Oxford, UK—An inexpensive generic medication is showing promise for reducing mortality in patients hospitalized with severe cases of COVID-19.

The as-yet unpublished study, RECOVERY (Randomized Evaluation of COVid-19 thERapY), documented that dexamethasone reduced deaths by one-third in ventilated patients (rate ratio 0.65 [95% confidence interval 0.48 to 0.88]; P = .0003) and by one-fifth in other patients receiving oxygen only (0.80 [0.67 to 0.96]; P = .0021). Results of the trial were announced by researchers from the University of Oxford in the UK.

“Dexamethasone is the first drug to be shown to improve survival in COVID-19,” said cochief investigator Peter Horby, MD, PhD, professor of emerging infectious diseases in the Nuffield Department of Medicine at the University of Oxford. “This is an extremely welcome result. 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.”

The randomized clinical trial was designed to test a range of potential treatments for COVID-19, including low-dose dexamethasone, and enrolled more than 11,500 patients from more than 175 NHS hospitals in the UK.

Researchers note that recruitment to the dexamethasone arm of the trial was halted after the steering committee determined that sufficient patients had been enrolled to establish whether or not the drug had a meaningful benefit.

The study team randomized 2,104 patients to receive dexamethasone 6 mg once per day—either by mouth or by IV injection—for 10 days and were compared with 4,321 patients randomized to usual care alone. Results indicate that, 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%).

No benefit was determined, however, among patients who did not require respiratory support (1.22 [0.86 to 1.75]; P = 0.14).

Researchers calculated that, based on the results, one death would be prevented by treatment of around eight ventilated patients or about 25 patients requiring oxygen alone.

“Since the appearance of COVID-19 six months ago, the search has been on for treatments that can improve survival, particularly in the sickest patients,” recounted co-chief investigator Martin Landray, MB ChB, PhD, professor of medicine and epidemiology at the Nuffield Department of Population Health, University of Oxford. “These preliminary results from the RECOVERY trial are very clear—dexamethasone reduces the risk of death among patients with severe respiratory complications. COVID-19 is a global disease—it is fantastic that the first treatment demonstrated to reduce mortality is one that is instantly available and affordable worldwide.”

Corticosteroids have not been generally recommended as appropriate in COVID-19 treatment. In guidelines entitled, “Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected,” the World Health Organization recommended in March, “Given the lack of effectiveness and possible harm, routine corticosteroids should be avoided unless they are indicated for another reason. “
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