Monkeypox

World-leading research team to lead clinical trial on monkeypox

The National Institute for Health and Care Research are funding a new clinical trial investigating the effectiveness of tecovirimat against the monkeypox virus.

As part of the PLATINUM trial, participants will be randomly allocated either a two-week course of 600mg of tecovirimat to be taken twice a day or a comparable placebo treatment. Unlike many other studies, the PLATINUM trial will take place in the community with patients taking the treatment in their own home rather than in a hospital setting.

Tecovirimat works by preventing the virus from leaving infected cells thus limiting its spread – the medicine was licensed for monkeypox by the Medicines and Health products Regulatory Agency earlier this year after promising results in initial human and animal trials.

The trial is being led by the team behind the ground-breaking RECOVERY study – Professor of Emerging Infections and Global Health at the University of Oxford, Sir Peter Horby, and Professor of Medicine and Epidemiology at Oxford Population Health, Sir Martin Landray.

The report will also include the insights from experts at the UK Health Security Agency, Chelsea and Westminster Hospital NHS Foundation Trust, and the University of Liverpool.

Professor Sir Peter 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.”

Even though the treatment is already being used against severe cases of monkeypox, there are currently no treatments that are clinically proven to help patients recover from the disease.

Therefore, the clinical trial will test if tecovirimat helps people recover faster by assessing the rate at which skin and mucosal lesions heal. It will also evaluate the time taken until throat and lesion swabs test negative for monkeypox, as well as the proportion of patients who end up in hospital as result of complications from the disease.

Professor Lucy Chappell, Chief Executive 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.”

Participants for the study will be identified after clinical assessments with at least 500 patients expected to be recruited.

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NHE May/June 2024

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