The UK government on Wednesday authorized the state-funded National Health Service (NHS) to use steroid dexamethasone, the world’s first coronavirus treatment proven to reduce the risk of death among severely ill patients.
The Department of Health said the cheap and widely available anti-inflammatory steroid has been immediately approved to treat all hospitalised COVID-19 patients requiring oxygen, including those on ventilators, after an Oxford University trial confirmed positive results on Tuesday.
UK Prime Minister Boris Johnson hailed the government-funded trial as the biggest breakthrough, which has greatly reduced patients’ chances of dying from COVID-19.
I am proud of these British scientists, backed by UK government funding, who have led the first, robust clinical trial anywhere in the world to find a coronavirus treatment proven to reduce the risk of death, he said.
According to scientists, the drug has been proven to reduce the risk of death significantly in COVID-19 patients on ventilation by as much as 35 per cent and patients on oxygen by 20 per cent.
The standard treatment for COVID-19 will include dexamethasone, helping save thousands of lives while we deal with this terrible virus, said UK Health Secretary Matt Hancock.
This astounding breakthrough is testament to the incredible work being done by our scientists behind the scenes, he said.
The drug has also been added to the UK 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, the Department of Health said.
The trial formed part of the 2.1-million pounds Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial, backed by the UK government to explore innovative medicines in the fight against the novel coronavirus.
With over 177,000 patients enrolled, it is described as the largest randomised clinical trial anywhere in the world and will continue to trial other medicines, such as azithromycin and lopinavir-ritonavir.
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. Although these data have not yet been peer-reviewed, said UK Deputy Chief Medical Officer Professor Jonathan Van-Tam.
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, he said.
The medical expert said the dexamethasone findings are very encouraging because the signal on reduced mortality applies to many of the patients admitted to hospitals and the drug is comparatively low priced and available worldwide.
The UK government believes the trial will impact the global response to the coronavirus pandemic.
The vital information collected by UK researchers will also be used by other countries to reduce mortality rates worldwide, the Department of Health said.
The RECOVERY trial reported the findings of 2,104 patients randomised to dexamethasone in comparison with 4,321 patients randomised allocated to usual standard of care alone.
The trial has reported at a dose of 6mg dexamethasone once a day for up to 10 days or discharge if sooner. No benefit is seen for patients hospitalised and not on oxygen.
The drug, according to the scientists, is inexpensive, on the shelf, and can be used immediately to save lives worldwide.
However, the drug is banned in-competition by the World Anti-Doping Agency (WADA) but its usage is allowed out-of-competition if athletes have the requisite Therapeutic Usage Exemption (TUE).
Asian bronze-winning Indian javelin thrower Davinder Singh Kang is currently under provisional suspension after returning positive for the substance in an in-competition test conducted last year.
In 2017, Real Madrid star Sergio Ramos had tested positive for the drug during the Champions League but was let off after offering an apology for the team doctor’s failure to disclose the medication he had taken.