COVID-19: Full Results of Dexamethasone Trial Confirm Benefits

Peter Russell

July 20, 2020

Full results of a randomised clinical trial into low-dose dexamethasone confirmed earlier preliminary findings that it could save the lives of up to a third of hospitalised patients with severe respiratory complications from COVID-19.

The RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial led by the University of Oxford found that the use of dexamethasone resulted in lower 28-day mortality among those receiving either invasive mechanical ventilation or oxygen alone.

However, there was "no clear effect" of dexamethasone for patients who were not receiving respiratory support.

In the controlled, open-label trial, 2104 patients were randomly assigned to receive 6 mg of oral or intravenous dexamethasone once daily for up to 10 days, while 4321 patients were assigned to receive usual care.

At randomisation, 16% were receiving invasive mechanical ventilation or extracorporeal membrane oxygenation, 60% were receiving oxygen only, and 24% were receiving neither.

Trial Results

Overall, 482 patients (22.9%) in the dexamethasone group, and 1110 patients (25.7%) in the usual care group died within 28 days.

Incidence of death among patients receiving invasive mechanical ventilation was 29.3% for those given dexamethasone, compared with 41.4% of those receiving usual care.

In those who received oxygen without invasive mechanical ventilation, incidence of death was 23.3%, compared with 26.2% for those who received usual care.

When the preliminary results were presented in June, the researchers said that based on the findings, one death would be prevented by the use of dexamethasone for around eight ventilated patients, or for around 25 patients requiring oxygen alone.

The authors did not comment further on the trial following its publication in The New England Journal of Medicine (NEJM).

Last month, Peter Horby, professor of emerging infectious diseases in the Nuffield Department of Medicine, at the University of Oxford, and one of the chief investigators for the trial, said: "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."

In an editorial in the NEJM, Dr H. Clifford Lane and Dr Anthony Fauci from the US National Institute of Allergy and Infectious Diseases said the results provided "clarity to an area of therapeutic controversy and probably will result in many lives saved".

They said that while during an outbreak, when people were dying, there was a temptation that all therapies should be 'given a chance', "there will need to be fewer small or inconclusive studies and more studies such as the dexamethasone trial", for "the field to move forward and for patients' outcomes to improve".

Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report. The RECOVERY Collaborative Group. DOI: 10.1056/NEJMoa2021436. Published online July 17 2020.

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