The UK Department of Health and Social Care has approved the low-dose steroid treatment dexamethasone for use by the NHS ‘with immediate effect’ to treat patients who are seriously ill with coronavirus. The cheap and widely available drug is the world’s first coronavirus treatment proven to reduce the risk of death, and has been hailed as a major breakthrough in the fight against COVID-19.
Dexamethasone was part of a UK government-funded £2.1 million clinical trial at Oxford, RECOVERY, whose mission was to test known drugs for existing health conditions to see if they also worked against COVID-19. The life-saving drug was shown to significantly improve treatment outcomes for hospitalised patients, cutting the risk of death by 35% for patients on ventilators and 20% for those on oxygen. The total mortality rate over a 28-day period was shown to drop by 17% with the drug.
This is the most important trial result for COVID-19 so far. Significiant reduction in mortality in those requiring oxygen or ventilation from a widely available, safe and well known drug. Many thanks to those who took part and made it happen. It will save lives around the world. https://t.co/zRIaHulHOe
— Professor Chris Whitty (@CMO_England) June 16, 2020
Researchers estimate that 5,000 lives in the UK could have been saved had dexamethasone been used from the start of the pandemic; now, this ground-breaking discovery could save thousands of lives across the world. Prime Minister Boris Johnson celebrated the ‘remarkable British scientific achievement‘, and noted the UK government took early action to secure supplies of dexamethasone, buying additional stocks ahead of time in anticipation of a positive outcome by RECOVERY trials; this means there is already enough treatment for over 200,000 people from stockpiles alone. The drug has also been added to the government’s parallel export list, which bans companies from buying medicines meant for UK patients and selling them on for a higher price in another country. This will protect supply for UK patients by enforcing regulatory action on those who flout the restrictions.
Health Secretary Matt Hancock said:
I’m absolutely delighted that today we can announce the world’s first successful clinical trial for a treatment for COVID-19. This astounding breakthrough is testament to the incredible work being done by our scientists behind the scenes. From today the standard treatment for COVID-19 will include dexamethasone, helping save thousands of lives while we deal with this terrible virus.
Guided by the science, the UK is leading the way in the global fight against coronavirus – with the best clinical trials, the best vaccine development and the best immunology research in the world. I want to thank the brilliant scientists at Oxford University, the thousands of patients who took part in the study, and my own team, led by Professor Jonathan Van-Tam, who has done such a brilliant job driving this work.
Deputy Chief Medical Officer, Professor Jonathan Van-Tam, added:
The RECOVERY trial is an outstanding example of the UK leading the world with an impressive study capable of delivering robust answers to critical questions […] The positive findings on dexamethasone follow the disappointing findings on hydroxychloroquine. Together these two results illustrate the power of properly conducted clinical trials and the inherent danger of assuming things work without robust data.
Dexamethasone could be of huge benefit to poorer countries with a high COVID-19 infection rate, as Professor Martin Landray of Oxford University explains:
The treatment is up to 10 days of dexamethasone and it costs about £5 per patient. So essentially it costs £35 to save a life. This is a drug that is globally available and, when appropriate, hospital patients should now be given it without delay.
The RECOVERY trials also identified several other potential COVID-19 treatments; the malaria drug hydroxychloroquine was dropped due to negative publicity over the potential for increased fatalities and heart problems when used. The antiviral agent remdesivir was shown to shorten recovery time for COVID-19 patients, but has limited availability compared to dexamethasone due to it being a more recent innovation, and does not have a fixed price.
Dexamethasone is a corticosteroid drug that has been used for decades for a wide variety of health conditions, since glucocorticoid receptors are found in most organ tissues and thus give this class of drug a range of actions in the body. Dexamethasone is primarily used as an anti-inflammatory agent, as it inhibits physiological signalling pathways that normally promote immune responses such as inflammation. This allows it to treat conditions like asthma, eczema and arthritis. Dexamethasone’s mode of action is therefore uniquely suited to work against COVID-19, as it can alleviate some of the major bodily damage caused by the ‘Cytokine storm’ when the immune system goes into overdrive while trying to fight off coronavirus. While this is welcome news for high-risk patients admitted to hospital who need help with their breathing, Dexamethasone does not appear to help people with milder symptoms of coronavirus and so is not recommended for the 19 out of 20 coronavirus patients who will recover naturally in their homes.
A GOV.UK press release has hailed the ‘rigour of world-class and world-leading British life-sciences‘ research that made this breakthrough possible. It went on to add that ‘the government backed British science from the very beginning of this pandemic and today has proven that this was the right call.’