RECOVERY STEROID DISCOVERY!

RECOVERY STEROID DISCOVERY

Dexamethasone reduces mortality in hospitalised patients with respiratory complications of COVID-19

In March this year, RECOVERY was established as a randomised clinical trial to test a range of potential treatments for COVID-19, including low-dose dexamethasone (a steroid treatment). Over 11,500 patients have been enrolled from over 175 NHS hospitals in the UK. (including over 150 patients from Buckinghamshire Healthcare NHS Trust)

8th June

Recruitment to the dexamethasone arm was halted since, in the view of the trial Steering Committee, sufficient patients had been enrolled to establish whether or not the drug had a meaningful benefit.

Recruitment

A total of 2104 patients were randomised to dexamethasone 6 mg once per day for ten days & were compared with 4321 patients randomised to usual care alone. Among the usual care control group, 28-day mortality was highest in those on ventilators (41%), intermediate in those on oxygen only (25%), & lowest among those who were not receiving any respiratory intervention (13%).

Significance

Dexamethasone reduced the risk of dying by one-third in ventilated patients (risk ratio 0.65 [95% confidence interval 0.48 to 0.88]; p=0.0003) & by one fifth in other patients receiving oxygen only (0.80 [0.67 to 0.96]; p=0.0021). There was no benefit among those who did not need respiratory support (1.22 [0.86 to 1.75; p=0.14).

Based on these results, 1 death would be prevented by treatment of just 7 ventilated patients or 20 patients on oxygen.

(Statement from the Chief Investigators of the Randomised Evaluation of COVid-19 thERapY (RECOVERY) Trial on dexamethasone, 16 June 2020)

The RECOVERY Trial

The RECOVERY Trial is a large, randomised controlled trial of possible treatments for patients admitted to hospital with COVID-19. Over 11,500 patients have been randomised to one of the treatment arms, or no additional treatment. More information about the trial & the drugs being used, can be found here.

Findings

Overall dexamethasone reduced the risk of 28-day mortality by 17% with a highly significant trend showing greatest benefit among those on ventilators. But it is important to recognise that no evidence of benefit for patients who did not receive oxygen was found and the RECOVERY Trial did not study patients outside the hospital setting.

Follow-up is complete for over 90% of participants.

The RECOVERY trial involves many thousands of doctors, nurses, pharmacists, & research administrators at over 175 hospitals across the whole of the UK, supported by staff at the NIHR Clinical Research Network, NHS DigiTrials, Public Health England, Public Health Scotland, Department of Health & Social Care, and the NHS in England, Scotland, Wales and Northern Ireland.

Reaction

Peter Horby, Professor of Emerging Infectious Diseases in the Nuffield Department of Medicine, University of Oxford, & Chief Investigator for the trial, said:

‘This is the first drug to be shown to improve survival in COVID-19. This is an extremely welcome result. The survival benefit is clear & quite large in those patients who are sick enough to require oxygen treatment, so this treatment should become standard of care in these patients. Dexamethasone is cheap, on the shelf, & can be used immediately to save lives worldwide.’

Martin Landray, Professor of Medicine & Epidemiology at the Nuffield Department of Population Health, University of Oxford, & Deputy Chief Investigator, said:

‘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. These preliminary results from the RECOVERY trial are very clear – dexamethasone reduces the risk of death among patients with 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 & affordable worldwide.’

Dr Raha West, Anaesthetic Research Lead, Staff and Associate Specialist in Anaesthesia & Intensive Care & RECOVERY Trial principle investigator at Buckinghamshire NHS Trust said:

'A triumphant day with the life changing discovery of dexamethasone saving lives in the critically ill COVID-19 patients. I am glad as a Trust we made a significant contribution to these findings. This is why research matters.'