COVID vaccine pioneers to tackle Monkeypox threat

The team behind the world-leading RECOVERY trial of COVID-19 treatments has turned its attentions to the rise in the spread of monkeypox, in an effort to identify effective treatment.

With the US having already classified Monkeypox as a national health emergency the National Institute for Health and Care Research (NIHR) has commissioned and funded the study which will be led by Sir Peter Horby, Professor of Emerging Infections and Global Health at the University of Oxford and the Director of the new Pandemic Sciences Institute, and Sir Martin Landray, Professor of Medicine & Epidemiology at Oxford Population Health, the joint chief investigators of the Randomised Evaluation of COVID-19 (RECOVERY) trial.

It will investigate a potential treatment for people who have been diagnosed with monkeypox and hopes to repeat the success the team had with COVID-19.

Monkeypox, a member of the smallpox family of viruses, has historically been rare outside west and central Africa. However, in May this year, an outbreak was identified in the UK, followed by cases appearing in multiple other countries outside Africa. On 23 July the World Health Organization declared monkeypox to be a Public Health Emergency of International Concern. Typical symptoms of monkeypox include a rash with painful blisters, which may be widespread or affect just one part of the body. Other symptoms can include fever, muscle ache, and swelling of lymph glands. Monkeypox usually gets better without treatment but this can take several weeks and, rarely, there may be serious complications.

Although vaccines developed for smallpox may reduce the risk of catching monkeypox, there are currently no proven therapeutics to speed recovery in those who develop the disease. The Placebo-controlled randomised trial of tecovirimat in non-hospitalised monkeypox patients (PLATINUM) study will test the efficacy and safety of tecovirimat, an antiviral treatment originally developed for smallpox.

Tecovirimat (also known as TPOXX®) prevents the virus from leaving infected cells, stopping its spread within the body. It was licensed earlier this year by the Medicines and Health products Regulatory Agency (MHRA) for monkeypox based on promising results from initial studies in animals and evidence of safety in healthy human volunteers. It is currently in use for the treatment of patients with severe complications of monkeypox who are admitted to hospital. However, to date there have been no clinical trials to confirm whether the drug can help monkeypox patients recover from the disease.

Horby said: ‘Monkeypox is a distressing and sometimes dangerous infection. For the benefit of current and future patients worldwide who have been diagnosed with monkeypox, we need definitive evidence that tecovirimat is safe and effective. Although the early data on tecovirimat are promising, only a randomised clinical trial will provide the level of evidence we need to treat patients with confidence. PLATINUM will provide that evidence.’

Professor Lucy Chappell, CEO of the NIHR and chief scientific adviser at the Department of Health and Social Care said: “This study is a very important next step towards looking at treatments for monkeypox for those being outside of hospital. It’s crucial that we invest in developing, refining and evaluating treatments for this disease. We have commissioned this research to show the sense of and seriousness with which the health research community is collectively approaching this issue.

“The trial will be run by a team including Sir Peter Horby’s preeminent RECOVERY team, whose world-leading work was so impactful for improving patient outcomes during throughout the COVID-19 pandemic. The rigour and robustness of this study will ensure that the findings are widely recognised and help us to move forward in evaluating treatments for monkeypox.”

To find out whether tecovirimat helps patients to recover faster, the study will assess the rate at which skin and mucosal lesions heal. It will also assess the time taken until throat and lesion swabs test negative for monkeypox virus and the proportion of patients who require hospitalisation due to complications from the disease.

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