The analysis is part of the RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial which was established to test a range of potential therapies for COVID-19, including low-dose dexamethasone -- a steroid treatment.
The RECOVERY trial included over 11,500 patients, enrolled from more than 175 hospitals in the UK, noted a statement by the University of Oxford.
In the trial, a total of 2,104 patients were randomised to receive dexamethasone 6 milligrammes once per day -- either by mouth or by intravenous injection -- for ten days and were compared with 4321 patients randomised to usual care alone.
Among the patients who received usual care alone, mortality was highest in those who required ventilation (41 per cent), intermediate in those patients who required oxygen only (25 per cent), and lowest among those who did not require any respiratory intervention (13%), the scientists said.
They found that dexamethasone reduced deaths by one-third in ventilated patients, and by one fifth in other patients receiving oxygen only.
However, the researchers said there was no benefit from dexamethasone among the patients who did not require respiratory support.
Based on these results, the scientists believe that the drug could prevent nearly one death in the treatment of around eight ventilated patients, or around 25 patients requiring oxygen alone.
"Dexamethasone is the first drug to be shown to improve survival in COVID-19. This is an extremely welcome result," said Peter Horby, one of the chief investigators of the trial from the University of Oxford in the UK.
"The survival benefit is clear and large in those patients who are sick enough to require oxygen treatment, so dexamethasone should now become standard of care in these patients," Horby said.
The drug, according to the scientists, is inexpensive, on the shelf, and can be used immediately to save lives worldwide.
"These preliminary results from the RECOVERY trial are very clear --dexamethasone reduces the risk of death among patients with severe respiratory complications," said Martin Landray, another chief investigator of the trial from the University of Oxford.
"COVID-19 is a global disease it is fantastic that the first treatment demonstrated to reduce mortality is one that is instantly available and affordable worldwide," Landray added.
(PTI)
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The benefit was only seen in patients seriously ill with COVID-19, and was not observed in patients with milder disease.
“This is the first treatment to be shown to reduce mortality in patients with COVID-19 requiring oxygen or ventilator support,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “This is great news and I congratulate the Government of the UK, the University of Oxford, and the many hospitals and patients in the UK who have contributed to this lifesaving scientific breakthrough.”
Dexamethasone is a steroid that has been used since the 1960s to reduce inflammation in a range of conditions, including inflammatory disorders and certain cancers. It has been listed on the WHO Model List of Essential Medicines since 1977 in multiple formulations, and is currently off-patent and affordably available in most countries.
The researchers shared initial insights about the results of the trial with WHO, and we are looking forward to the full data analysis in the coming days. WHO will coordinate a meta-analysis to increase our overall understanding of this intervention. WHO clinical guidance will be updated to reflect how and when the drug should be used in COVID-19.
Today’s news builds off the WHO Research & Development Blueprint meeting, which took place in Geneva in mid-February to accelerate health technologies for COVID-19, where further research into the use of steroids was highlighted as a priority. The findings reinforce the importance of large randomized control trials that produce actionable evidence. WHO will continue to work together with all partners to further develop lifesaving therapeutics and vaccines to tackle COVID-19 including under the umbrella of the Access to COVID-19 Tools Accelerator.
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The updated 'Clinical Management Protocols for COVID-19' advises the use of dexamethasone, which is already used in a wide range of conditions for its anti-inflammatory and immunosuppressant effects, as an alternative choice to methylprednisolone for managing moderate to severe cases of COVID-19.
Keeping pace with the evolving knowledge about COVID-19, especially in terms of effective drugs, the change has been made after considering the latest available evidence and expert consultation, the health ministry said.
Union Health Secretary Preeti Sudan has also forwarded the updated protocol to all states and Union Territories to make necessary arrangements for availability and use of the new protocols and the dexamethasone at the institutional level also, it said.
The health ministry had on June 13 also allowed the use of antiviral drug remdesivir for restricted emergency use and off-label application of tocilizumab, a drug that modifies the immune system or its functioning, and convalescent plasma for treating COVID-19 patients in the moderate stage of the illness as an 'investigational therapy'.
It also recommended hydroxychloroquine in patients during the early course of the disease and not on critically ill patients. The use of these drugs continues to be included in the 'Clinical Management Protocols for COVID-19' under 'investigational therapy'.
The updated treatment protocols for moderate cases advised considering methylprednisolone 0.5 to 1 mg/kg or dexamethasone 0.1 to 0.2 mg/kg for three days, preferably within 48 hours of admission or if oxygen requirement is increasing and if inflammatory markers are increased.
The duration of administration should be reviewed as per clinical response, it said.
For patients having respiratory distress requiring mechanical ventilation, both non-invasive and invasive, the ministry said methylprednisolone 1 2mg/kg/day or dexamethasone 0.2 to 0.4 mg/kg per day should be considered for five to seven days in two divided doses, if not given already.
"Note that a larger dose of glucocorticoid will delay the removal of coronavirus due to immunosuppressive effects," the treatment protocols stated.
The revised treatment protocols were issued as India's COVID-19 tally raced past the five-lakh mark on Saturday with the biggest single-day surge of 18,552 cases, while the death toll climbed to 15,685 with 384 fatalities.
Dexamethasone is a corticosteroid drug used in a wide range of conditions for its anti-inflammatory and immunosuppressant effects.
"The drug has been tested in hospitalised patients with COVID-19 in the recovery clinical trial and was found to have benefits for critically ill patients and has been shown to reduce mortality by about one third for patients on ventilators, and by about one fifth for patients being maintained on oxygen therapy," the ministry said.
The drug is also a part of the National List of Essential Medicines (NLEM) and is widely available, it said.
(PTI)
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