The world’s largest randomised clinical trial of potential coronavirus treatments is well underway in the UK as part of the race to find a treatment.
The trial is being coordinated by 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.
A number of promising treatments are being tested and, if the science supports it, will be given to NHS patients as quickly as possible.
Definitive results on whether the treatments are safe and effective are expected within months and, if positive, they could potentially benefit hundreds of thousands of people worldwide.
Almost 1,000 patients from 132 different hospitals have been already recruited in just 15 days and thousands more are expected to join the Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial in the coming weeks, making it the largest randomised controlled trial of potential COVID-19 treatments in the world.
Health and Social Care Secretary Matt Hancock said: “As one of three major trials funded by the government, this marks a major milestone in our battle against coronavirus and offers renewed hope that together we can beat this.
“The public still has a crucial role to play by staying at home so we can protect the NHS and save lives.”
The trial is testing a number of medicines recommended by an expert panel advising the Chief Medical Officer for England. They 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
The trial is being conducted in more than 130 NHS hospitals across the UK. Adult patients who have been admitted to hospital with COVID-19 are being invited to take part. The trial is specially designed so that as further medicines are identified, these can be added to the study within days.
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 two 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.”
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.
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.
Peter Horby, Professor of Emerging Infectious Diseases and Global Health in the Nuffield Department of Medicine, University of Oxford, 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.
“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.”
Patients with COVID-19 are being offered the opportunity to participate in this trial. If they agree, they will be randomly allocated to standard of care alone, or standard of care plus 1 of 3 additional treatments
The trial began on 19 March. It was set up in record time: first protocol to first patient in 9 days and 13 days to reach 500 patients. Within the first 2 weeks, nearly 1,000 patients have been enrolled
The data will be analysed on a rolling basis so that any beneficial treatments can be identified as soon as possible. The faster that patients are recruited, the sooner the reliable results
The other 2 key national trials are PRINCIPLE which is also being co-ordinated by the University of Oxford and REMAP-CAP, a global network of leading experts, institutions and research networks which has more than fifty sites participating world-wide.