Remdesivir improves 68% patients of severe Covid 19 in NEJM study
More than two-thirds of severely ill COVID-19 patients, 68% to be precise improved after treatment with remdesivir, an experimental drug being developed by Gilead Sciences Inc., according to new data based on patient observation.The analysis has been published in the New England Journal of Medicine.
Remdesivir is a nucleotide analogue prodrug that inhibits viral RNA polymerases, has shown in vitro activity against SARS-CoV-2.
There are currently no approved treatments or preventive vaccines for COVID-19, the respiratory illness caused by the novel coronavirus that has killed more than 150,000 people worldwide.
Gilead last month sharply limited its compassionate use program for remdesivir and is conducting its own clinical trials of the antiviral drug, with results expected in coming weeks. Researchers in China as well as the U.S. National Institutes of Health are also testing the drug in COVID-19 patients.
The new analysis includes patients in the United States, Europe, Canada and Japan who received a 10-day course of intravenous remdesivir.
The researchers provided remdesivir on a compassionate-use basis to patients hospitalized with Covid-19, the illness caused by infection with SARS-CoV-2. Patients were those with confirmed SARS-CoV-2 infection who had an oxygen saturation of 94% or less while they were breathing ambient air or who were receiving oxygen support. Patients received a 10-day course of remdesivir, consisting of 200 mg administered intravenously on day 1, followed by 100 mg daily for the remaining 9 days of treatment. This report is based on data from patients who received remdesivir during the period from January 25, 2020, through March 7, 2020, and have clinical data for at least 1 subsequent day.
Before the treatment, 30 patients were on mechanical ventilators, and four were on a machine that pumps blood from the patient's body through an artificial oxygenator. After a median follow-up of 18 days, 36 patients, or 68%, had an improvement in oxygen-support class, including more than half of the 30 patients receiving mechanical ventilation who had their breathing tubes removed. A total of 25 patients, or 47%, were discharged from the hospital. Seven patients, 13% of the total, died.
The paper's author called the findings "hopeful," but cautioned that it is difficult to interpret the results since they do not include comparison to a control group, as would be the case in a randomized clinical trial. In addition, the patient numbers were small, the details being disclosed are limited, and the follow-up time was relatively short.
The researchers concluded that 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.
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