AUGUST 13, 2020
Originally published by our sister publication, Pharmacy Practice News
The dexamethasone arm of the RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial was halted early because the anti-inflammatory drug improved survival in patients with severe respiratory complications of COVID-19.
{RELATED-HORIZONTAL}Dexamethasone, an inexpensive and widely available steroid medication, is the first drug proven to reduce deaths from COVID-19, said the U.K. government’s chief scientific adviser,
Originally published by our sister publication, Pharmacy Practice News
The dexamethasone arm of the RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial was halted early because the anti-inflammatory drug improved survival in patients with severe respiratory complications of COVID-19.
Dexamethasone, an inexpensive and widely available steroid medication, is the first drug proven to reduce deaths from COVID-19, said the U.K. government’s chief scientific adviser, Sir Patrick Vallance, FRS, FMedSci, FRCP.
“Dexamethasone is the first drug to be shown to improve survival in COVID-19. This is an extremely welcome result,” added Peter Horby, MD, PhD, a professor of emerging infectious diseases in the Nuffield Department of Medicine, University of Oxford, in England, and one of the chief investigators for the trial.
“The survival benefit is clear and large in those patients who are sick enough to require oxygen treatment, so dexamethasone should now become standard of care in these patients. Dexamethasone is inexpensive, on the shelf, and can be used immediately to save lives worldwide.”
A total of 2,104 patients were randomized to receive dexamethasone 6 mg once per day (by mouth or IV injection) for 10 days, and were compared with 4,321 patients randomized to usual care alone. Among the patients who received usual care alone, 28-day mortality was highest in those who required ventilation (41%), intermediate in those patients who required oxygen only (25%), and lowest among those who did not require any respiratory intervention (13%).
Dexamethasone reduced deaths by one-third in ventilated patients (rate ratio [RR], 0.65; 95% CI, 0.48-0.88; P=0.0003) and by one-fifth in other patients receiving oxygen only (RR, 0.80; 95% CI, 0.67-0.96; P=0.0021). There was no benefit among patients who did not require respiratory support (RR, 1.22; 95% CI, 0.86-1.75; P=0.14).
Based on these results, one death would be prevented by treatment of around eight ventilated patients or around 25 patients requiring oxygen alone, according to the researchers. The review committee closed this arm of the study because it said the arm was large enough to demonstrate benefit.In March, the RECOVERY trial was established as a randomized clinical trial to test a variety of potential treatments for COVID-19, including low-dose dexamethasone.
"The results are a huge step forward in being able to make a large difference to survival rates for the sickest patients with COVID-19," Mark Wilcox, MD, FRCPath, a consultant and the head of microbiology research and development at Leeds Teaching Hospitals NHS Trust; a professor of medical microbiology and the Sir Edward Brotherton Chair of Bacteriology at the University of Leeds, in England.
"Dexamethasone will likely now be part of the standard of care for COVID-19 patients requiring oxygen support and/or ventilation. We hope that the other arms in the RECOVERY trial will provide additional evidence of benefit for the other therapeutics under study," Dr. Wilcox said in an interview.
More than 11,500 patients have been enrolled from more than 175 National Health Service hospitals in the United Kingdom.The dexamethasone result “shows the importance of doing high-quality clinical trials and basing decisions on the results of those trials,” Dr. Vallance said.
Results from another arm of this trial helped to inform the FDA's decision to revoke the emergency use authorization from hydroxychloroquine and chloroquine.
—Marie Rosenthal
