Data from a large British clinical trial testing multiple treatments for Covid-19 have shown that a commonly used steroid drug was able to reduce deaths in patients hospitalized with severe disease compared with those who only received standard treatment.
The University of Oxford announced the data on Tuesday, from the 11,500-patient Phase II/III RECOVERY study, which was conducted at 175 National Health Service hospitals in the U.K. The study included 2,104 patients who were randomized to receive the oral or injected dexamethasone at 6mg per day and compared with 4,321 patients who received standard treatment.
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The study included patients who required ventilation, oxygen only or no respiratory intervention at all. Among those who received standard treatment, the respective rates of death at 28 days were 41%, 25% and 13%. Among those who received dexamethasone, deaths were reduced by one-third and one-fifth in patients who required ventilation or oxygen, respectively, while there was no benefit observed among patients not requiring respiratory support. The results have not been published, but the university said it was working to publish the full details as soon as possible.
One of the trial investigators, Dr. Peter Horby, a professor of emerging infectious diseases at Oxford’s medical school, said the benefit was “clear and large” and that dexamethasone should become a standard of care in patients sick enough to require oxygen, noting also that it is a cheap and off-the-shelf therapy.
“Dexamethasone is the first drug to be shown to improve survival in Covid-19,” Horby said in a statement. “This is an extremely welcome result.”
Dexamethasone, which dates back to the 1950s and is widely available in the U.S. as a generic, is commonly used as an anti-inflammatory and immunosuppressant drug, both for immune system-related diseases and to mitigate the side effects of some drugs. Indeed, several of the drugs in development for Covid-19 are designed not to target the virus itself, but the overreaction by the body’s immune system known as a cytokine storm. Several companies have announced efforts to repurpose existing anti-inflammatory drugs – ranging from small-molecule kinase inhibitors to monoclonal antibodies that target immune cytokines – for Covid-19. Antivirals that target the SARS-CoV-2 virus itself are also available or in development, such as Gilead Sciences’ remdesivir and drugs in development by companies like Regeneron Pharmaceuticals and Vir Biotechnology.
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The ClinicalTrials.gov database lists a dozen studies in which dexamethasone is being investigated as a treatment for Covid-19, mostly for severe acute respiratory distress syndrome, or ARDS. The RECOVERY study itself is testing the drug alongside several other potential therapies, such as Roche’s IL-6 inhibitor Actemra (tocilizumab), convalescent plasma, AbbVie’s HIV drug Kaletra (lopinavir, ritonavir), and the malaria drug hydroxychloroquine.
Photo: Arman Soldin, Getty Images
