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The RECOVERY Trial, from the University of Oxford, have announced results for the drug dexamethasone, which reportedly reduces death by up to one third in hospitalised COVID-19 patients with severe respiratory complications.
This Roundup accompanied an SMC Briefing.
Prof Duncan Young, Professor of Intensive Care Medicine, University of Oxford, said:
“The results of the RECOVERY trial dexamethasone arm show an improved 28 day survival after randomisation in the sub-groups of patients with COVID-19 disease severe enough to require artificial ventilation or supplemental oxygen. The results are very robust due to the large number of patients recruited to the trial. The drug prevented one death in 8 in ventilated patients, and one death in 25 in patients on oxygen. Although this appears a relatively modest effect on outcome, for ventilated patients the NNT (number needed to treat) of 8 is better than almost any other intervention studied in patients on ventilators for any disease.
“It will be interesting to see if the improvement in survival with dexamethasone persists unchanged beyond 28 days, and whether the drug attenuates the severity of the disease or reduces longer-term complications in the survivors.
“The patients not receiving oxygen and yet dying likely had other life-limiting disease in addition to COVID-19, which is why they were not started on oxygen. It is therefore not surprising the drug had no effect in this group.”
Dr Penny Ward, Visiting Professor in Pharmaceutical Medicine at King’s College London and Chair of the Education and Standards Committee of the Faculty of Pharmaceutical Medicine, said:
“At last some good news for COVID-19 patients with respiratory failure requiring ventilatory support in ICU, the group in whom antiviral therapy with remdesivir was less successful and in whom fatality rate is highest. Clinicians will need to see the detailed results of the trial, particularly those in patients not requiring oxygen therapy/ventilator support, as the breakdown of outcomes by disease stage suggests that the timing for start of steroid use may be relevant to use the treatment most efficiently. That said, for patients going onto a ventilator, good news today. Congratulations to the RECOVERY team, great news for patients most severely affected, looking forward to seeing the publication.”
Dr Ayfer Ali, Assistant Professor in the Strategy and International Group specialising in drug repurposing, Warwick Business School, said:
“The results seem to be extremely encouraging and this will be now one of the most important tools against COVID-19 in seriously ill patients. Dexamethasone is cheap and easily available in tablet form.
“As such it can be much more easily deployed than the antiviral drug remdesivir, which needs to be administered in hospital as an infusion.
”This would also be the first drug that actually shows reduction in death rates, rather than just lowering duration of disease.
“Now we have to wait for the full results to be peer-reviewed and remember that it is not a cure for all, just one more tool. But this shows the potential of drug repurposing.
“The important thing is to determine which patients should get this drug, as presumably not all would need it, and what would be the most appropriate time to start treatment in COVID-19 positive patients as clearly this drug should not be taken as a preventative measure.”
Prof Simon Maxwell, Professor of Clinical Pharmacology and Prescribing, University of Edinburgh, said:
“This is the first major breakthrough in the therapeutics of COVID-19 infection. It demonstrates the efficacy of a simple, cheap, familiar and widely successful treatment in those who are most severely affected. Although many units have already been using corticosteroid therapy, these results provide confidence that this treatment delivers a better outcome for many patients. Today’s results also emphasise the importance of conducting carefully controlled randomised clinical trials as the only means of providing reliable information to guide healthcare providers and patients facing this unprecedented challenge.”
Prof Robin Ferner, Honorary Professor of Clinical Pharmacology, University of Birmingham and Honorary Consultant Physician, City Hospital Birmingham, said:
“The Oxford group’s important results, based on a scientific trial in over 6000 NHS patients, show that dexamethasone – a common, widely used, inexpensive medicine – can save lives in seriously ill patients with COVID-19. It is not a treatment for mild disease. We hope the data on which these results are based will be published as soon as possible so that doctors can confidently put the treatment into practice.”
Dr Stephen Griffin, Associate Professor in the School of Medicine, University of Leeds, said:
“This outcome for patients suffering from severe COVID-19 in need of respiratory assistance is of tremendous importance. It highlights the enormous power of the RECOVERY trial to confidently assign benefit, or lack thereof, to the numerous therapies postulated to help treat SARS-CoV2 infected patients. Profs Horby, Landray and the clinical team involved all deserve immense credit.
“The fact that dexamethasone helps patients in severe respiratory distress highlights the probable contribution of immune-mediated pathology in COVID-19. It will be of great interest to determine the precise mechanisms by which lung tissue damage has presumably been reduced. The low cost and broad availability of this drug means that there is potential for considerable clinical impact by including it as part of standard treatment. Nevertheless, it will be important to assess how this important success might be further-improved in order to increase patient survival, perhaps through the combination of low dose dexamethasone with other inflammatory mediators, or with virus-targeted therapies, such as Remdesivir.
“Now that effective treatments for COVID-19 are being confidently discovered through trials on the scale of RECOVERY, there is realistic scope for further improving the clinical management of this devastating disease.”
Dr Nick Cammack, COVID-19 Therapeutics Accelerator Lead, Wellcome Trust, said:
“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.
“Large-scale randomised controlled studies like the RECOVERY Trial give us the best possible understanding of whether drugs like dexamethasone are safe and effective against COVID-19. To see these results in such a short period of time is an incredible scientific achievement. The data will give researchers around the world a better understanding of why the drug is effective in these patients.
“This is extremely promising news and a significant step forward, but we still have a long way to go. To end this pandemic, we still need better diagnostics to detect, medicines to treat and vaccines to prevent COVID-19.”
Dr Siu Ping Lam, Director of Licensing, Medicines and Healthcare products Regulatory Agency, said:
“The RECOVERY trial has shown very encouraging preliminary results with the use of dexamethasone in hospitalised COVID-19 patients that required oxygen supplements or were on a ventilator.
“In our commitment to rapidly supporting the work on potential treatments for COVID-19 infection we will continue to closely monitor all emerging data on safety and efficacy. By working together with the key health organisations, we can ensure faster timelines for access to medicines useful in treating patients with COVID-19.”
Background
Dexamethasone is a licensed corticosteroid medication that is used for a number of allergic or inflammatory and rheumatic diseases. It is also used for allergic skin diseases.
The Recovery trial showed no benefit of Dexamethasone to hospitalised patients who were not on Oxygen supplements. Additionally there is no evidence to suggest that patients with COVID-19 who are not in hospital benefit from taking dexamethasone.
https://www.recoverytrial.net/files/recovery_dexamethasone_statement_160620_final.pdf
All our previous output on this subject can be seen at this weblink:
www.sciencemediacentre.org/tag/covid-19
Declared interests
Dr Penny Ward: “No COIs. I am semi-retired, but I am owner/Director of PWG Consulting (Biopharma) Ltd a consulting firm advising companies on drug and device development. Between December 2016 and July 2019 I served as Chief Medical Officer of Virion Biotherapeutics Ltd, a company developing antiviral treatments for respiratory viral diseases. Previous employee of Roche, makers of tocilizumab (anti IL6 antibody) and CMO of Novimmune, makers of empalumab (anti IFN gamma antibody).”
Dr Stephen Griffin: “The team I work with are just about to start a project screening for SARS-CoV-2 antivirals, funded by the MRC Confidence in Concept scheme.”
Dr Nick Cammack: “The RECOVERY trial receives core funding from Wellcome.”
None others received.