Gilead Science’s remdesivir, one of the most highly anticipated drugs being tested against the new coronavirus, showed positive results in a large-scale US government trial, the company said Wednesday.
Remdesivir is an anti-viral drug.
“We understand that the trial has met its primary endpoint and that National Institute of Allergy and Infectious Diseases (Niaid) will provide detailed information at an upcoming briefing,” the company said.
Though it is difficult to precisely quantify the finding in the absence of results, it represents the first time any drug has been shown to improve outcomes against the Covid-19 illness, which has claimed more than 200 000 lives globally and brought the world economy to a grinding halt.
There have been mixed results for the intravenous antiviral in recent weeks. A summary of results posted on the website of the World Health Organization showed it failed in a smaller Chinese trial, but days before that, Stat reported it had shown significant efficacy at a Chicago hospital.
Trial
However, this trial, begun in late February and overseen by the US government, is the largest and technically most robust.
According to a data sheet, its estimated enrollment was 800 patients, a portion of whom received the drug while the rest received a placebo.
Neither the patients nor their physicians were aware of which group they belonged to, in order to eliminate unconscious bias.
Study
However, researchers found that remdesivir showed no “significant clinical benefits” in the first randomised trial of its kind, according to research released on Wednesday.
In a study among more than 200 Covid-19 patients in Wuhan, China, published in The Lancet, doctors found no positive effects of administering the drug compared with a control group of adults.
The findings were released after US pharmaceutical giant Gilead, which makes remdesivir, said a separate large-scale trial with the drug had showed positive results.
‘Not what we hoped for’
“Unfortunately, our trial found that while safe and adequately tolerated, remdesivir did not provide significant benefits over placebo,” said Bin Cao from China-Japan Friendship Hospital and Capital Medical University in China, who led the research.
“This is not the outcome we hoped for.”
The Wuhan study was conducted in 237 Covid-19 patients, half of whom were given remdesivir. The other half were treated as a control group and given standard antibiotics.
The mortality rate was the same in both groups, around 14 percent of each.
However those patients who required ventilators spend far less time on the devices than the control group — an average of seven days compared with an average of 15 days.
“No significant differences were noted between the groups in duration of oxygen support, length of hospital stay, or time to discharge or death,” the study said.
The authors said the trial has several limitations, including the fact that it was stopped prematurely when patient numbers dropped too low to continue as Wuhan got a grip on the outbreak.
But they called for further randomised trials of the drug.
