The spread of COVID-19 earlier this year quickly saw the rise of trials towards potential vaccines and treatments.
One such trial, the RECOVERY (Randomised Evaluation of COVid-19 theERapY) in the UK, which was established to test a range of potential treatments for COVID-19, including low-dose dexamethasone (a steroid treatment), has revealed some promising results.
The trial, which began in March this year involved a total of 2104 COVID-19 patients who were randomised to receive dexamethasone 6mg oncer per day (orally or by intravenous injection) for 10 days. This group was then compared with a control group, which included 4321 COVID-19 patients randomised to usual care alone.
This was done to establish whether or not the drug had any meaningful benefit in the treatment of COVID-19.
While the full details of the study have not yet been published, reportedly, among the patients who received usual care alone, 28-day mortality was highest in those who required ventilation (41%), intermediated in those patients who required oxygen only (25%), and lowest among those who did not require any respiratory intervention (13%).
In patients who were randomised to receive dexamethasone it was found that the steroid reduced deaths by one-third in ventilated patients and by one fifth in other patients receiving oxygen. There was no benefit among those patients who did not require respiratory support.
Professor of Emerging Infectious Disease in the Nuffield Department of Medicine, University of Oxford and one of the Chief Investigators in the trial, Professor Peter Horby said: “Dexamethasone is the first drug to be shown to improve survival in COVID-19. 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 care in these patients,” he continued.
“Dexamethasone is inexpensive, on the shelf, and can be used immediately to save lives worldwide.”
According to Dr Roger Lord, Lecturer (Medical Sciences) with the Faculty of Health Sciences at the Australian Catholic University and Research Fellow with The Prince Charles Hospital (Brisbane), the results of this research trial are “significant” as they “demonstrates how this cost-effective intervention can potentially impact globally on the number of deaths caused by COVID-19”.
Professor Lord cautioned though that as the study showed that dexamethasone had no benefit among patients who did not require respiratory support, “dexamethasone does not represent a treatment to prevent or treat COVID-19”.
“Its value lies specifically as a rescue therapy for those who might otherwise not recover from more severe complications associated with the infection,” he said.
Dr Gaeton Burgio, Group Leader and Head of the Transgenesis Facility, John Curtin School of Medical Research at the Australian National University said: “While we are awaiting the full report, the preliminary results indicate a significant reduction in mortality for patients predominantly in ICU.
“This is the first report demonstrating that a drug can significantly increase survival for critically ill COVID-19 patients.
“Overall, this is an important and significant result that, in my view, is likely to save lives.”
Dr Ian Musgrave, Senior Lecturer in the Faculty of Medicine, School of Medicine Sciences within the Discipline of Pharmacology at the University of Adelaide cautioned that, while the results are promising, “so far we only have press releases to go on, the actual study data have not been released”.
Dr Musgrave says that because of this, the results “need to be examined carefully”.
“The retracted Lancet paper on hydroxychloroquine has taught us that lesson,” he added.
Professor Andrew McLachlan, Head of School and Dean of the Sydney Pharmacy School at the University of Sydney agrees, saying that, while this is a “high quality trial with a rigorous study design”, the results are “a preliminary summary of key findings”.
“… Researchers will be keen to review the peer reviewed publication to critically analyse the details, confirm the rigour of the study and also explore broader issues of potential harmful effects of dexamethasone to see how the results can be translated into critical care of critically unwell people with COVID-19,” said Dr McLachlan.
For more information on the RECOVERY trial, visit: recoverytrial.net/.