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The Randomised Evaluation of COVID-19 Therapy (RECOVERY) Trial – the world’s largest investigation of potential COVID-19 treatments – has today launched a new comparison study in the UK to compare high doses of dexamethasone (a corticosteroid drug) against standard low doses given to most COVID-19 hospital patients.

The RECOVERY Trial was set up as an emergency response in March 2020 and has since identified several effective treatments for patients hospitalised with COVID-19. In June 2020, RECOVERY showed that a low dose (6 mg daily) of dexamethasone significantly reduced deaths from COVID-19 by up to one third in the sickest patients. Low dose dexamethasone immediately became part of standard of care for patients admitted to hospital with COVID-19 in the UK, a move that was replicated all around the world, saving hundreds of thousands of lives.

However, using a higher dose of dexamethasone might be even better. Other clinical trials of corticosteroids, some of which used higher doses, have since confirmed the benefit of suppressing the immune response to COVID-19 for patients with inadequate levels of oxygen (hypoxia). Meanwhile, the RECOVERY trial has shown that the addition of other anti-inflammatory treatments, such as the arthritis drug tocilizumab, to low dose dexamethasone further reduces the risk of death for these patients. It is therefore possible that higher doses of dexamethasone might provide an additional benefit over the low dose now used as standard practice. 

Higher doses of corticosteroids are used to control inflammatory processes in other illnesses, including bacterial meningitis, tuberculous meningitis, and community acquired pneumonia; they may be also beneficial for COVID-19 patients and could offer a better treatment option for clinicians. Through this new study, the RECOVERY trial aims to generate robust evidence to answer this question.

Sir Martin Landray, Professor of Medicine and Epidemiology at Oxford Population Health, University of Oxford, and Joint Chief Investigator for RECOVERY, said ‘Although the RECOVERY Trial showed clearly that low dose dexamethasone can greatly benefit critically ill COVID-19 patients, it is possible that using a higher dose could deliver an even greater benefit for these people, shortening hospital stays and saving more lives from COVID-19. The RECOVERY trial will now answer that question.’

Sir Peter Horby, Professor of Emerging Infectious Diseases in the Nuffield Department of Medicine, University of Oxford, and Joint Chief Investigator of RECOVERY said ‘Given how quickly the Omicron variant is spreading, we can expect to see patients admitted to hospital with severe COVID-19 for a while to come. This makes it very important that we continue to explore ways to further improve the care of patients with severe COVID-19.’

The high dose dexamethasone study is taking place across the 177 UK-wide NHS hospital sites involved in RECOVERY. This comparison is already open in hospitals in Vietnam, Nepal, Indonesia and South Africa through RECOVERY International. All patients admitted to hospital with confirmed COVID-19 are eligible to take part in the RECOVERY Trial. Patients with low oxygen levels will be eligible to take part in the higher dose dexamethasone comparison. The trial aims to recruit at least 4000 patients to the high dose dexamethasone treatment arm, to be compared with at least 4000 patients who receive usual standard of care only.

RECOVERY will compare high dose dexamethasone (20 mg once daily for five days followed by 10mg once daily for a further five days) with the usual treatment of low dose dexamethasone (6 mg once daily), given for up to ten days. The main aim is to assess whether the treatment reduces the risk of death among patients admitted to hospital with COVID-19. The trial will also investigate whether the treatment shortens the length of hospital stay or reduces the need for a mechanical ventilator. It is likely to be several months before the first results are available.

The decision to add high dose dexamethasone to the trial was made by the University of Oxford researchers and the Trial Steering Committee in conjunction with the Chief Medical Officer, following a recommendation by the UK COVID-19 Therapeutics Advisory Panel.

The RECOVERY Trial is continuing to investigate other treatments including empagliflozin, a routine treatment for diabetes that may help reduce the symptoms of severe COVID-19, and sotrovimab, an investigational monoclonal antibody that targets the coronavirus spike protein.