Quietly and without fanfare, the UK government has just launched the world’s most extensive randomised clinical trial of potential coronavirus treatments as part of the race to find a treatment.
Almost 1,000 patients from 132 different hospitals have joined what is being called the Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial, and thousands more are expected to take part in the following weeks. The government claims it is the biggest randomised controlled trial of potential COVID-19 treatments in the world, and the researchers will be looking at more than 30 different treatments.
The trial is testing a number of medicines recommended by an expert panel advising the Chief Medical Officer for England. These include:
Lopinavir-Ritonavir, commonly used to treat HIV
Dexamethasone, a type of steroid use in a range of conditions to reduce inflammation
Hydroxychloroquine, a treatment for malaria
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Some of these treatments, such as the administration of hydroxychloroquine, have been used in many other countries including the US, Spain and France as part of a cocktail of medicines.
Conducting the RECOVERY trial are researchers at the University of Oxford, led by Peter Horby, Professor of Emerging Infectious Diseases and Global Health in the Nuffield Department of Medicine, and Martin Landray, Professor of Medicine and Epidemiology at the Nuffield Department of Population Health.
Announcing the trial, Professor Horby said:
“The RECOVERY trial will provide much-needed evidence on the best care for patients with COVID-19. The more patients that are enrolled, the sooner we will know how best to treat this disease.”
Horby added: “We are very grateful to those patients who are participating and to the hospital and research staff who are helping us to find the best treatments.”
To ensure that the healthcare system research resource is directed to benefit the national effort, the National Institute for Health Research (NIHR) has put in place a national process to prioritise COVID-19 research. The RECOVERY trial is one of those prioritised.
In a statement on the government’s website, Chief Medical Officer Professor, Chris Whitty said:
“The UK has world-leading life sciences and research sectors and, because of our joined up healthcare and health research system, we have been able to get hundreds of patients involved in this clinical trial in just 2 weeks.”
“This marks a significant step in identifying treatments for coronavirus that could benefit patients and underpins our science-backed approach to fighting this virus.”
Working with the National Institute for Health Research (NIHR), all parts of the country’s health services and research bodies are working together to prioritise COVID-19 research with the RECOVERY trial being put top of the list…
So far the study has received £2.1 million from UK Research and Innovation (UKRI) and the Department of Health and Social Care, through the NIHR. It is part of a wider £20 million rapid research response investment by the government to support looking at ways to tackle the coronavirus outbreak.
It follows decisive action by the UK’s medicines regulator to fast-track clinical trials for potential coronavirus treatments, meaning NHS patients could have faster access if medicines are proven to be effective.
According to the government’s data, the trial began on 19 March, and has been progressing rapidly. It took 9 days for the first protocol to first patient and 13 days to reach 500 patients, Every COVID-19 patient in the UK over the age of 18 years may be invited to participate.
Those who have accepted are randomly allocated to standard of care alone, or standard of care plus one of the additional treatments. Specifically, randomisation will be to one of the following arms:
Usual care plus lopinavir-ritonavir (commonly used to treat HIV).
Usual care plus low-dose dexamethasone (a type of steroid use in a range of conditions to reduce inflammation).
Usual care plus hydroxychloroquine (a treatment for malaria).
The Recovery trial is the third major research project which is being backed by the government, alongside the Oxford University PRINCIPLE research and another REMAP-CAP.
In the statement, Matthew Hancock, the health secretary, says that the government is “doing everything we can to fight it on all fronts through our evidence-based action plan” by working closely with the UK’s world-class life sciences sector.
At the same time, the decision by the UK’s medicines regulator to fast-track clinical trials for potential coronavirus treatments means that NHS patients could have faster access if medicines are proven to be effective.
In a noticeable shift in speed, the Medicines and Healthcare products Regulatory Agency (MHRA) has been worked hard to support manufacturers and researchers developing these treatments and approve clinical trial applications in days, rather than weeks without compromising patient safety.