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From today, the RECOVERY Trial – the world’s largest study investigating potential COVID-19 treatments – will begin testing the antiviral treatment molnupiravir. The study is open to all patients hospitalised with severe COVID-19, and is taking place in 177 NHS hospital sites across the UK. Over 46,500 participants have taken part in the study so far.

The RECOVERY Trial was launched as an emergency response in March 2020 and has so far discovered three effective treatments for COVID-19 : the inexpensive steroid dexamethasone; the arthritis drug tocilizumab; and an artificial antibody treatment, now known as Ronapreve. These results have been adopted into clinical guidelines worldwide and likely saved many thousands of lives. However, as the emergence of the Omicron variant demonstrates, it remains important to investigate new potential treatments.

Molnupiravir, a tablet treatment originally developed for influenza, causes errors to accumulate in the genetic code of the coronavirus, preventing the virus from replicating. Whilst it has already been approved in the UK for treating people in the community with mild COVID-19 who are at high risk of developing severe disease (for instance, cancer patients), it is not known whether it can also benefit patients who have been hospitalised because of COVID-19.

RECOVERY will compare molnupiravir (800 mg twice daily for five days) with the usual standard of hospital care in adult patients who are hospitalised because of COVID-19. Molnupiravir is also being investigated as an at-home treatment by the PANORAMIC Trial, led by Oxford University's Nuffield Department of Primary Care Health Sciences.

Sir Martin Landray, Professor of Medicine and Epidemiology at Oxford Population Health, University of Oxford, and Joint Chief Investigator for RECOVERY, said ‘Throughout this pandemic we have seen the important role that clinical trials play in assessing possible treatments for patients admitted to hospital with COVID-19. Because RECOVERY is now an established part of the routine care of NHS patients, the trial is well placed to recruit participants whenever and wherever patients are hospitalised with this disease.’ 

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 I believe we need to tackle the cause as well as the consequences of infection, so I am very excited that we are adding another new antiviral drug to RECOVERY. Adding molnupiravir will allow us to study this drug on its own but also in combination with other COVID-19 treatments. Combination therapy may be more potent than monotherapy and may help avoid drug resistance’.

Participants recruited to the RECOVERY Trial will be randomly allocated to either receive one of the treatments plus usual standard-of-care, or usual standard-of-care on its own. The trial aims to recruit at least 4000 patients to each treatment arm, to be compared with at least 4000 patients who receive usual standard-of-care only. The main aim is to assess whether any of these treatments reduce 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.

Molnupiravir is being provided by the UK Department of Health and Social Care. The decision to add molnupiravir to the trial was made by Oxford University researchers and the Trial Steering Committee in conjunction with the Chief Medical Officer, following a recommendation by the UK COVID-19 Therapeutics Advisory Panel.

The RECOVERY Trial is continuing to investigate other treatments including empagliflozin, a routine treatment for diabetes, sotrovimab, an investigational monoclonal antibody that targets the coronavirus, and a higher dose of the corticosteroid dexamethasone.