* Drug is first so far shown to reduce COVID-19 death rates
* Steroid dexamethasone already widely available and cheap
* It will “save lives worldwide,” scientists in trial say (Adds New York hospital system comment, U.S. availability)
By Kate Kelland and Alistair Smout
Trial results announced on Tuesday showed dexamethasone, which is used to reduce inflammation in other diseases such as arthritis, reduced death rates by around a third among the most severely ill COVID-19 patients admitted to hospital.
The preliminary results, which have not been peer-reviewed, suggest the drug should immediately become standard care in patients with severe cases of the pandemic disease, said the researchers who led the trials.
They said they would work to publish the full details of the trial as soon as possible, with some scientists saying they wished to review the evidence for themselves.
Britain’s health ministry wasted no time, saying the drug had been approved for use in the state-run health service, export restrictions had been introduced and 200,000 courses of the treatment had been stockpiled.
“This is a (trial) result that shows that if patients who have COVID-19 and are on ventilators or are on oxygen are given dexamethasone, it will save lives, and it will do so at a remarkably low cost,” said Martin Landray, an Oxford University professor co-leading the trial, known as the RECOVERY trial. “It’s going to be very hard for any drug really to replace this, given that for less than 50 pounds ($63), you can treat eight patients and save a life,” he said in an online briefing.
His co-lead investigator, Peter Horby, called dexamethasone “a major breakthrough.”
There are currently no approved treatments or vaccines for COVID-19, the disease caused by the new coronavirus, which has killed more than 431,000 people globally.
England’s chief medical officer, Chris Whitty, said Tuesday’s announcement was “the most important trial result for COVID-19 so far.”
His deputy, Jonathan Van-Tam, said the results highlighted the importance of properly conducted clinical trials and robust data.
The RECOVERY trial compared outcomes of around 2,100 patients who were randomly assigned to get the steroid, with those of around 4,300 patients who did not get it.
“We hope the data on which these results are based will be published as soon as possible so that doctors can confidently put the treatment into practice,” said Robin Ferner, honorary professor of clinical pharmacology at University of Birmingham.
The results suggest one death would be prevented by treatment with dexamethasone in every eight ventilated COVID-19 patients, Landray said, and one death would be prevented in every 25 COVID-19 patients that received the drug and were on oxygen.
Dr. Thomas McGinn, deputy physician-in-chief at Northwell Health, New York’s largest healthcare system, told Reuters that physicians at Northwell hospitals have been using steroids on a case-by-case basis because they can suppress patients’ immune systems and possibly make them susceptible to other infections.
He said that if the data is peer-reviewed and legitimized, it could spread the use of steroids in the sickest COVID-19 patients.
“Across the country now intensivists have been using it based on their judgment calls. If this is legitimate, you may find … instead of say five out of 10 intensive-care COVID patients getting it, maybe everybody would get it,” McGinn said.
Dexamethasone is on the U.S. Food and Drug Administration’s list of drugs in shortage, but several manufacturers, including the largest supplier to the United States, say it is available.
Among patients with COVID-19 who did not require respiratory support, there was no benefit from treatment with dexamethasone. (Additional reporting by Mike Erman in New York; Editing by Timothy Heritage, Edmund Blair, Peter Henderson and Paul Simao)