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A Major Drug Trial Reduced Deaths In People With Severe COVID-19

"It is highly affordable, easy to make, can be scaled up quickly and only needs a small dosage," said one expert.

Last updated on June 16, 2020, at 3:21 p.m. ET

Posted on June 16, 2020, at 10:37 a.m. ET

Coronavirus particles
NIAID / Via Flickr: niaid

Low doses of the drug dexamethasone reduced deaths in severely ill COVID-19 patients by about a third, according to preliminary results of a clinical trial underway in the United Kingdom.

The early results from the RECOVERY trial, which is testing five drugs and plasma from recovered coronavirus patients on 11,500 hospitalized COVID-19 patients, were released on Tuesday in a news release.

The arm of the trial testing dexamethasone — an anti-inflammatory drug used to treat arthritis, allergies, and other ailments — was halted early because of the positive results seen in severely ill patients on ventilators or requiring oxygen. No benefit from the drug was seen in patients less severely ill.

"This is an extremely welcome result. The survival benefit is clear and large," said trial investigator Peter Horby of the University of Oxford, in a statement. "Dexamethasone should now become standard of care in these patients."

Some medical observers urged caution about the results, since the underlying data has yet to be released, and in light of numerous too-good-to-be-true study results either retracted or repudiated during the pandemic.

It will be great news if dexamethasone, a cheap steroid, really does cut deaths by 1/3 in ventilated patients with COVID19, but after all the retractions and walk backs, it is unacceptable to tout study results by press release without releasing the paper. https://t.co/ZP5GVMUCW3

"We all saw the release with excitement, but I think we should take it with a pinch of salt," said clinical researcher Bruno Tomazini of Hospital Sírio-Libanês in São Paulo, Brazil, who is conducting a different clinical trial of dexamethasone in critically ill patients. His team will not know their study's results, he said, until an interim analysis is conducted later this week. At that point, data and safety boards will help decide if they need to stop randomly giving the drug to some study volunteers and not to others.

"In the final instance, we’ll do what is in the best interest of our patients," Tomazini told BuzzFeed News by email. "We do not change practice based on press releases."

However, Nick Cammack of Wellcome, a major medical foundation in the UK, called the results a major breakthrough. "Dexamethasone must now be rolled out and accessed by thousands of critically ill patients around the world," he said in a statement. "It is highly affordable, easy to make, can be scaled up quickly and only needs a small dosage."

In the study, outcomes for 2,104 hospitalized patients randomly receiving dexamethasone were compared against 4,321 patients who received standard care for COVID-19. Among the patients who received standard care, the death rate was 41% among those on ventilators — the most severely ill — and was 25% among those on oxygen. Dexamethasone cut that death rate by around one-third in ventilated patients, according to the clinical trial results, and by about a fifth in those receiving only oxygen.

"Based on these results, 1 death would be prevented by treatment of around 8 ventilated patients or around 25 patients requiring oxygen alone," the study team concluded.

"Given the public health importance of these results, we are now working to publish the full details as soon as possible."

UPDATE

This post has been updated with comment from Bruno Tomazini of Hospital Sírio-Libanês.


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