Remdesivir - First drug to show improvement in COVID patients in formal clinical trials
Remdesivir is the first drug to show improvement in COVID-19 patients in formal clinical trials. It was granted emergency use authorization by the US Food and Drug Administration last month and has received approval by Japanese health regulators.
Remdesivir, a nucleotide analogue prodrug that inhibits viral RNA polymerases, has shown in vitro activity against SARS-CoV-2.
Of the 61 patients who received at least one dose of remdesivir, data from 8 could not be analyzed (including 7 patients with no post-treatment data and 1 with a dosing error). Of the 53 patients whose data were analyzed, 22 were in the United States, 22 in Europe or Canada, and 9 in Japan. At baseline, 30 patients (57%) were receiving mechanical ventilation and 4 (8%) were receiving extracorporeal membrane oxygenation.
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| Remdesivir To Treat COVID patients |
During a median follow-up of 18 days, 36 patients (68%) had an improvement in oxygen-support class, including 17 of 30 patients (57%) receiving mechanical ventilation who were extubated. A total of 25 patients (47%) were discharged, and 7 patients (13%) died; mortality was 18% (6 of 34) among patients receiving invasive ventilation and 5% (1 of 19) among those not receiving invasive ventilation.
In this cohort of patients hospitalized for severe Covid-19 who were treated with compassionate-use remdesivir, clinical improvement was observed in 36 of 53 patients (68%). Measurement of efficacy will require ongoing randomized, placebo-controlled trials of remdesivir therapy. (Funded by Gilead Sciences.)
European and South Korean authorities are also looking at remdesivir, with South Korean health authorities last Friday saying they would request imports of the drug. Gilead is yet to gain regulatory approval in either market.
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Source:
https://www.nejm.org/doi/full/10.1056/NEJMoa2007016?query=recirc_curatedRelated_article
https://www.gilead.com/purpose/advancing-global-health/covid-19
https://www.ndtv.com/india-news/covid-19-government-approves-remdesivir-under-emergency-use-for-covid-19-2239371
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