Pfizer begins Phase 2/3 study for COVID-19 oral antiviral in exposed adults

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Investigative protease inhibitor aims to slow viral replication and prevent disease

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Pfizer is beginning a phase 2/3 study of an investigational oral antiviral with a low dose of ritonavir to prevent the COVID-19 disease, the company announced Monday. Treatment aims to reduce symptomatic disease and slow viral replication after infection has begun in others.

“With the continuing impact of COVID-19 around the world, we believe that combating the virus will require effective treatment for those who contract, or have been exposed to the virus, to complement that effect.” vaccines that have helped reduce infections,” Dr. Mikel Dolston, PhD, chief scientific officer and president of Pfizer’s Worldwide Research, Development and Medicine, said in a statement. News release Posted Monday. “If successful, we believe this therapy could help stop the virus early – before it has a chance to replicate on a large scale – potentially preventing symptomatic disease in people who are infected with others.” prevent the onset of infection.”

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The phase 2/3 study, called EPIC-PEP (Evaluation of protease inhibition for COVID-19 in post-exposure prophylaxis), is a randomized, double-blind, placebo-controlled trial in 2,660 adults 18 years of age Scheduled for enrollment of healthy adults. and elderly living with a household member who has a confirmed symptomatic COVID-19 infection. According to the news release, study participants will be randomly assigned to receive PF-07321332/ritonavir or a placebo twice a day for five or 10 days. The treatment is designed to be administered early (such as at the first sign or awareness of infection or risk) while ritonavir aims to slow the metabolism of the PF-07321332 antiviral to help fight the virus over a longer period of time .

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“Given the continued emergence and development of SARS-CoV-2 variants and their immense impact, we continue to work diligently to develop and study new methods to help our investigational oral antiviral candidates with potential for COVID-19.” not only on patients’ lives, but also on the lives of their families and household members,” Dolston said.

Pfizer said the company intends to evaluate the candidate’s safety and efficacy in preventing confirmed SARS-CoV-2 infection and symptoms over the course of two weeks, noting that early-stage trials suggested that the oral antiviral Was safe and well tolerated. The global program includes other ongoing studies, such as COVID-infected patients at high risk of poor outcomes, while another trial includes standard-risk patients, which began in July and August, respectively.


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