The full results of a randomized low-dose dexamethasone clinical trial confirmed previous preliminary findings that it could save the lives of up to a third of hospitalized patients with severe respiratory complications from COVID-19.
The RECOVERY (Randomized Evaluation of COVid-19 thERapY) trial led by the University of Oxford found that the use of dexamethasone resulted in a lower mortality of 28 days among those who received invasive mechanical ventilation or oxygen alone.
However, “there was no clear effect” of dexamethasone in patients who were not receiving respiratory support.
In the open-label controlled trial, 2104 patients were randomized to receive oral or intravenous dexamethasone 6 mg once daily for up to 10 days, while 4321 patients were assigned to receive usual care.
At randomization, 16% received invasive mechanical ventilation or extracorporeal membrane oxygenation, 60% received oxygen alone, and 24% received none.
Test results
Overall, 482 patients (22.9%) in the dexamethasone group and 1,110 patients (25.7%) in the usual care group died within 28 days.
The incidence of death among patients who received invasive mechanical ventilation was 29.3% for those who received dexamethasone, compared to 41.4% for those who received usual care.
In those who received oxygen without invasive mechanical ventilation, the incidence of death was 23.3%, compared to 26.2% for those who received usual care.
When the preliminary results were presented in June, the researchers said, based on the findings, one death would be avoided by using dexamethasone for about eight ventilated patients, or for about 25 patients requiring oxygen alone.
The authors did not comment further on the trial after its publication in the New England Journal of Medicine (NEJM)
Last month, Peter Horby, professor of emerging infectious diseases at the Nuffield Department of Medicine at Oxford University, and one of the trial’s leading researchers, said: “The survival benefit is clear and great in those patients who they are ill enough to require oxygen treatment, so dexamethasone should now become a standard of care in these patients.
“Dexamethasone is inexpensive, available on the shelf, and can be used immediately to save lives around the world.”
In an editorial at NEJM, Dr. H. Clifford Lane and Dr. Anthony Fauci of the US National Institute of Allergy and Infectious Diseases said the results provided “clarity to an area of therapeutic controversy and will likely result in many lives saved. “
They said that while during an outbreak, when people died, there was a temptation that all therapies should “have a chance,” “there will have to be fewer small or inconclusive studies and more studies like the dexamethasone trial,” for “the field to advance and to improve patient outcomes. “
Dexamethasone in hospitalized patients with Covid-19 – Preliminary report. The Collaborative RECOVERY Group. DOI: 10.1056 / NEJMoa2021436. Published online July 17, 2020.
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