The results of the first randomised control trial for remdesivir, a drug originally developed for Ebola, in patients of COVID-19 are in, and the results are not promising.
In a study in the medical journal The Lancet, Chinese researchers have reported that they could not find any “statistically significant clinical benefits”.
The researchers reported: “Although not statistically significant, patients receiving remdesivir had a numerically faster time to clinical improvement than those receiving placebo among patients with symptom duration of 10 days or less. Adverse events were reported in 102 (66%) of 155 remdesivir recipients versus 50 (64%) of 78 placebo recipients. Remdesivir was stopped early because of adverse events in 18 (12%) patients versus four (5%) patients who stopped placebo early.”
It was used in between February 6, and March 12, and 237 patients were enrolled and randomly assigned to a treatment group. Of these, 158 patients in 10 hospitals in Wuhan, China, had actually received the drug.
The study, however, was stopped midway by the data safety monitoring board since there were not enough COVID patients left in Wuhan after the outbreak there was brought under control. So the authors highlighted the need for larger studies.
Remdesivir, developed by Gilead Sciences Inc, a research-based biopharmaceutical company, is a broad-spectrum antiviral previously tested in humans with Ebola virus and has also shown promise as a drug against the Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS), both of which, like COVID-19, are caused by coronaviruses. It has been touted as one of the most promising therapies against COVID.
It is a part of the SOLIDARITY trial of WHO, under which it is likely to be used in Indian patients, too.
There are other trials underway, including one at the University of Nebraska Medical Center (UNMC) in Omaha, USA, whose regulatory sponsor is the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
Prof Bin Cao from China-Japan Friendship Hospital and Capital Medical University in China, who led the research, wrote: “Our trial found that while safe and adequately tolerated, remdesivir did not provide significant benefits over placebo… but we are mindful that we were only able to enrol 237 of the target 453 patients because the COVID-19 outbreak was brought under control in Wuhan… restrictions on bed availability resulted in most patients being enrolled later in the disease course, so we were unable to adequately assess whether earlier treatment with remdesivir might have provided clinical benefit.”
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