hospitalized and are at risk for severe disease.
"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," Mikael Dolsten, chief scientific officer and president of Worldwide Research, Development and Medical at Pfizer, said in the release.
Pfizer's trial will include about 140 patients and will evaluate them in two groups to determine the effects of different doses based on weight. Paxlovid combines two antiviral drugs: nirmatrelvir and ritonavir. Participants in the first group who weigh at least 88 pounds would receive 300 mg of nirmatrelvir and 100 mg of ritonavir by mouth twice a day for five days. This is the dosage currently authorized by the U.S. Food and Drug Administration for high-risk COVID-19 patients 12 years and older who weigh at least 88 pounds. Participants in the second group who weigh between 44 and 88 pounds will be given 150 mg of nirmatrelvir and 100 mg of ritonavir by mouth twice a day for five days.
Clinical trials in patients 18 years and older have shown that Paxlovid cuts the risk for hospitalization or death by 89 percent if given within a few days of the first symptoms, according to Pfizer.
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