Biggest coronavirus breakthrough yet as £5 steroid dexamethasone 'reduces risk of death by third' - Daily Mail

Biggest coronavirus breakthrough yet as £5 steroid dexamethasone 'reduces risk of death by up to one third in ventilated patients' as scientists say 5,000 Brits could have been saved if they were given the drug

• The steroid is given either via an injection or as a tablet and costs £5 per patient
• Dexamethasone becomes the first drug proven to treat incurable coronavirus
• Scientists hailed finding as 'biggest breakthrough in search for Covid therapy' 
• Here’s how to help people impacted by Covid-19

By Connor Boyd Health Reporter For Mailonline

Published: 13:00 BST, 16 June 2020 | Updated: 13:33 BST, 16 June 2020

A £5 steroid reduces the risk of dying from coronavirus by a third in patients on ventilators, a major British trial has found.

In the biggest coronavirus breakthrough to date, dexamethasone was also shown to save the lives of a fifth of Covid-19 sufferers with moderate illness receiving oxygen.  

The results from the RECOVERY trial suggest the steroid can prevent death in one in eight ventilated coronavirus patients and one in 25 on breathing support. 

Dexamethasone, which is given either via an injection or as a once-a-day tablet, becomes the first drug proven to treat the incurable viral disease.

The steroid prevents the release of substances in the body that cause inflammation, a nasty side effect of coronavirus infection that makes breathing difficult. 

It is commonly prescribed to patients with allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus and psoriasis.   

In seriously unwell Covid-19 patients, the lungs become so inflamed they struggle to take in oxygen and keep vital organs functioning.  

Scientists behind RECOVERY, led by Oxford University, are recommending all 400 coronavirus patients currently intubated in NHS hospitals are prescribed the drug.   

Professor Martin Landray, lead author of the study, said dexamethasone could have saved around 5,000 lives if it was used throughout the UK's crisis.

He hailed today's finding as the biggest breakthrough so far in the search for a Covid-19 treatment, adding: 'If you were to design a drug that treats coronavirus, this would be exactly how you'd hope it works.' 

In the biggest coronavirus breakthrough to date, dexamethasone was found to reduce the risk of dying by coronavirus by up to a third

The RECOVERY trial has recruited more than 11,500 Covid-19 patients from 170 NHS hospitals across the country.

A total of 2,104 patients were randomised to receive 6mg of dexamethasone once per day, either by mouth or by intravenous injection for 10 days.

They were compared with 4,321 patients randomised to receive standard care alone, which involves painkillers and in some cases antibiotics.

Professor Martin Landray, deputy chief investigator of the Recovery trial, said dexamethasone could have saved around 5,000 lives if it was used throughout the UK's crisis

Among the patients who received usual care alone, 28-day mortality was highest in those who required ventilation (41 per cent).

In patients who required oxygen, a quarter passed away, while 13 per cent of sufferers who did not need any breathing assistance also died.  

Dexamethasone reduced deaths by one-third in ventilated patients  and by one fifth in other patients on breathing support. There was no benefit among patients who did not require oxygen. 

Co-lead study author Peter Horby, professor of emerging infectious diseases at Oxford, said: 'Dexamethasone is the first drug to be shown to improve survival in COVID-19. This is an extremely welcome result. 

'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.

'Dexamethasone is inexpensive, on the shelf, and can be used immediately to save lives worldwide.' 

Professor Landray, an epidemiologist at Oxford, added: '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 severe 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 and affordable worldwide.'  

Health bosses hailed the results as a 'huge breakthrough' which will 'dramatically improve Covid-19 survival' for patients in the UK.

NHS chief executive Simon Stevens said: 'NHS hospitals, researchers and clinicians have worked together at breakneck speed to test new treatments for covid-19, and it is amazing to see work that would normally take years bear fruit in just a matter of months. 

'This research agility is not only important for coronavirus patients, but augurs well for the streamlined innovation that the NHS and the UK life sciences now must pioneer.' 

Professor Stephen Powis, NHS medical director, added: 'This is a huge breakthrough in our search for new ways to successfully treat patients with Covid, both in the UK and across the world.

'It is thanks to NHS staff and patients who participated in the trial that from now, we are able to use this drug to dramatically improve Covid-19 survival for people in hospital who require oxygen or ventilation.'

The Government’s Chief Scientific Adviser, Sir Patrick Vallance, said the news was 'particularly exciting' because the drug was so widely available and cheap.

He added: 'This is a ground-breaking development in our fight against the disease, and the speed at which researchers have progressed finding an effective treatment is truly remarkable. 

'It shows the importance of doing high quality clinical trials and basing decisions on the results of those trials.'

