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The Randomised Evaluation of COVID-19 Therapy (RECOVERY) Trial – the world’s largest study investigating potential COVID-19 treatments – will begin testing sotrovimab, a monoclonal antibody that targets the virus. The treatment will be evaluated in the UK initially.

The RECOVERY Trial was launched as an emergency response in March 2020 and has since identified several effective treatments for patients hospitalised with COVID-19. These include the inexpensive steroid dexamethasone and the arthritis drug tocilizumab. It also showed that an antibody treatment, now known as Ronapreve, which binds to the virus can save the lives of patients who have not mounted their own immune response. These results have been adopted into clinical guidelines worldwide and together have saved hundreds of thousands of lives.

However, the emergence of the Omicron variant poses new challenges. In particular, Omicron’s multiple mutations render some monoclonal antibody drugs ineffective, including Ronapreve, which has been in use across the NHS for the past few months. Consequently, there is an urgent need to evaluate alternative therapies for hospitalised patients.

Sotrovimab is an investigational monoclonal antibody that targets a highly conserved region of the coronavirus spike protein. Pre-clinical data show that sotrovimab retains activity against the Omicron variant, as well as other variants of concern, and can therefore prevent the virus from entering human cells and replicating. Sotrovimab is already approved in the UK for patients with mild COVID-19 who are at high risk of developing severe disease, but there is very limited information about its effectiveness in hospitalised patients with more severe disease.

Sir Martin Landray, Professor of Medicine and Epidemiology in the Nuffield Department of Population Health, University of Oxford, and Joint Chief Investigator for RECOVERY, said ‘Given how quickly Omicron is spreading, it is imperative that we investigate treatments for patients admitted to hospital suffering from this and other variants. RECOVERY is now established as part of routine care in NHS hospitals. As in previous waves, it can rapidly assess the true benefits of potential treatments and reduce the burden of this pandemic on patients and the NHS.’

Sir Peter Horby, Professor of Emerging Infectious Diseases in the Nuffield Department of Medicine, University of Oxford, and Joint Chief Investigator of RECOVERY said ‘In the sickest COVID patients, we need to tackle the cause as well as the consequences of infection, so I am very excited that we are adding this drug to RECOVERY. We hope to begin testing sotrovimab next week. I hope that we will be able to add other potential treatments to the trial so that we can study each drug on its own as well as together, in combination.’

Participants recruited to the RECOVERY Trial will be randomly allocated to either receive one of the trial treatments plus usual standard of care, or usual standard of care on its own. The trial aims to recruit at least 4000 patients to the sotrovimab treatment arm, to be compared with at least 4000 patients who receive usual standard of care only. The main aim is to assess whether the treatment reduces the risk of death among patients admitted to hospital with COVID-19. The trial will also investigate whether the treatment shortens the length of hospital stay or reduces the need for a mechanical ventilator. It is likely to be several months before the first results are available.

The decision to add sotrovimab to the trial was made by the University of Oxford researchers and the Trial Steering Committee in conjunction with the Chief Medical Officer, following a recommendation by the UK COVID-19 Therapeutics Advisory Panel.

Sotrovimab is being provided by GlaxoSmithKline (GSK) and Vir Biotechnology Inc., who developed the treatment. GSK and Vir have no involvement in the study design, conduct, or analysis of the results.

The RECOVERY Trial is continuing to investigate other treatments including empagliflozin, a routine treatment for diabetes that may help reduce the symptoms of severe COVID-19, and a higher dose of dexamethasone than the one previously demonstrated to improve survival for patients on oxygen or a mechanical ventilator.