RECOVERY trial update: Dexamethasone shows promise for treating COVID-19

By Dorothy L. Tengler, via Multibriefs
June 22,2020

Several potential treatments have been suggested for COVID-19, but no one is sure if any of them will turn out to be more effective in helping people recover from the virus than the usual standard of hospital care that all patients will receive, if necessary.

The Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial, with an estimated enrollment of 12,000 patients, is currently testing some of these suggested treatments:

• Lopinavir-Ritonavir (commonly used to treat HIV)
• Low-dose Dexamethasone (now only recruiting children)
• Azithromycin (a commonly used antibiotic)
• Tocilizumab (an anti-inflammatory treatment given by injection)
• Convalescent plasma (collected from donors who have recovered from COVID-19 and contains antibodies against the SARS-CoV-2 virus)

Although the results of this trial are not available until July 2020, it is already quite clear that hydroxychloroquine does not reduce the risk of death among hospitalized patients with COVID-19. A total of 1,542 patients were randomized to hydroxychloroquine and compared with 3,132 patients randomized to usual care alone.

There was no significant difference in the primary endpoint of 28-day mortality (25.7% hydroxychloroquine vs. 23.5% usual care). The Centers for Disease Control and Prevention (CDC) have removed that specific hydroxychloroquine information from its website.

However, interim trial results indicate that dexamethasone, which is used to reduce inflammation in other diseases, reduced death rates by about a third among the most severely ill COVID-19 patients admitted to the hospitals.The Oxford team recruited 2,104 patients who received 6 mg of dexamethasone once a day either orally or by intravenous injection for 10 days.

Their outcomes were compared with a control group of 4,321 patients. The mortality rate of those with COVID-19 who end up on a ventilator is above 40%, but this figure was reduced by a third among those prescribed dexamethasone. Based on results so far, one death would be prevented by treatment of around eight patients on ventilators or about 1 in every 25 patients requiring oxygen alone.

According to the trial’s lead investigator, Peter Horby, Professor of Emerging Infectious Diseases and Global Health at the University of Oxford and Chair of the UK government's New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG), dexamethasone is the only drug that’s so far shown to significantly reduce mortality and could be a major breakthrough.

Dexamethasone, a steroid, is widely prescribed to reduce inflammation and has been used to treat a number of different conditions, including rheumatoid arthritis and asthma, brain tumors to reduce swelling, and can work to prevent the immune system from destroying blood platelets in people with blood disorders.

It should be noted, however, that the trial found dexamethasone had no benefit in those patients who were in hospitals with COVID-19 but who did not need oxygen or a ventilator. Investigators warn that dexamethasone has not been studied in patients in the community, and people should not be taking dexamethasone for COVID-19, stressing that dexamethasone does not stop people from catching the coronavirus.

The first results of the RECOVERY trial should be available in early July 2020. The trial has so far enrolled 11,000 patients ranging from ages 1 to 109 years of ages at 175 hospitals in the United Kingdom since it was set up in March 2020.

Dorothy L. Tengler, MA, is a freelance medical writer/communication specialist with nearly 20 years of experience in the pharmaceutical and medical communication industries. She has developed educational and medical marketing materials, including monographs, slide kits, health articles, primary and review manuscripts, and pharmaceutical sales training materials.