Dr Nick Cammack, head of the research-charity Wellcome Trust, which is conducting its own studies into Covid-19 therapies, added: 'This is a major breakthrough: dexamethasone is the first and only drug that has made a significant difference to patient mortality for Covid-19. 

'Potentially preventing 1 death in every 8 ventilated patients would be remarkable. Finding effective treatments like this will transform the impact of the Covid-19 pandemic on lives and economies across the world. 

'While this study suggests dexamethasone only benefits severe cases, countless lives will be saved globally. 

'Dexamethasone must now be rolled out and accessed by thousands of critically ill patients around the world. It is highly affordable, easy to make, can be scaled up quickly and only needs a small dosage. 

Any and every successful treatment against Covid-19 must be made available to everyone who needs it globally, regardless of their ability to pay.' 

Earlier this month the RECOVERY trial found the promising anti-malaria drug hydroxychloroquine does not treat coronavirus.  

A total of 1,542 patients were randomly given hydroxychloroquine and compared with 3,132 patients randomised to receive standard care in the Oxford trial.

After 28 days, 25.7 per cent of patients taking the malaria tablets passed away from the virus compared to 23.5 per cent who were not given the medicine.  

Dexamethasone and hydroxychloroquine are just two of five promising therapies being trialled as part of the RECOVERY study.

Participants are also being given the HIV drug lopinavir/ritonavir, marketed as Kaletra and Aluvia; azithromycin, a commonly used antibiotic; and tocilizumab, an anti-inflammatory given by injection. 

Professor Landray had previously admitted he did not expect one single drug to treat coronavirus.

Just two months ago he said there was an 'extraordinarily' low chance of one of the five medicines being effective on its own and claimed it was more likely a combination of several drugs will have 'modest effect' on patients.

NOW RESEARCHERS TURN THEIR ATTENTION TO OTHER ANTI-INFLAMMATORY DRUGS 

Researchers are to begin clinical trials of a new anti-inflammatory drug it is hoped may cut severe lung damage and deaths among Covid-19 patients.

Scientists from the University of Dundee's School of Medicine will work with drug development company Evgen Pharma to test whether the drug, known as SFX-01, improves outcomes for patients.

Covid-19 causes the development of slowly worsening lung damage called acute respiratory distress syndrome (ARDS) in around 10 per cent of patients admitted to hospital.

When this occurs, no currently available drug can slow the progression of ARDS and patients ultimately require mechanical ventilation in intensive care until the inflammation resolves itself and the lungs begin to heal.

However, around 30 per cent of patients with ARDS may go on to die, while the number of patients requiring ventilation for the syndrome has been one of the major challenges for health services.

Evgen Pharma develops medicines for the treatment of multiple diseases based on sulforaphane, a naturally occurring compound known to have anti-inflammatory properties, and its lead product is SFX-01, which scientists hope could help Covid-19 patients.

James Chalmers, British Lung Foundation professor of respiratory research at the university, said: 'SFX-01 is an anti-inflammatory medication that we believe may have the potential to reduce some of the worst outcomes of Covid-19.

'The body defends itself against inflammatory and oxidative stress by increasing levels of a chemical called Nrf2.

'SFX-01 activates the Nrf2 system and puts it into overdrive to enhance defences against inflammatory damage.

'There is evidence that Nrf2 activation can reduce the severity of acute lung injury and ARDS.

'As such, we hypothesise that early treatment with an Nrf2 activator in patients hospitalised with Covid-19 may prevent deterioration and help to preserve precious intensive care unit (ICU) resources in the context of the pandemic.

'This is a completely new mechanism as there is currently no drug that targets Nrf2.'

The study will recruit up to 300 volunteers from hospitals across the UK, with patients offered the chance to participate immediately after their diagnosis.

Half the group will receive SFX-01 in addition to standard hospital care while the other half will receive a placebo.

The trial is due to start imminently with results expected by the end of the year.

Nrf2 is part of the human natural defence against inflammatory and oxidative stress such as the inflammation that occurs during a severe viral infection.

In animal tests, increasing the amount of available Nrf2 reduces the severity of ARDS, demonstrating its protective properties, however the university said there have so far been no human trials of SFX-01 in humans with ARDS.

SFX-01 has been shown to halt the growth of, or even shrink, tumours of breast cancer patients in clinical trials while causing very few side effects, researchers said.

Barry Clare, chairman of Evgen Pharma, said: 'We are excited at the opportunity to test whether an Nrf2 activator such as SFX-01 may have a role in helping the recovery of Covid-19 patients.'

The research is being supported by a grant from the medical research charity LifeArc, as part of its activities to address the need for new Covid-19 therapies.

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2020-06-16 12:35:54Z
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