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Data from NHS Digital has helped researchers discover that an anti-inflammatory drug reduces the risk of death in patients with severe coronavirus (COVID-19).
The Randomised Evaluation of COVid-19 Therapy (RECOVERY) trial, run by scientists at the University of Oxford, is using data from NHS Digital’s Secondary Uses Service (SUS+) and other datasets to help assess the effectiveness of a range of potential treatments for coronavirus.
Tocilizumab, an intravenous drug used to treat rheumatoid arthritis, was added to the RECOVERY trial in April 2020 and new results show it reduces the risk of death when given to hospitalised patients with severe coronavirus.
In the trial of 2,022 patients, 596 (29%) of the patients in the tocilizumab group died within 28 days compared with 694 (33%) patients in the usual care group. This means that for every 25 patients treated with tocilizumab, one additional life would be saved.
The study also showed that tocilizumab shortens the time until patients are discharged from hospital and reduces the need for a mechanical ventilator.
Data used to identify patients for the RECOVERY trial came from datasets held by NHS Digital and was provided through the NHS DigiTrials Health Data Research hub, which links experts with relevant data to help support clinical trials.
Jem Rashbass, Executive Director for Data and Analytical Services at NHS Digital, said: “This is a fantastic development and a great example of the lifesaving impact that research, using the data that we securely curate at NHS Digital and provide through the NHS DigiTrials service, can have.
“In supporting this trial, we are helping the Oxford-led team find new ways the NHS and health systems globally can make data-driven decisions on how best to care for COVID-19 patients.”
In June 2020, the RECOVERY trial found that the inexpensive and widely available steroid dexamethasone reduces death for patients with severe coronavirus and this is now widely used. The benefits of tocilizumab were clearly seen to be in addition to the benefits from steroids.
Martin Landray, Professor of Medicine and Epidemiology at the Nuffield Department of Population Health, University of Oxford, and Joint Chief Investigator, said: “The results from the RECOVERY trial clearly show the benefits of tocilizumab and dexamethasone in tackling the worst consequences of COVID-19 – improving survival, shortening hospital stay, and reducing the need for mechanical ventilators. “Used in combination, the impact is substantial. This is good news for patients and good news for the health services that care for them in the UK and around the world. We simply would not know this if it wasn’t for the incredible support of NHS patients and staff in the most challenging of circumstances.”
Wendy Coleman, 62, received tocilizumab through the RECOVERY trial last year when she was admitted to Chesterfield Royal Hospital with severe COVID-19.
She said: “I was struggling to breathe quite badly and on the verge of being placed in an intensive care unit when I was asked if I wanted to take part in the RECOVERY trial. After I was given tocilizumab, my condition stabilised and I didn’t get any worse. Up until then, it was quite scary as I didn’t know if I was going to make it or not.’
‘I’d like to thank those who run the RECOVERY trial, besides all the staff at the Royal Hospital at Chesterfield. You never think about clinical trials, until you are in need of these treatments and then you realise what happens behind the scenes to find out if they work.”
The support of the RECOVERY trial is part of a wider set of services being developed by the NHS DigiTrials Health Data Research hub to support researchers undertaking clinical trials through the NHS.
The hub, which is run through a consortium involving NHS Digital, the University of Oxford’s Big Data Institute, IBM and Microsoft, and supported by Health Data Research UK. NHS DigiTrials aims to provide data services to support clinical trials in order to reduce the time, effort and cost of developing new drugs, treatments and services, bringing benefits to patients, the public and the NHS.
The results of these trials will influence the day-to-day care of millions of future NHS patients with a wide range of conditions including heart disease, diabetes, asthma, and arthritis.
Notes for editors
About the RECOVERY trial
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 tocilizumab (an anti-inflammatory used to treat rheumatoid arthritis). Over 35,000 patients have been enrolled so far from 177 NHS hospitals in the UK.
Patients eligible for the tocilizumab comparison in RECOVERY were required to have an oxygen saturation less than 92% on room air or requiring oxygen (with or without other forms of respiratory support), and a C-reactive protein (a marker of inflammation) level of at least 75mg/L.
In June 2020, the RECOVERY trial demonstrated that the inexpensive and widely available steroid, dexamethasone, reduced the risk of death by one-third for patients on an invasive mechanical ventilator and by one-fifth for those requiring oxygen. This was the first treatment for COVID-19 shown to save lives and was rapidly adopted as part of standard hospital treatment around the world.
The trial has previously announced results showing that hydroxychloroquine, lopinavir-ritonavir, azithromycin, and convalescent plasma have no benefits for patients hospitalised with COVID-19.
The RECOVERY trial is continuing to investigate the following treatments:
- aspirin (commonly used to thin the blood)
- baricitinib (an anti-inflammatory used to treat rheumatoid arthritis)
- colchicine (a commonly used anti-inflammatory drug)
- Regeneron’s antibody cocktail (a combination of monoclonal antibodies directed against coronavirus)
The RECOVERY trial involves many thousands of doctors, nurses, pharmacists, and research administrators at 177 hospitals across the whole of the UK, supported by staff at the NIHR Clinical Research Network, NHS DigiTrials, Public Health England, Public Health Scotland, Department of Health & Social Care, and the NHS in England, Scotland, Wales and Northern Ireland.
The RECOVERY Trial is conducted by the registered clinical trials units with the Nuffield Department of Population Health in partnership with the Nuffield Department of Medicine. The trial is supported by a grant to the University of Oxford from UK Research and Innovation/National Institute for Health Research (NIHR) and by core funding provided by NIHR Oxford Biomedical Research Centre, Wellcome, the Bill and Melinda Gates Foundation, the Foreign, Commonwealth & Development Office, Health Data Research UK, the Medical Research Council Population Health Research Unit, and NIHR Clinical Trials Unit Support Funding. Roche Products Ltd supported the RECOVERY trial through the provision of tocilizumab.
- Tocilizumab is an anti-intereukin (IL)-6 receptor therapy.
- IL-6 is a cellular messenger in the body, known as a cytokine, involved in the regulation of the immune system, inflammation, bone formation and blood cell development (among other functions).
- IL-6 is believed to play a key role in activating the inflammatory pathway that contributes to the signs and symptoms of rheumatoid arthritis. Tocilizumab binds to IL-6 receptors, blocking the pro-inflammatory effect of IL-6.
- In the UK, tocilizumab is approved for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, giant cell arteritis, and chimeric antigen receptor T cell-induced cytokine release syndrome.
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