The investigational antiviral remdesivir is superior to the standard of care for the treatment of COVID-19, according to a report published Friday in the New England Journal of Medicine. The much anticipated preliminary analysis is based on data from the Adaptive COVID-19 Treatment Trial (ACTT), sponsored by the USA’s National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
The randomized, controlled trial enrolled hospitalized adults with COVID-19 with evidence of lower respiratory tract involvement (generally moderate to severe disease). Investigators found that remdesivir was most beneficial for hospitalized patients with severe disease who required supplemental oxygen. Findings about benefits in other patient subgroups were less conclusive in this preliminary analysis.
The study began on February 21, 2020 and enrolled 1,063 participants in 10 countries in 58 days. Initial results from the trial, which led to the Gilead Sciences (Nasdaq: GILD) developed drug’s emergency authorization by the Food and Drug Administration, were released late last month. Based in this, the Japanese Ministry of Health, Labor and Welfare (MHLW) granted regulatory approval of remdesivir – which has now been given the trade name Veklury - as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19, under an exceptional approval pathway.
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