Steroid drug hailed as 'breakthrough' for seriously ill COVID-19 patients

By Kate Kelland and Alistair Smout
LONDON (Reuters) - A cheap and widely used steroid called dexamethasone is the first drug that has been shown to save the lives of COVID-19 patients, which is a "major breakthrough" in the coronavirus pandemic, according to scientists.
The study results announced on Tuesday showed that dexamethasone, used to reduce inflammation in other diseases such as arthritis, reduced the mortality rate among the most seriously ill COVID-19 patients admitted to hospital by around a third.
Preliminary results, which have not been reviewed by experts, suggest that the drug should immediately become standard care in patients with severe pandemic cases, the researchers who led the studies said.
They said they would work to publish the full details of the study as soon as possible, and many scientists hoped to be able to review the evidence themselves soon, especially given the recent withdrawal of an influential COVID-19 study.
The UK Department of Health wasted no time, saying the drug was approved for use in government healthcare, export restrictions were imposed, and 200,000 cycles of treatment had been stored.
"This is a (study) result that shows that COVID-19 patients who receive ventilators or oxygen receive dexamethasone, save lives, and do so at remarkably low cost," said Martin Landray, a professor at Oxford University, who said co-leads the study, known as the RECOVERY study.
"You can treat eight patients and save a life for less than $ 63," he said in an online briefing. A death would be prevented in 25 COVID-19 patients with oxygen who received the drug, he calculated.
His co-lead investigator Peter Horby described dexamethasone as a "big breakthrough".
Treatment of COVID-19, the disease caused by the new coronavirus that has killed more than 431,000 people worldwide, has been shown to reduce the mortality of the disease, although Gilead Sciences Inc's Remdesivir <GILD.O> reduces recovery time for shortened hospital patients.
"This blows Remdesivir out of the water in terms of effect size and type of effect," said Dr. Mark Wurfel, professor of medicine at the University of Washington.
Wurfel warned that it is important that the data be published and verified, "but this level of mortality improvement for a critically ill population is about the largest effect size we've ever seen," he said.

AVAILABILITY OF MEDICINAL PRODUCTS
In the RECOVERY study, the results of around 2,100 patients who were randomly assigned to the steroid were compared with those of around 4,300 patients who did not receive it.
"We hope that the data on which these results are based will be published as soon as possible so that physicians can safely put the treatment into practice," said Robin Ferner, honorary professor of clinical pharmacology at the University of Birmingham.
Dr. Thomas McGinn, deputy chief medical officer at Northwell Health, New York's largest healthcare system, told Reuters that Northwell hospital doctors use steroids on a case-by-case basis because they can suppress patients' immune systems and potentially make them susceptible to other infections.
He said that if the data were peer reviewed and legitimized, it could spread steroids to the sickest COVID-19 patients.
"Across the country, ICUs have now used it because of their demands for judgment. If this is legitimate, you may find ... instead of saying that 5 out of 10 COVID ICU patients get it, everyone might get it," said McGinn said.
Dexamethasone is currently on the list of the United States Food and Drug Administration. Several suppliers, including one of the largest - the German Fresenius SE <FREG.DE> - still say that they have the medicine on hand.
"We will try to increase delivery volume or even production to maintain sufficient deliveries," a Fresenius spokesman told Reuters.
Treatment with dexamethasone was not beneficial in patients with COVID-19 who did not require airway support.

(Additional reporting by Ludwig Berger and Mike Erman; editing by Timothy Heritage, Edmund Blair, Peter Henderson, Paul Simao and Jonathan Oatis)

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