Based on these results, 1 death would be prevented by treatment of around 8 ventilated patients or around 25 patients requiring oxygen alone.
South Africa (17 June 2020) – As the number of COVID-19 cases increases to 76 334 in South Africa, the Health Department says it is pleased about the results of the affordable Coronavirus breakthrough drug used to treat critically ill COVID-19 patients in the UK.
In March 2020, the RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial was established as a randomised clinical trial to test a range of potential treatments for COVID-19, including low-dose dexamethasone (a steroid treatment). Over 11,500 patients have been enrolled from over 175 NHS hospitals in the UK.
On 8 June, recruitment to the dexamethasone arm was halted since, in the view of the trial Steering Committee, sufficient patients had been enrolled to establish whether or not the drug had a meaningful benefit.
A total of 2104 patients were randomised to receive dexamethasone 6 mg 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, 28-day mortality was highest in those who required ventilation (41%), intermediate in those patients who required oxygen only (25%), and lowest among those who did not require any respiratory intervention (13%).
Dexamethasone reduced deaths by one-third in ventilated patients (rate ratio 0.65 [95% confidence interval 0.48 to 0.88]; p=0.0003) and by one fifth in other patients receiving oxygen only (0.80 [0.67 to 0.96]; p=0.0021). There was no benefit among those patients who did not require respiratory support (1.22 [0.86 to 1.75; p=0.14).
Based on these results, 1 death would be prevented by treatment of around 8 ventilated patients or around 25 patients requiring oxygen alone.
Given the public health importance of these results, they are now working on publishing the full details as soon as possible.
Peter Horby, Professor of Emerging Infectious Diseases in the Nuffield Department of Medicine, University of Oxford, and one of the Chief Investigators for the trial, 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.’
Martin Landray, Professor of Medicine and Epidemiology at the Nuffield Department of Population Health, University of Oxford, one of the Chief Investigators, said: ‘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.’
According to South Africa’s Health Minister, Dr Zweli Mkhize, the drugs are also “easily implementable” in South Africa.
“Dexamethasone is a well-known and widely used steroid, which has potent anti-inflammatory properties. It is used in allergic reactions, asthma and other conditions where the inflammatory component of the disease needs to be controlled for better outcomes,” said Mkhize.
The World Health Organisation (WHO) has welcomed the initial clinical trial and said they are looking forward to the full data analysis in the coming days.
“For patients on ventilators, the treatment was shown to reduce mortality by about one third, and for patients requiring only oxygen, mortality was cut by about one fifth,” according to preliminary findings shared with WHO.
The agency said the benefit is only visible in seriously ill COVID-19 patients and not those with milder disease.
“This is the first treatment to be shown to reduce mortality in patients with COVID-19 requiring oxygen or ventilator support. 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,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.
Meanwhile, SA recorded 57 more COVID-19 related deaths, of which 44 are from the Western Cape, nine from the Eastern Cape and four from KwaZulu-Natal, bringing the total death toll to 1 625. The Western Cape, with the highest infection rate, has 45 357 cases, followed by Gauteng with 13 032, the Eastern Cape with 11 039 and KwaZulu-Natal with 4 048. The North West has 1 281, Free State 578, Limpopo 391, Mpumalanga 343, Northern Cape 211 and 63 are still unallocated.
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