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Video courtesy of NIHR

On International Clinical Trials Day, the RECOVERY Trial team are reflecting on an unprecedented collaboration that has seen over 10,000 patients enrolled in the world’s largest trial of potential COVID-19 treatments.

20 May is the anniversary of recruitment into what is thought to be the first clinical trial in 1747. At a time when scurvy was rife among seamen, James Lind, then a surgeon’s mate on the HMS Salisbury, followed a hunch that it was caused by putrefaction of the body. Lind noted that ‘No physician conversant with this disease at sea had undertaken to throw light upon the subject’. He recruited 12 sailors and allocated two men to each of six different treatments (vinegar, nutmeg, oranges and lemons, sea water, cider, and elixir of vitriol) and found that those given oranges and lemons experienced ‘the most sudden and good visible effects.’

273 years later, clinical research at Oxford University is at the forefront of global efforts to tackle the coronavirus pandemic. The RECOVERY Trial is the world’s biggest trial of potential COVID-19 treatments and the fastest ever recruiting individually randomised controlled trial. It was set up in record time, taking just nine days from conception to launch, and has recruited over 10,000 patients in 176 UK hospitals in just two months.

Deputy Chief Investigator, Professor Martin Landray said ‘International Clinical Trials Day recognises the contribution of all those involved in conducting clinical trials to improving public health. What we have achieved with RECOVERY is unprecedented, but it couldn’t have been done without the support and commitment of everyone involved – the participants, the staff at hospital sites and our coordinating centre, and the regulators and funders who have helped to make this possible.’

The RECOVERY Trial is testing existing drugs on hospital in-patients with suspected or confirmed COVID-19. Each participant is randomised to receive either standard hospital care, or one of four active treatments. Very soon, convalescent plasma will be offered on top of the main first line randomisation options.

In a second randomisation, patients with progressive COVID-19 receive the usual standard care or the immunosuppressive drug, tocilizumab. The researchers will compare each active treatment with standard care and work out which, if any, makes a difference on important outcomes.

Data on patient outcomes are being provided through NHS DigiTrials, a new service that is being developed by a consortium of partners to enable more efficient clinical trials. Recognising the urgent need for rapid access to outcomes data by COVID-19 researchers, the NHS DigiTrials team have made it possible for researchers to link trial data with NHS data sources.

Associate Professor Ed Juszczak said the astonishing speed of the trial set up is down to the global importance of the research question, and the single-mindedness and professionalism of the trial team: ‘For this trial, the timeline has been re-written. All of the UK Chief Medical Officers and the NHS England Medical Director have broadcast that this trial is a national priority, and that it has to happen, so everything has been sped up remarkably. That’s been fundamental to its success. The timescales have gone from months and years to hours and days, which is just phenomenal, and shows what’s possible.’

‘It’s been a magnificent collaboration, and it will change the way we work together going forwards. I think we will work differently, closer together, and we will share even more of what we do and how we do it. This has been an exemplar of what is possible. Together, through the RECOVERY Trial, we can hopefully change clinical practice and make history.’

Read more about how the RECOVERY Trial was set up